Терминологичен речник

Definitions in digital health

 

1000BASE-T A type of Ethernet interface distinguished by its IEEE 802.3 physical layer specification for operation over four pairs of unshielded twisted-pair (UTP) cabling at a media access control (MAC) data rate of 1000 Mb/s. ISO/IEEE 11073-30400:2012(E)
100BASE-TX A type of Ethernet interface distinguished by its IEEE 802.3 physical layer specification for operation over two pairs of unshielded twisted-pair (UTP) cabling at a media access control (MAC) data rate of 100 Mb/s. ISO/IEEE 11073-30400:2012(E)
10BASE-T IEEE Std 802.3, 1998 Edition, physical layer specification for Ethernet over two pairs of unshielded twisted-pair (UTP) media at 10 Mb/s. ISO/IEEE 11073-30200:2004(E)
10BASE-T ISO/IEC 8802-3 and IEEE Std 802.3 physical layer specification for Ethernet over two pairs of unshielded twisted pair (UTP) media at 10 Mbit/s. ISO/IEEE 11073-30300:2004(E)
10BASE-T A type of Ethernet interface distinguished by its IEEE 802.3 physical layer specification for operation over two pairs of unshielded twisted-pair (UTP) cabling at a media access control (MAC) data rate of 10 Mb/s. ISO/IEEE 11073-30400:2012(E)
10GBASE-X A type of Ethernet interface distinguished by its IEEE 802.3 physical layer specification for operation over four pairs of unshielded twisted-pair (UTP) cabling at a media access control (MAC) data rate of 10 Gb/s. ISO/IEEE 11073-30400:2012(E)
2D component two-dimensional portion of a GS1 Composite symbol, which encodes supplemental information about an item, such as its lot number or expiration date ISO/IEC 24724:2011(E)
abbreviation designation formed by omitting words or letters from a longer form and designating the same concept ISO/TS 17439:2014(E)
abstract class virtual common parent to two or more classes which cannot itself be instantiated ISO 13606 -1:2008(E)
abstract class in Unified Modelling Language a “virtual” common parent to two or more classes

NOTE The abstract class will never be instantiated. Its value in modelling terms is to provide a container for attributes and associations that might apply to several other classes (its subclasses).

ISO 13606-2:2008(E)
abstract syntax Specification of the structure of a data item without reference to or requirement for a specific implementation technology. ISO/IEEE 11073-20101:2004(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized entities in authorized ways ISO 10781:2015(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized entities in authorized ways ISO 13606 -1:2008(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized entities in authorized ways

[ISO/IEC 2382-8:1998, definition 08.04.01]

ISO 13606-5:2010(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized

entities in authorized ways

[ISO/IEC 2382‑8]

ISO 21091:2013(E)
access control means to ensure that access to assets is authorized and restricted based on business and security

requirements

ISO 27789:2013(E)
access control a means of ensuring that resources of data processing systems can only be accessed through authorized

channels by authorized entities

NOTE Adapted from ISO/IEC 2382-8:1998.

ISO/TS 13606-4:2009(E)
access control prevention of unauthorized use of a resource, including the prevention of use of a resource in an unauthorized manner

[ISO 7498-2:1989, definition 3.3.1]

ISO/TS 14265:2011(E)
access control a means of ensuring that the resources of a data processing system can be accessed only by authorized

entities in authorized ways

ISO/TS 14441:2013(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized entities in

authorized ways

[ISO/IEC 2382-8:1998]

ISO/TS 17090-1:2002(E)
access control a means of ensuring that the resources of a data processing system can be accessed only by authorized

entities in authorized ways

ISO/TS 18308:2004(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized

entities in authorized ways

ISO/IEC 2382-8:1998, definition 08.04.01.

ISO/TS 21547:2010(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized

entities in authorized ways

[ISO/IEC 2382-8, definition 08.04.01]

ISO/TS 22600-1:2006(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized

entities in authorized ways

[ISO/IEC 2382-8, definition 08.04.01]

ISO/TS 22600-2:2006(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized

entities in authorized ways

[ISO/IEC 2382-8:1998]

ISO/TS 22600-3:2009(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized

entities in authorized ways

[ISO/IEC 2382-8:1998, definition 08.04.01]

ISO/TS 25237:2008(E)
access control means of ensuring that the resources of a data processing system can be accessed only by authorized

entities in authorized ways

ISO/TS 27790:2009(E)
access control decision function

ADF

specialized function that makes access control decisions by applying access control policy rules to a

requested action

ISO/TS 22600-3:2009(E)
access control enforcement function

AEF

specialized function that is part of the access path between a requester and a protected resource that

enforces the decisions made by the ADF

ISO/TS 22600-3:2009(E)
access control information any information used for access control purposes, including contextual information ISO/TS 22600-3:2009(E)
access point (AP) A subsystem that consolidates data from one or more point-of-care (POC) devices

onto another communication link.

NOTE—Examples of APs include a multiport concentrator or a dedicated single-port AP, typically connected to a local area network (LAN), or an AP that is part of a multifunctional device such as a patient monitor or personal computer (PC).

ISO/IEEE 11073-30300:2004(E)
access point (AP) interface The interface (principally input) to an AP or concentrator.

NOTE—This term is used extensively in the National Committee for Clinical Laboratory Standards Point- of-Care

Connectivity; Approved Standard (NCCLS POCT1) and is equivalent to an ISO/IEEE 11073 bedside communications

controller (BCC).

ISO/IEEE 11073-30300:2004(E)
access policy definition of the obligations for authorizing access to a resource ISO 27789:2013(E)
access policy process that defines obligations for authorizing access control to a resource ISO/TS 13606-4:2009(E)
accountability property that ensures that the actions of an entity may be traced uniquely to that entity

[ISO/IEC 2382-8:1998, definition 08.01.10]

ISO 13606 -1:2008(E)
accountability property that ensures that the actions of an entity may be traced uniquely to that entity

[ISO/IEC 2382-8:1998, definition 08.01.10]

ISO 13606-5:2010(E)
Accountability principle that individuals, organizations and the community are responsible for their actions and may be required to explain them to others ISO 27789:2013(E)
accountability property that ensures that the actions of an entity may be traced uniquely to the entity

[ISO/IEC 13335-1:2004, definition 2.1]

ISO/TR 11633-1:2009(E)
accountability property that ensures that the actions of an entity may be traced uniquely to the entity

[ISO/IEC 13335-1:2004, definition 2.1]

ISO/TR 11633-2:2009(E)
accountability be required to explain them to others

[SOURCE: ISO 15489‑1:2001, definition 3.2]

Note 1 to entry: This requires that all users of PHI be traceable.

ISO/TS 14441:2013(E)
accountability property that ensures that the actions of an entity may be traced uniquely to the entity

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
Accountability the property that ensures that the actions of an entity may be traced uniquely to that entity ISO/TS 18308:2004(E)
accountability property that ensures that the actions of an entity may be traced uniquely to the entity

ISO 7498-2:1989, definition 3.3.3.

ISO/TS 21547:2010(E)
accountability property that ensures that the actions of an entity may be traced uniquely to the entity

[ISO 7498-2, definition 3.3.3]

ISO/TS 22600-1:2006(E)
accountability property that ensures that the actions of an entity may be traced uniquely to the entity

[ISO 7498-2, definition 3.3.3]

ISO/TS 22600-2:2006(E)
accountability property that ensures that the actions of an entity may be traced uniquely to the entity

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
accountability property that ensures that the actions of an entity may be traced uniquely to that entity ISO/TS 27790:2009(E)
accreditation third party attestation related to a conformity assessment body conveying formal demonstration of its competence

to carry out specific conformity assessment tasks

ISO TR 16056-1:2004(E)
accreditation third party attestation related to a conformity assessment body conveying formal demonstration of its competence

to carry out specific conformity assessment tasks

ISO TR 16056-2:2004(E)
accreditation body authoritative body that performs accreditation

Note 1 to entry: The authority of an accreditation body is generally derived from government.

[SOURCE: ISO/IEC 17000:2004, definition 2.6]

ISO/TS 14441:2013(E)
acquiring cardiograph cardiograph recording the original ECG signal ISO 11073-91064:2009(E)
acronym abbreviation made up of the initial letters of the components of the full form of the designation or from

syllables of the full form and pronounced syllabically

[SOURCE: ISO 1087‑1:2000]

EXAMPLE UNICEF – United Nations Children’s Fund

ISO/TS 17439:2014(E)
active ingredient ingredient that alone or in combination with one or more other ingredients is considered to fulfil the intended

activity of a medicinal product

[ENV 12610]

ISO/TR 22790:2007(E)
active marker constituent, or groups of constituents, of an herbal substance, herbal preparation or herbal medicinal product which are of interest for control purposes and are generally accepted to contribute to therapeutic activity ISO 11238:2012(E)
actor user of the system-of-interest interacting with the system in a particular usage context (role) ISO/TS 27790:2009(E)
actor (in the healthcare system) health professional, healthcare employee, patient/consumer, sponsored healthcare provider, healthcare organisation, device or application that acts in a health related communication or service ISO/TS 18308:2004(E)
administrable dose form pharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured dose form has been carried out ISO 11239:2012(E)
administrable dose form pharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured dose form has been carried out EXAMPLES Solution for injection, tablet for oral use, hard-capsule powder for inhalation. NOTE The administrable dose form is identical to the manufactured dose form in cases where no transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the pharmaceutical product). ISO 11615:2012(E)
administrable dose form pharmaceutical dose form as administered to the patient, after any necessary transformation of the packaged pharmaceutical dose form has been carried out EXAMPLES Solution for injection, tablet for oral use, hard-capsule powder for inhalation. ISO 11616:2012(E)
administration act of (self-)administering a (prescribed) medicinal product to the patient, using an administration method, and via a defined route, and recording that the act has actually happened at a particular date and time ISO/TS 19256:2016(E)
administration archival entity that contains the services and functions needed to control the operation of functional entities on

a day-to-day basis

ISO/TS 21547:2010(E)
administration device equipment intended for correct administration of the medicinal product ISO 11239:2012(E)
administration device equipment intended for correct administration of the Medicinal Product EXAMPLES Applicator, oral syringe. NOTE An administration device may be an integral part of an immediate container or a closure. [ENV 12610:1997] ISO 11615:2012(E)
administration device equipment intended for correct administration of the Medicinal Product

EXAMPLE Applicator, needle, oral syringe.

Note 1 to entry: An administration device can be an integral part of an immediate container or a closure.

[SOURCE: ISO 11239:2012, 3.1.2, modified]

ISO/TS 19256:2016(E)
administration method general method by which a pharmaceutical product is intended to be administered to the patient ISO 11239:2012(E)
administration method general method by which a pharmaceutical product is intended to be administered to the patient

EXAMPLE Application, inhalation, injection.

Note 1 to entry: The administration method is a general term that is used to group related pharmaceutical dose form concepts, and is not intended to describe a precise method or route of administration.

[SOURCE: ISO 11239:2012, 3.1.3]

ISO/TS 19256:2016(E)
adverse drug reaction noxious and unintended response associated with the use of a drug in humans NOTE 1 This can be post-approval (an adverse event that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function) or pre-approval (an adverse event that occurs at any dose and where a causal relationship is at least a reasonable possibility). NOTE 2 FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, “whether or not considered to be drug-related.” CDISC recognizes that current usage incorporates the concept of causality. NOTE 3 Adapted from WHO Technical Report 498(1972); ICH E2A. ISO 11616:2012(E)
adverse event any unfavourable and unintended sign, symptom, disease, or other medical occurrence with a temporal

association with the use of a medical product, procedure, or other therapy, or in conjunction with a

research study, regardless of causal relationship

EXAMPLE Death, back pain, headache, pulmonary embolism, heart attack.

ISO 14199:2015(E)
agent A node that collects and transmits personal health data to an associated manager. ISO/IEEE

11073-10420

agent A node that collects and transmits personal health data to an associated manager. ISO/IEEE 11073-00103:2015(E)
agent Device that provides data in a manager-agent communicating system. ISO/IEEE 11073-10201:2004(E)
agent A node that collects and transmits personal health data to an associated manager. ISO/IEEE 11073-10406:2012(E)
agent A node that collects and transmits personal health data to an associated manager. ISO/IEEE 11073-10407:2010(E)
agent A node that collects and transmits personal health data to an associated manager. ISO/IEEE 11073-10408:2010(E)
agent A node that collects and transmits personal health data to an associated manager. ISO/IEEE 11073-10415:2010(E)
agent A node that collects and transmits personal health data to an associated manager. ISO/IEEE 11073-10425:2016(E)
agent A node that collects and transmits personal health data to an associated manager. ISO/IEEE 11073-10472:2012(E)
agent A node that collects and transmits personal health data to an associated manager. ISO/IEEE 11073-20601:2016(E)
agent device that provides data in a manager/agent communicating system ISO/TS 27790:2009(E)
agent A node that collects and transmits personal health data to an associated manager. ISO_IEEE_11073-10417_2015
agent: A node that collects and transmits personal health data to an associated manager. ISO/IEEE 11073-10421:2012(E)
AI element string character string containing an application identifier followed by its associated data field ISO/IEC 24724:2011(E)
AIDC

automatic identification and data capture

methods or technologies for automatically identifying objects, collecting data about them, and entering

that data directly into computer systems, eliminating manual entry

Note 1 to entry: The methods or technologies typically considered as part of AIDC include bar codes which can be

linear or 2-dimensional symbols and Radio Frequency Identification (RFID) tags/chips.

ISO/TS 16791:2014(E)
AIDC

automatic identification and data capture

refers to the methods or technologies for automatically identifying objects, collecting data about them,

and entering that data directly into computer systems, eliminating manual entry

Note 1 to entry: The methods or technologies typically considered as part of AIDC include bar codes which can be

linear or 2-dimensional symbols and Radio Frequency Identification (RFID) tags/chips.

ISO/TS 18530:2014(E)
alarm Signal that indicates abnormal events occurring to the patient or the device system. ISO/IEEE 11073-10201:2004(E)
A-law variant of the G.711 audio encoding used primarily in North America and Japan

NOTE Related terms include -law and G.711

ISO TR 16056-1:2004(E)
A-law variant of the G.711 audio encoding used primarily in North America and Japan

NOTE Related terms include -law and G.711

ISO TR 16056-2:2004(E)
alert Synonym for the combination of patient-related physiological alarms, technical alarms, and equipment-

user advisory signals.

ISO/IEEE 11073-10201:2004(E)
alert monitor Object representing the output of a device or system alarm processor and as such the

overall device or system alarm condition.

ISO/IEEE 11073-10201:2004(E)
alert status Object representing the output of an alarm process that considers all alarm conditions in a

scope that spans one or more objects.

ISO/IEEE 11073-10201:2004(E)
allele one of several alternate forms of a gene which occur at the same locus on homologous chromosomes and which become separated during meiosis and can be recombined following fusion of gametes

[SOURCE: ISO 16577:2016, 3.6]

ISO/TS 20428:2017(E)
allergens materials of concern ingredients in a device capable of stimulating a type-I hypersensitivity or allergic reaction in atopic individuals EXAMPLE Latex. ISO 11615:2012(E)
Analyte component indicated in the name of a measurable quantity ISO 18812:2003(E)
analytical data set of elements to describe and capture methods and reference material used to determine purity, potency or identity in a specified substance ISO 11238:2012(E)
analytical instrument

AI

named set of equipment that provides implementations of laboratory services ISO 18812:2003(E)
anonymization process that removes the association between the identifying data set and the data subject

[SOURCE: ISO/TS 25237:2008, definition 3.2]

ISO/TS 14441:2013(E)
anonymization process that removes the association between the identifying data set and the data subject

[SOURCE: ISO/TS 25237:2008, 3.2]

ISO/TS 17975:2015(E)
anonymization process that removes the association between the identifying data set and the data subject ISO/TS 25237:2008(E)
anonymized data data from which the patient cannot be identified by the recipient of the information

[General Medical Council Confidentiality Guidance]

ISO/TS 25237:2008(E)
anonymous identifier identifier of a person which does not allow the unambiguous identification of the natural person ISO/TS 25237:2008(E)
ANSI American National Standards Institute ISO 21731:2006(E) & ANSI/HL7 RIM R1-2003
application that which is provided for specific services in healthcare fields and which could be carried out by using a

separate set of information stored in the healthcare data card

EXAMPLE An application for making appointments for medical treatment, an application for providing access to

medical records and an application for certifying health funding status are all examples of healthcare applications.

ISO 20301:2006(E)
application identifiable computer running software process that is the holder of a private encipherment key

NOTE 1 Application, in this context, can be any software process used in healthcare information systems including those

without any direct role in treatment or diagnosis.

NOTE 2 In some jurisdictions, including software processes can be regulated medical devices.

ISO/TS 17090-1:2002(E)
application any software process used in healthcare information systems, including those without any direct role in

treatment or diagnosis

NOTE In some jurisdictions, software processes can be regulated medical devices.

ISO/TS 21547:2010(E)
application identifier

AI

GS12) prefix that defines the meaning and purpose of the data element that follows, as defined in ISO/IEC

15418 and GS1 General Specifications

[SOURCE: ISO 19762-1:2008, 01.01.94]

ISO/TS 16791:2014(E)
application identifier

AI

GS1 prefix that defines the meaning and purpose of the data element that follows, as defined in ISO/IEC

15418 and GS1 General Specifications

[SOURCE: ISO 19762-1:2008, 01.01.94]

ISO/TS 18530:2014(E)
application programming interface set of functions, procedures, methods or classes that an operating system, library or service provides to support requests made by computer programs ISO/HL7 27951:2009(E)
application programming interface set of functions, procedures, methods or classes that an operating system, library or service provides to support requests made by computer programs ISO/HL7 27951:2009(E)
arbitrary unit arbitrarily defined unit of measurement, where a relation of the unit to a physical unit of the SI does not exist or is unknown NOTE Arbitrary units represent references to materials or procedures that are defined outside the SI system. A quantity value is arbitrarily assigned to the reference preparation or the result of a measurement procedure, usually specific for a particular substance. This generally precludes comparability of quantity values across different systems and components for this type of units. ISO 11240:2012(E)
archetype descriptivemodel of a clinical or other domain-specific concept which defines the structure and business

rules of the concept

NOTE Archetypes may define simple compound concepts such as “blood pressure” or “address”, or more complex

compound concepts such as “family history” or “microbiology result”. They are not used to define atomic concepts such as

anatomical terms. Archetypes use terms which may be derived from external terminologies to identify archetype

components.

[Beale:2003[11]]

ISO/TR 20514:2005(E)
archetype technicalcomputable expression of a domain-level concept in the form of structured constraint statements,

based on some reference information model

NOTE 1 Archetypes are one-to-one with domain concepts, which can themselves have interior complexity.

NOTE 2 Archetypes all have the same formalism but can be either part of a standardized/shared ontology

(i.e. definitional) or only used locally or regionally (i.e. not considered definitional).

[Beale:2003[11]]

ISO/TR 20514:2005(E)
archetype model of a clinical or other domain-specific concept which defines the structure and business rules

of the concept

[SOURCE: ISO/TR 20514:2005]

ISO/TS 13972:2015(E)
archetype instance metadata class instance of an archetype model, specifying the clinical concept and the value constraints that

apply to one class of record component instances in an electronic health record extract

ISO 13606 -1:2008(E)
archetype instance individual metadata class instance of an archetype model, specifying the clinical concept and the value

constraints that apply to one class of record component instances in an electronic health record extract

ISO 13606-2:2008(E)
archetype instance individual metadata class instance of an Archetype Model, specifying the clinical concept and the value

constraints that apply to one class of Record Component instance in an electronic health record extract

ISO 13606-3:2009(E)
archetype instance individual metadata class instance of an archetype model, specifying the clinical concept and the value

constraints that apply to one class of record component instances in an electronic health record extract

ISO 13606-5:2010(E)
archetype model information model of the metadata to represent the domain-specific characteristics of electronic health record

entries by specifying values or value constraints for classes and attributes in the electronic health record

reference model

ISO 13606 -1:2008(E)
archetype model information model of the metadata to represent the domain-specific characteristics of electronic health record

entries by specifying values or value constraints for classes and attributes in the electronic health record

reference model

ISO 13606-2:2008(E)
archetype model information model of the metadata to represent the domain-specific characteristics of electronic health record

entries, by specifying values or value constraints for classes and attributes in the electronic health record

reference model

ISO 13606-5:2010(E)
archetype model information model of the metadata to represent the domain-specific characteristics of Electronic

Health Record entries by specifying values or value constraints for classes and attributes in the EHR

reference model

[SOURCE: ISO 13606‑1:2008]

ISO/TS 13972:2015(E)
archetype repository persistent repository of archetype definitions, accessed by a client authoring tool or by a run-time component

within an electronic health record service

ISO 13606 -1:2008(E)
archetype repository persistent repository of archetype definitions, accessed by a client-authoring tool or by a run-time component

within an electronic health record service

ISO 13606-2:2008(E)
archetype repository persistent repository of archetype definitions, accessed by a client authoring tool or by a run-time component

within an electronic health record service

ISO 13606-5:2010(E)
architecture that set of design artefacts or descriptive representations that are relevant for describing an object such that it

can be produced to requirements (quality) as well as maintained over the period of its useful life (change)

[Zachman:1996[24]]

ISO/TR 20514:2005(E)
Architecture that set of design artefacts or descriptive or descriptive representations that are relevant for describing an object such that it can be produced to requirements (quality) as well as maintained over the period of its useful

life (change)

ISO/TS 18308:2004(E)
architecture that set of design artefacts or descriptive representations that are relevant for describing an object such that it

can be produced to requirements (quality) as well as maintained over the period of its useful life (change)

ISO/TS 27790:2009(E)
archival Relating to the storage of data over a prolonged period. ISO/IEEE 11073-10201:2004(E)
archival relating to the storage of data over a prolonged period ISO/TS 27790:2009(E)
archive organization that intends to preserve information for access and use for any designed users or process

NOTE Adapted from OAIS Red Book, June 12, 2001. Electronic archive (EHR-archive) preserves information in

digital format. It is an information system that manages and provides access to records through their whole lifecycle.

EHR-archive is an archive preserving digitalized health records.

ISO/TS 21547:2010(E)
Archiving (of an EHR) the process of moving one or more EHR extracts to off-line storage in a way that ensures the possibility of restoring them to on-line storage when needed without loss of meaning ISO/TS 18308:2004(E)
archiving process holistic long-term preservation process covering the whole lifecycle of the health record ISO/TS 21547:2010(E)
artefact any model, document, or work product ISO/TR 17119:2005(E)
artefact any model, document, or work product ISO/TS 18790-1:2015(E)
asset anything that is of value to the organization

NOTE 1 Adapted from ISO/IEC 13335-1.

NOTE 2 In the context of health information security, information assets include:

a) health information;

b) IT services;

c) hardware;

d) software;

e) communication facilities;

f) media;

g) IT facilities;

h) medical devices that record or report data.

ISO/TR 11633-1:2009(E)
asset anything that is of value to the organization

NOTE 1 Adapted from ISO/IEC 13335-1.

NOTE 2 In the context of health information security, information assets include:

a) health information;

b) IT services;

c) hardware;

d) software;

e) communication facilities;

f) media;

g) IT facilities;

h) medical devices that record or report data.

ISO/TR 11633-2:2009(E)
asset anything that has value to the organization

Note 1 to entry: In the context of health information security, information assets include health information, IT

services, hardware, software, communications facilities, media, IT facilities, and medical devices that record or

report data.

Note 2 to entry: Adapted from ISO/IEC 27000:2012, definition 2.4.

ISO/TS 14441:2013(E)
association A reference from one class to another class or to itself, or a connection between two objects (instances of

classes).

ISO 21731:2006(E) & ANSI/HL7 RIM R1-2003
association control service element (ACSE) Method used to establish logical connections between

medical device systems (MDSs).

ISO/IEEE 11073-10201:2004(E)
association role name A name for each end of an association. The name is a short verb phrase depicting the role of the class at

the opposite end of the association from the perspective of the class adjacent to the role.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
associative relation relation between two concepts (2.9) having a non-hierarchical thematic connection by virtue of experience

[ISO 1087-1:2000, definition 3.2.23]

EXAMPLE An associative relation (2.1) exists between the concepts (2.9) “education” and “teaching”, “baking”

and “oven”.

NOTE Other relations between concepts (2.9) are: hierarchical, generic, partitive, sequential, temporal and causal.

ISO/TS 22789:2010(E)
Assumed Consent Informational Consent (3.20) done in the absence of any formal recorded or verbal indication of

agreement or any overt action (or inaction) on the part of the data subject

Note 1 to entry: Assumed Consent is most often done by care providers and information collectors.

ISO/TS 17975:2015(E)
assurance result of a set of compliance processes through which an organization achieves confidence in the status of its

information security management

ISO/TR 11633-1:2009(E)
assurance result of a set of compliance processes through which an organization achieves confidence in the status of its

information security management

ISO/TR 11633-2:2009(E)
assurance result of a set of compliance processes through which an organization achieves confidence in the status

of its information security management

ISO/TS 14441:2013(E)
asymmetric cryptographic algorithm algorithm for performing encipherment or the corresponding decipherment in which the keys used for encipherment

and decipherment differ

[ISO 10181-1:1996]

ISO/TS 17090-1:2002(E)
asymmetric cryptographic algorithm encipherment and decipherment differ

ISO/IEC 10181-1:1996, definition 3.3.1.

ISO/TS 21547:2010(E)
asymmetric cryptographic algorithm algorithm for performing encipherment or the corresponding decipherment in which the keys used for

encipherment and decipherment differ

[ISO/IEC 10181-1:1996]

ISO/TS 22600-3:2009(E)
asynchronous transmission transmission of individual bytes without time-dependency between the bytes ISO TR 16056-1:2004(E)
asynchronous transmission transmission of individual bytes without time-dependency between the bytes ISO TR 16056-2:2004(E)
attestation process of certifying and recording legal responsibility for a particular unit of information ISO 13606 -1:2008(E)
attestation process of certifying and recording legal responsibility for a particular unit of information ISO 13606-5:2010(E)
attestation issue of a statement, based on a decision following review, that fulfilment of specified requirements has

been demonstrated

Note 1 to entry: The resulting statement, referred to in this Technical Specification as a “statement of conformity”,

conveys the assurance that the specified requirements have been fulfilled. Such an assurance does not, of itself,

afford contractual or other legal guarantees.

Note 2 to entry: See also scope of attestation.

Note 3 to entry: Adapted from ISO/IEC 17000:2004, definition 5.2.

ISO/TS 14441:2013(E)
Attestation the process of certifying and recording legal responsibility for a particular unit of information ISO/TS 18308:2004(E)
attestation process of certifying and recording legal responsibility for a particular unit of information ISO/TS 27790:2009(E)
attester party (person) who certifies and records legal responsibility for a particular unit of information ISO 13606 -1:2008(E)
attester party (person) who certifies and records legal responsibility for a particular unit of information ISO 13606-5:2010(E)
attribute descriptive feature of a class (3.3) depicted as being contained within the class ISO 14199:2015(E)
attribute characteristic of an object that is assigned a name and a type ISO 21090:2011(E)
attribute characteristic of an object or entity ISO 21549-7:2007(E)
attribute An abstraction of a particular aspect of a class. Attributes become the data values that are passed in HL7

messages.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
attribute Data representing a property of an object. Attributes, together with actions, define an object. ISO/IEEE 11073-20601:2016(E)
attribute characteristic of an object or entity

Note 1 to entry: In the context of this Technical Specification: a specific characteristic of a data element.

[SOURCE: ISO/IEC 11179‑1:2004]

ISO/TS 13972:2015(E)
attribute characteristic of an object or entity

Note 1 to entry: In the context of this Technical Specification: a specific characteristic of a data element.

[SOURCE: ISO/IEC 11179‑1:2015, 3.1.1, modified]

ISO/TS 19256:2016(E)
attribute authority

AA

authority which assigns privileges by issuing attribute certificates

[X.509]

ISO 21091:2013(E)
attribute authority

AA

authority which assigns privileges by issuing attribute certificates

[X.509]

ISO/TS 17090-1:2002(E)
attribute authority

AA

authority that assigns privileges by issuing attribute certificates ISO/TS 22600-2:2006(E)
attribute authority

AA

authority which assigns privileges by issuing attribute certificates

[ISO/IEC 9594-8:2001]

ISO/TS 22600-3:2009(E)
attribute authority revocation list

AARL

revocation list containing a list of references to attribute certificates issued to AAs that are no longer

considered valid by the certificate-issuing authority

ISO/TS 22600-3:2009(E)
attribute certificate data structure, digitally signed by an attribute authority, that binds some attribute values with

identification about its holder

[X.509]

ISO 21091:2013(E)
attribute certificate data structure, digitally signed by an attribute authority, that binds some attribute values with identification about its

holder

[X.509]

ISO/TS 17090-1:2002(E)
attribute certificate data structure, digitally signed by an attribute authority, which binds some attribute values with identification

about its holder

ISO/TS 22600-1:2006(E)
attribute certificate data structure, digitally signed by an attribute authority, which binds some attribute values with identification

about its holder

ISO/TS 22600-2:2006(E)
attribute certificate data structure, digitally signed by an attribute authority, that binds some attribute values with identification

about its holder

[ISO/IEC 9594-8:2001]

ISO/TS 22600-3:2009(E)
attribute certificate revocation list

ACRL

revocation list containing a list of references to attribute certificates that are no longer considered valid by the

certificate-issuing authority

ISO/TS 22600-3:2009(E)
AttributeChangeSet: The set of attribute value changes that represents an atomic update of an object. The

medical device system (MDS) or scanner is notified when an AttributeChangeSet is completed. Collections

of these AttributeChangeSets are mapped by the MDS or scanner into one of the ObservationScan

structures in a scan event report that is sent to the manager. The manager updates its object with the set of

attribute value changes contained in the ObservationScan before deriving any semantic behavior.

ISO/IEEE 11073-20601:2016(E)
audiographics terminal terminal that has audio and graphics capabilities, but no video capability ISO TR 16056-1:2004(E)
audiographics terminal terminal that has audio and graphics capabilities, but no video capability ISO TR 16056-2:2004(E)
audiovisual terminal terminal that has audio, video, and graphics capabilities ISO TR 16056-2:2004(E)
Audit systematic and independent examination of accesses, additions or alterations to electronic health records to determine whether the activities were conducted, and the data were collected, used, retained or disclosed according to organizational standard operating procedures, policies, good clinical practice, and applicable regulatory requirement(s) ISO 27789:2013(E)
audit systematic, independent, documented process for obtaining records, statements of fact or other relevant

information and assessing them objectively to determine the extent to which specified requirements

are fulfilled

Note 1 to entry: While “audit” applies to management systems, “assessment” applies to conformity assessment

bodies as well as more generally.

[SOURCE: ISO/IEC 17000:2004, definition 4.4]

ISO/TS 14441:2013(E)
audit archive archival collection of one or more audit logs ISO 27789:2013(E)
audit data data obtained from one or more audit records ISO 27789:2013(E)
audit log chronological sequence of audit records, each of which contains data about a specific event ISO 27789:2013(E)
audit record record of a single specific event in the life cycle of an electronic health record ISO 27789:2013(E)
audit system information processing system that maintains one or more audit logs ISO 27789:2013(E)
audit trail chronological record of activities of information system users which enables prior states of the information to

be faithfully reconstructed

ISO 13606 -1:2008(E)
audit trail chronological record of activities of information system users which enables prior states of the information to

be faithfully reconstructed

ISO 13606-2:2008(E)
audit trail chronological record of activities of information system users which enables prior states of the information to

be faithfully reconstructed

[ISO 13606-1:2008, definition 3.9]

ISO 13606-5:2010(E)
audit trail record of the resources that were accessed and/or used and by whom

NOTE This may involve a formal monitoring technique for comparison between the actual use of a medical

information system and pre-established criteria.

ISO 21549-7:2007(E)
audit trail collection of audit records from one or more audit logs relating to a specific subject of care or a specific electronic health record ISO 27789:2013(E)
audit trail chronological record of activities of information system users which enables prior states of the information to be faithfully reconstructed

[ISO 13606-1:2008, definition 3.9]

ISO/TS 14265:2011(E)
audit trail a chronological record of activities of information system users which enables prior states of the information to

be faithfully reconstructed

ISO/TS 18308:2004(E)
auditability property that ensures that any action of any security subject on any security object may be examined in order

to establish the real operational responsibilities

[ENV 13608-1:2000]

ISO/TS 13606-4:2009(E)
authentication process of reliably identifying security subjects by securely associating an identifier and its authenticator ISO 13606 -1:2008(E)
authentication process of reliably identifying security subjects by securely associating an identifier and its authenticator ISO 13606-5:2010(E)
authentication formalized process of verification that, if successful, results in an authenticated identity for an entity

Note 1 to entry: The authentication process involves tests by a verifier of one or more identity attributes provided by an entity to determine, with the required level of assurance, their correctness.

Note 2 to entry: Authentication typically involves the use of a policy to specify a required level of assurance for the result of a successful completion.

Note 3 to entry: Identification is usually done as authentication to obtain a specific level of assurance in the result.

[SOURCE: ISO/IEC 24760‑1:2011, 3.3.1, modified]

ISO 17523:2016(E)
authentication process of reliably identifying security subjects by securely associating an identifier and its authenticator

[ISO 7498‑2]

ISO 21091:2013(E)
authentication process of reliably identifying security objects by securely associating an identifier and its authenticator ISO 21549-7:2007(E)
Authentication provision of assurance that a claimed characteristic of an entity is correct ISO 27789:2013(E)
authentication process of reliably identifying security subjects by securely associating an identifier and authenticator ISO/TS 13606-4:2009(E)
authentication comparing the attributes of the object itself to what is known about objects of that origin

Note 1 to entry: Attributes include unique identifier besides overt, covert, and/or forensic solutions.

ISO/TS 16791:2014(E)
authentication process of reliably identifying security subjects by securely associating an identifier and its authenticator

[ISO 7498-2:1989]

NOTE See also data origin authentication and peer entity authentication.

ISO/TS 17090-1:2002(E)
Authentication the act of verifying the claimed identity of an entity ISO/TS 18308:2004(E)
authentication process of reliably identifying security subjects by securely associating an identifier and its authenticator

NOTE See also data origin authentication (3.2.11).

ISO/TS 21547:2010(E)
authentication process of reliably identifying security subjects by securely associating an identifier and its authenticator

NOTE See also data origin authentication and peer entity authentication.

ISO/TS 22600-1:2006(E)
authentication process of reliably identifying security subjects by securely associating an identifier and its authenticator

NOTE See also data origin authentication and peer entity authentication.

ISO/TS 22600-2:2006(E)
authentication process of reliably identifying security subjects by securely associating an identifier and its authenticator

NOTE See also data origin authentication (3.50).

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
authentication assurance of the claimed identity ISO/TS 25237:2008(E)
authentication act of verifying the claimed identity of an entity ISO/TS 27790:2009(E)
authentication token information conveyed during a strong authentication exchange, which can be used to authenticate its sender ISO/TS 22600-3:2009(E)
authenticity quality of being authentic or of established authority for truth and correctness

NOTE An authentic record is one that can be proven to be what it purports to be, to have been created or sent by

persons purporting to have created or sent it and to have been created or sent at the time purported [Records

Management, NHS Code of Practice].

ISO/TS 21547:2010(E)
Authority entity responsible for issuing certificates ISO 27789:2013(E)
authority entity responsible for issuing certificates ISO/TS 13606-4:2009(E)
authority entity that is responsible for the issuance of certificates

NOTE Two types are defined in this part of ISO/TS 22600: certification authority that issues public-key certificates

and attribute authority that issues attribute certificates.

ISO/TS 22600-1:2006(E)
authority entity that is responsible for the issuance of certificates

NOTE Two types are defined in this part of ISO/TS 22600: certification authority that issues public-key certificates

and attribute authority that issues attribute certificates.

ISO/TS 22600-2:2006(E)
authority entity, which is responsible for the issuance of certificates

NOTE Two types of authority are defined in this part of ISO/TS 22600: certification authority, which issues public key

certificates, and attribute authority, which issues attribute certificates.

ISO/TS 22600-3:2009(E)
authority certificate certificate issued to a certification authority or to an attribute authority

NOTE Adapted from X.509.

ISO/TS 17090-1:2002(E)
authority certificate certificate issued to a certification authority or an attribute authority

NOTE Adapted from ISO/IEC 9594-8:2001.

ISO/TS 22600-3:2009(E)
authority revocation list

ARL

revocation list containing a list of public key certificates issued to authorities, which are no longer considered

valid by the certificate issuer

ISO/TS 22600-3:2009(E)
authorization granting of rights ISO 13606 -1:2008(E)
authorization granting of rights ISO 13606-5:2010(E)
authorization granting of rights, which includes the granting of access based on access rights

[SOURCE: ISO 7498‑2:1989, 3.3.10]

ISO 17523:2016(E)
authorization granting of rights, which includes the granting of access based on access rights

[ISO 7498‑2]

ISO 21091:2013(E)
Authorization granting of privileges, which includes the granting of privileges to access data and functions ISO 27789:2013(E)
authorization granting of rights ISO/TS 13606-4:2009(E)
authorization permission to perform certain operations or use certain methods or services ISO/TS 14265:2011(E)
authorization granting of rights, which includes the granting of access based on access rights

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
Authorization granting of privileges which includes the granting of privileges to access data and functions

[SOURCE: SKMT derived from ISO 7498‑2, the granting of rights, which includes the granting of access

based on access rights]

ISO/TS 17975:2015(E)
Authorization the granting of rights, which includes the granting of access based on access rights ISO/TS 18308:2004(E)
authorization granting of rights, which includes the granting of access based on access rights

ISO 7498-2:1989, definition 3.3.10.

ISO/TS 21547:2010(E)
authorization process of granting rights, which includes the granting of access rights ISO/TS 22600-1:2006(E)
authorization process of granting rights, which includes the granting of access rights ISO/TS 22600-2:2006(E)
authorization granting of privileges, which includes the granting of access based on access privileges or conveyance of

privileges from one entity that holds higher privileges, to another entity holding lower privileges

NOTE Adapted from ISO 7498-2:1989.

ISO/TS 22600-3:2009(E)
authorization granting of rights, including the granting of access based on access rights ISO/TS 27790:2009(E)
authorization credential signed assertion of a user’s permission attributes

 

ISO/TS 22600-3:2009(E)
authorization date date when the authorization was granted by a Medicines Regulatory Agency for a specific activity EXAMPLE The date of the marketing authorization, which allows the Marketing Authorization Holder to put a Medicinal Product on the market. ISO 11615:2012(E)
authorization procedure marketing authorization procedure formal procedure applied by a Medicines Regulatory Agency to grant a marketing authorization, to amend an existing one, to extend its duration or to revoke it EXAMPLE Revocation of a marketing authorization due to an unfavourable benefit/risk balance of the medicine. NOTE The terms authorization procedure and marketing authorization procedure are synonymous. ISO 11615:2012(E)
authorization status actual state of the marketing authorization EXAMPLES Active, suspended, expired, revoked. ISO 11615:2012(E)
authorized product medicinal product that has a marketing authorization ISO/TS 19256:2016(E)
availability property of being accessible and useable upon demand by an authorized entity

[ISO 7498‑2]

ISO 21091:2013(E)
availability property of being accessible and useable upon demand by an authorized entity

[ISO 7498-2, definition 3.3.11]

ISO 21549-7:2007(E)
Availability property of being accessible and useable upon demand by an authorized entity ISO 27789:2013(E)
availability property of being accessible and usable upon demand by an authorized entity

[ISO/IEC 13335-1:2004, definition 2.4]

ISO/TR 11633-1:2009(E)
availability property of being accessible and usable upon demand by an authorized entity

[ISO 13335-1:2004, definition 2.4]

ISO/TR 11633-2:2009(E)
availability property of being accessible and useable upon demand by an authorized entity

[ISO 7498-2:1989, definition 3.3.11]

ISO/TS 13606-4:2009(E)
availability property of being accessible and usable upon demand by an authorized entity

[SOURCE: ISO/IEC 27000:2012, definition 2.10]

ISO/TS 14441:2013(E)
availability property of being accessible and useable upon demand by an authorized entity

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
availability property of being accessible and usable upon demand by an authorized entity

ISO 7498-2:1989, definition 3.3.11.

ISO/TS 21547:2010(E)
availability property of being accessible and useable upon demand by an authorized entity

[ISO 7498-2, definitioin 3.3.11]

ISO/TS 22600-1:2006(E)
availability property of being accessible and useable upon demand by an authorized entity

[ISO 7498-2, definition 3.3.17]

ISO/TS 22600-2:2006(E)
availability property of being accessible and usable upon demand by an authorized entity

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
availability in computer scienceproperty of data or of resources being accessible and usable on demand by an

authorized entity

ISO/TS 27790:2009(E)
availability (in computer security) the property of data or of resources being accessible and usable on demand by an authorized entity ISO/TS 18308:2004(E)
average beat typical heart beat used for measurement and analysis in standard 12-lead ECG

Note 1 to entry: This is averaged for waveforms excluding abnormal beats for each lead.

ISO/TS 22077-2:2015(E)
axiomatic concept representation axiom concept representation present in a formal system (2.5.1) without a formal definition (2.4.3)

EXAMPLES Liver; Incision act; Pain.

NOTE This often represents a “natural kind” from the perspective of a particular terminology system; i.e. something that

“just exists”. It may have a definition or description outside the system but, by choice, this is not represented in the system.

ISO 17115:2007(E)
bag A form of collection whose members are unordered, and need not be unique. ISO 21731:2006(E) & ANSI/HL7 RIM R1
BAID_1 unique identifier allocated to a specific batch of a medicinal product which appears on the outer

packaging of the medicinal product

ISO/TS 16791:2014(E)
BAID_2 unique identifier allocated to a specific batch of a medicinal product which appears on the immediate

packaging (not the outer packaging)

ISO/TS 16791:2014(E)
bar code optical machine-readable representation of data, showing data about the object to which it attaches

Note 1 to entry: Originally bar codes represented data by varying the widths and spacings of parallel lines, and

can be referred to as linear or one-dimensional (1D). Later they evolved into rectangles, dots, hexagons, and other

geometric patterns in two dimensions (2D). Although 2D systems use a variety of symbols, they are generally

referred to as bar codes as well.

ISO/TS 16791:2014(E)
base CRL CRL that is used as the foundation in the generation of a dCRL ISO/TS 22600-3:2009(E)
base functional profile existing domain or companion functional profile from which new functional profiles are created and/or derived ISO 10781:2015(E)
base functional profile existing functional profile from which new (child) functional profiles are created/derived ISO/HL7 16527:2016(E)
base quantity quantity in a conventionally chosen subset of a given system of quantities, where no subset quantity can be expressed in terms of the others NOTE 1 A base quantity is used to define a base unit (e.g. Length, Time, Temperature). NOTE 2 Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
base term A fundamental semantic concept. ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
base unit measurement unit that is adopted by convention for a base quantity NOTE 1 A set of base units defines a system of units. EXAMPLE In the SI, the metre is the base unit of length. NOTE 2 Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
basic dose form generalised version of the pharmaceutical dose form, used to group together related pharmaceutical dose forms ISO 11239:2012(E)
basic rate interface

BRI

ISDN service comprising two B (bearer) channels operating at 64 Kbps each and one D (data) channel operating at

16 Kbps

ISO TR 16056-1:2004(E)
basic rate interface

BRI

ISDN service comprising two B (bearer) channels operating at 64 Kbps each and one D (data) channel operating at

16 Kbps

ISO TR 16056-2:2004(E)
batch specific manufacturing release of a Medicinal Product or item by the manufacturer ISO 11615:2012(E)
batch amount of material which is uniform in character and quantity as shown by compliance with production and

quality assurance test requirements and produced during a defined validated process of manufacture

[EN 375:1992 E] [EN 376:1992 E]

ISO 21549-7:2007(E)
batch

lot

specific manufacturing release of a medicinal product or item by the manufacturer

[SOURCE: ISO 11615:2012, 3.1.7 — modified, “lot” was added as a preferred term.]

ISO/TS 16791:2014(E)
batch number identifier assigned to a specific batch of a Medicinal Product or item resulting from a manufacturing process at a specific point of time ISO 11615:2012(E)
batch number

lot number

specific manufacturing release of a medicinal product or item by the manufacturer

[SOURCE: ISO 11615:2012, 3.1.7 — modified, “lot” was added as a preferred term.]

ISO/TS 16791:2014(E)
batch number

lot number

identifier assigned to a specific batch of a medicinal product or item resulting from a manufacturing

process at a specific point of time

Note 1 to entry: Batch number permits its manufacturing history to be traced.

Note 2 to entry: Batch number is made of series of ASCII characters.

[SOURCE: ISO 11615:2012, 3.1.8 — modified, “lot number” was added as a preferred term; notes were

added.]

ISO/TS 16791:2014(E)
Battery group of analytical instrument investigations ordered together ISO 18812:2003(E)
baud A unit of signaling speed, expressed as the number of times per second the signal can change

the electrical state of the transmission line or other medium.

NOTE—Depending on the encoding strategies, a signal event may represent a single bit, more, or less, than one bit.

ISO/IEEE 11073-30200:2004(E)
baud (Bd) A unit of signaling speed, expressed as the number of times per second the signal can

change the electrical state of the transmission line or other medium.

NOTE—Depending on the encoding strategies, a signal event may represent a single bit, more, or less, than one bit.

ISO/IEEE 11073-30300:2004(E)
bedside communications controller (BCC) A communications controller, typically located at a

patient bedside, that serves to interface between one or more medical devices. The BCC may be embedded

into local display, monitoring, or control equipment. Alternatively, it may be part of a communications

router to a remote hospital host computer system.

ISO/IEEE 11073-30200:2004(E)
bedside communications controller (BCC) A communications controller, typically located at a

patient bedside, that serves to interface between one or more medical devices associated with a single

patient. The BCC may be embedded into local display, monitoring, or control equipment. Alternatively, it

may be part of a communications router to a remote hospital host computer system.

ISO/IEEE 11073-30300:2004(E)
bedside communications controller (BCC) A communications controller, which is typically located at a

patient bedside, that serves to interface between one or more medical devices. The BCC may be embedded

into local display, monitoring, or control equipment. Alternatively, it may be part of a communications

router to a remote hospital host computer system.

ISO/IEEE 11073-30400:2012(E)
beginning of frame (BOF) An octet specified by infrared link access protocol (IrLAP). ISO/IEEE 11073-30200:2004(E)
beginning of frame (BOF) An octet specified by Infrared Link Access Protocol (IrLAP) that marks

the beginning of a frame.

ISO/IEEE 11073-30300:2004(E)
benign alterations with very strong evidence against pathogenicity ISO/TS 20428:2017(E)
big endian A byte order sequence where the most significant byte is sent first. For example, a 32 bit

integer is communicated with the most significant byte (bits 24–31) first and the least significant byte (bits

0–7) last.

ISO/IEEE 11073-20101:2004(E)
bimodal compression use of low pass filtering and sample decimation outside of a protected zone containing the QRS complex, with no decimation or filtering within the protected zone, indicated by 5.9.3 byte 6 ISO 11073-91064:2009(E)
biological specimen

biospecimen

specimen

sample of tissue, body fluid, food, or other substance that is collected or acquired to support the assessment, diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms ISO/TS 20428:2017(E)
biomaterial materials taken from the human body such as tissue, blood, plasma or urine ISO/TS 20428:2017(E)
blood glucose Glucose concentration in the blood. ISO/IEEE 11073-10425:2016(E)
blood pressure The cyclic pressure (i.e., amount of force applied over a given area divided by the

size of this area) exerted by blood against the walls of blood vessels. Noninvasive blood pressure

measurement is typically performed at the brachial artery (arm) or radial artery (wrist). There are usually

two numbers reported for blood pressure, and with the home monitors, a third number is typically available.

The first, and higher, number is produced by the contraction of the heart (See: systolic pressure). The

second, lower number is produced by relaxation of the heart (See: diastolic pressure). The third number is

the mean arterial pressure.

ISO/IEEE 11073-10407:2010(E)
body composition analyzer An agent for measuring the fundamental constituents of the human body that

consists of water, protein, mineral, and fat.

ISO/IEEE

11073-10420

body fat The difference between the body weight and the fat free mass. ISO/IEEE

11073-10420

body function-TM activity or purpose natural to or intended for body structure-TM (3.3.1) or body substance-TM (3.3.2.1)

EXAMPLE 1 <upbearing and effusion of qi-TM> and <purification and down-sending of lung-TM> function,

<transportation and transformation-TM> of <spleen-TM function>, <regulation of waterways-TM>, <qi absorption-

TM> as collaborated function between <lung-TM> and <kidney-TM>.

EXAMPLE 2 Functional interaction between <body systems-TM> (3.3.1.1) or between <body system-TM>

(3.3.1.1) such as <heart-kidney interaction-TM>, <spleen opening at the mouth-TM>.

ISO/TS 16277-1:2015(E)
body part-TM body structure-TM (3.3.1) that is physical anatomical entity (3.1.8), has a spatial dimension, and is

uniquely used in TM-CJK

EXAMPLE 1 Any acupuncture points.

EXAMPLE 2 <high bone-TM> that is the bony area including the styloid process of the radius.

EXAMPLE 3 <upper orifices-TM> that refers to the eyes, ears, mouth and nose.

ISO/TS 16277-1:2015(E)
body state-TM normal or abnormal condition of body structure-TM (3.3.1) or body substance-TM (3.3.2.1)

EXAMPLE 1 <cold state-TM>, <heat state-TM>, <deficiency state-TM>, <excess state-TM> in eight principle.

EXAMPLE 2 <lung sector excessiveness> of four constitutional medicine, <yin deficiency constitution>.

Note 1 to entry: There can be more specific or subsumed category (3.1.4) like normal body state-TM (3.3.3.1) or

abnormal body state-TM (3.3.3.1) if needed.

Note 2 to entry: body state-TM (3.3.3.1) refers to relatively static condition of body and sometimes refers to consequence

of body function-TM (3.3.3.2). Dynamic change in body is described by pathological process-TM (3.3.3.3).

Note 3 to entry: body state-TM (3.3.3.1) includes constitutional characteristics of patients, which are the

characteristics of an individual, including structural and functional characteristics, temperament, capability of

adapting to environments. See Example 2.

ISO/TS 16277-1:2015(E)
body structure-TM abstract or physical arrangement of parts of the body for explanatory framework according to TM-CJK ISO/TS 16277-1:2015(E)
body substance-TM substance-TM (3.3.2) that is originated in body

Note 1 to entry: This refers to an entity (3.1.8) which is contained by body structure-TM (3.3.1). Because the body

structure-TM (3.3.1) is abstract as well as physical, the body substance (3.3.2.1) is abstract or physical.

EXAMPLE 1 <essence-TM>, <vitality-TM>, <qi, <blood-TM>.

EXAMPLE 2 <phlegm-TM>, < static blood-TM>, <yang of yang collapse pattern>, <deficiency fire> which

deficiency of yin fluid give rise to, <stagnant qi>.

ISO/TS 16277-1:2015(E)
body system-TM body structure-TM (3.3.1) that works to perform a certain task as a part of a whole in intimate

interconnection according to TM-CJK

EXAMPLE 1 <liver-TM>, <heart-TM>, and <lung-TM>.

EXAMPLE 2 <liver meridian-TM>, <heart meridian-TM> and <lung meridian-TM> of meridian system and also

<exterior–TM> and <interior-TM>.

Note 1 to entry: A body system-TM (3.3.1.1) can include anatomical structure, functional system and abstract

notion for its constituents. They are mutually independent as well as complementary because they may reflect

different aspects of body and health problems and are also closely related to each other.

Note 2 to entry: Body system-TM (3.3.1.1) may have subcategories according to different needs of the terminology

system. Meridian system, Sanjiao system and Four constitutional system could be examples.

ISO/TS 16277-1:2015(E)
body temperature The measurement of the core body temperature of the person. ISO/IEEE 11073-10408:2010(E)
body water The total water of the human body. ISO/IEEE

11073-10420

body weight The sum of the body water mass, protein mass, mineral mass, and the body fat mass. ISO/IEEE

11073-10420

business entity recognised formal business entity, such as a corporation or company

Note 1 to entry: This entity holds details of the formal ‘owner’ entity of the organization.

[SOURCE: ISO/TS 27527:2010, 3.1 — modified, Note 1 to entry added.]

ISO/TS 18530:2014(E)
business entity recognized formal business entity, such as a corporation or company

NOTE This entity holds details of the formal “owner” entity of the organization.

ISO/TS 27527:2010(E)
business partner agreement document used to demarcate the legal, ethical and practical responsibilities between subscribers to a PMI and

between cooperating PMI implementations

ISO/TS 22600-3:2009(E)
byte order The sequence in which multibyte data primitives are communicated in a protocol data unit

(PDU). For example, a 32 bit integer comprises 4 bytes. See also: big endian.

ISO/IEEE 11073-20101:2004(E)
CA certificate certificate for one CA issued by another CA ISO/TS 22600-3:2009(E)
call point-to-point multimedia communication between two H.32x endpoints ISO TR 16056-1:2004(E)
call point-to-point multimedia communication between two H.32x endpoints ISO TR 16056-2:2004(E)
call setup process of establishing a group of communication users and includes the initialization of any shared application and

other resources which the user may require to be available

ISO TR 16056-1:2004(E)
call setup process of establishing a group of communication users and includes the initialization of any shared application and

other resources which the user may require to be available

ISO TR 16056-2:2004(E)
call signalling channel reliable channel used to convey call setup messages following Q.931 ISO TR 16056-1:2004(E)
call signalling channel reliable channel used to convey call setup messages following Q.931 ISO TR 16056-2:2004(E)
call teardown process of ending a call and freeing any resources reserved for that call ISO TR 16056-1:2004(E)
call teardown process of ending a call and freeing any resources reserved for that call ISO TR 16056-2:2004(E)
canonical term preferred atomic or pre-coordinated term for a particular medical concept ISO/TS 17117:2002(E)
capture deliberate action, which results in the registration of a record into a record keeping system ISO/TS 22220:2011(E)
capture deliberate action that results in the registration of a record in a record-keeping system

[ISO/TS 22220:2009, definition 3.1]

ISO/TS 27527:2010(E)
card issuer entity that records the information to activate the card, register and distribute to the healthcard holder

EXAMPLE A hospital could be a card issuer of cards for handling appointments for medical treatment or for

accessing medical records. A health funding agency could be a card issuer of cards for health funding.

ISO 20301:2006(E)
card issuer entity that records the information to activate the card and registers and distributes it to the healthcard holder

EXAMPLE A hospital could be a card issuer of cards for handling appointments for medical treatment or for

accessing medical records. A health funding agency could be a card issuer of cards for health funding.

ISO 20302:2006(E)
cardinality Property of a data element (the number of times a data element may repeat within an individual occurrence

of an object view).

ISO 21731:2006(E) & ANSI/HL7 RIM R1
care provision type and scope of responsibility taken-on by the performer of the act for a specific subject of care

Note 1 to entry: The “Act of Care Provision” is the recording of a process that defines the responsibility for

supplying support to the target of care. It is a statement of supervision, management, and custody.

[SOURCE: HL7 International]

ISO/TS 13972:2015(E)
care unit subdivision of an organization where the subject of care (3.16) receives the care they need during their

stay

Note 1 to entry: A care unit may also be referred to as a ward.

ISO/TS 18530:2014(E)
Catalogue of Somatic Mutations in Cancer

COSMIC

online database of somatically acquired mutations found in human cancer

Note 1 to entry: http:// cancer .sanger .ac .uk/ cosmic.

ISO/TS 20428:2017(E)
categorial structure minimal set of domain constraints (2.3.2) for representing concept systems (A.3.2.11) in a subject field

(A.3.1.2)

ISO 17115:2007(E)
categorial structure minimal set of domain constraints for representing health care terminological systems entities in a precise subject field to achieve a precise goal NOTE Adapted from ISO 17115. ISO 1828:2012(E)
categorial structure minimal set of categories (3.1.4) and the valid relationships between them for representing concepts

(3.1.1) in terminological systems for a specified subject field

[SOURCE: ISO 18104, definition 3.1.2]

ISO/TS 16277-1:2015(E)
categorial structure minimal set of categories (3.4) and the valid relationships between them for representing concepts (3.2) in terminological systems (3.7) for a specified subject field [SOURCE: ISO 18104:2014, 4.2] ISO/TS 18790-1:2015(E)
categorial structure minimal set of domain constraints (2.11) for representing concept systems (2.10) in a subject field

[ISO 17115:2007, definition 2.4.5]

ISO/TS 22789:2010(E)
category type of entity shared by all the individual instances in existence in the present, past and future EXAMPLE The category “liver” is instantiated by this liver and all individual livers in existence in the present, past and future. NOTE 1 Categories may be more or less general. Where one category is subsumed by another, the is_a relation is asserted to obtain a hierarchy between the more specific or subsumed category and the more general or subsuming category. NOTE 2 Each entity instantiates some category. NOTE 3 Category is a synonym of generic concept as it is in ISO 17115. ISO 1828:2012(E)
category type of entity (3.1.8) shared by all the individual instances in existence in the present, past and future

EXAMPLE The category (3.1.4) <Route> is instantiated by oral route and all other routes that meet the

defining characteristics (3.5) for <Route>.

Note 1 to entry: category (3.1.4) is usually described by a superordinate and generic concept (3.1.1).

Note 2 to entry: categories (3.1.4) may be more or less general. Where one category (3.1.4) is subsumed by another,

the isA relation is asserted to obtain a hierarchy between the more specific or subsumed category (3.1.4) and the

more general or subsuming category (3.1.4). For example, parenteral route is more general than intravenous route.

Note 3 to entry: Each entity (3.1.8) instantiates some category (3.1.4).

[SOURCE: ISO 18104, definition 3.1.3]

ISO/TS 16277-1:2015(E)
category type of entity (3.3) shared by all the individual instances in existence in the present, past, and future ISO/TS 18790-1:2015(E)
category formal category

concept (2.9) represented by a formal definition (2.12)

NOTE Adapted from ISO 17115:2007, definition 2.5.3.

ISO/TS 22789:2010(E)
category 5 (Cat 5) balanced cable: The designation applied to 100 Ω unshielded twisted-pair (UTP)

cables and associated connecting hardware whose transmission characteristics are specified up to 100 MHz.

(ANSI/TIA/EIA 568-A-1995). See also: Class D cable.

ISO/IEEE 11073-30400:2012(E)
category 5 (CAT-5) balanced cable The designation applied to 100 unshielded twisted-pair (UTP)

cables and associated connecting hardware whose transmission characteristics are specified up to 100 MHz.

(ANSI/TIA/EIA-568-A-1995)

ISO/IEEE 11073-30200:2004(E)
category 5e (Cat 5e) balanced cable The designation applied to 100 Ω unshielded twisted-pair (UTP)

cables and associated connecting hardware whose transmission characteristics are specified up to 100 MHz.

This designation is an enhanced version of the Category 5 cable, which adds specifications for far end

crosstalk. The Category 5e specification (ANSI/TIA/EIA 568-B.1-2001 [B1]) has deprecated the Category

5 specification. See also: Class D cable.

ISO/IEEE 11073-30400:2012(E)
Category-5 (CAT-5) balanced cable The designation of 100 unshielded twisted pair (UTP) cables

and associated connecting hardware whose transmission characteristics are specified up to 100 MHz.

(ANSI/TIA/EIA-568-A)

ISO/IEEE 11073-30300:2004(E)
causal property-TM aetiological factor that give rise to or influence clinical finding-TM (3.1.6) according to TM-CJK

EXAMPLE <abnormal body substances-TM> (3.3.2.1) such as <phlegm-TM> and <static blood-TM>, concepts

(3.1.1) related to weather factors such as <external wind-TM>, <external dryness-TM>, <external cold-TM> and

<external heat-TM>; <pathological processes-TM> (3.3.3.3) such as <qi movement stagnation> and <qi movement

disturbance>; <body state-TM> (3.3.3.1) such as <cold-TM>, <heat-TM>, <deficiency-TM>, <excess-TM>, <lung

sector excessiveness-TM>; concepts (3.1.1) related emotional state or trait such as <anger-TM>, <anxiety-TM>

<joy-TM>; life styles such as <sexual overindulgence-TM>.

Note 1 to entry: <causal property-TM> (3.3.4) may include concepts (3.1.1) from <body substance-TM> (3.3.2.1)

and <state-TM> (3.3.3) when those work as aetiological factors.

Note 2 to entry: <causal property-TM> (3.3.4) also includes underlying explanatory construct or environment

for aetiological factor in TM-CJK, such as weather factors, emotional factors, life style or many other risk factors.

ISO/TS 16277-1:2015(E)
CDISC Clinical Data Interchange Standards Consortium ISO 11239:2012(E)
central prescription store repository for electronic prescriptions in a geographical area which receives prescriptions from several

prescriber locations and serves several, possibly all, pharmacies in that area

ISO/TR 22790:2007(E)
centralized multipoint conference conference call in which all participating terminals communicate in a point-to-point fashion with an MCU ISO TR 16056-1:2004(E)
centralized multipoint conference conference call in which all participating terminals communicate in a point-to-point fashion with an MCU ISO TR 16056-2:2004(E)
centralized multipoint conference A call in which all participating terminals communicate in a point-to-point fashion with an MCU ISO TS 16058:2004(E)
certificate public key certificate ISO 21091:2013(E)
certificate public key certificate ISO/TS 17090-1:2002(E)
certificate public key certificate ISO/TS 22600-3:2009(E)
certificate distribution act of publishing certificates and transferring certificates to security subjects ISO 21091:2013(E)
certificate distribution act of publishing certificates and transferring certificates to security subjects ISO/TS 17090-1:2002(E)
certificate distribution act of publishing certificates and transferring certificates to security subjects ISO/TS 22600-3:2009(E)
certificate extension extension fields (known as extensions) in X.509 certificates that provide methods for associating additional

attributes with users or public keys and for managing the certification hierarchy

NOTE Certificate extensions may be either critical (i.e. a certificate-using system has to reject the certificate if it encounters

a critical extension it does not recognize) or non-critical (i.e. it may be ignored if the extension is not recognized).

ISO/TS 17090-1:2002(E)
certificate generation act of creating certificates ISO/TS 17090-1:2002(E)
certificate holder entity that is named as the subject of a valid certificate ISO/TS 17090-1:2002(E)
certificate holder entity that is named as the subject of a valid certificate ISO/TS 22600-3:2009(E)
certificate issuer authority trusted by one or more relying parties to create and assign certificates

Note 1 to entry: Optionally the certification authority may create the relying parties’ keys.

[ISO/IEC 9594‑8]

ISO 21091:2013(E)
certificate management procedures relating to certificates, i.e. certificate generation, certificate distribution, certificate

archiving and revocation

ISO 21091:2013(E)
certificate management procedures relating to certificates, i.e. certificate generation, certificate distribution, certificate archiving and

revocation

ISO/TS 17090-1:2002(E)
certificate management procedures relating to certificates: certificate generation, certificate distribution, certificate archiving and

revocation

ISO/TS 22600-3:2009(E)
certificate policy

CP

named set of rules that indicates the applicability of a certificate to a particular community and/or class of

application with common security requirements

[IETF 2527]

ISO/TS 17090-1:2002(E)
certificate policy named set of rules that indicates the applicability of a certificate to a particular community and/or class of

application with common security requirements

EXAMPLE A particular certificate policy might indicate the applicability of a type of certificate to the authentication of

electronic data interchange transactions for the trading of goods within a given price range.

ISO/TS 22600-3:2009(E)
certificate profile specification of the structure and permissible content of a certificate type ISO/TS 17090-1:2002(E)
certificate revocation act of removing any reliable link between a certificate and its related owner (or security subject owner)

because the certificate is not trusted any more, even though it is unexpired

ISO 21091:2013(E)
certificate revocation act of removing any reliable link between a certificate and its related owner (or security subject owner) because the

certificate is not trusted any more, even though it is unexpired

ISO/TS 17090-1:2002(E)
certificate revocation act of removing any reliable link between a certificate and its certificate holder because the certificate is not

trusted any more, whereas it is unexpired

ISO/TS 22600-3:2009(E)
certificate revocation list

CRL

published list of the suspended and revoked certificates (digitally signed by the CA) ISO 21091:2013(E)
certificate revocation list

CRL

assigned list indicating a set of certificates that are no longer considered valid by the certificate issuer

NOTE In addition to the generic term CRL, some specific CRL types are defined for CRLs that cover particular

scopes. A published list of the suspended and revoked certificates exists (digitally signed by the CA).

ISO/TS 22600-3:2009(E)
certificate serial number integer value, unique within the issuing authority, which is unambiguously associated with a certificate issued

by that CA

ISO/TS 22600-3:2009(E)
certificate suspension list

CSL

published list of the suspended certificates (digitally signed by the CA) ISO/TS 22600-3:2009(E)
certificate user entity that needs to know, with certainty, the public key of another entity ISO/TS 22600-3:2009(E)
certificate using system implementation of those functions defined in this Directory Specification that are used by a certificate user ISO/TS 22600-3:2009(E)
certificate validation process of ensuring that a certificate was valid at a given time, including possibly the construction and

processing of a certification path, and ensuring that all certificates in that path were valid (i.e. were not expired

or revoked) at that given time

ISO/TS 22600-2:2006(E)
certificate validation process of ensuring that a certificate was valid at a given time, possibly including the construction and

processing of a certification path, and ensuring that all certificates in that path were valid (i.e. were not expired

or revoked) at that given time

ISO/TS 22600-3:2009(E)
certificate verification verifying that a certificate (3.7) is authentic ISO 21091:2013(E)
certificate verification verifying that a certificate is authentic ISO/TS 17090-1:2002(E)
certificate verification verification that a certificate is authentic ISO/TS 22600-3:2009(E)
certification third-party attestation related to products, processes, systems or persons

NOTE 1 Certification of a management system is sometimes also called registration.

NOTE 2 Certification is applicable to all objects of conformity assessment except for conformity assessment bodies

themselves, to which accreditation is applicable.

ISO TR 16056-1:2004(E)
certification third-party attestation related to products, processes, systems or persons

NOTE 1 Certification of a management system is sometimes also called registration.

NOTE 2 Certification is applicable to all objects of conformity assessment except for conformity assessment bodies

themselves, to which accreditation is applicable.

ISO TR 16056-2:2004(E)
certification third-party attestation related to products, processes, systems or persons

Note 1 to entry: Adapted from ISO/IEC 17000:2004, definition 5.5.

ISO/TS 14441:2013(E)
certification procedure by which a third party gives assurance that all or part of a data processing system conforms to security

requirements

[ISO/IEC 2382-8:1998]

ISO/TS 17090-1:2002(E)
certification authority

CA

authority trusted by one or more relying parties to create and assign certificates and which may,

optionally, create the relying parties’ keys

Note 1 to entry: Adapted from ISO/IEC 9594‑8.

Note 2 to entry: Authority in the CA term does not imply any government authorization, but only denotes that

it is trusted.

Note 3 to entry: “Certificate issuer” may be a better term, but CA is very widely used.

ISO 21091:2013(E)
certification authority

CA

certificate issuer

authority trusted by one or more relying parties to create and assign certificates and which may, optionally, create

the relying parties’ keys

NOTE 1 Adapted from ISO 9594-8:2001.

NOTE 2 Authority in the CA term does not imply any government authorization, but only denotes that it is trusted.

NOTE 3 Certificate issuer may be a better term, but CA is very widely used.

ISO/TS 17090-1:2002(E)
certification authority

CA

authority trusted by one or more relying parties to create and assign certificates

[ISO/IEC 9594-8, definition 3.3.17]

NOTE 1 Optionally the certification authority may create the relying parties’ keys.

NOTE 2 Authority in the CA term does not imply any government authorization only that it is trusted. Certificate issuer

may be a better term but CA is used very broadly.

ISO/TS 22600-1:2006(E)
certification authority

CA

authority trusted by one or more relying parties to create and assign certificates

[ISO/IEC 9594-8, definition 3.3.17]

NOTE 1 Optionally the certification authority may create the relying parties’ keys.

NOTE 2 Authority in the CA term does not imply any government authorization only that it is trusted. Certificate issuer

may be a better term but CA is used very broadly.

ISO/TS 22600-2:2006(E)
certification authority

CA

certificate issuer; an authority trusted by one or more relying parties to create and assign certificates;

optionally the certification authority may create the relying parties’ keys

NOTE Adapted from ISO/IEC 9594-8:2001.

ISO/TS 22600-3:2009(E)
certification authority entity that issues certificates by signing certificate data with its private signing key.

NOTE Authority in the CA term does not imply any government authorization; it only means that it is trusted.

Certificate issuer may be a better term but CA is used very broadly.

ISO/TS 22600-3:2009(E)
certification authority revocation list

CARL

revocation list containing a list of public key certificates issued to certification authorities, which are no longer

considered valid by the certificate issuer

ISO/TS 22600-3:2009(E)
certification path connection of a series of certificates binding the certificate which is to be validated to a trusted root

trust anchor

ISO 17090-4:2014(E)
certification path ordered sequence of certificates of objects in the DIT which, together with the public key of the initial object in

the path, can be processed to obtain that of the final object in the path

ISO/TS 22600-2:2006(E)
certification path ordered sequence of certificates of objects in the DIT which, together with the public key of the initial object in

the path, can be processed to obtain that of the final object in the path

ISO/TS 22600-3:2009(E)
certification path validation path to be validated to a trusted root trust anchor including revocation checking ISO 17090-4:2014(E)
certification practices statement

CPS

statement of the practices which a certification authority employs in issuing certificates

[IETF/RFC 2527]

ISO/TS 17090-1:2002(E)
channel Umbrella object in the object model that groups together physiological measurement data and

data derived from these data.

ISO/IEEE 11073-10201:2004(E)
channel service unit

CSU

interface used to connect a terminal or computer to a digital medium in the same way that a modem is used for

connection to an analogue medium

ISO TR 16056-1:2004(E)
channel service unit

CSU

interface used to connect a terminal or computer to a digital medium in the same way that a modem is used for

connection to an analogue medium

ISO TR 16056-2:2004(E)
characteristic abstraction of a property of an object ISO 11615:2012(E)
characteristic abstraction of a property of an object or of a set of objects

[SOURCE: ISO 1087‑1:2000, definition 3.2.4]

EXAMPLE Red and gold are the characteristic (3.1.5) colours of autumn.

Note 1 to entry: Characteristics (3.5) are used for describing concepts (3.1.1).

ISO/TS 16277-1:2015(E)
characteristic abstraction of a property of an object or of a set of objects

[SOURCE: ISO 1087‑1:2000, A.3.2.4]

ISO/TS 18790-1:2015(E)
characteristic abstraction of a property of an object or of a set of objects

[ISO 1087-1:2000, definition 3.2.4]

NOTE Characteristics are used for describing concepts (2.9).

ISO/TS 22789:2010(E)
characterizing category category (3.1.4) which is allowed by a domain constraint (3.1.7) to specialise a concept (3.1.1) in a

particular domain

EXAMPLE in {performedUsing} <instrument>; {hasLocation} <bodyPartOrImplantedDevice>,

“<instrument>” and “<bodyPartOrImplantedDevice>” is the characterizing category (3.1.3).

Note 1 to entry: (3.1.1).

ISO/TS 16277-1:2015(E)
characterizing category formal category (2.3) whose specialization by a domain constraint (2.11) is allowed to be used as

characterizing concept (2.5) in a particular context

[ISO 17115:2007, definition 2.3.3]

EXAMPLE <INFECTIOUS_ORGANISM>={bacterium, virus, parasite}, in the context of “Infection that hasCause

INFECTIOUS_ORGANISM”.

ISO/TS 22789:2010(E)
characterizing concept concept (A.3.2.1) that is referenced by a semantic link (2.2.3) in a composite characteristic (2.2.1)

EXAMPLES “Bacterium” in the construct “Disease that hasCause Bacterium”; “Yellow” in the construct “SkinLesion that

hasColour Yellow”.

ISO 17115:2007(E)
characterizing concept concept (2.9) that is referenced by a semantic link (2.17) in a composite characteristic (2.7)

[ISO 17115:2007, definition 2.2.2]

EXAMPLE “Bacterium” in the construct “Disease that hasCause Bacterium” and “Yellow” in the construct

“SkinLesion that hasColor Yellow”.

ISO/TS 22789:2010(E)
characterizing generic concept characterizing category

value domain

formal category (2.5.3) whose specialization by a domain constraint (2.3.2) is allowed to be used as

characterizing concept (2.2.2) in a particular context

EXAMPLE <INFECTIOUS_ORGANISM> = {bacterium, virus, parasite}, in the context of “Infection that hasCause

INFECTIOUS_ORGANISM”.

NOTE The context includes a superordinate concept (A.3.2.13) and a semantic link (2.2.3).

ISO 17115:2007(E)
charge coupled device

CCD

device used in cameras as an optical scanning mechanism.

NOTE It consists of a shift register that stores samples of analog signals. An analog charge is sequentially passed along

the device by the action of stepping voltages and stored in potential wells formed under electrodes. The charge is moved from

one well to another by the stepping voltages.

ISO TR 16056-1:2004(E)
charge coupled device

CCD

device used in cameras as an optical scanning mechanism.

NOTE It consists of a shift register that stores samples of analog signals. An analog charge is sequentially passed along

the device by the action of stepping voltages and stored in potential wells formed under electrodes. The charge is moved from

one well to another by the stepping voltages.

ISO TR 16056-2:2004(E)
chemical bond condition that occurs when forces acting between two atoms or groups of atoms lead to the formation of a stable discrete molecular entity ISO 11238:2012(E)
chemical substance type of substance that can be described as a stoichiometric or non-stoichiometric single molecular entity and is not a protein or nucleic acid substance ISO 11238:2012(E)
chiral substance substance whose molecular structure is not superimposable on its mirror image ISO 11238:2012(E)
chromosome structure that comprises discrete packages of DNA and proteins that carries genetic information which condense to form characteristically shaped bodies during nuclear division

[SOURCE: ISO 19238:2014, 2.7]

ISO/TS 20428:2017(E)
ciphertext data produced through the use of encipherment, the semantic content of which is not available

NOTE Adapted from ISO 7498-2:1989.

ISO/TS 17090-1:2002(E)
ciphertext data produced through the use of encipherment

NOTE The semantic content of the resulting data is not available.

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
ciphertext data produced through the use of encryption, the semantic content of which is not available without the use of

cryptographic techniques

[ISO/IEC 2382-8:1998, definition 08-03-8]

ISO/TS 25237:2008(E)
claimant entity requesting that a sensitive service be performed or provided by a verifier, based on the claimant’s

privileges as identified in their attribute certificate or subject directory attributes extension of their public key

certificate

ISO/TS 22600-3:2009(E)
class concept of primary importance, i.e. the domain of interest

1) Available at http://www.cdisc.org/bridg.

ISO 14199:2015(E)
class descriptor for a set of objects with similar structure, behaviour and relationships ISO 21090:2011(E)
class An abstraction of a thing or concept in a particular application domain. ISO 21731:2006(E) & ANSI/HL7 RIM R1
class In object-oriented modeling, it describes the attributes, methods, and events that objects instantiated

from the class utilize.

ISO/IEEE

11073-10420

class Description of one or more objects with a uniform set of attributes and services including a

description of how to create new objects in the class.

ISO/IEEE 11073-10201:2004(E)
class In object-oriented modeling, it describes the attributes, methods, and events that objects instantiated

from the class utilize.

ISO/IEEE 11073-10406:2012(E)
class In object-oriented modeling, a class describes the attributes, methods, and events that objects

instantiated from the class utilize.

ISO/IEEE 11073-10407:2010(E)
class In object-oriented modeling, it describes the attributes, methods, and events that objects

instantiated from the class utilize.

ISO/IEEE 11073-10408:2010(E)
class In object-oriented modeling, it describes the attributes, methods, and events that objects

instantiated from the class utilize.

ISO/IEEE 11073-10415:2010(E)
class In object-oriented modeling, a class describes the attributes, methods, and events that objects

instantiated from the class utilize.

ISO/IEEE 11073-10421:2012(E)
class In object-oriented modeling, it describes the attributes, methods, and events that objects instantiated

from the class utilize.

ISO/IEEE 11073-10425:2016(E)
class In object-oriented modeling, it describes the attributes, methods, and events that objects instantiated

from the class utilize.

ISO/IEEE 11073-10472:2012(E)
class description of a set of objects that share the same attributes, methods and associations ISO/TS 27790:2009(E)
class In object-oriented modeling, it describes the attributes, methods, and events that objects instantiated

from the class utilize.

ISO_IEEE_11073-10417_2015
Class D cable A category of cabling specified in ISO/IEC 11801-2002 [B9]. 100BASE-TX uses Class D

as specified in the 1995 revision (corresponding to the ANSI/TIA/EIA 568-A specification for Category 5

cabling). 1000BASE-T uses Class D as specified in the 2001 revision (corresponding to the ANSI/TIA/EIA

568-A specification for Category 5e cabling).

ISO/IEEE 11073-30400:2012(E)
classification exhaustive set of mutually exclusive categories (2.1.4) to aggregate data at a pre-prescribed level of

specialization (2.1.3) for a specific purpose

EXAMPLE ICD 10.

ISO 17115:2007(E)
classification terminology which aggregates data at a prescribed level of abstraction for a particular domain

NOTE 1 This fixing of the level of abstraction that can be expressed using the classification system is often done to enhance

consistency when the classification is to be applied across a diverse user group, such as is the case with some of the current

billing classification schemes.

NOTE 2 See Annex A for the history of classification.

ISO/TS 17117:2002(E)
classifier attribute An attribute used in generalization hierarchies to indicate which of the specializations is the focus of the

class .

ISO 21731:2006(E) & ANSI/HL7 RIM R1
client individual who is a subject of care

NOTE The terms “client” and “patient” are synonymous but the usage of one or other of these terms tends to differ

between different groups of health professionals. Clinicians working in a hospital setting and medical practitioners in most

settings tend to use the term “patient” whereas allied health professionals tend to use the term “client”.

ISO/TR 20514:2005(E)
client application healthcare application that is behaving at that moment as a requester of health record data from a shareable

electronic health record

ISO 13606 -1:2008(E)
clinical pertaining to healthcare, in particular to characterize activities in which a patient and care professional

interact directly or indirectly

ISO/TS 13972:2015(E)
clinical concept unit of knowledge, expressed by means of characteristics pertinent to its use in health care ISO/TS 13972:2015(E)
clinical context the variable situations in healthcare that influence the interpretation of health(care) information ISO/TS 13972:2015(E)
clinical data repository

CDR

data store that holds and manages clinical data collected from service encounters at point of service locations

(e.g. hospitals, clinics)

NOTE 1 Adapted from Infoway:2003[13].

NOTE 2 Data from a CDR can be fed to the EHR for that subject of care; in that sense the CDR is recognized as a

source system for the EHR.

NOTE 3 A CDR complies with the definition of a basic-generic EHR but not with the more specialized definition of an

Integrated Care EHR (ICEHR).

ISO/TR 20514:2005(E)
clinical data repository

CDR

operational data store that holds and manages clinical data collected from service encounters at point of

service locations

NOTE Data from a CDR can be fed to the EHR for that client, such that the CDR is recognised as a source system

for the EHR. The CDR can be used to trigger alerts in real time.

ISO/TS 29585:2010(E)
clinical data warehouse

CDW

grouping of data accessible by a single data management system, possibly of diverse sources, pertaining to a

health system or sub-system and enabling secondary data analysis for questions relevant to understanding

the functioning of that health system, and hence supporting proper maintenance and improvement of that

health system

NOTE A CDW tends not to be used in real time. However, depending on the rapidity of transfer of data to the data

warehouse, and data integrity, near real-time applications are not excluded.

ISO/TS 29585:2010(E)
clinical document architecture A document markup standard that specifies the structure and semantics of “clinical documents” for the purpose of exchange. ISO/HL7 27932:2009(E)
clinical findings-TM any state observed directly or indirectly concerning a patient and their relationship with the environment

according to TM-CJK theories

Note 1 to entry: Modified from ISO/TS 22789 for TM-CJK theories.

ISO/TS 16277-1:2015(E)
clinical information information about a person, relevant to his or her health or healthcare ISO 13606 -1:2008(E)
clinical information information about a person, relevant to his or her health or health care ISO 13606-3:2009(E)
clinical information information about a patient, relevant to the health or treatment of that patient, that is recorded by or on

behalf of a healthcare professional

[SOURCE: ENV 1613]

ISO 21549-4:2014(E)
clinical information information about a subject of care, relevant to the health or treatment of that subject of care, which is

recorded by or on behalf of a healthcare person

NOTE Clinical information about a subject of care can include information about the subject of care’s environment or

about related people where this is relevant.

[ENV 1613]

ISO 21549-7:2007(E)
clinical information data that is meaningful in a clinical context

[SOURCE: ISO 13940:—]

ISO/TS 13972:2015(E)
clinical information information about a person, relevant to his or her health or health care

[ISO 13606-1:2008, definition 3.13]

ISO/TS 14265:2011(E)
clinical knowledge part of medical knowledge pertaining to the promotion of good health and the management and prevention

of ill health

ISO 13119:2012(E)
clinical knowledge of ill health

Note 1 to entry: Used to diagnose, treat, and alleviate disease/dysfunction.

Note 2 to entry: In ISO 13940 (Contys) proposed to be understood clinical information.

[SOURCE: ISO 13119:2012]

ISO/TS 13972:2015(E)
clinical process the steps that are involved in the delivery of healthcare services to a patient/consumer ISO/TS 18308:2004(E)
clinical process steps that are involved in the delivery of healthcare services to a patient/consumer ISO/TS 27790:2009(E)
clinical sequencing next generation sequencing or later sequencing technologies with human samples for clinical practice and clinical trials ISO/TS 20428:2017(E)
clinical statement expression of a discrete item of clinical, clinically related, or public health information recorded because

of its relevance to the care of a patient or other entities

[SOURCE: HL7 International]

ISO/TS 13972:2015(E)
clinical template clinical information model that structures information round discrete clinical concepts in a way that

supports reuse of components across different clinical communication and record keeping activities

and promotes common approaches to clinical information system development and interoperability

[SOURCE: Hoy et al., 2007, 2009]

ISO/TS 13972:2015(E)
clinical terminology terminology required directly or indirectly to describe health conditions and healthcare activities

NOTE 1 Health conditions include symptoms, complaints, illness, diseases, disorders, etc.

NOTE 2 It is used in, for example, medical records, clinical communication, and medical science.

ISO 17115:2007(E)
clinical trial

clinical study

any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an Investigational Medicinal Product(s), and/or to study absorption, distribution, metabolism and excretion of Investigational Medicinal Product(s) with the object of ascertaining its safety and/or efficacy NOTE The terms clinical trial and clinical study are synonymous. ISO 11615:2012(E)
clinical trial research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device [ICH E6 Glossary, Directive 2001/20/EC:2002, Version: 1-2009/04/19] ISO 11616:2012(E)
clinical trial authorization authorization granted by a Medicines Regulatory Agency to conduct a clinical trial in a jurisdiction ISO 11615:2012(E)
clinical trial registration number registration number (identifier for tracking purposes) for a clinical trial as assigned by the Regulatory Medicines Authority ISO 11616:2012(E)
clinician health professional who delivers health services directly to a patient/client

NOTE Adapted from ISO/TS 18308[3].

ISO/TR 20514:2005(E)
Clinician a healthcare professional who is delivers healthcare services directly to a patient/consumer ISO/TS 18308:2004(E)
clinician healthcare professional who delivers healthcare services directly to a patient/consumer ISO/TS 27790:2009(E)
ClinVar freely accessible, public archive of reports of the relationships among human variations and phenotypes, with supporting evidence

Note 1 to entry: http:// www .ncbi .nlm .nih .gov/ clinvar/ .

ISO/TS 20428:2017(E)
closure item used to close a container for the purpose of the correct storage and (where appropriate) use of the product ISO 11239:2012(E)
coalescing The function of combining multiple presentation-layer protocol data units (PPDUs) into a

single session-layer protocol data unit (SPDU) that is then communicated across a transport.

ISO/IEEE 11073-20101:2004(E)
co-constraint A rule describing a constraint whose scope is inclusive of more than one term. ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
code concept representation published by the author of a code system as part of the code system, being an entity

of that code system

1) Revision of IETF RFC 2806.

2) Revision of FIPS PUB 180-1.

3) Regenstrief Institute, Inc. and the UCUM Organization, Indianapolis, Indiana, USA [viewed 2010-08-23]. Available

from: http://aurora.regenstrief.org/ucum.

4) World Wide Web Consortium (W3C) [viewed 2010-08-23]. Available from: http://www.w3.org/TR/xmldsig-core/.

ISO 21090:2011(E)
code meaning element within a coded set

EXAMPLE “Paris Charles-de-Gaulle” which is mapped on to the three-letter abbreviation “CDG” by the coding

scheme for three-letter abbreviations of airport names.

ISO 21549-7:2007(E)
code system managed collection of concept identifiers, usually codes, but sometimes more complex sets of rules and

references

NOTE They are often described as collections of uniquely identifiable concepts with associated representations,

designations, associations and meanings.

EXAMPLES ICD-9, LOINC and SNOMED

ISO 21090:2011(E)
code system system of codes, descriptions, designations, properties and relationships also sometimes known as “vocabular7”, “terminology”, “coding scheme”, “classification scheme” and “ontology” ISO/HL7 27951:2009(E)
code system system of codes, descriptions, designations, properties and relationships also sometimes known as “vocabular7”, “terminology”, “coding scheme”, “classification scheme” and “ontology” ISO/HL7 27951:2009(E)
code term pair data type that groups together the attributes required to describe a single concept in a specified language and for a specified geographical location ISO 11239:2012(E)
code value result of applying a coding scheme to an element within a coded set NOTE Adapted from ISO/IEC 2382-4:1999 ISO 11616:2012(E)
code value result of applying a coding scheme to a code meaning

EXAMPLE “CDG” as the representation of “Paris Charles-De-Gaulle” in the coding scheme for three-letter

representations of airport names.

ISO 21549-7:2007(E)
codec device used to covert analog signals into digital (and vice versa), and perform encoding / decoding and

compression / decompression of the digital data

ISO TR 16056-1:2004(E)
CODEC (COder/DECoder COmpression/ DECompression) hardware and/or software used with interactive video systems that converts an analog signal to digital, then compresses it so that lower bandwidth telecommunications lines can be used ISO TS 16058:2004(E)
coded attribute An attribute in the Reference Information Model (RIM) with a base data type of CD, CE, CS, or CV. ISO 21731:2006(E) & ANSI/HL7 RIM R1
coded concept data type that groups together a set of code term pairs that represent a single concept but differ in language and/or geographical region NOTE The coded concept is used to manage translations, and is the basic data type that is found in all of the highlevel conceptual models. ISO 11239:2012(E)
COder/DECoder

COmpression/DECompression

CODEC

hardware and/or software used with interactive video systems that converts an analog signal to digital, then

compresses it so that lower bandwidth telecommunications lines can be used

NOTE The signal is decompressed and converted back to analog output by a compatible CODEC at the receiving end. The

compression method (algorithm) may be proprietary or standards -based.

ISO TR 16056-2:2004(E)
coding scheme collection of rules that maps the elements of one set onto the elements of a second set

NOTE 1 The coding scheme applied in this International Standard refers to the following standards:

— ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information;

— ISO 11238, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances; — ISO 11239, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging;

— ISO 11240, Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement.

NOTE 2 Adapted from ISO/IEC 2382-4:1999.

ISO 11616:2012(E)
coding scheme collection of rules that maps the elements in one set, the “coded set” onto the elements in a second set “the

code set”

[ISO 2382-4]

NOTE The two sets are not part of the coding scheme.

ISO 17115:2007(E)
coding scheme collection of rules that maps the elements of one set on to the elements of a second set ISO 21549-7:2007(E)
coding strength An extensibility qualifier that specifies whether or not a code set can be expanded to meet local implementation

needs.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
coding system combination of a set of concepts (A.3.2.1) [coded concepts], a set of code values, and at least one coding

scheme (2.7.2) mapping code values to coded concepts

NOTE Coded concepts are typically represented by terms (A.3.4.3) but can have other representation. Code values are

typically numeric or alphanumeric.

ISO 17115:2007(E)
coding system A scheme for representing concepts using (usually) short concept identifiers to denote the concepts that

are members of the system; defines a set of unique concept codes. Examples of coding systems are ICD-9,

LOINC and SNOMED.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
coherent derived unit derived unit that, for a given system of quantities and for a chosen set of base units, is a product of powers of base units with no other proportionality factor than one NOTE Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
collected obtained and persisted ISO/TS 14265:2011(E)
collection An aggregation of similar objects. The forms of collection used by HL7 are set , bag, and list. Objects which

may be found in collections include data types.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
Collection <of data> to obtain data by any means including that of viewing it

[SOURCE: ISO/TS 14265:2011, term derived from “Collected”.]

ISO/TS 17975:2015(E)
collision domain A single, half duplex mode Carrier Sense Multiple Access (CSMA)/Collision Detection

(CD) network. If two or more media access control (MAC) sublayers are within the same collision domain

and both transmit at the same time, a collision will occur. MAC sublayers separated by a repeater are in the

same collision domain. MAC sublayers separated by a bridge are within different collision domains. (See

IEEE Std 802.3-2008.)

ISO/IEEE 11073-30400:2012(E)
combined pharmaceutical dose form single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product, and which includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product ISO 11239:2012(E)
combined pharmaceutical dose form single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product, and that includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product EXAMPLE Powder and solvent for solution for injection. The Medicinal Product contains two manufactured items: a powder for solution for injection and a solvent for solution for injection. The pharmaceutical product that is prepared from the two manufactured items is a solution for injection; the combined pharmaceutical dose form for the Medicinal Product is “powder and solvent for solution for injection”. ISO 11615:2012(E)
committed information that has been persisted within an electronic health record system and which constitutes part of the

electronic health record of a subject of care

ISO 13606 -1:2008(E)
committed information that has been persisted within an electronic health record system and which constitutes part of the

electronic health record for a subject of care

ISO 13606-3:2009(E)
committed information that has been persisted within an electronic health record system and which constitutes part of the

electronic health record of a subject of care

[ISO 13606-1:2008, definition 3.14]

ISO 13606-5:2010(E)
committer agent (party, device or software) whose direct actions have resulted in data being committed to an electronic

health record

ISO 13606 -1:2008(E)
committer agent (party, device or software) whose direct actions have resulted in data being committed to an electronic

health record

ISO 13606-3:2009(E)
committer agent (party, device or software) whose direct actions have resulted in data being committed to an electronic

health record

[ISO 13606-1:2008, definition 3.15]

ISO 13606-5:2010(E)
common access point (AP) An AP that can service ISO/IEEE 11073, National Committee for Clinical

Laboratory Standards Point-of-Care Connectivity; Approved Standard (NCCLS POCT1), and handheld

personal digital assistant (PDA) devices.

ISO/IEEE 11073-30300:2004(E)
common intermediate format

CIF

ITU-T standard video picture scanning format where information is stored in luminance (brightness) and two color

difference (chrominance) components

NOTE CIF represents 352 pixels/line by 288 lines/image for luminance and 176 pixels/line by 144 lines/image for

chrominance. See also QCIF.

ISO TR 16056-1:2004(E)
common intermediate format

CIF

ITU-T standard video picture scanning format where information is stored in luminance (brightness) and two color

difference (chrominance) components

NOTE CIF represents 352 pixels/line by 288 lines/image for luminance and 176 pixels/line by 144 lines/image for

chrominance. See also QCIF.

ISO TR 16056-2:2004(E)
common name

generic name

international nonproprietary name recommended by the World Health Organization (WHO), or, if one does not exist, a nonproprietary name recommended by the jurisdiction within which the name is used [WHO 46th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances] ISO 11615:2012(E)
communication controller Part of a medical device system (MDS) responsible for communications. ISO/IEEE 11073-10201:2004(E)
communication party Actor of the problem domain that participates in the communication in that

domain.

ISO/IEEE 11073-10201:2004(E)
communication role Role of a party in a communication situation defining the party’s behavior in the

communication. Associated with a communication role is a set of services that the party provides to other

parties.

ISO/IEEE 11073-10201:2004(E)
compatibility capability of a functional unit to meet the requirements of a specified interface without appreciable modification

[ENV 12443:1996]

ISO/TR 17119:2005(E)
compliance the action of doing what is necessary to meet a specified requirement ISO/TS 14441:2013(E)
compliance assessment processes by which an organization confirms that the information security controls put in place remain both

operational and effective

NOTE Legal compliance relates specifically to the security controls put in place to deliver the requirements of

relevant legislation such as the European Union Directive on the protection of personal data.

ISO/TR 11633-1:2009(E)
compliance assessment processes by which an organization confirms that the information security controls put in place remain both

operational and effective

NOTE Legal compliance relates specifically to the security controls put in place to deliver the requirements of

relevant legislation such as the European Union Directive on the protection of personal data.

ISO/TR 11633-2:2009(E)
component intended constituent of a specified substance EXAMPLE Dimethicone and silicon dioxide are components of simethicone. Human insulin protamine and zinc are the components in human insulin isophane. ISO 11238:2012(E)
Component single data element or data elements that express a finer aggregation or extension of data elements that

precede it

ISO 18812:2003(E)
composer agent (party, device or software) responsible for creating, synthesising or organizing information that is

committed to an electronic health record

NOTE This agent takes responsibility for its inclusion in that electronic health record, even if not the originator of it

and even if not the committer of it.

ISO 13606 -1:2008(E)
composer agent (party, device or software) responsible for creating, synthesising or organizing information that is

committed to an electronic health record

ISO 13606-3:2009(E)
composite characteristic qualifier

representation of a characteristic (A.3.2.4)

EXAMPLE hasCause Bacteria; Location = LeftUpperLobeOfLung.

NOTE 1 Typically expressed by a semantic link (2.2.3) and a characterizing concept (2.2.2).

NOTE 2 Can be compared to an attribute-value pair in a compositional system (2.5.2).

NOTE 3 A qualifier often denotes characteristics with a small simple characterizing generic concept (2.3.3), such as

laterality (left or right), or severity (low, moderate, high).

ISO 17115:2007(E)
composite characteristic qualifier

formal representation of a characteristic (2.6)

EXAMPLE hasCause Bacteria; Location = LeftUpperLobeOfLung.

NOTE 1 Adapted from ISO 17115:2007, definition 2.2.1.

NOTE 2 Can be compared to an attribute-value pair.

ISO/TS 22789:2010(E)
composite video type of video signal in which all information — the red, blue, and green signals, and sometimes audio signals as well,

are mixed together

NOTE Composite video is used by NTSC-compliant devices (see NTSC Standard).

ISO TR 16056-1:2004(E)
composite video type of video signal in which all information — the red, blue, and green signals, and sometimes audio signals as well,

are mixed together

NOTE Composite video is used by NTSC-compliant devices (see NTSC Standard).

ISO TR 16056-2:2004(E)
composite video a video signal combining luminance, chrominance and synchronization data on a single coax cable using RCA

connectors and color-coded yellow

ISO TS 16058:2004(E)
COMPOSITION sub-class of RECORD_COMPONENT in the EN13606 Reference Model that contains the set of

RECORD_COMPONENTS composed (authored) during one user’s clinical session or record interaction, for

committal within one HER

[ENV 13606-1[6]]

ISO/TR 20514:2005(E)
composition stoichiometry quantitative relationships between the chemical elements or moieties that make up a substance EXAMPLE Sodium phosphate dibasic heptahydrate and sodium phosphate dibasic dihydrate are defined as different substances. ISO 11238:2012(E)
compositional concept representation intensional definition (A.3.3.2) of a concept (A.3.2.1) using as delimiting characteristics (A.3.2.7) one or

more composite characteristics (2.2.1)

NOTE This allows inference and subsumption within a compositional system (2.5.2). It is usually expressed in a

formalism, such as description logic.

ISO 17115:2007(E)
compositional concept representation intensional definition of a concept (2.9) using as delimiting characteristics one or more composite

characteristics (2.7)

[ISO 17115:2007, definition 2.4.1]

NOTE Allows inference and subsumption within a compositional system. Usually expressed in a formalism, such as

description logic.

ISO/TS 22789:2010(E)
compositional system system that supports the creation of compositional concept representations (2.4.1)

2.5.3

formal

ISO 17115:2007(E)
compute engine See: manager ISO/IEEE

11073-10420

compute engine See: manager ISO/IEEE 11073-10407:2010(E)
compute engine See: manager. ISO/IEEE 11073-10408:2010(E)
compute engine See: manager. ISO/IEEE 11073-10415:2010(E)
compute engine See: manager. ISO/IEEE 11073-10421:2012(E)
compute engine See: manager. ISO/IEEE 11073-10425:2016(E)
compute engine See: manager. ISO/IEEE 11073-10472:2012(E)
compute engine See: manager ISO/IEEE 11073-20601:2016(E)
compute engine See: manager ISO_IEEE_11073-10417_2015
computer processable information Information  which can be programmatically created, stored, manipulated, and retrieved in an electronic

computer

ISO/TR 20514:2005(E)
concept unit of knowledge constructed through combining characteristics expressed in words ISO 11615:2012(E)
concept unit of knowledge created by a unique combination of characteristics

[ISO 1087-1:2000, definition 3.2.1]

NOTE Concepts are not necessarily bound to particular languages. They are, however, influenced by the social or

cultural background, often leading to different categorizations.

ISO 13606-2:2008(E)
concept unitary mental representation of a real or abstract thing; an atomic unit of thought

NOTE 1 It should be unique in a given code system.

NOTE 2 A concept can have synonyms in terms of representation and it can be a primitive or compositional term.

ISO 21090:2011(E)
concept units of thought constituted through abstraction on the basis of properties common to a set of objects

[ENV 12443:1999]

ISO/TR 13054:2012(E)
concept units of thought constituted through abstraction on the basis of properties common to a set of objects

[ENV 12443:1996]

ISO/TR 17119:2005(E)
concept unit of knowledge created by a unique combination of characteristics

[SOURCE: ISO 1087‑1:2000]

ISO/TS 13972:2015(E)
concept unit of knowledge created by a unique combination of characteristics

[SOURCE: ISO 1087‑1:2000, definition 3.2.1]

ISO/TS 16277-1:2015(E)
concept unit of knowledge created by a unique combination of characteristics

[SOURCE: ISO 1087‑1:2000]

Note 1 to entry: A concept can be represented using one or more terms, pictures, icons, or sounds.

Note 2 to entry: Informally, the term “concept” is often used when what is meant is “concept representation”.

However, this leads to confusion when precise meanings are required. Concepts arise out of human individual

and social conceptualizations of the world around them. Concept representations are artefacts constructed of

symbols. [SOURCE: ISO 17115].

Note 3 to entry: Concepts are not necessarily bound to particular languages. They are, however, influenced by the

social or cultural background which often leads to different categorizations. [SOURCE: ISO 1087-1:2000]

Note 4 to entry: For the purposes of health informatics glossaries, a term (in a given language and context) is

considered to represent a concept uniquely and therefore, term and concept are synonymous in their intent.

These words are not synonyms in a terminological resource context.

ISO/TS 17439:2014(E)
concept unit of knowledge created by a unique combination of characteristics

[SOURCE: ISO 1087‑1:2000, 3.2.1]

ISO/TS 18790-1:2015(E)
concept unit of knowledge created by a unique combination of characteristics

[SOURCE: ISO 1087‑1:2000, 3.2.1, modified]

ISO/TS 19256:2016(E)
concept unit of knowledge created by a unique combination of characteristics

[ISO 1087-1:2000, definition 3.2.1]

ISO/TS 22789:2010(E)
concept analysis formal linguistic strategy that allows the defining attributes or characteristics of a concept to be examined

[SOURCE: Walker LO Avant KC (1988). Strategies for Theory Construction in Nursing. 2nd edition.

Norwalk/ San Mateo, Appleton and Lange]

ISO/TS 13972:2015(E)
concept definition description of the attributes of a concept to delineate the meaning ISO/TS 13972:2015(E)
concept name canonical expression

term (A.3.4.3) which uniquely designates a concept (A.3.2.1) within a concept system (A.3.2.11)

EXAMPLE 1 Machine readable: <Inflammation that <hasCause Bacteria hasLocation Lung>> (with compositional

characteristics sorted alphabetically after semantic link) instead of <pulmonaryInfection that hasCause Bacteria>.

EXAMPLE 2 General language: Inflammation that has cause bacteria and has location lung (with compositional

characteristics sorted alphabetically after semantic link) instead of pulmonary infection that has cause bacteria.

NOTE 1 It is the preferred expression to represent a concept (A.3.2.1) in a given terminology system.

NOTE 2 It is unique within the system and unambiguous.

ISO 17115:2007(E)
concept system system of concepts

set of concepts (2.9) structured according to the relations among them

[ISO 1087-1:2000, definition 3.2.11]

ISO/TS 22789:2010(E)
conceptual model describes common concepts and their relationships particularly in order to facilitate exchange of

information between parties within a specific domain of healthcare

[SOURCE: ENV 1613 CR 12587]

ISO/TS 13972:2015(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities or

processes

[ISO 7498-2:1989]

ISO 13606 -1:2008(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities, or processes

[ISO 7498-2:1989, definition 3.3.16]

ISO 13606-5:2010(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities, or

processes

[ISO 7498‑2]

ISO 21091:2013(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities or

processes

[SOURCE: ISO 7498‑2:1989, definition 3.3.16]

ISO 21549-3:2014(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities or processes

[ISO 7498-2:1989, definition 3.3.16]

ISO 21549-7:2007(E)
Confidentiality property that information is not made available or disclosed to unauthorized individuals, entities or processes ISO 27789:2013(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities or processes

[ISO/IEC 13335-1:2004, definition 2.6]

ISO/TR 11633-1:2009(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities or processes

[ISO 13335-1:2004, definition 2.6]

ISO/TR 11633-2:2009(E)
confidentiality process that ensures that information is accessible only to those authorized to have access ISO/TS 13606-4:2009(E)
confidentiality process that ensures that information is not made available or disclosed to unauthorized individuals, entities or processes

NOTE Adapted from ISO/TS 13606-4:2009.

ISO/TS 14265:2011(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities, or

processes

[SOURCE: ISO 7498‑2:1989, definition 3.3.16]

ISO/TS 14441:2013(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities, or processes

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
Confidentiality the property of data that indicates the extent to which these data have not been made available or disclosed to

unauthorized individuals, processes, or other entities

ISO/TS 18308:2004(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities, or processes

ISO 7498-2:1989, definition 3.3.16.

ISO/TS 21547:2010(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities or processes

[ISO 7498-2, definition 3.3.16]

ISO/TS 22600-1:2006(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities or processes

[ISO 7498-2, definition 3.3.16]

ISO/TS 22600-2:2006(E)
confidentiality property indicating that information is not made available or disclosed to unauthorized individuals, entities or

processes

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities or processes

[ISO 7498-2:1989, definition 3.3.16]

ISO/TS 25237:2008(E)
confidentiality property that information is not made available or disclosed to unauthorized individuals, entities or processes ISO/TS 27790:2009(E)
confirmed An application-level, completion notification service mechanism. For EVENT REPORT

services (i.e., the data plane), confirmation allows the agent to know when the manager has “accepted

responsibility” for a piece of data so that the agent can delete that piece of data. For the ACTION, GET,

and SET services (i.e., the control plane), confirmation allows the manager to know when the agent has

“completed” the requested transaction.

ISO/IEEE 11073-20601:2016(E)
confirming process whereby a trained and experienced cardiologist reviews the computer-generated (or overread) interpretation of an ECG in order to confirm the computer-generated (or overread) interpretation or to make the final changes to the interpretation text ISO 11073-91064:2009(E)
conformance fulfilment of a product, process or service of specified requirements ISO 10781:2015(E)
conformance fulfillment of a specified requirement; adherence of an information processing entity to the requirements of one

or more specific specifications or standards

ISO 21090:2011(E)
conformance fulfillment of a product, process, or service of specified requirements ISO/HL7 16527:2016(E)
conformance clause section of a specification that defines the requirements, criteria or conditions to be satisfied in order to claim conformance ISO 10781:2015(E)
conformance clause section of a specification that defines the requirements, criteria, or conditions to be satisfied in order to

claim conformance

ISO/HL7 16527:2016(E)
conformance criteria requirements indicating the behaviour, action and/or capability that constitutes implementation of the function ISO 10781:2015(E)
conformance criteria requirements indicating the behavior, action, or capability that constitutes implementation of the

function

ISO/HL7 16527:2016(E)
conformance statement description of the functions in an EHR system that have been implemented, reflecting the degree to which an EHR system has met the functional profile’s requirements and which may include optional functions and information ISO 10781:2015(E)
conformance statement description of the function in a PHR system that has been implemented. It reflects the degree to which

a PHR system has met the functional profile’s requirements and may include optional functions and

information

ISO/HL7 16527:2016(E)
conformity assessment demonstration that specified requirements relating to a product, process, system, person or body are fulfilled

NOTE Conformity to a set of specifications is a prerequisite to interoperability. However, conformity to the specifications

alone does not guarantee interoperability of systems.

ISO TR 16056-1:2004(E)
conformity assessment demonstration that specified requirements relating to a product, process, system, person or body are fulfilled

NOTE Conformity to a set of specifications is a prerequisite to interoperability. However, conformity to the specifications

alone does not guarantee interoperability of systems.

ISO TR 16056-2:2004(E)
conformity assessment demonstration that specified requirements relating to a product, process, system, person or body are fulfilled ISO TS 16058:2004(E)
conformity assessment demonstration that specified requirements relating to a product, process, system, person or organization

are fulfilled

Note 1 to entry: Adapted from ISO/IEC 17000:2004, definition 2.1.

ISO/TS 14441:2013(E)
conformity assessment system rules, procedures and management for carrying out conformity assessment

Note 1 to entry: Conformity assessment systems may be operated at international, regional, national or subnational

level.

[SOURCE: ISO/IEC 17000:2004, definition 2.7]

ISO/TS 14441:2013(E)
connection In an information model, a specified relationship between two classes . ISO 21731:2006(E) & ANSI/HL7 RIM R1
Connectivity Industry Consortium (CIC) A consortium, no longer in existence, that was organized

to specify, recommend, and develop communication protocols for point-of-care (POC) diagnostic medical

devices.

ISO/IEEE 11073-30300:2004(E)
consent freely given specific and informed indication of a subject’s agreement to personal data relating to him/her being processed ISO/TS 14265:2011(E)
consent agreement, approval or permission as to some act given voluntarily by a competent person

[SOURCE: Black’s Law Dictionary, 2008]

ISO/TS 17975:2015(E)
consent special policy which defines an agreement between an entity playing the role of the subject of an act and an

entity acting

ISO/TS 22600-3:2009(E)
constituent substance present within a specified substance NOTE Constituents can be impurities, degradants, active markers or signature substances, or single substances mixed together to form a product. Constituents shall have an associated role and amount. Constituent specifications shall be used to describe components as well as limits on impurities or related substances for a given material. ISO 11238:2012(E)
Constraint logical expression that limits (or constrains) the values in a set of related objects to a logically related subset of that set ISO/HL7 27951:2009(E)
Constraint logical expression that limits (or constrains) the values in a set of related objects to a logically related subset of that set ISO/HL7 27951:2009(E)
constraint A restriction on the set of values being assigned. ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
consumer individual who may become a subject of care ISO/TR 20514:2005(E)
consumer person requiring, scheduled to receive, receiving or having received a healthcare service ISO/TS 27790:2009(E)
consumer (in relation to healthcare services) a person requiring, scheduled to receive, receiving or having received a healthcare service ISO/TS 18308:2004(E)
container item of packaging that is part of a medicinal product and is used for storage, identification and/or transport of the components of the medicinal product ISO 11239:2012(E)
container item of packaging that is part of a Medicinal Product and is used for storage, identification and/or transport of the components of the Medicinal Product ISO 11615:2012(E)
content information set of information that is the original target for preserving ISO/TS 21547:2010(E)
content-encryption key cryptographic key used to encrypt the content of a communication ISO/TS 25237:2008(E)
context units of thought constituted through abstraction on the basis of properties common to a set of objects

[ENV 12443:1996]

ISO/TR 17119:2005(E)
context related conditions and situations that provide a useful understanding and meaning of a subject

[SOURCE: ISO/TR 17119:2005]

ISO/TS 13972:2015(E)
context text which defines the use case, situation, or environment of a specific definition for a term

EXAMPLE Noun, verb, country (e.g. UK), area of healthcare (e.g. Pharmacy), or organization (e.g. HL7).

Note 1 to entry: This definition differs from ISO 1087-1:2000 as there is a business need in the environment of

standards development organizations sharing health informatics glossary content to make context explicit and to

move towards having a single definition for a term in a specified context.

ISO/TS 17439:2014(E)
context related conditions and situations that provide a useful understanding and meaning of a subject

[SOURCE: ISO/TR 17119:2005, 2.4]

ISO/TS 19256:2016(E)
continuity of care component of patient care quality consisting of the degree to which the care needed by a patient is

coordinated among practitioners and across organizations and time

[SOURCE: ISO/TR 18307:2001]

ISO/TS 13972:2015(E)
continuous glucose monitor (CGM) A medical device to provide a series of estimates of blood glucose

concentration; typically from body fluid.

ISO/IEEE 11073-10425:2016(E)
contribution set of record components committed by one user at one point in time in the electronic health record of one

subject of care

ISO 13606 -1:2008(E)
controlled health terminology set of terms intended for clinical use

NOTE This implies enough content and structure to provide a representation capable of encoding comparable data, at a

granularity consistent with that generated by the practice within the domain being represented, within the purpose and scope of

the terminology.

ISO/TS 17117:2002(E)
controlled vocabulary finite set of values that represent the only allowed values for a data item NOTE 1 The allowed values can be codes, text or numeric. NOTE 2 Adapted from CDISC Clinical Research Glossary V8.0, 2009. ISO 11238:2012(E)
controlled vocabulary finite set of values that represent the only allowed values for a data item ISO 11239:2012(E)
controlled vocabulary controlled terminology finite set of values that represent the only allowed values for a data item NOTE 1 The allowed values can be codes, text, or numeric. NOTE 2 Adapted from CDISC Clinical Research Glossary V8.0, 2009. ISO 11240:2012(E)
controlled vocabulary finite set of values that represent the only allowed values for a data item NOTE The allowed values can be codes, text or numeric. [CDISC Clinical Research Glossary V8.0, 2009] ISO 11615:2012(E)
controlled vocabulary finite set of values that represent the only allowed values for a data item NOTE These values may be codes, text, or numeric. [CDISC Clinical Research Glossary V8.0, 2009] ISO 11616:2012(E)
controlled vocabulary term identifier concept identifier intended to be used as the preferred unique identifier for that concept in that code system and which is published by the author of a code system ISO 11239:2012(E)
controller natural or legal person, public authority, agency or any other body which alone or jointly with others

determines the purposes and means of the processing of personal data

ISO/TS 25237:2008(E)
controller natural or legal person, public authority, agency or any other body that, alone or jointly with others, determines

the purposes and means of the processing of personal data

ISO/TS 27790:2009(E)
conversion factor between units ratio of two measurement units for quantities of the same kind NOTE Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
Coordinated Universal Time

UTC

time scale which forms the basis of a coordinated radio dissemination of standard frequencies and time signals; it corresponds exactly in rate with international atomic time, but differs from it by an integral number of seconds ISO 27789:2013(E)
copolymer polymer with more than one type of structural repeating unit linked through covalent bonds ISO 11238:2012(E)
copy number variation

CNV

variation in the number of copies of one or more sections of the DNA ISO/TS 20428:2017(E)
corollary a semantic and a syntactical representation that are correlated by a unique code. ISO/IEEE 11073-10101:2004(E)
country code that identifies the country of origin of the device issuer

NOTE This may not necessarily be the same as the nationality of the device holder.

ISO 21549-2:2004(E)
credential prerequisite for the entitlement of, or the eligibility for, a role ISO/TS 22600-2:2006(E)
credential information describing the security attributes (identity or privilege or both) of a principal, which is a prerequisite

for the entitlement of, or the eligibility for, a role

NOTE Credentials are claimed through authentication or delegation and used by access control.

ISO/TS 22600-3:2009(E)
critical process step manufacturing step necessary for production of a specified substance ISO 11238:2012(E)
CRL distribution point directory entry or other distribution source for CRLs

NOTE A CRL distributed through a CRL distribution point may contain revocation entries for only a subset of the full

set of certificates issued by one CA or may contain revocation entries for multiple CAs.

ISO/TS 22600-3:2009(E)
cryptographic algorithm

cipher

method for the transformation of data in order to hide its information content, prevent its undetected modification

and/or prevent its unauthorized use

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
cryptographic algorithm

cipher

method for the transformation of data in order to hide its information content, prevent its undetected

modification and/or prevent its unauthorized use

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
cryptographic algorithm ciphermethod for the transformation of data in order to hide its information content, prevent its undetected

modification and/or prevent its unauthorized use

ISO/TS 25237:2008(E)
cryptographic system

cryptosystem

collection of transformations from plaintext into ciphertext and vice versa, the particular transformation(s) to be

used being selected by keys

NOTE The transformations are normally defined by a mathematical algorithm.

ISO/TS 22600-3:2009(E)
cryptography discipline which embodies principles, means and methods for the transformation of data in order to hide its

information content, prevent its undetected modification and/or prevent its unauthorized use

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
cryptography discipline which embodies principles, means and methods for the transformation of data in order to hide its

information content, prevent its undetected modification and/or prevent its unauthorized use

ISO 7498-2:1989, definition 3.3.20.

ISO/TS 21547:2010(E)
cryptography discipline which embodies principles, means, and methods for the transformation of data in order to hide its

information content, prevent its undetected modification and/or prevent its unauthorized use

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
cryptography discipline which embodies principles, means and methods for the transformation of data in order to hide its

information content, prevent its undetected modification and/or prevent its unauthorized use

[ISO 7498-2:1989, definition 3.3.20]

ISO/TS 25237:2008(E)
CSE Project project supported by DG XII of the European Commission aiming at the development of Common Standards for (Quantitative) Electrocardiography ISO 11073-91064:2009(E)
CTS Combined Terminology Services ISO 11239:2012(E)
cyclic redundancy check (CRC) The result of a calculation carried out on the octets within an IrLAP

frame; also called a frame check sequence. The CRC is appended to the transmitted frame. At the receiver,

the calculation creating the CRC may be repeated, and the result compared to that encoded in the signal.

Syn: frame check sequence.

ISO/IEEE 11073-30200:2004(E)
cyclic redundancy check (CRC) The result of a calculation carried out on the octets within an

Infrared Link Access Protocol (IrLAP) frame; it is also called a frame check sequence (FCS). The CRC is

appended to the transmitted frame. At the receiver, the calculation creating the CRC may be repeated, and

the result compared to that encoded in the signal.

ISO/IEEE 11073-30300:2004(E)
dashboard user interface based on predetermined reports, indicators and data fields, upon which the end user can apply

filters and graphical display methods to answer predetermined business questions and which is suited to

regular use with minimal training

ISO/TS 29585:2010(E)
data “raw” alphanumeric text, objects, and symbols defined without any context in such a way that by itself one

cannot tell its correct meaning

ISO/TR 17119:2005(E)
data reinterpretable representation of information in a formalized manner suitable for communication,

interpretation or processing

[SOURCE: ISO/IEC 2382‑1:1993]

ISO/TS 13972:2015(E)
data “raw” alphanumeric text, objects, and symbols defined without any context in such a way that by itself

one cannot tell its correct meaning

[SOURCE: ISO/TR 17119:2005, 2.5]

ISO/TS 18790-1:2015(E)
data reinterpretable representation of information in a formalized manner suitable for communication, interpretation or processing

[SOURCE: ISO/IEC 2382:2015, 2121272, modified]

ISO/TS 19256:2016(E)
data re-interpretable representation of information in a formalized manner suitable for communication,

interpretation or processing

ISO/TS 21547:2010(E)
data agent As a medical device, a patient data acquisition system that provides the acquired data for

other devices.

ISO/IEEE 11073-10201:2004(E)
data aggregation a process by which information is collected, manipulated and expressed in summary form. Data aggregation is primarily performed for reporting purposes, policy development, health service management, research, statistical analysis, and population health studies ISO/TS 18308:2004(E)
data aggregation process by which information is collected, manipulated and expressed in summary form

NOTE Data aggregation is primarily performed for reporting purposes, policy development, health service

management, research, statistical analysis and population health studies.

ISO/TS 27790:2009(E)
data capture deliberate action which results in the registration of a record into a record keeping system ISO/TS 18530:2014(E)
data confidentiality service that can be used to provide for protection of data from unauthorized disclosure

NOTE The data confidentiality service is supported by the authentication framework. It can be used to protect against

data interception.

ISO/TS 22600-3:2009(E)
data destruction operation that results in the permanent, unrecoverable removal of information about a subject from memory or storage

EXAMPLE Data destruction can be performed by multiple overwrites with a series of random bits.

ISO/TS 14265:2011(E)
data dictionary database used for data that refer to the use and structure of other data, i.e. a database for the storage of

metadata

ISO/TS 29585:2010(E)
data element unit of data that is considered, in context, to be indivisible

[SOURCE: ISO/IEC 14957:2010]

ISO/TS 13972:2015(E)
data format Arrangement of data in a file or stream. ISO/IEEE 11073-10201:2004(E)
data format arrangement of data in a file or stream ISO/TS 27790:2009(E)
data integrity property that data has not been altered or destroyed in an unauthorized manner

[ISO 7498‑2]

ISO 21091:2013(E)
data integrity the property that data have not been altered or destroyed in an unauthorized manner

[ISO 7498-2:1989]

ISO 21549-2:2004(E)
data integrity property that data has not been altered or destroyed in an unauthorized manner

[ISO 7498-2:1989, definition 3.3.21]

ISO 21549-7:2007(E)
data integrity property that data have not been altered or destroyed in an unauthorized manner ISO 27789:2013(E)
data integrity property that data have not been altered or destroyed in an unauthorized manner

[ISO/IEC 9797-1:1999, definition 3.1.1]

ISO/TR 11633-1:2009(E)
data integrity property that data have not been altered or destroyed in an unauthorized manner

[ISO/IEC 9797-1:1999, definition 3.1.1]

ISO/TR 11633-2:2009(E)
data integrity property that data has not been altered or destroyed in an unauthorized manner

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
data integrity property that data have not been altered or destroyed in an unauthorized manner

ISO 7498-2:1989, definition 3.3.21.

ISO/TS 21547:2010(E)
data integrity property that data has not been altered or destroyed in an unauthorized manner

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
data integrity property that data have not been altered or destroyed in an unauthorized manner

[ISO 7498-2:1989, definition 3.3.21]

ISO/TS 25237:2008(E)
data integrity property that data have not been altered or destroyed in an unauthorized manner

[ISO 7498-2:1989, definition 3.3.21]

ISO/TS 27790:2009(E)
data item expression of a single data element or a composite data element represented in a specific format and

identified by the preceding field tag

[SOURCE: ISO 15022‑1:1999]

ISO/TS 13972:2015(E)
data linking matching and combining data from multiple databases ISO/TS 25237:2008(E)
data logger A medical device that is functioning in its capacity as a data storage and archival system. ISO/IEEE 11073-10201:2004(E)
data manager (DM) Typically, a network server that performs such functions as point-of-care

(POC) data storage and forwarding, quality assurance and quality control, and other POC instrument and

data management functions.

ISO/IEEE 11073-30300:2004(E)
data mart subject area of interest within the data warehouse (3.6)

EXAMPLE An inpatient data mart.

NOTE Data marts can also exist as a standalone database tuned for query and analysis, independent of a data

warehouse.

ISO/TS 29585:2010(E)
data object collection of data that has a natural grouping and may be identified as a complete entity ISO 21549-1:2004(E)
data object collection of data that has a natural grouping and may be identified as a complete entity ISO 21549-2:2004(E)
data object collection of data that has a natural grouping and may be identified as a complete entity ISO 21549-7:2007(E)
data object collection of data that have a natural grouping and may be identified as a complete entity ISO/TS 27790:2009(E)
data origin authentication corroboration that the source of data received is as claimed

[SOURCE: ISO 7498‑2:1989, definition 3.3.22]

ISO 21549-3:2014(E)
data origin authentication corroboration that the source of data received is as claimed

[ISO 7498-2:1989, definition 3.3.22]

ISO 21549-7:2007(E)
data origin authentication corroboration that the source of data received is as claimed

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
data origin authentication corroboration that the source of data received is as claimed

ISO 7498-2:1989, definition 3.3.22.

ISO/TS 21547:2010(E)
data origin authentication corroboration that the source of data received is as claimed

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
data protection technical and social regimen for negotiating, managing, and ensuring informational privacy, confidentiality, and security

[ISO/TS 25237:2008, definition 3.15]

ISO/TS 14265:2011(E)
data protection technical and social regimen for negotiating, managing and ensuring informational privacy, confidentiality and

security

ISO/TS 25237:2008(E)
data service unit

DSU

device used in digital transmission for connecting a CSU to data terminal equipment (a terminal or computer), in the

same way that a modem is used for connection to an analogue medium

Note See also CSU.

ISO TR 16056-1:2004(E)
data service unit

DSU

device used in digital transmission for connecting a CSU to data terminal equipment (a terminal or computer), in the

same way that a modem is used for connection to an analogue medium

Note See also CSU.

ISO TR 16056-2:2004(E)
data structure Manner in which application entities construct the data set information resulting from

the use of an information object.

ISO/IEEE 11073-10201:2004(E)
data structure manner in which application entities construct the data set information resulting from the use of an information

object

ISO/TS 27790:2009(E)
data subject identified or identifiable natural person, who is the subject of personal data ISO/TS 14265:2011(E)
data subject person to whom data refer

Note 1 to entry: In this Technical Specification, a data subject refers to a single person (versus persons).

ISO/TS 14441:2013(E)
data subject identified or identifiable natural person that is the subject of personal data

Note 1 to entry: With the Collection (3.4) of their data, a subject of care (3.32) automatically becomes a data subject.

[SOURCE: ISO/TS 14265:2011, 2.10]

ISO/TS 17975:2015(E)
data subject’s consent any freely given specific and informed indication of his wishes by which the data subject signifies his

agreement to personal data relating to him being processed

ISO/TS 27790:2009(E)
data sub-object component of a data object that itself may be identified as a discrete entity ISO 21549-2:2004(E)
data type The structural format of the data carried in an attribute. It may constrain the set of values an attribute may

assume.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
data type set of distinct values, characterized by properties of those values and by operations on those values

[SOURCE: ISO/IEC 11404:2007]

ISO/TS 13972:2015(E)
data use handling or dealing with information for a specific purpose

NOTE This includes reproducing the information but does not include disclosing the information.

ISO/TS 14265:2011(E)
data validation a process used to determine if data are accurate, complete, or meet specified criteria ISO/TS 18308:2004(E)
data validation process used to determine if data are accurate, complete or meet specified criteria ISO/TS 27790:2009(E)
data warehouse subject-oriented, integrated, time-variant and non-volatile collection of data

NOTE See Reference [5].

ISO/TS 29585:2010(E)
data warehouse dimension subject-oriented, often hierarchical business relevant grouping of data ISO/TS 29585:2010(E)
data-subjects persons to whom data refer ISO/TS 25237:2008(E)
datatype set of distinct values, characterized by properties of those values, and by operations on those values [ISO 11404:2007, definition 3.12] ISO 11615:2012(E)
datatype set of distinct values, characterized by properties of those values, and by operations on those values ISO 21090:2011(E)
dbSNP database of SNPs provided by the US National Center for Biotechnology Information (NCBI)

Note 1 to entry: https:// www .ncbi .nlm .nih .gov/ SNP/ .

ISO/TS 20428:2017(E)
decentralized multipoint conference demonstration that specified requirements relating to a product, process, system, person or body are fulfilled

NOTE Conformity to a set of specifications is a prerequisite to interoperability. However, conformity to the specifications

alone does not guarantee interoperability of systems.

ISO TR 16056-1:2004(E)
decentralized multipoint conference conference in which the participating terminals multicast to all other participating terminals without an MCU ISO TR 16056-2:2004(E)
decentralized multipoint conference a conference in which the participating terminals multicast to all other participating terminals without an MCU ISO TS 16058:2004(E)
decipherment

decryption

process of obtaining, from a ciphertext, the original corresponding data

[ISO/IEC 2382-8:1989]

NOTE A ciphertext may be enciphered a second time, in which case a single decipherment does not produce the original

plaintext.

ISO/TS 17090-1:2002(E)
decipherment

decryption

process of obtaining, from a ciphertext, the original corresponding data

NOTE 1 A ciphertext may be enciphered a second time, in which case a single decipherment does not produce the

original plaintext.

NOTE 2 Adapted from ISO/IEC 2382-8:1998.

ISO/TS 22600-3:2009(E)
decipherment

decryption

process of obtaining, from a ciphertext, the original corresponding data

[ISO/IEC 2382-8:1998, definition 08-03-04]

NOTE A ciphertext can be enciphered a second time, in which case a single decipherment does not produce the

original plaintext.

ISO/TS 25237:2008(E)
decryption process of obtaining, from a cipher text, the original corresponding data

ISO/IEC 2382-8:1998, definition 08-03-04.

ISO/TS 21547:2010(E)
definition representation of a concept by a descriptive statement which services to differentiate it from related

concepts

[SOURCE: ISO 1087‑1:2000]

ISO/TS 17439:2014(E)
degree of polymerization number of structural repeating units in a polymeric block or chain NOTE Applies to both homopolymers and block copolymers where it refers to the degree of polymerization within a block. ISO 11238:2012(E)
de-identification general term for any process of removing the association between a set of identifying data and the data subject

[ISO/TS 25237:2008, definition 3.18]

ISO/TS 14265:2011(E)
de-identification general term for any process of removing the association between a set of identifying data and the data

subject

ISO/TS 25237:2008(E)
delegation conveyance of privilege from one entity that holds such privilege, to another entity ISO/TS 22600-1:2006(E)
delegation conveyance of privilege from one entity that holds such privilege, to another entity ISO/TS 22600-2:2006(E)
delegation conveyance of privilege from one entity that holds such a privilege to another entity ISO/TS 22600-3:2009(E)
delegation path ordered sequence of certificates which, together with authentication of a privilege asserter’s identity, can be

processed to verify the authenticity of a privilege asserter’s privilege

ISO/TS 22600-2:2006(E)
delegation path ordered sequence of certificates which, together with authentication of a privilege asserter’s identity, can be

processed to verify the authenticity of a privilege asserter’s privilege

ISO/TS 22600-3:2009(E)
deletion mutation in which a part of a chromosome or a sequence of DNA is lost during DNA replication ISO/TS 20428:2017(E)
delta CRL

dCRL

partial revocation list that only contains entries for certificates that have had their revocation status changed

since the issuance of the referenced base CRL

ISO/TS 22600-3:2009(E)
Denial refusal of Informational Consent (3.20)

Note 1 to entry: Denial is sometimes called Dissent (3.9). Denial can apply to the Collection (3.4), Use (3.33) and/or

Disclosure (3.8) of data for all or some specific data and/or Purpose(s) of Use as specified by the subject of care (3.32).

ISO/TS 17975:2015(E)
deoxyribonucleic acid

DNA

molecule that encodes genetic information in the nucleus of cells

[SOURCE: ISO 25720:2009, 4.7]

ISO/TS 20428:2017(E)
derived functional profile functional domain or companion profile that is created from a base functional profile (i.e. child functional domain profile to children’s hospital domain profile) ISO 10781:2015(E)
derived functional profile functional profile that is created from a base functional profile, also known as a child functional profile ISO/HL7 16527:2016(E)
derived unit measurement unit for a derived quantity NOTE Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
designation symbolic representation of a concept NOTE Adapted from ISO 1087-1:2000. ISO 11616:2012(E)
designation representation of a concept by a sign which denotes it

[SOURCE: ISO 1087‑1:2000]

ISO/TS 17439:2014(E)
Detailed Clinical Model

DCM

logical model designed to express one or more clinical concepts and their context in a standardized and

reusable manner, specifying the requirements for clinical information as a discrete set of logical clinical

data elements

ISO/TS 13972:2015(E)
device A term used to refer to a physical apparatus implementing either an agent or a manager role. ISO/IEEE

11073-10420

device A term used to refer to a physical apparatus implementing either an agent or a manager role. ISO/IEEE 11073-00103:2015(E)
device A term used to refer to a physical apparatus implementing either an agent or a manager role. ISO/IEEE 11073-10406:2012(E)
device A term used to refer to a physical apparatus implementing either an agent or a manager role. ISO/IEEE 11073-10407:2010(E)
device A term used to refer to a physical apparatus implementing either an agent or a manager role. ISO/IEEE 11073-10408:2010(E)
device A term used to refer to a physical apparatus implementing either an agent or a manager role. ISO/IEEE 11073-10415:2010(E)
device A term used to refer to a physical apparatus implementing either an agent or a manager role. ISO/IEEE 11073-10421:2012(E)
device A term used to refer to a physical apparatus implementing either an agent or a manager role. ISO/IEEE 11073-10425:2016(E)
device A term used to refer to a physical apparatus implementing either an agent or a manager role. ISO/IEEE 11073-10472:2012(E)
device A physical device implementing either an agent or manager role. ISO/IEEE 11073-20601:2016(E)
device identifiable computer controlled apparatus or instrument that is the holder of a private encipherment key

NOTE 1 This includes the class of regulated medical devices that meet the above definition.

NOTE 2 Device, in this context, is any device used in healthcare information systems, including those without any direct role

in treatment or diagnosis.

ISO/TS 17090-1:2002(E)
device A term used to refer to a physical apparatus implementing either an agent or a manager role. ISO_IEEE_11073-10417_2015
device communications controller (DCC) A communications interface associated with a medical

device. A DCC may support one or more physically distinct devices acting as a single network communications

unit. Its purpose is to provide a point-to-point serial communication link to a BCC.

ISO/IEEE 11073-30200:2004(E)
device communications controller (DCC) A communications interface associated with a medical

device. A DCC may support one or more physically distinct devices acting as a single network communications

unit. Its purpose is to provide a point-to-point communication link to a bedside communications

controller (BCC).

ISO/IEEE 11073-30300:2004(E)
device communications controller (DCC) A communications interface associated with a medical

device. A DCC may support one or more physically distinct devices acting as a single network communications

unit. Its purpose is to provide a point-to-point serial communication link to a bedside communications

controller (BCC).

ISO/IEEE 11073-30400:2012(E)
device holder individual transporting a data card which contains a record with the individual identified as the major record

person

ISO 21549-2:2004(E)
device listing number

device model number

type of information which identifies a specific device ISO 11615:2012(E)
device manager In the context of this standard, a network server that gathers, processes, stores, and

forwards data from ISO/IEEE 11073 instruments and devices, typically using one or more networked access

points (APs).

NOTE—A device manager is not a required component for an ISO/IEEE 11073 compatible infrastructure.

ISO/IEEE 11073-30300:2004(E)
diastolic pressure This is minimum pressure achieved during the cardiac cycle. It is typically the

second and the lower of the readings given as the blood pressure.

ISO/IEEE 11073-10407:2010(E)
DICOM persistent object instance of a data object as defined by DICOM PS 3.3, which has been allocated a unique identifier in the

format specified for SOP Instance UID in DICOM PS 3.3 and has been chosen as an object to be saved

securely for some period of time

NOTE Within the DICOM Standard, a DICOM Persistent Object is referred to as a Composite Service Object Pair

(SOP) Instance.

ISO 17432:2004(E)
dictionary Description of the contents of the medical data information base (MDIB) containing vital

signs information, device information, demographics, and other elements of the MDIB.

ISO/IEEE 11073-10201:2004(E)
digital preservation storage, maintenance, and access to a digital object over a long time, usually as a consequence of applying

one or more preservation strategies

NOTE 1 Adapted from ELAG1) 2001.

NOTE 2 Preservation consists of processes and operations involved in ensuring the technical and intellectual survival

of authentic records through time (see ISO 15489-1).

ISO/TS 21547:2010(E)
digital signature data appended to, or a cryptographic transformation of, a data unit that allows a recipient of the data unit to

prove the source and integrity of the unit and protect against forgery e.g. by the recipient

[ISO 7498-2:1989, definition 3.3.16]

ISO 13606 -1:2008(E)
digital signature data appended to, or a cryptographic transformation of, a data unit that allows a recipient of the data unit to

prove the source and integrity of the unit and protect against forgery e.g. by the recipient

[ISO 7498-2:1989, definition 3.3.26]

ISO 13606-5:2010(E)
digital signature signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified

Note 1 to entry: Digital signatures employ a type of asymmetric cryptography. For messages sent through an insecure channel, a properly implemented digital signature gives the receiver reason to believe the message was sent by the claimed sender.

ISO 17523:2016(E)
digital signature data appended to, or a cryptographic transformation of, a data unit that allows a recipient of the data

unit to prove the source and integrity of the data unit and protect against forgery e.g. by the recipient

[ISO 7498‑2]

ISO 21091:2013(E)
digital signature data appended to, or a cryptographic transformation of a data unit that allows a recipient of the data unit to prove

the source and integrity of the data unit and protect against forgery, e.g. by the recipient

[ISO 7498-2:1989]

NOTE See cryptography.

ISO/TS 17090-1:2002(E)
digital signature data appended to, or a cryptographic transformation [see cryptography (3.2.9)] of a data unit that allows a

recipient of the data unit to prove the source and integrity of the data unit and protect against forgery, e.g. by

the recipient

ISO 7498-2:1989, definition 3.3.26.

ISO/TS 21547:2010(E)
digital signature data appended to, or a cryptographic transformation (see cryptography) of, a data unit that allows a recipient

of the data unit to prove the source and integrity of the data unit and protect against forgery, e.g. by the

recipient

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
dimension of a quantity quantity dimension expression of the dependence of a quantity on the base quantities of a system of quantities as a product of powers of factors corresponding to the base quantities, omitting any numerical factor NOTE Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
dimensionless quantity quantity of dimension one quantity for which all the exponents of the factors corresponding to the base quantities in its quantity dimension are zero NOTE 1 The term “dimensionless quantity” is commonly used and is kept here for historical reasons. It stems from the fact that all exponents are zero in the symbolic representation of the dimension for such quantities. The term “quantity of dimension one” reflects the convention in which the symbolic representation of the dimension for such quantities is the symbol 1 (see ISO 31-0:1992, 2.2.6). NOTE 2 Some quantities of dimension one are defined as the ratios of two quantities of the same kind. EXAMPLE 1 Plane angle, solid angle, refractive index, relative permeability, mass fraction, friction factor, Mach number. NOTE 3 Numbers of entities are quantities of dimension one. EXAMPLE 2 Number of turns in a coil, number of cells in a given sample, degeneracy of the energy levels of a quantum system. NOTE 4 Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
direct identifying data data that directly identifies a single individual

NOTE Direct identifiers are those data that can be used to identify a person without additional information or with

cross-linking through other information that is in the public domain.

ISO/TS 25237:2008(E)
directory organizational unit or container, used to organize folders and files into a hierarchical structure ISO/TS 21547:2010(E)
disclose reveal data to those not routinely authorized to have it ISO/TS 14265:2011(E)
Disclosure <of health information> divulging of or provision of access to data

[SOURCE: ISO/TS 25237:2008, 3.20]

Note 1 to entry: Whether the recipient actually looks at the data, takes them into knowledge or retains them is

irrelevant to whether Disclosure has occurred. Disclosure occurs inside the organization if the data are made

available to someone who is not authorized to have it, or it is used for a purpose not authorized. Disclosure is

justified if authorized. Disclosure is not justified if not authorized.

ISO/TS 17975:2015(E)
disclosure divulging of, or provision of access to, data

NOTE Whether the recipient actually looks at the data, takes them into knowledge, or retains them, is irrelevant to

whether disclosure has occurred.

ISO/TS 25237:2008(E)
discrete parameter Vital signs measurement that can be expressed as a single numeric or textual

value.

ISO/IEEE 11073-10201:2004(E)
discriminators: A mechanism to provide additional semantic refinement to multiple base terms. ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
disorder-TM condition which represents a set of dysfunction with associated manifestations and is often defined

by typical chief symptom, sequential pathological process-TM (3.3.3.3), body state-TM (3.3.3.1), or

aetiology according to TM-CJK theories

EXAMPLE <consumptive disorder>, <lung distention>, <heat wheezing>, <plum-pit qi>, <water distention>,

<qi strangury>.

Note 1 to entry: Disorder-TM may have multiple underlying causes, corresponding multiple patterns-TM (3.2.1),

and consequently multiple different treatments.

Note 2 to entry: It is useful to capture an individual health condition over time using a fixed concept (3.1.1) in

disorder-TM while pattern-TM may change over time.

Note 3 to entry: This concept (3.1.1) may be expressed by disease or disorder in English, 病 in Chinese and

Japanese, and 병 in Korean in TM-CJK related literature.

Note 4 to entry: This concept (3.1.1) is subcategories of clinical findings-TM and it can be used for

characterizing category (3.1.3) with semantic link (3.1.10) such as hasAssociatedPattern-TM (3.4.5) and

hasAssociatedFinding-TM (3.4.6).

ISO/TS 16277-1:2015(E)
dispense medication prepare and give out a medicinal product in accordance with a prescription

Note 1 to entry: This includes asessing the pharmaceutical appropriateness including decision support.

ISO/TS 16791:2014(E)
dispense record record of dispensed medicinal product and dispense process

Note 1 to entry: Dispensed medicinal product includes the actual product dispensed identifiers, brand, type, form, quantity etc. Dispense process record includes details of the delivery method, date and recipient (where this is not the subject of care) and the dispenser. The ability to record a comment where assessments of prescriptions are undertaken might also be part of this record.

ISO/TS 19256:2016(E)
dispenser healthcare professional authorized to dispense medicinal products ISO 17523:2016(E)
dispenser specialization of a more qualified healthcare person, which is a representation of an individual who has a

pharmacist status and who is filling/dispensing the prescription

ISO 21549-7:2007(E)
dispenser healthcare professional responsible for filling/dispensing prescriptions

Note 1 to entry: The dispenser is usually a pharmacist but can be other individuals according to local jurisdiction.

[SOURCE: ISO 21549‑7:—, 3.5, modified]

ISO/TS 19256:2016(E)
dispensing process of validation of the electronic prescription, preparation of the medicinal product, labelling, informing and handing the medication to the patient or administering healthcare professional ISO 17523:2016(E)
dispensing process by which an individual healthcare provider takes in a prescription, assesses that prescription, selects the prescribed medicinal product and delivers that medicinal product to the subject of care or their representative

Note 1 to entry: In most cases, but not necessarily always, the individual healthcare provider concerned will be a Pharmacist.

[SOURCE: IHE Pharmacy – Technical Framework Specification]

ISO/TS 19256:2016(E)
dissection systematic representation of a phrase according to a predefined domain concept model ISO 18104:2003(E)
Dissent refusal of Informational Consent (3.20)

Note 1 to entry: Dissent is sometimes used as an alternative term for Denial (3.7).

ISO/TS 17975:2015(E)
distal class From the perspective of a class in an information model, it is the class at the opposite end of an association

between the two.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
distributed processing information processing in which discrete components may be located in different places, or where

communication between components may suffer delay or may fail

ISO 13606 -1:2008(E)
distributed processing information processing in which discrete components may be located in different places ISO 13606-5:2010(E)
distributor organization in possession of a licence covering the procuring, holding, supplying or exporting of Medicinal Products, apart from supplying Medicinal Products to the public NOTE This is applicable to “wholesale distribution of Medicinal Products”. ISO 11615:2012(E)
diverse origin substances that are not isolated together or the result of the same chemical synthetic process ISO 11238:2012(E)
DNA sequencing determining the order of nucleotide bases (adenine, guanine, cytosine and thymine) in a molecule of DNA

Note 1 to entry: Sequence is generally described from the 5’ end.

[SOURCE: ISO/TS 17822‑1:2014, 3.20]

ISO/TS 20428:2017(E)
docking station A mechanical and electrical interface that supports the use of a point-of-care (POC)

device, typically employing legacy mechanical interfaces, connectors, protocols, and power delivery

methods.

ISO/IEEE 11073-30300:2004(E)
domain 1. A particular area of interest. For example, the domain for HL7 is healthcare.

2. The set of possible values of a data type , attribute, or data type component. See also vocabulary domain.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
domain analysis model

DAM

abstract representation of a subject area of interest that is the basis for development of lower-level

design artefacts for computer software, databases, or data exchange standards

Note 1 to entry: In this case, the subject area of interest is protocol-driven research.

ISO 14199:2015(E)
domain concept model set of formal categories, semantic links and sanctions describing potential characteristics for representing

concepts in a domain

[ISO 17115]

ISO 18104:2003(E)
domain constraint sanction rule prescribing the set of sanctioned characteristics (2.3.1) that are valid to specialize (2.1.1) a

concept (A.3.2.1) in a certain subject field (A.3.1.2)

EXAMPLE “Infection possibly hasLocation SkeletalStructure” describes that an infection in a certain context can be

located in a structure that is a kind of skeletal structure.

NOTE 1 The rule describes the set of potential characteristics (A.3.2.4) by combining the semantic link (2.2.3) and

the characterizing generic concept (2.3.3) it links to, possibly by enumeration of the concepts in the characterizing

generic concept.

NOTE 2 Different levels of sanctioning are possible (e.g. conceivable, sensible, normal, usuallyInTheContextOf,

necessary).

ISO 17115:2007(E)
domain constraint rule prescribing the set of representations of relations that are valid to specialize a category in a certain domain NOTE Adapted from ISO 17115. ISO 1828:2012(E)
domain constraint rule prescribing the set of sanctioned characteristics(3.1.9) that are valid to specialise a concept

representation in a certain subject field

EXAMPLE “Infection possibly hasLocation SkeletalStructure” explains that an infection in a certain context

can be located in a structure that is a kind of skeletal structure.

[SOURCE: ISO 17115:2007, definition 2.3.2]

Note 1 to entry: The rule describes the set of sanctioned characteristics (3.1.9) by combining the semantic link

(3.1.10) and the characterizing category (3.1.3)

ISO/TS 16277-1:2015(E)
domain constraint sanction

rule prescribing the set of sanctioned characteristics (2.15) that are valid to specialize a concept

representation in a certain subject field

EXAMPLE “Infection possibly hasLocation SkeletalStructure” explains that an infection in a certain context can be

located in a structure that is a kind of skeletal structure.

NOTE 1 Adapted from ISO 17115:2007, definition 2.3.2.

NOTE 2 The rule describes the set of sanctioned characteristics (2.15) by combining the semantic link (2.17) and

the characterizing category (2.4) it links to, possibly by enumeration of the concepts in the characterizing category

(2.4).

NOTE 3 Different levels of sanctioning are possible, e.g. conceivable, sensible, normal, usuallyInTheContextOf,

necessary.

ISO/TS 22789:2010(E)
Domain Information Model

DIM

information model describing concepts and relationships relevant to a specific problem area ISO/TS 13972:2015(E)
domain information model (DIM) The model describing common concepts and relationships for a problem domain. ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
domain information model (DIM) The model describing common concepts and relationships for a

problem domain.

ISO/IEEE 11073-10201:2004(E)
dominant beat typical heart beat used for measurement and analysis in standard 12-lead ECG

Note 1 to entry: In general, it is the primary heart beat excepting extrasystole or drifts of baseline.

ISO/TS 22077-2:2015(E)
dose specified quantity of a medicine, to be taken at one time or at stated intervals ISO 11615:2012(E)
dose form

dosage form

pharmaceutical dose form physical manifestation of a Medicinal Product that contains the active ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient

NOTE 1 Dose form, dosage form and pharmaceutical dose form are synonymous.

NOTE 2 “Pharmaceutical dose form” can refer to the administered dose form or the manufactured dose form.

ISO 11615:2012(E)
dose form pharmaceutical dose form physical manifestation of a product that contains the active ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient NOTE Pharmaceutical dose form may refer to the administered dose form or the packaged dose form, depending on the product it is describing. ISO 11616:2012(E)
dose form pharmaceutical dose form physical manifestation of a product that contains the active ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient

Note 1 to entry: Pharmaceutical dose form can refer to the administered dose form or the packaged dose form, depending on the product it is describing.

[SOURCE: ISO 11616:2012, 3.1.10]

ISO/TS 19256:2016(E)
Download transmission of data from an LIS to an AI ISO 18812:2003(E)
downsampling factor

decimation factor

factor that gives the reduction of samples in data sections where the sampling rate is reduced with reference to the original sampling rate. ISO 11073-91064:2009(E)
downstream device A term used to differentiate the two ends of an Ethernet connection. The

matching term (identifying the other end of the Ethernet connection) is “upstream device.”

ISO/IEEE 11073-30400:2012(E)
drill down exploration of multidimensional data which makes it possible to move down from one level of detail to the next

depending on the granularity of data

EXAMPLE Number of patients by departments and/or by services.

ISO/TS 29585:2010(E)
DTD (Document Type Definition) The XML document type declaration contains or points to markup declarations that provide a grammar for a class of documents. ISO/HL7 27932:2009(E)
dynamic attribute An attribute with a value that may change during an association. The attribute value

should be sent at configuration time and shall be sent at or before the time when the value would be needed

for interpreting a reported observation. The value may be updated later (e.g., in a scan or segment data

event report). The attribute value remains in effect until updated by a later scan or segment data event

report or the system exits the association.

ISO/IEEE 11073-20601:2016(E)
eArchiving process holistic long-term preservation process covering the whole lifecycle of the electronic health record (EHR) ISO/TS 21547:2010(E)
EHR comprehensive, structured set of clinical, demographic, environmental, social and financial data and

information in electronic form, documenting the healthcare given to a single individual

NOTE Adapted from ASTM E1769.

ISO/TS 21547:2010(E)
EHR extract unit of communication of all or part of the EHR which is itself attestable and which consists of one or more

EHR compositions

NOTE Adapted from ISO/TS 18308[3].

ISO/TR 20514:2005(E)
EHR extract healthcare subject’s partial or full electronic health record, communicated so that it complies with this part of

ISO 13606

ISO/TS 13606-4:2009(E)
EHR extract the unit of communication of the EHR which is itself attestable and which consists of one or more HER transactions ISO/TS 18308:2004(E)
EHR node physical location where EHRs are stored and maintained ISO/TR 20514:2005(E)
EHR provider entity to whom EHR data is communicated by an EHR provider ISO/TS 13606-4:2009(E)
EHR requester entity initiating a request for EHR communication to take place between an EHR provider and an EHR

recipient

ISO/TS 13606-4:2009(E)
EHR segment part of an EHR that constitutes a distinct resource for the access policy ISO 27789:2013(E)
EHR system componentsset of components that form the mechanism by which electronic health records are created,

used, stored and retrieved including people, data, rules and procedures, processing and storage devices, and

communication and support facilities

NOTE 1 Adapted from IOM:1991[14].

NOTE 2 The original IOM definition referred to a “CPR System” (Computer-based Patient Record System) and used

the term “patient records” rather than “electronic health records”.

ISO/TR 20514:2005(E)
EHR system systemsystem for recording, retrieving and manipulating information in electronic health records

NOTE 1 Adapted from ENV 13606-1[6].

NOTE 2 This definition is identical to the original CEN definition except that the original term “electronic health care

record” has been abbreviated to “electronic health record” to be consistent with the terminology used throughout this

Technical Report.

ISO/TR 20514:2005(E)
EHR system the set of components that form the mechanism by which patient records are created, used, stored, and retrieved. It includes people, data, rules and procedures, processing and storage devices, and communication and support facilities

a system for recording, retrieving, and manipulating information in electronic health records

ISO/TS 18308:2004(E)
EHR transaction the minimum unit of storage, review, modification, version control, and transfer within an EHR ISO/TS 18308:2004(E)
EHR-archive EHR-archive that preserves fixed EHRs for a long time ISO/TS 21547:2010(E)
EHR-system set of components that forms the mechanism from which patients, records are created, used, stored and

retrieved.

NOTE 1 It includes people, data, rules and procedures, processing and storage of data, and communication facilities.

NOTE 2 A narrow definition says that the EHR-system is a system for recording, retrieving, and manipulating

information in electronic healthcare records. See EN 13606.

ISO/TS 21547:2010(E)
electrode An electrical sensor in contact with a specified part of the body. Two or more electrodes are

used to detect heart action voltage. See: lead.

ISO/IEEE 11073-10406:2012(E)
electromagnetic compatibility (EMC) The ability of a device, equipment, or system to function satisfactorily

in its electromagnetic environment without introducing intolerable electromagnetic disturbances

to anything in that environment.

ISO/IEEE 11073-30200:2004(E)
electromagnetic compatibility (EMC) The ability of a device, equipment, or system to function

satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances

to anything in that environment.

ISO/IEEE 11073-30300:2004(E)
electromagnetic interference (EMI) Signals emanating from external sources (e.g., power supplies,

transmitters) or internal sources (e.g., adjacent electronic components, energy sources) that disrupt or prevent

operation of electronic systems.

ISO/IEEE 11073-30200:2004(E)
electromagnetic interference (EMI) Signals emanating from external sources (e.g., power supplies

and transmitters) or internal sources (e.g., adjacent electronic components, energy sources) that disrupt or

prevent operation of electronic systems.

ISO/IEEE 11073-30300:2004(E)
electronic health record repository of information regarding the health of a subject of care, in computer processable form

NOTE Adapted from ISO/TR 20514:2005, definition 2.11.

ISO 13606-2:2008(E)
electronic health record

EHR

comprehensive, structured set of clinical, demographic, environmental, social and financial data in electronic form, documenting the health care given to a single individual ISO 27789:2013(E)
electronic health record

EHR

basic generic formrepository of information regarding the health status of a subject of care, in computer

processable form

NOTE The definition of the EHR for integrated care in 2.10 is considered to be the primary definition of an electronic

health record. The definition of a basic-generic EHR is given only for completeness and to acknowledge that there are still

currently many variants of the EHR in health information systems which do not comply with the main (ICEHR) EHR

definition (e.g. a CDR complies with the basic-generic EHR definition but not with the ICEHR definition).

ISO/TR 20514:2005(E)
Electronic Health Record

EHR

logical representation of information regarding or relevant to the health of a subject of care

[SOURCE: ISO 18308:2011, modified]

ISO/TS 13972:2015(E)
electronic health record

EHR

an electronic longitudinal collection of personal health information, usually based on the individual, entered or accepted by health care providers, which can be distributed over a number of sites or aggregated at a particular source. The information is organised primarily to support continuing, efficient and quality health care.The record is under the control of the consumer and is stored and transmitted securely

a longitudinal collection of personal health information of a single individual, entered or accepted by health care providers, and stored electronically. The record may be made available at any time to providers, who have been authorized by the individual, as a tool in the provision of health care services. The individual has access to the record and can request changes to its contents. The transmission and storage of the record is under strict security

a collection of data and information gathered or generated to record clinical care rendered to an individual

a comprehensive, structured set of clinical, demographic, environmental, social, and financial data and information in electronic form, documenting the health care given to a single individual

a healthcare record in computer readable format

an electronic patient record that resides in a system designed to support users through availability of complete and accurate data, practitioner reminders and alerts, clinical decision support systems, links to bodies of medical knowledge, and other aids

a virtual compilation of non-redundant health data about a person across a lifetime, including facts, observations, interpretations, plans, actions, and outcomes. Health data include information on allergies, history of illness and injury, functional status, diagnostic studies, assessments, orders, consultation reports, treatment records, etc. Health data also include wellness data such as immunization history, behavioural data, environmental information, demographics, health insurance, administrative data for care delivery processes, and legal data such as consents

ISO/TS 18308:2004(E)
Electronic Health Record

EHR

logical representation of information regarding or relevant to the health of a subject of care

[SOURCE: ISO 18308:2011, 3.20, modified]

ISO/TS 19256:2016(E)
Electronic health record

EHR

repository of information regarding the health status of a subject of care, in computer processable form

electronic longitudinal collection of personal health information, usually based on the individual, entered or accepted by healthcare providers, which can be distributed over a number of sites or aggregated at a particular source

longitudinal collection of personal health information of a single individual, entered or accepted by healthcare providers, and stored electronically

collection of data and information gathered or generated to record clinical care rendered to an individual comprehensive, structured set of clinical, demographic, environmental, social, and financial data and information in electronic form, documenting the health care given to a single individual

healthcare record in computer-readable format

electronic patient record that resides in a system designed to support users through availability of complete and accurate data, practitioner reminders and alerts, clinical decision support systems, links to bodies of medical knowledge, and other aids

virtual compilation of non-redundant health data about a person across a lifetime, including facts, observations, interpretations, plans, actions and outcomes

ISO/TS 27790:2009(E)
electronic health record architecture

EHRA

generic structural components from which all EHRs are built, defined in terms of an information model

[ISO/TS 18308[3]]

NOTE A more descriptive informal definition of an EHRA is that of a model of the generic features necessary in any

electronic healthcare record in order that the record may be communicable, complete, a useful and effective ethico-legal

record of care and may retain integrity across systems, countries and time. The architecture does not prescribe or dictate

what anyone stores in their healthcare records. Nor does it prescribe or dictate how any electronic healthcare record

system is implemented. It places no restrictions on the types of data which can appear in the record, including those that

have no counterpart in paper records. Details like “field sizes”, coming from the world of physical databases, are not

relevant to the electronic healthcare record architecture.

[EU-CEN:1997[12]]

ISO/TR 20514:2005(E)
electronic health record architecture logical generic components from which electronic health records are designed, defined in terms of an

information model and computational services

[SOURCE: ISO 18308:2011, modified]

ISO/TS 13972:2015(E)
electronic health record architecture

EHRA

the generic structural components from which all EHRs are built, defined in terms of an information model ISO/TS 18308:2004(E)
electronic health record entry health record data in general

EXAMPLE Clinical observations, statements, reasoning, intentions, plans or actions, without particular specification

of their formal representation, hierarchical organization or particular record component class(es) that might be used to

represent them.

ISO 13606-2:2008(E)
electronic health record extract part or all of the electronic health record of a subject of care, communicated in compliance with this part of

ISO 13606

ISO 13606 -1:2008(E)
electronic health record extract part or all of the electronic health record of a subject of care, communicated in compliance with EN 13606 ISO 13606-2:2008(E)
electronic health record extract part or all of the electronic health record for a subject of care, communicated in compliance with the

ISO 13606 series of International Standards

ISO 13606-3:2009(E)
electronic health record extract part or all of the electronic health record of a subject of care, communicated in compliance with ISO 13606 ISO 13606-5:2010(E)
electronic health record for integrated care

ICEHR

repository of information regarding the health status of a subject of care, in computer processable form, stored

and transmitted securely and accessible by multiple authorized users, having a standardized or commonly

agreed logical information model that is independent of EHR systems and whose primary purpose is the

support of continuing, efficient and quality integrated health care

NOTE It contains information which is retrospective, concurrent and prospective.

ISO/TR 20514:2005(E)
electronic health record information architecture ODP information viewpoint specification of an electronic health record ISO 13606 -1:2008(E)
electronic health record information architecture ODP Information Viewpoint specification of an electronic health record ISO 13606-5:2010(E)
electronic health record provider entity in legitimate possession of electronic health record data and in a position to communicate it to another

appropriate entity

ISO 13606 -1:2008(E)
electronic health record provider entity in legitimate possession of electronic health record data and in a position to communicate it to another

appropriate entity

ISO 13606-5:2010(E)
electronic health record recipient entity to whom electronic health record data is communicated by an electronic health record provider ISO 13606 -1:2008(E)
electronic health record recipient entity to whom electronic health record data are communicated by an electronic health record provider ISO 13606-5:2010(E)
electronic health record requester entity initiating a request for electronic health record communication to take place between an electronic

health record provider and an electronic health record recipient

ISO 13606 -1:2008(E)
electronic health record requester entity initiating a request for electronic health record communication to take place between an electronic

health record provider and an electronic health record recipient

ISO 13606-5:2010(E)
electronic health record system system for recording, retrieving and manipulating information in electronic health records ISO 13606 -1:2008(E)
electronic health record system system for recording, retrieving and manipulating information in electronic health records ISO 13606-2:2008(E)
electronic health record system system for recording, retrieving and manipulating information in electronic health records ISO 13606-3:2009(E)
electronic health record system system for recording, retrieving, manipulating and processing information in electronic health records ISO 13606-5:2010(E)
electronic health records A longitudinal collection of electronic health information about individual

patients or populations. It is a record in digital format that is capable of being shared within or across

different health care settings by being embedded in network-connected enterprise-wide information system.

ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
electronic healthcare record healthcare record concerning the subject of care in computer-readable form

[ENV 13606-1]

ISO 21549-7:2007(E)
electronic prescription

e-prescription

prescription (issued by electronic means) that complies with this International Standard ISO 17523:2016(E)
electrostatic discharge (ESD) The sudden transfer of charge between bodies of differing electrostatic

potentials that may produce voltages or currents that could destroy or damage electrical components.

ISO/IEEE 11073-30200:2004(E)
electrostatic discharge (ESD) The sudden transfer of charge between bodies of differing electrostatic

potentials that may produce voltages or currents that could destroy or damage electrical components.

ISO/IEEE 11073-30300:2004(E)
emergency access access to data for an appropriate and specified purpose whereby threat of injury or death requires special permissions or override of other controls in order to ensure availability of data in an uninterrupted and urgent fashion ISO/TS 14265:2011(E)
encipherment

encryption

cryptographic transformation of data to produce ciphertext

[ISO 7498-2:1989]

NOTE See cryptography.

ISO/TS 17090-1:2002(E)
encipherment

encryption

cryptographic transformation of data (see cryptography) to produce ciphertext

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
encipherment

encryption

cryptographic transformation of data to produce ciphertext (3.6)

[ISO 7498-2:1989, definition 3.3.27]

NOTE See cryptography (3.10).

ISO/TS 25237:2008(E)
encodation methods compaction schemes used by GS1 DataBar Expanded and 2D components to encode commonly used AI

element strings in binary strings that are shorter than would be required using general data compaction for the

symbology

ISO/IEC 24724:2011(E)
encoding rules Specification for how data primitives used in an abstract syntax are converted to an

implementation format. Generally synonymous with transfer syntax.

ISO/IEEE 11073-20101:2004(E)
encounter contact in the course of which health activities are delivered to a subject of care in her or his presence, and

her or his health record is accessed or managed

NOTE 1 Adapted from EN 13940-1[8].

NOTE 2 This definition is identical to the original CEN definition except that the original term “health care” has been

abbreviated to “health” to be consistent with the terminology used throughout this Technical Report.

ISO/TR 20514:2005(E)
encounter

patient contact

contact between a clinician and patient ISO/TS 27790:2009(E)
Encounter patient contact a contact between a clinician and patient ISO/TS 18308:2004(E)
end entity certificate subject that uses its private key for purposes other than signing certificates or an entity that is a

relying party

ISO/TS 22600-3:2009(E)
end-entity attribute certificate revocation list

EARL

revocation list containing a list of attribute certificates that are no longer considered valid by the certificate

issuer and that were issued to certificate holders that were not also AAs

ISO/TS 22600-3:2009(E)
end-entity public key certificate revocation list

EPRL

revocation list containing a list of public key certificates, issued to subjects that are not also CAs, which are no

longer considered valid by the certificate issuer

ISO/TS 22600-3:2009(E)
endpoint terminal, gateway, or MCU ISO TR 16056-1:2004(E)
endpoint terminal, gateway, or MCU ISO TR 16056-2:2004(E)
enhancer cis-acting sequence of DNA that increases the utilization of some eukaryotic promoters and which can function in either orientation and in any location (upstream or downstream) relative to the promoter ISO 11238:2012(E)
entity concrete or abstract thing of interest, including associations among things

[SOURCE: ISO/IEC 2382:—]

ISO/TS 13972:2015(E)
entity natural or legal person, public authority or agency or any other body

Note 1 to entry: In the context outside the scope of this Technical Specification, an entity may refer to a natural

person, animal, organization, active or passive object, device or group of such items that has an identity.

ISO/TS 14441:2013(E)
entity any concrete or abstract thing of interest

EXAMPLE Aspirin, environment, parent, symptom, mobility.

Note 1 to entry: While in general the word entity can be used to refer to anything, in the context of modelling it is

reserved to refer to things in the universe of discourse being modelled.

Note 2 to entry: This definition is similar to that for object in ISO:1087–1[4] which is: anything perceivable or

conceivable. ISO 1087‑1 notes that Objects may be material (e.g. an engine, a sheet of paper, a diamond), immaterial

(e.g. conversion ratio, a project plan) or imagined (e.g. a unicorn). However, the term object is normally interpreted

as representing a material thing, therefore entity is preferred.

ISO/TS 16277-1:2015(E)
entity any concrete or abstract thing of interest

[SOURCE: ISO/IEC 10746‑2, 6.1]

ISO/TS 18790-1:2015(E)
entity concrete or abstract thing of interest, including associations among things

[SOURCE: ISO/IEC 2382:2015, 2120770]

ISO/TS 19256:2016(E)
entity authentication corroboration that an entity is the one claimed

[ISO/IEC 9798-1:1997]

ISO 21549-2:2004(E)
entries health record data in general (clinical observations, statements, reasoning, intentions, plans or actions)

without particular specification of their formal representation, hierarchical organization or of the particular

record component class(es) that might be used to represent them

ISO 13606 -1:2008(E)
entries health record data in general (clinical observations, statements, reasoning, intentions, plans or actions)

without particular specification of their formal representation, hierarchical organization or of the particular

Record Component class(es) that might be used to represent them

ISO 13606-3:2009(E)
entry documentation of a discrete item of health information

Note 1 to entry: An entry may for example represent the documentation of a clinical observation, an inference, an

intention, a plan or an action.

[SOURCE: ISO 18308]

ISO/TS 13972:2015(E)
enumeration datatype whose instances are a set of user-specified named enumeration literals

NOTE The literals have a relative order, but no algebra is defined on them.

ISO 21090:2011(E)
environmental variables aspects of policy required for an authorization decision, which are not contained within static structures, but

are available through some local means to a privilege verifier (e.g. time of day or current account balance)

ISO/TS 22600-2:2006(E)
environmental variables those aspects of policy required for an authorization decision that are not contained within static structures,

but are available through some local means to a privilege verifier (e.g. time of day or current account balance)

ISO/TS 22600-3:2009(E)
episode (of care) identifiable grouping of healthcare related activities characterized by the entity relationship between the

subject of care and a healthcare provider, such grouping determined by the healthcare provider

ISO/TS 18308:2004(E)
episode of care identifiable grouping of healthcare-related activities characterized by the entity relationship between the

subject of care and a healthcare provider, such grouping determined by the healthcare provider

[ISO/TS 18308:2004, definition 3.23]

ISO/TS 29585:2010(E)
erasure process whereby, after a given point in time, access to a data entity is permanently removed or access

permanently denied to all parties

NOTE This may not necessarily involve physical removal from the device, but may merely be the result of altering

security such that access is permanently denied to all parties.

ISO 21549-2:2004(E)
event 1. A stimulus that causes a noteworthy change in the state of an object, or a signal that invokes the behavior

of an object.

2. A vocabulary domain value for Mood.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
event A change in device status that is communicated by a notification reporting service. ISO/IEEE 11073-10201:2004(E)
event change in device status that is communicated by a notification reporting service ISO/TS 27790:2009(E)
event (in relation to the EHR) a discrete activity of the healthcare system on, with, or for the patient ISO/TS 18308:2004(E)
event report Service [provided by the common medical device information service element

(CMDISE)] to report an event relating to a managed object instance.

ISO/IEEE 11073-10201:2004(E)
exome part of the genome formed by exons ISO/TS 20428:2017(E)
explicit consent

express consent

permission that is freely and directly given, expressed either orally or in writing

NOTE Adapted from ISO 18308:2011.

ISO/TS 14265:2011(E)
Expressed Consent Informational Consent (3.20) that is freely and directly given, expressed either viva voce or in writing

Note 1 to entry: Can also refer to the details of the process of obtaining Informational Consent.

ISO/TS 17975:2015(E)
Expressed Denial refusal of Informational Consent (3.20) that is freely and directly given, expressed either viva voce

or in writing

Note 1 to entry: Can also refer to the details of the process of Denial (3.7).

ISO/TS 17975:2015(E)
extensibility qualifier A vocabulary domain qualifier used in a domain specification, which indicates whether or not the existing

vocabulary domain can be extended with additional values. There are two possible values: CNE (coded, no

extension) and CWE (coded with extension).

ISO 21731:2006(E) & ANSI/HL7 RIM R1
extension capability of an EHR-S to incorporate additional functionality beyond what is defined in the Functional Profile ISO 10781:2015(E)
extension ability for a PHR-S to incorporate additional functionality beyond what is defined in a functional profile ISO/HL7 16527:2016(E)
extremity body temperature The measurement of the temperature at the extremities of the body of

the person, such as finger or toe.

ISO/IEEE 11073-10408:2010(E)
falsified medicines fake medicines that pass themselves off as real, authorized medicines

[SOURCE: European Medicines Agency]

Note 1 to entry: It can be contaminated or contain the wrong or no active ingredient. They could have the right

active ingredient but at the wrong dose.

Note 2 to entry: WHO is using the concept of “Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines”.

ISO/TS 16791:2014(E)
fat free mass The sum of the soft lean mass and mineral mass. ISO/IEEE

11073-10420

federated health record virtual view of a patient’s health record that can be obtained from all electronic health record entries about that

patient that are held by different systems in communication using standard electronic health record extracts

ISO 13606 -1:2008(E)
federated health record virtual view of a patient’s health record that can be obtained from all electronic health record entries about that

patient that are held by different systems in communication using standard electronic health record extracts

ISO 13606-5:2010(E)
feeder system repository (for health record data) that may be queried within a federation of electronic health record systems

in order to contribute to a federated health record

ISO 13606 -1:2008(E)
feeder system repository (for health record data) that may be queried within a federation of electronic health record systems

in order to contribute to a federated health record

ISO 13606-5:2010(E)
Field specific attribute of a record that may contain a single data element or aggregates of data elements ISO 18812:2003(E)
field identifier character strings, numeric characters and/or icons placed near the visually readable data that help to identify

the visually readable data

ISO 20301:2006(E)
first-party conformity assessment activity conformity assessment activity that is performed by the person or organization that provides the object

Note 1 to entry: See also second-party conformity assessment activity, and third-part conformity assessment

activity.

Note 2 to entry: Adapted from ISO/IEC 17000:2004, definition 2.2.

ISO/TS 14441:2013(E)
fixity permanent character or condition

NOTE Fixity information is that which documents mechanisms to ensure that the Content Information object has not

been altered in an undocumented manner. See ISO 14721.

ISO/TS 21547:2010(E)
focus concept representation specified representation of the concept (A.3.2.1) of interest within a formal system (2.5.1)

EXAMPLE “Moderately severe inflammation caused by pneumococci located in the upper lobe of the left lung,

ascertained by plain film pulmonary X-ray and sputum culture” in the context of a diagnosis with confirmatory evidence.

NOTE It includes context information, enabling independent use.

ISO 17115:2007(E)
forced expiratory volume The expiratory volume of a subject under forced conditions at time t in

seconds, measured from time zero.

ISO/IEEE 11073-10421:2012(E)
formal [concept representation] system set of machine processable definitions in a subject field (A.3.1.2) ISO 17115:2007(E)
formal [concept representation] system set of machine processable definitions in a subject field

[ISO 17115:2007, definition 2.5.1]

ISO/TS 22789:2010(E)
formal category generic concept (2.1.4) represented by a formal definition (2.4.3)

NOTE This implies that the generic concept’s extension (A.3.2.8) can be determined algorithmically and includes

extensionally defined concepts (A.3.2.1) and formal intensional definitions (A.3.3.2).

ISO 17115:2007(E)
formal definition definition within a formal system (2.5.1)

NOTE 1 This can be done by a compositional concept representation (2.4.1) or a formal extensional definition

(A.3.3.3).

NOTE 2 It is usually automatically processable and governed by explicit rules.

ISO 17115:2007(E)
formal definition definition within a formal [concept representation] system (2.13)

NOTE Adapted from ISO 17115:2007, definition 2.4.3.

ISO/TS 22789:2010(E)
fraction distinct portion of material derived from a complex matrix, the composition of which differs from antecedent material ISO 11238:2012(E)
frame check sequence The sudden transfer of charge between bodies of differing electrostatic

potentials that may produce voltages or currents that could destroy or damage electrical components.

ISO/IEEE 11073-30200:2004(E)
frame check sequence See: cyclic redundancy check. ISO/IEEE 11073-30200:2004(E)
frame check sequence (FCS) The result of a calculation performed on a series of octets to verify

their integrity (i.e., that the octets were transferred without error). For Infrared Data Association (IrDA)

communications, the FCS may be a 16-bit cyclic redundancy check (CRC).

ISO/IEEE 11073-30300:2004(E)
framework A structure of processes and specifications designed to support the accomplishment of a

specific task.

ISO/IEEE 11073-10201:2004(E)
framework logical structure for classifying and organising complex information

[FEAF:1999]

ISO/TR 13054:2012(E)
framework a structure for supporting or enclosing something else, often acting to partition something complex into simple

components

ISO/TR 17119:2005(E)
Framework essential supporting or underlying structure ISO/TR 17791:2013(E)
Framework a logical structure for classifying and organising complex information ISO/TS 18308:2004(E)
framework structure for supporting or enclosing something else, often acting to partition something complex into

simple components

[SOURCE: ISO/TR 17119:2005, 2.6]

ISO/TS 18790-1:2015(E)
framework logical structure for classifying and organizing complex information ISO/TS 27790:2009(E)
front side of the card

back side of the card

see International Standards related to the applied recording techniques and card technologies, namely:

⎯ISO/IEC 7811 for cards with embossing and/or magnetic stripe;

⎯ISO/IEC 7816 for integrated circuit cards;

⎯ISO/IEC 14443 for contactless integrated circuit cards(proximity cards);

⎯ISO/IEC 11693 for optical memory cards

ISO 20301:2006(E)
full CRL complete revocation list that contains entries for all certificates that have been revoked for the given scope ISO/TS 22600-3:2009(E)
functional interoperability ability of two or more systems to exchange information ISO/TR 20514:2005(E)
functional profile subset of the Functional Model, in which functions have been designated (sometimes in varying degrees) for certain EHR systems or healthcare delivery settings or narrow operation requirements ISO 10781:2015(E)
functional profile subset of the PHR-S FM in which functions have been designated (sometimes in varying degrees) for

certain PHR systems or sources or level of functionality

ISO/HL7 16527:2016(E)
functional role roles bound to an act and that can be assigned to be performed during an act

NOTE 1 Functional roles correspond to the RIM participation.

NOTE 2 Adapted from ISO/TS 21298:2008.

NOTE 3 See also structural role (3.105).

ISO/TS 22600-3:2009(E)
G.711 ITU-T recommendation for the digital representation of speech up to 3.4 KHz of frequency producing a 64 Kbps

data stream

NOTE Commonly used in telephone networks. It comes in two variants: A-law and -law.

ISO TR 16056-1:2004(E)
G.711 ITU-T recommendation for the digital representation of speech up to 3.4 KHz of frequency producing a 64 Kbps

data stream

NOTE Commonly used in telephone networks. It comes in two variants: A-law and -law.

ISO TR 16056-2:2004(E)
G.722 ITU-T recommendation for the digital representation of audio up to 7 KHz of frequency producing a 64 Kbps data

stream with a much higher quality than G.711

ISO TR 16056-1:2004(E)
G.722 ITU-T recommendation for the digital representation of audio up to 7 KHz of frequency producing a 64 Kbps data

stream with a much higher quality than G.711

ISO TR 16056-2:2004(E)
G.728 ITU-T recommendation for the digital representation of audio producing a 16 Kbps data stream producing neartelephone

quality audio.

ISO TR 16056-1:2004(E)
G.728 ITU-T recommendation for the digital representation of audio producing a 16 Kbps data stream producing neartelephone

quality audio.

ISO TR 16056-2:2004(E)
gatekeeper H.323 entity that provides address translation, control access, and sometimes bandwidth management to the LAN

for H.323 terminals, gateways, and MCUs

ISO TR 16056-1:2004(E)
gatekeeper H.323 entity that provides address translation, control access, and sometimes bandwidth management to the LAN

for H.323 terminals, gateways, and MCUs

ISO TR 16056-2:2004(E)
gateway H.323 entity, which provides real-time, two-way communications between H.323 terminals on the LAN and other

ITU terminals on a WAN, or to another H.323 gateway

ISO TR 16056-1:2004(E)
gateway H.323 entity, which provides real-time, two-way communications between H.323 terminals on the LAN and other

ITU terminals on a WAN, or to another H.323 gateway

ISO TR 16056-2:2004(E)
gene basic unit of hereditary material that encodes and controls the expression of a protein or protein subunit ISO 11238:2012(E)
gene basic unit of hereditary material that encodes and controls the expression of a protein or protein subunit

[SOURCE: ISO 11238:2012, 2.1.16]

ISO/TS 20428:2017(E)
gene element individual element within a gene such as a promoter, enhancer, silencer or coding sequence ISO 11238:2012(E)
gene panel technique for sequencing the targeted genes in a genome ISO/TS 20428:2017(E)
generalization taxonomic relationship between a more general class, interface or concept and a more specific class,

interface or concept

NOTE 1 Each instance of the specific element is also an instance of the general element. Thus, the specific element

has all the features of the more general element.

NOTE 2 The more specific element is fully consistent with the more general element and contains additional

information.

NOTE 3 An instance of the more specific element can be used where the more general element is allowed.

ISO 21090:2011(E)
generalization An association between two classes, referred to as superclass and subclass, in which the subclass is derived

from the superclass. The subclass inherits all properties from the superclass, including attributes,

relationships, and states, but also adds new ones to extend the capabilities of the parent class. Essentially,

a specialization from the point-of-view of the subclass.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
generalization taxonomic relationship between a more general element and a more specific element ISO/TS 27790:2009(E)
generalization hierarchy All superclasses and subclasses with a common root superclass. ISO 21731:2006(E) & ANSI/HL7 RIM R1
generalize form a more generic concept (A.3.2.15) [that represents a superset of the extension(s) (A.3.2.8) of one or

more specific concepts (A.3.2.16)]

EXAMPLE Infection that hasCause Pneumococcus can be generalized to Infection that hasCause Bacterium.

NOTE 1 To generalize is to decrease the intension (A.3.2.9) and increase the extension of a concept. Specialization

and generalization can be achieved in many ways, including replacing a semantic link with a less specific semantic link

(and vice versa for specialization).

NOTE 2 This can be done by removing one or more characteristics (A.3.2.4) or by replacing the characterizing

concept (2.2.2) in one or more characteristics with a more generic concept.

NOTE 3 The opposite is specialize (2.1.1).

ISO 17115:2007(E)
generic applicable to requirements or information models across healthcare professions, domains and countries ISO 13606 -1:2008(E)
generic applicable to requirements or information models across health care professions, domains and countries ISO 13606-2:2008(E)
generic concept category

concept (A.3.2.1) in a generic relation (A.3.2.21) having the narrower intension (A.3.2.9) [and the wider

extension (A.3.2.8)]

[ISO 1087-1:2000, A.3.2.15]

ISO 17115:2007(E)
generic conference call

GCC

set of conference services described in the ITU-T T.124 Recommendation ISO TR 16056-1:2004(E)
generic conference call

GCC

set of conference services described in the ITU-T T.124 Recommendation ISO TR 16056-2:2004(E)
generic relation subtype relation

relation between two concepts (A.3.2.1) where the intension (A.3.2.9) of one of the concepts includes that of

the other concept and at least one additional delimiting characteristic (A.3.2.7)

[ISO 1087-1:2000, A.3.2.21]

NOTE All individuals in the extension (A.3.2.8) of the second are included in the extension of the first.

EXAMPLE A generic relation exists between the concepts ‘internal organ’ and ‘heart’, ‘surgical deed’ and

‘appendectomy’, ‘inflammatory disease’ and ‘pericarditis’.

ISO 17115:2007(E)
genomic medicine medical discipline that involves using genomic information about an individual as part of their clinical care (e.g. for diagnostic or therapeutic decision-making) and the health outcomes and policy implications of that clinical use ISO/TS 20428:2017(E)
germline series of germ cells each descended or developed from earlier cells in the series, regarded as continuing through successive generations of an organism ISO/TS 20428:2017(E)
Global Trade Identification Number GTIN GS1 unique identifier of items that are traded (e.g. pharmaceuticals, medical devices) in the supply chain NOTE A GTIN is used to identify any item upon which there is a need to retrieve pre-defined information and that may be priced, ordered or invoiced at any point in any supply chain. GTINs may be 8, 12, 13 or 14 digits in length. ISO 11615:2012(E)
globally unique identifier identifier that is different from any other such identifier in any domain namespace ISO 11616:2012(E)
glucagon Naturally occurring hormone released by the pancreas when glucose levels are low. ISO_IEEE_11073-10417_2015
glucose Commonly referred to as “sugar,” it is the major source of energy used by the body cells. ISO/IEEE 11073-10425:2016(E)
glucose Commonly referred to as “sugar,” it is the major source of energy used by the body cells. ISO_IEEE_11073-10417_2015
glucose meter A medical device for determining the approximate concentration of glucose in the blood. ISO_IEEE_11073-10417_2015
glycosylation enzymatic process that links saccharides or oligosaccharides to proteins, lipids or other organic molecules ISO 11238:2012(E)
glycosylation type significant differences in glycosylation between different types of organisms ISO 11238:2012(E)
goal statement on situations and applications for which the categorial structure is intended and its limits of use ISO 1828:2012(E)
governance for Detailed Clinical Models system by which development, distribution, responsibility, accountability, delegation of authoritative

powers, including legal and ethical aspects and maintenance of Detailed Clinical Models are directed

and controlled

Note 1 to entry: The management framework which governs DCM development and maintenance decision making

[SOURCE: ISO/IEC 38500:2015, modified]

ISO/TS 13972:2015(E)
grade set of specifications indicating the quality of a specified substance ISO 11238:2012(E)
granularity the boundary where an object functions as a self-contained, stand-alone unit to support a common vision or

goal

ISO/TR 17119:2005(E)
Granularity level of complexity or the extent to which a system is broken down into smaller parts ISO/TR 17791:2013(E)
graphic parameter Vital signs measurement that requires a number of regularly sampled data points

in order to be expressed properly.

ISO/IEEE 11073-10201:2004(E)
graphical expression A visual representation of a model that uses graphic symbols to represent the components of the model

and the relationships that exist between those components.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
GS1-128 subset, specified in GS1 General Specifications, of Code 128 as defined in ISO/IEC 15417 ISO/IEC 24724:2011(E)
GSRN3)

global service relation number

used to identify the relationship between an organization offering services and the recipient or provider

of services

Note 1 to entry: GSRN are encoded on data carriers with an Application Identifier 8018 for the recipient of a service

(Subject of Care) and with an Application Identifier 8017 for the provider of a service (Individual Provider).

ISO/TS 18530:2014(E)
GTIN3)

global trade item number

number that is used for the unique identification of trade items worldwide

EXAMPLE 1 GS1 Identification Key which comprises a GS1 Company Prefix, an Item Reference and Check Digit.

EXAMPLE 2 Used to identify trade items such as pharmaceuticals and medical devices.

Note 1 to entry: See Annex C for the relationship between MPID, PCID, and GTIN.

[SOURCE: ISO/IEC 15420:2009, 3.7 — modified, examples added; note 1 to entry added; digit length

removed.]

ISO/TS 16791:2014(E)
H.221 ITU-T recommendation defining how to multiplex video and audio into frames using 64-1920 Kbps channels for

switched and leased network services, excluding packetized networks

ISO TR 16056-1:2004(E)
H.221 ITU-T recommendation defining how to multiplex video and audio into frames using 64-1920 Kbps channels for

switched and leased network services, excluding packetized networks

ISO TR 16056-2:2004(E)
H.225D ITU-T recommendation that specifies messages for call control including signaling, registration and admissions,

and packetization/synchronization of media systems

ISO TR 16056-1:2004(E)
H.225D ITU-T recommendation that specifies messages for call control including signaling, registration and admissions,

and packetization/synchronization of media systems

ISO TR 16056-2:2004(E)
H.230 ITU-T recommendation that specifies the frame-synchronous control and indication signals for audiovisual systems ISO TR 16056-1:2004(E)
H.230 ITU-T recommendation that specifies the frame-synchronous control and indication signals for audiovisual systems ISO TR 16056-2:2004(E)
H.231 ITU-T recommendation that specifies the multipoint control unit ISO TR 16056-1:2004(E)
H.231 ITU-T recommendation that specifies the multipoint control unit ISO TR 16056-2:2004(E)
H.235 ITU-T recommendation that defines the security framework used to provide authentication, encryption, and integrity

for H.323 systems

ISO TR 16056-1:2004(E)
H.235 ITU-T recommendation that defines the security framework used to provide authentication, encryption, and integrity

for H.323 systems

ISO TR 16056-2:2004(E)
H.242 ITU-T recommendation that specifies how to establish the communication between audiovisual terminals using

digital channels with speeds up to 2 Mbps

ISO TR 16056-1:2004(E)
H.242 ITU-T recommendation that specifies how to establish the communication between audiovisual terminals using

digital channels with speeds up to 2 Mbps

ISO TR 16056-2:2004(E)
H.243 ITU-T recommendation that specifies the establishment of communication between three or more audiovisual

terminals using digital channels with speeds up to 2 Mbps

ISO TR 16056-1:2004(E)
H.243 ITU-T recommendation that specifies the establishment of communication between three or more audiovisual

terminals using digital channels with speeds up to 2 Mbps

ISO TR 16056-2:2004(E)
H.245 ITU-T recommendation that specifies messages for opening and closing channels for media streams, and other

commends, requests and indications between two H.323 endpoints

ISO TR 16056-1:2004(E)
H.245 ITU-T recommendation that specifies messages for opening and closing channels for media streams, and other

commends, requests and indications between two H.323 endpoints

ISO TR 16056-2:2004(E)
H.261 ITU-T recommendation that specifies the video encoding and compression algorithm for two video resolutions: 352

x 288 CIF and 176 x 144 QCIF

NOTE H.261 is used in both H.320 and T.120.

ISO TR 16056-1:2004(E)
H.261 ITU-T recommendation that specifies the video encoding and compression algorithm for two video resolutions: 352

x 288 CIF and 176 x 144 QCIF

NOTE H.261 is used in both H.320 and T.120.

ISO TR 16056-2:2004(E)
H.263 ITU-T recommendation that specifies a new video codec for video over packet-switched networks or POTS

NOTE H.263 optimizes H.261 for very low bit rate of video coding below 64 Kbps. H.263 provides better motion

compensation, more accurate motion vectors, optimized quantization for very low bit rates, and arithmetic coding.

ISO TR 16056-1:2004(E)
H.263 ITU-T recommendation that specifies a new video codec for video over packet-switched networks or POTS

NOTE H.263 optimizes H.261 for very low bit rate of video coding below 64 Kbps. H.263 provides better motion

compensation, more accurate motion vectors, optimized quantization for very low bit rates, and arithmetic coding.

ISO TR 16056-2:2004(E)
H.310 family of ITU-T standards ratified in 1995 that describes the technical specifications for adapting narrow-band ISDN

visual telephone terminals, as defined in H.320, to broadband ISDN (BISDN) and ATM environments

NOTE H.310 adds the MPEG-2 video-compression algorithm that provides MPEG-2 video quality.

ISO TR 16056-1:2004(E)
H.310 family of ITU-T standards ratified in 1995 that describes the technical specifications for adapting narrow-band ISDN

visual telephone terminals, as defined in H.320, to broadband ISDN (BISDN) and ATM environments

NOTE H.310 adds the MPEG-2 video-compression algorithm that provides MPEG-2 video quality.

ISO TR 16056-2:2004(E)
H.320 family of ITU-T standards, ratified in 1990, that specifies how voice and video conferencing systems communicate

over ISDN or leased networks, using a bandwidth from 64 Kbps to 1920 Kbps

ISO TR 16056-1:2004(E)
H.320 family of ITU-T standards, ratified in 1990, that specifies how voice and video conferencing systems communicate

over ISDN or leased networks, using a bandwidth from 64 Kbps to 1920 Kbps

ISO TR 16056-2:2004(E)
H.323 family of ITU-T standards, ratified in 1996, that extends H.320 to computer networks, including LANs and the

Internet

NOTE H.323 supports both point-to-point and multipoint operations. In addition, H.323 shares many components of the

H.32x specification, such as the H.261 video codec, the G.711 audio codec, the H.263 video codec, G.722, G.723 and G.728.

As a new feature, H.323 specifies a gatekeeper component that allows LAN administrators to manage video traffic for QoS. The

H.323 specification also defines a LAN/H.320 gateway that permits a H.323 node to interoperate with H.320/H.324 terminals.

ISO TR 16056-1:2004(E)
H.323 family of ITU-T standards, ratified in 1996, that extends H.320 to computer networks, including LANs and the

Internet

NOTE H.323 supports both point-to-point and multipoint operations. In addition, H.323 shares many components of the

H.32x specification, such as the H.261 video codec, the G.711 audio codec, the H.263 video codec, G.722, G.723 and G.728.

As a new feature, H.323 specifies a gatekeeper component that allows LAN administrators to manage video traffic for QoS. The

H.323 specification also defines a LAN/H.320 gateway that permits a H.323 node to interoperate with H.320/H.324 terminals.

ISO TR 16056-2:2004(E)
H.324 family of ITU-T standards, ratified in 1996, that allows video conferencing over standard analog phone lines with

features similar to those in H.320

NOTE The H.324 standard uses H.263, which contains a better codec for POTS than H.261. H.263 is an improved version

of H.261 that adds a 128 x 96 sub-QCIF (SQCIF) format. By using a 28.8 or 36.6 Kbps modem, H.263 may produce frame rates

approaching those achieved by H.320 systems over ISDN.

ISO TR 16056-1:2004(E)
H.324 family of ITU-T standards, ratified in 1996, that allows video conferencing over standard analog phone lines with

features similar to those in H.320

NOTE The H.324 standard uses H.263, which contains a better codec for POTS than H.261. H.263 is an improved version

of H.261 that adds a 128 x 96 sub-QCIF (SQCIF) format. By using a 28.8 or 36.6 Kbps modem, H.263 may produce frame rates

approaching those achieved by H.320 systems over ISDN.

ISO TR 16056-2:2004(E)
handle An unsigned 16-bit number that is locally unique and identifies one of the object instances within

an agent.

ISO/IEEE

11073-10420

handle According to the World Health Organization, “[it] is a state of complete physical, mental, and

social well-being and not merely the absence of disease or infirmity.”3 This covers wellness monitoring and

assistance in activities of daily living, not just clinical healthcare.

ISO/IEEE 11073-00103:2015(E)
handle An unsigned 16-bit number that is locally unique and identifies one of the object instances within

an agent.

ISO/IEEE 11073-10406:2012(E)
handle An unsigned 16-bit number that is locally unique and identifies one of the object instances

within an agent.

ISO/IEEE 11073-10407:2010(E)
handle An unsigned 16-bit number that is locally unique and identifies one of the object instances

within an agent.

ISO/IEEE 11073-10408:2010(E)
handle An unsigned 16-bit number that is locally unique and identifies one of the object instances

within an agent.

ISO/IEEE 11073-10415:2010(E)
handle An unsigned 16-bit number that is locally unique and identifies one of the object instances

within an agent.

ISO/IEEE 11073-10421:2012(E)
handle An unsigned 16-bit number that is locally unique and identifies one of the object instances within

an agent.

ISO/IEEE 11073-10425:2016(E)
handle An unsigned 16-bit number that is locally unique and identifies one of the object instances within

an agent.

ISO/IEEE 11073-10472:2012(E)
handle An unsigned 16-bit number that is locally unique and identifies one of the object instances within

an agent.

ISO/IEEE 11073-20601:2016(E)
handle An unsigned 16-bit number that is locally unique and identifies one of the object instances within

an agent.

ISO_IEEE_11073-10417_2015
Harm death, physical injury and/or damage to health or wellbeing of a patient ISO/TR 17791:2013(E)
harm death, physical injury and/or damage to health or well being of a patient ISO/TR 27809:2007(E)
harm death, physical injury and/or damage to the health or well-being of a patient

[adapted from ISO/IEC Guide 51:1999]

ISO/TS 25238:2007(E)
harmonization process whereby a DCM is designed and presented in such a way as to fulfill a range of criteria originally

expressed as distinct requirements and possibly originally put forward as distinct DCMs

ISO/TS 13972:2015(E)
hasAnatomicalSite semantic link (3.1.10) between the <clinical finding-TM> (3.1.6).and the characterizing category (3.1.3)

<anatomical structure>

EXAMPLE <cold lumbago {hasAnatomicalSite (3.5.1)} <lower back>.

Note 1 to entry: This domain constraint (3.1.7) would mainly be used to describe <disorders-TM>.

ISO/TS 16277-1:2015(E)
hasAssociatedBodyStructure-TM semantic link (3.1.10) between the <clinical finding-TM> (3.1.6) and the characterizing category (3.1.3)

<body structure-TM> (3.3.1)

ISO/TS 16277-1:2015(E)
hasAssociatedCausalProperty-TM semantic link (3.1.10) between the <clinical finding-TM> (3.1.6) and the characterizing category (3.1.3)

<causal property-TM> (3.3.4)

EXAMPLE 1 <Phlegm syncope> {hasCausalProperty-TM (3.4.4)} <phlegm>.

EXAMPLE 2 <Kidney yin deficiency pattern> {hasCausalProperty-TM (3.4.4)} <sexual overindulgence>.

EXAMPLE 3 <Taiyang wind-cold pattern> {hasCausalProperty-TM (3.4.4)} <external wind-TM>.

ISO/TS 16277-1:2015(E)
hasAssociatedFinding-TM category (3.1.3) <sign&symptom-TM> (3.2.3)

EXAMPLE 1 <spleen qi deficiency pattern> {hasAssociatedFinding-TM (3.4.6)} <decreased blood production-TM>.

EXAMPLE 2 <spleen deficiency and blood depletion pattern> {hasAssociatedFinding-TM (3.4.6)} <pale tongue>.

ISO/TS 16277-1:2015(E)
hasAssociatedPattern-TM semantic link (3.1.10) between the <clinical findings-TM> (3.1.6) and the characterizing category (3.1.3)

<pattern-TM> (3.3.1)

EXAMPLE <liver qi depression pattern> {hasAssociatedPattern-TM (3.4.5)} <liver depression and spleen

deficiency>.

ISO/TS 16277-1:2015(E)
hasAssociatedState-TM semantic link (3.1.10) between the <clinical finding-TM> (3.1.6) and the characterizing category (3.1.3)

<state-TM> (3.3.3)

EXAMPLE 1 <lung-kidney qi deficiency pattern> {hasAssociatedState-TM (3.4.3)} <qi absorption>.

EXAMPLE 2 <spleen failing to control the blood pattern> {hasAssociatedState-TM (3.4.3)} <controlling blood>.

EXAMPLE 3 <liver qi invading the stomach pattern> {hasAssociatedState-TM (3.4.3)} <qi depression>.

ISO/TS 16277-1:2015(E)
hasAssociatedSubstance-TM semantic link (3.1.10) between the <clinical finding-TM> (3.1.6) and the characterizing category (3.1.3)

<substance-TM> (3.2.2)

ISO/TS 16277-1:2015(E)
hasCourse semantic link (3.1.10) between the <clinical finding-TM> (3.1.6) and the characterizing category

(3.1.3) <courses>

EXAMPLE <fluid collapse> {hasCourse (3.5.2)} <paroxysmal>.

Note 1 to entry: This domain constraint (3.1.7) would mainly be used to describe <disorders-TM>.

ISO/TS 16277-1:2015(E)
hasEpisodicity semantic link (3.1.10) between the <clinical finding-TM> (3.1.6) and the characterizing category (3.1.3)

<episodicity>

EXAMPLE <chronic cold lumbago> {hasEpisodicity (3.5.3)} <chronic episode>.

ISO/TS 16277-1:2015(E)
hash function computation method used to generate a random value of fixed length from the data of any optional

length

Note 1 to entry: The generated value is called a “hash value”, which has the properties of being uni-directional

(the original data cannot be back calculated from it) and of having a low probability of having been generated

from two different data (collision).

Note 2 to entry: Because of these properties, when sending/receiving data, if the hash value generated on the

sending side and the hash value of the data obtained by the receiving side match on comparison, it can be confirmed

with a high degree of confidence that the data were not tampered with during transmission.

ISO 17090-4:2014(E)
hash function (mathematical) function which maps values from a large (possibly very large) domain into a smaller range

NOTE A “good” hash function is such that the results of applying the function to a (large) set of values in the domain

will be evenly distributed (and apparently at random) over the range.

ISO/TS 22600-3:2009(E)
hasMeans representation of relations referring to the means by which the surgical deed is carried out EXAMPLE 1 In the terminological phrase “bypass coronary artery using mammary artery”, “bypass” hasObject “coronary artery” and hasMeans “mammary artery”. EXAMPLE 2 In the terminological phrase “removing polyp from colon by means of endoscope”, “removing” hasObject “polyp” which hasSite “colon” and hasMeans “endoscope”. NOTE The categories that can have this representation of relations with the surgical deed belong to the categories human anatomy (3.8.2) and interventional equipment (3.8.4). ISO 1828:2012(E)
hasObject representation of relations between the category “surgical deed” and the categories on which the surgical deed is carried out EXAMPLE 1 In the terminological phrase “removing colon”, the surgical deed “removing” hasObject “Colon”. EXAMPLE 2 In the terminological phrase “removing polyp from colon”, “removing” hasObject “Polyp”. EXAMPLE 3 In the terminological phrase “inserting two pins into left femur”, “inserting” hasObject “two pins”. NOTE 1 The categories which can have this representation of relation with the surgical deed belong to the categories human anatomy (3.8.2), lesion (3.8.3) and interventional equipment (3.8.4). NOTE 2 Every surgical procedure terminological phrase complying with this International Standard has this semantic link. NOTE 3 When the object is a physiologic or function entity, an additional category (3.3) function can be used but the category human anatomy (3.8.2) is mentioned. ISO 1828:2012(E)
hasOccurrence semantic link (3.1.10) between the <clinical finding-TM> (3.1.6) and the characterizing category (3.1.3)

<temporal period>

EXAMPLE 1 <afternoon tidal fever> {hasOccurrence (3.5.4)} <afternoon>.

EXAMPLE 2 <fifth-watch diarrhoea> {hasOccurrence (3.5.4)} <early morning>.

ISO/TS 16277-1:2015(E)
hasOnset semantic link (3.1.10) between the <clinical finding-TM> (3.1.6) and the characterizing category

(3.1.3) <onset>

ISO/TS 16277-1:2015(E)
hasSeverity semantic link (3.1.10) between the <clinical finding-TM> (3.1.6) and the characterizing category

(3.1.3) <severities>

EXAMPLE 1 <interior sinking of severe fire pattern> {hasSeverity (3.5.6)} <severe>.

EXAMPLE 2 <intense heat pattern> {hasSeverity (3.5.6)} <severe>.

ISO/TS 16277-1:2015(E)
hasSite representation of relations referring to that site to which, from which or in which the surgical deed is carried out EXAMPLE 1 In the terminological phrase “removing cyst from left kidney”, “removing” hasObject “cyst” which hasSite “left kidney”. EXAMPLE 2 In the terminological phrase “removing fluid from cyst in left kidney”, “removing” hasObject “fluid” which hasSite “cyst” which hasSite “leftkidney”. EXAMPLE 3 In the terminological phrase “replacing battery in pacemaker in chest wall”, “replacing” hasObject “battery” whic hasSite “pacemaker” which hasSite “chest wall”. NOTE 1 The categories which can have this representation of relation with the categories lesion (3.8.3) and interventional equipment (3.8.4) belong to the categories human anatomy (3.8.2), or lesion (3.8.3) or interventional equipment (3.8.4). NOTE 2 This representation of relation can be used several times in the same terminological phrase allowing the different parts of a complex interventional equipment, such as the battery of a pace maker or the different parts of a stent, to be represented. ISO 1828:2012(E)
hasSubsurgicaldeed representation of relations referring to the subprocess by which the main surgical deed is carried out EXAMPLE 1 In the terminological phrase “straightening penis by plicating and excising of the corpus cavernosum”, “straightening” hasObject “penis” and hasSubsurgicaldeed “plicating”, which hasObject ”corpus cavernosum” and hasSubsurgicaldeed “excising” which hasObject “corpus cavernosum”. EXAMPLE 2 In the terminological phrase “endarteriectomy of the carotid bifurcation by everting”, “excising” hasObject “endarterium” of “carotid bifurcation” and hasSubsurgicaldeed “everting” which hasObject “carotid bifurcation”. NOTE 1 The category that can have this semantic relation with the category surgical deed (3.8.1) belongs to the category surgical deed (3.8.1).

NOTE 2 This representation of relation is a hasPart type relation

ISO 1828:2012(E)
Hazard potential source of harm ISO/TR 17791:2013(E)
hazard death, physical injury and/or damage to health or well being of a patient ISO/TR 27809:2007(E)
hazard potential source of harm

[ISO/IEC Guide 51:1999]

ISO/TS 25238:2007(E)
health state of complete physical, mental and social well-being and not merely the absence of disease or infirmity

[WHO:1948[23]]

ISO/TR 20514:2005(E)
health care terminological system set of designations within the domain of health care with, when appropriate, any associated rules, relationships and definitions. EXAMPLE Annex A details the five types of terminological systems given in ISO 17115:2007, 2.7. NOTE Adapted from ISO 1087-1:2000 which defines terminology as a set of designations belonging to one language used in a subject field for a special purpose. ISO 1828:2012(E)
health condition alterations or attributes of the health status of an individual which may lead to distress, interference with daily

activities, or contact with health services; it may be a disease (acute or chronic), disorder, injury or trauma, or

reflect other health-related states such as pregnancy, aging, stress, congenital anomaly or genetic disposition

[WHO:1948[23]]

ISO/TR 20514:2005(E)
health indicator single summary measure, most often expressed in quantitative terms, that represents a key dimension of

health status, the health care system, or related factors

NOTE A health indicator is to be informative and also sensitive to variations over time and across jurisdictions.

ISO/TS 21667:2004(E)
health indicator single summary measure, most often expressed in quantitative terms, that represents a key dimension of

health status, the healthcare system, or related factors

NOTE A health indicator is informative and also sensitive to variations over time and across jurisdictions.

[ISO/TS 21667:2004, definition 3.1]

ISO/TS 29585:2010(E)
health informatics intersection of clinical, IM/IT (Information Management/Information Technology) and management practices to achieve better health ISO/TR 17791:2013(E)
health informatics profiling framework

HIPF

an approach and tool to describe the variety of artefacts within the domain of health informatics standards ISO/TR 17119:2005(E)
health information system repository of information regarding the health of a subject of care in computer-processable form, stored

and transmitted securely, and accessible by multiple authorized users

[SOURCE: ISO 27799:2008, definition 3.1.2]

Note 1 to entry: It has a commonly agreed logical information model which is independent of EHR (electronic

health record) systems.

Note 2 to entry: Its primary purpose is the support of continuing, efficient and quality integrated healthcare and

it contains information which is retrospective, concurrent and prospective.

ISO/TS 14441:2013(E)
Health Level Seven

HL7

A standards developing organization based in the United States of America. ISO 21731:2006(E) & ANSI/HL7 RIM R1
health organization organisation involved in the direct provision of health activities

NOTE 1 Adapted from ENV 13940-1[8].

NOTE 2 This definition is identical to the original CEN definition except that the original term “health care” has been

abbreviated to “health” to be consistent with the terminology used throughout this Technical report.

ISO/TR 20514:2005(E)
health organization organization involved in the direct provision of health activities

Note 1 to entry: Adapted from ISO/TR 20514:2005, definition 2.21.

ISO/TS 14441:2013(E)
health problem health condition that results in some disability, pain and/or activity limitation ISO/TR 20514:2005(E)
health professional person who is authorized by a recognized body to be qualified to perform certain health duties

NOTE 1 Adapted from ISO/TS 17090-1[2].

NOTE 2 The defined term is often named “healthcare professional”. A convention has been adopted in this Technical

Report whereby the term “healthcare” is abbreviated to “health” when used in an adjectival form. When used in a noun

form, the word “care” is retained but as a separate word (e.g. delivery of health care).

ISO/TR 20514:2005(E)
health professional person who is authorized by a recognised body to be qualified to perform certain health duties

Note 1 to entry: Adapted from ISO 17090‑1:2008, definition 3.1.8.

Note 2 to entry: The defined term is often “healthcare professional”. A convention has been adopted in this

Technical Specification whereby the term “healthcare” is abbreviated to “health” when used in an adjectival form.

When used in a noun form, the word “care” is retained but as a separate word (e.g. delivery of healthcare).

ISO/TS 14441:2013(E)
health professional person who is authorized by a nationally recognised body, to be qualified to perform certain health services

NOTE 1 The types of registering or accrediting bodies differ by country and profession. Nationally recognised bodies

include local or regional governmental agencies, independent professional associations and other formally and nationally

recognised organizations. They can be exclusive or non-exclusive in their territory.

NOTE 2 A nationally recognised body in this definition does not imply one nationally controlled system of professional

registration but in order to facilitate international communication it would be preferable that one nationwide directory of

recognised health professional registration bodies exists.

EXAMPLE Physicians, registered nurses and pharmacists.

ISO/TS 21547:2010(E)
health provider health professional or health organization involved in the direct provision of health activities

NOTE 1 Adapted from ENV 13940-1[8].

NOTE 2 This definition is identical to the original CEN definition except that the original term “health care” has been

abbreviated to “health” to be consistent with the terminology used throughout this Technical Report.

ISO/TR 20514:2005(E)
health record repository of information regarding the health of a subject of care

NOTE Adapted from ENV 13940-1[8].

ISO/TR 20514:2005(E)
health software software used in the health sector that can have an impact on the health and healthcare of a subject of care ISO/TR 17791:2013(E)
health software product software product for use in the health sector for health related purposes but excluding software which is:

⎯necessary for the proper application of a medical device or

⎯an accessory to a medical device or

⎯a medical device in its own right.

NOTE For the purposes of this document software includes firmware.

ISO/TR 27809:2007(E)
health software product software proffered for use in the health sector for health-related purposes, but excluding software necessary

for the proper application of a medical device

ISO/TS 25238:2007(E)
health status individual’s current state of physical, mental and social well-being ISO/TR 20514:2005(E)
Health(care) information information about a person, relevant to his or her health or health care

[SOURCE: ISO 13606‑1:2008]

ISO/TS 13972:2015(E)
healthcard holder individual transporting a healthcare data card which contains a record with the individual identified as the

major record person

[ISO 21549-2:2004, definition 3.8]

ISO 20301:2006(E)
healthcard holder individual transporting a healthcare data card which contains a record with the individual identified as the

major record person

ISO 21549-2:2004(E)
healthcard holder individual transporting a healthcare data card that contains a record with themselves identified as the major

record person

ISO 21549-7:2007(E)
healthcare provision of health related services

NOTE This includes more than performing procedures on subjects of care. It includes also, e.g., the management of

information about patients, their health status and their relationship with their healthcare framework.

[CEN TC/251 PT30]

ISO 21549-7:2007(E)
healthcare any type of services provided by professionals or paraprofessionals with an impact on health status

[SOURCE: European Parliament, 1998, as cited by WHO]

ISO/TS 14441:2013(E)
healthcare actor regulated health professional, non-regulated health professional, sponsored healthcare provider, supporting

organization employee, patient/consumer, healthcare organization, device or application that acts in a health

related communication and requires a certificate for a PKI enabled security service

ISO/TS 17090-1:2002(E)
healthcare agent person, device, or software that performs a role in a healthcare activity

[EN 13940-1:2005]

ISO 13606 -1:2008(E)
healthcare agent person, device or software that performs a role in a healthcare activity

[EN 13940-1:2007]

ISO 13606-5:2010(E)
healthcare agent healthcare person, healthcare organization, healthcare device or healthcare software component that

performs a role in a healthcare activity

[ENV 13607]

ISO 21549-7:2007(E)
healthcare application provider entity that provides healthcare services to the healthcard holder and in the course doing so, makes use of the

card and records the health care application information onto the cards

EXAMPLE A hospital could be a healthcare application provider by handling appointments for medical treatment or

by providing access control to medical records. A health funding agency could be a healthcare application provider by

issuing cards for health funding. A health funding agency could also be a healthcare application provider by certifying the

health funding status of the healthcard holder.

NOTE If the card contains an application for medical appointments, a hospital could be an application provider as it

provides appointment services to the patients, while it could also be a user of the card if the card contains an application

for health funding services, as the hospital may get reimbursed from the health funding agency.

ISO 20301:2006(E)
healthcare application provider entity that provides healthcare services to the healthcard holder and in doing so, makes use of the card and records the healthcare application information on to the card ISO 20302:2006(E)
healthcare data card machine-readable card, conformant to ISO 7810 intended for use within the healthcare domain

[ISO 21549-1:2004, definition 3.2]

ISO 20301:2006(E)
healthcare data card machine-readable card conformant to ISO 7810 intended for use within the healthcare domain ISO 20302:2006(E)
healthcare data card machine-readable card, conformant to ISO/IEC 7810, intended for use within the healthcare domain ISO 21549-1:2004(E)
healthcare data card machine-readable card, conformant to ISO/IEC 7810, intended for use within the healthcare domain ISO 21549-2:2004(E)
healthcare data card machine-readable card conformant to ISO 7810 intended for use within the healthcare domain ISO 21549-7:2007(E)
healthcare device device or equipment involved in the direct or indirect provision of healthcare services to an individual or to a

population

ISO 13606 -1:2008(E)
healthcare device device or equipment involved in the direct or indirect provision of healthcare services to an individual or to a

population

ISO 13606-5:2010(E)
healthcare organization organization involved in the direct or indirect provision of healthcare services to an individual or to a population ISO 13606 -1:2008(E)
healthcare organization organization involved in the direct or indirect provision of healthcare services

NOTE Groupings or subdivisions of an organization, such as departments, may also be considered as organizations

where there is a need to identify them.

ISO 13606-5:2010(E)
healthcare organization organization involved in the direct or indirect provision of healthcare services to an individual or to a population

NOTE 1 Groupings or subdivisions of an organization, such as departments or sub-departments, may also be

considered as organizations where there is need to identify them.

NOTE 2 “Healthcare organizations” is a subset of “healthcare agents”.

[ENV 13607] [ENV 1613]

ISO 21549-7:2007(E)
healthcare organization officially registered organization that has a main activity related to healthcare services or health promotion

EXAMPLES Hospitals, Internet healthcare web site providers and healthcare research institutions.

NOTE 1 The organization is recognized to be legally liable for its activities but need not be registered for its specific role in

health.

NOTE 2 An internal part of an organization is called here an organizational unit, as in X.501.

ISO/TS 17090-1:2002(E)
healthcare organization organization involved in the direct or indirect provision of healthcare services (3.14)

Note 1 to entry: Service could be to an individual (3.19), group or population.

ISO/TS 17975:2015(E)
healthcare organization officially registered organization that has a main activity related to healthcare services or health promotion

NOTE 1 Examples include hospitals, internet healthcare website providers and healthcare research institutions.

NOTE 2 The organization should be recognised as legally liable for its activities but need not be registered for its

specific role in health. An internal part of an organization is called here an organizational unit as in X.501.

ISO/TS 21547:2010(E)
healthcare party person involved in the direct or indirect provision of healthcare services to an individual or to a population ISO 13606 -1:2008(E)
healthcare party person involved in the direct or indirect provision of healthcare services ISO 13606-5:2010(E)
healthcare party organization or person responsible for the direct or indirect provision of healthcare to an individual, or

involved in the provision of healthcare-related services

[SOURCE: ENV 1613]

ISO 21549-4:2014(E)
healthcare party organization or person involved in the direct or indirect provision of healthcare services to an individual or to a

population

NOTE “Healthcare parties” is a subset of “healthcare agents”.

[ENV 13607]

ISO 21549-7:2007(E)
healthcare person person involved in the direct or indirect provision of healthcare services to an individual or to a population

NOTE “Healthcare persons” is a subset of “healthcare parties”, which again is a subset of “healthcare agents”.

EXAMPLE Primary care physician, dentist, nurse, social worker, pharmacist, medical secretary.

[ENV 13607]

ISO 21549-7:2007(E)
healthcare professional person entrusted with the direct or indirect provision of defined healthcare services to a subject of care or a population of subjects of care EXAMPLES Qualified medical practitioner, pharmacist, nurse, social worker, radiographer, medical secretary or clerk. [ENV 1613:1995] ISO 11616:2012(E)
healthcare professional person entrusted with the direct or indirect provision of defined healthcare services to a subject of care or a

population of subjects of care

EXAMPLE Qualified medical practitioner, pharmacist, nurse, social worker, radiographer, medical secretary or clerk.

[ENV 1613:1995]

ISO 21549-7:2007(E)
healthcare professional Person entrusted with the direct or indirect provision of defined healthcare services to a subject of care or a population of subjects of care

EXAMPLE Qualified medical practitioner, pharmacist, nurse, social worker, radiographer, medical secretary or clerk

ISO/HL7 27932:2009(E)
healthcare professional person who is entrusted with direct or indirect provision of defined services to a subject of care (3.32)

or a population of subjects of care

[SOURCE: CEN ENV 1613:1995]

ISO/TS 17975:2015(E)
healthcare professional person who is authorised by a nationally recognised body to be qualified to perform certain health duties ISO/TS 18308:2004(E)
healthcare professional person who is authorized by a nationally recognized body to be qualified to perform certain health duties ISO/TS 27790:2009(E)
healthcare provider organization or facility that delivers healthcare to Subjects of Care ISO/TS 18530:2014(E)
healthcare record a repository of information regarding the health of a subject of care ISO/TS 18308:2004(E)
healthcare service service provided with the intention of directly or indirectly improving the health of the person or populations to

whom it is provided

ISO 13606 -1:2008(E)
healthcare service service provided with the intention of directly or indirectly improving the health of the person or populations to

whom it is provided

ISO 13606-5:2010(E)
healthcare service service provided with the intention of directly or indirectly improving the health of the person or

populations to whom it is provided

[SOURCE: ISO/TS 13606‑5:2010, 3.28]

ISO/TS 17975:2015(E)
healthcare system organization of people, institutions, and resources to deliver healthcare services to meet the health

needs of target populations

ISO/TS 16791:2014(E)
high-level data link control (HDLC) A standard protocol defined by ISO for bit-oriented, framedelimited

data communications.

ISO/IEEE 11073-30200:2004(E)
high-level data link control (HDLC) A standard protocol defined by the International Organization

for Standardization (ISO) for bit-oriented, frame-delimited data communications.

ISO/IEEE 11073-30300:2004(E)
HIPF cell the intersection of an HIPF perspective and an HIPF level of specificity that is defined within the context of the

HIPF classification matrix

ISO/TR 17119:2005(E)
HIPF classification matrix a structure that includes dimensions for health informatics standards artefacts, levels of specificity, and

perspectives

ISO/TR 17119:2005(E)
HIPF perspective a classification dimension for differentiating health informatics standards artefacts based on their viewpoints,

intended purpose or focus

NOTE This dimension includes the perspectives of what, how, where, who, when and why, which are further

described in 4.2.1.2.

ISO/TR 17119:2005(E)
HIPF specificity a classification dimension for differentiating health informatics standards artefacts based on their level of

abstraction with respect to implementation specifications

NOTE This dimension includes the conceptual, logical and physical levels, which are further described in 4.2.1.1.

ISO/TR 17119:2005(E)
HL7 Health Level Seven ISO 11239:2012(E)
holder entity to whom some privilege has been delegated either directly from the source of authority or indirectly

through another attribute authority

ISO/TS 22600-3:2009(E)
homopolymer polymer containing a single structural repeating unit ISO 11238:2012(E)
host system Term used as an abstraction of a medical system to which measurement devices are

attached.

ISO/IEEE 11073-10201:2004(E)
host system term used as an abstraction of a medical system to which measurement devices are attached ISO/TS 27790:2009(E)
human anatomy biological science that concerns the discovery, analysis and representation of the structural organization of the human body [EN 15521:2007] NOTE The categories of human anatomy are given in Annex C. The definition and names of categories of human anatomy should conform to EN 15521:2007. They are listed in Annex B. ISO 1828:2012(E)
identifiable person one who can be identified, directly or indirectly, in particular by reference to an identification number

or one or more factors specific to his physical, physiological, mental, economic, cultural or social identity

[SOURCE: Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the

protection of individuals with regard to the processing of personal data and on the free movement of

such data]

ISO/TS 14441:2013(E)
identifiable person one who can be identified, directly or indirectly, in particular by reference to an identification number

or one or more factors specific to his physical, physiological, mental, economic, cultural or social identity

[SOURCE: ISO 22857:2013, 3.7]

ISO/TS 17975:2015(E)
identifiable person one who can be identified, directly or indirectly, in particular by reference to an identification number or to one

or more factors specific to his physical, physiological, mental, economic, cultural or social identity

[Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of

individuals with regard to the processing of personal data and on the free movement of such data]

ISO/TS 25237:2008(E)
identifiable person one who can be identified, directly or indirectly, in particular by reference to an identification number or one or

more factors specific to his physical, physiological, mental, economic, cultural or social identity

ISO/TS 27790:2009(E)
identification process of recognizing an entity in a particular domain as distinct from other entities

Note 1 to entry: The process of identification applies verification to claimed or observed attributes.

Note 2 to entry: Identification typically is part of the interactions between an entity and the services in a domain and to access resources. Identification can occur multiple times while the entity is known in the domain.

[SOURCE: ISO/IEC 24760‑1:2011, 3.2.1, modified]

ISO 17523:2016(E)
identification performance of tests to enable a data processing system to recognize entities

[ISO/IEC 2382‑8]

ISO 21091:2013(E)
Identification performance of tests to enable a data processing system to recognize entities ISO 27789:2013(E)
identification

identity authentication

identity validation

performance of tests to enable a data processing system to recognise entities

[ISO/IEC 2382-8:1998, definition 08.04.12]

ISO/TS 13606-4:2009(E)
identification recognition of a person in a particular domain by a set of his or her attributes ISO/TS 14441:2013(E)
identification way information about an object such as a trade item can be found in IT systems such as databases

Note 1 to entry: It refers to a sequence of characters (numerals and/or alpha characters). The identifier is intended

to be a unique sequence structured according to a globally agreed architecture or syntax, and can or can not

contain inbuilt significance.

ISO/TS 16791:2014(E)
identification performance of tests to enable a data processing system to recognize entities

[ISO/IEC 2382-8:1998]

ISO/TS 17090-1:2002(E)
identification process of using claimed or observed attributes of an entity to single out the entity among other entities

in a set of identities

[SOURCE: ISO/TS 25237:2008, 3.24]

ISO/TS 17975:2015(E)
identification performance of tests to enable a data processing system to recognize entities ISO/TS 22600-1:2006(E)
identification performance of tests to enable a data processing system to recognize entities ISO/TS 22600-2:2006(E)
identification performance of tests to enable a data processing system to recognize entities

[ISO/IEC 2382-8:1998]

ISO/TS 22600-3:2009(E)
identification process of using claimed or observed attributes of an entity to single out the entity among other entities in a

set of identities

NOTE The identification of an entity within a certain context enables another entity to distinguish between the entities

with which it interacts.

ISO/TS 25237:2008(E)
identification schema

namespace

container for a set of identifiers that allows the disambiguation of homonym identifiers residing in

different identification schema

ISO/TS 16791:2014(E)
Identifier

 ID

description that is sufficient to represent an object in a given environment NOTE 1 In the context of this International Standard, this is a list of identifying characteristics that together unambiguously identify a Medicinal Product, pharmaceutical product, substance, specified substance, route of administration, pharmaceutical dose form or any other element which requires to be uniquely identified.

NOTE 2 Adapted from ENV 12610:1997.

ISO 11615:2012(E)
identifier description that is sufficient to differentiate objects in a given environment [ENV 12610] NOTE In the context of this International Standard, this is a list of identifying characteristics that together unambiguously identify a medicinal product, pharmaceutical product, substance, detailed substance description, excipient, route of administration, dose form and any other element that requires to be uniquely identified. ISO 11616:2012(E)
identifier piece of information used to claim an identity, before a potential corroboration by a corresponding

authenticator

[ENV 13608-1]

ISO 21091:2013(E)
Identifier piece of information used to claim an identity, before a potential corroboration by a corresponding authenticator ISO 27789:2013(E)
identifier piece of information used to claim an identity, before a potential corroboration by a corresponding

authenticator

[ENV 13608-1:2000]

ISO/TS 13606-4:2009(E)
identifier

ID

description that is sufficient to represent an object in a given environment identification schema ISO/TS 16791:2014(E)
identifier piece of information used to claim an identity, before a potential corroboration by a corresponding authenticator

[ENV 13608-1]

ISO/TS 17090-1:2002(E)
identifier piece of information used to claim an identity, before a potential corroboration by a corresponding

authenticator

ENV 13608-1:2000.

ISO/TS 21547:2010(E)
identifier piece of information used to claim an identity, before a potential corroboration by a corresponding

authenticator

[ENV 13608-1]

ISO/TS 22600-2:2006(E)
identifier piece of information used to claim an identity, before a potential corroboration by a corresponding

authenticator

[EN 13608-1:2007]

ISO/TS 22600-3:2009(E)
identifier information used to claim an identity, before a potential corroboration by a corresponding authenticator

[ENV 13608-1]

ISO/TS 25237:2008(E)
identifier attribute An attribute used to identify an instance of a class. ISO 21731:2006(E) & ANSI/HL7 RIM R1
identifiers sequence of characters, capable of uniquely identifying that with which it is associated, within a specified context

[SOURCE: ISO/IEC 11179‑1:2015, 3.1.3, modified]

ISO/TS 19256:2016(E)
identity set of attributes which make it possible to recognize, contact or locate the subject of care ISO/TS 14441:2013(E)
identity Collection (3.4) of data items, such as official name, postal address, etc. that are required for naming

non-ambiguously a given person

ISO/TS 17975:2015(E)
identity authentication

identity validation

performance of tests to enable a data processing system to recognise entities

ISO/IEC 2382-8:1998, definition 08.04.12.

ISO/TS 21547:2010(E)
identity information set of values of attributes that differentiate one entity from others

Note 1 to entry: In an information and communication technology system, an identity is present as identity information.

[SOURCE: ISO/IEC 24760‑1:2011, 3.2.4, modified]

ISO 17523:2016(E)
IDMP Identification of medicinal products ISO 11239:2012(E)
IHE4)

integrating the healthcare enterprise

initiative by healthcare professionals and industry to improve the way computer systems in healthcare

share information

Note 1 to entry: IHE promotes the coordinated use of established standards to address specific clinical need in

support of optimal patient care.

Note 2 to entry: Systems developed in accordance with IHE communicate with one another better, are easier to

implement, and enable care providers to use information more effectively.

ISO/TS 18530:2014(E)
immediate container immediate packaging in which a manufactured item or pharmaceutical product is contained and with which it is in direct contact ISO 11239:2012(E)
immediate container container that is in direct contact with the pharmaceutical product

[ENV 12610]

ISO 21549-7:2007(E)
immediate container immediate packaging in which a manufactured item or pharmaceutical product is contained and with which it is in direct contact

EXAMPLE Ampoule, vial, prefilled syringe, bottle, blister.

Note 1 to entry: An immediate container can be fitted with or have integrated into it an administration device and/or closure.

Note 2 to entry: A pharmaceutical dose form can fulfill the role of an immediate container, e.g. a capsule containing a powder for inhalation; the capsule in this case is not a container.

Note 3 to entry: An alternative, compatible definition of immediate container (“immediate packaging”) is given in Directive 92/27/EEC.

ISO/TS 19256:2016(E)
immediate container immediate packaging packaging in which a manufactured item or pharmaceutical product is contained and with which it is in direct contact EXAMPLES Ampoule, vial, prefilled syringe, bottle, blister.

NOTE 1 An immediate container can be fitted with or have integrated into it an administration device and/or closure.

NOTE 2 A pharmaceutical dose form can fulfil the role of an immediate container, e.g. a capsule containing a powder for inhalation; the capsule in this case is not a container.

NOTE 3 An alternative, compatible definition of immediate container (“immediate packaging”) is given in Directive 92/27/EEC.

NOTE 4 Adapted from ENV 12610:1997.

ISO 11615:2012(E)
implied consent voluntary agreement with what is being done or proposed that can be reasonably determined through the actions or inactions of the data subject ISO/TS 14265:2011(E)
Implied Consent Informational Consent (3.20) that is freely and directly given, indicated by an action or an inaction

rather than a formal verbal or written indication of agreement on the part of the data subject (3.6)

Note 1 to entry: This is derived from Expressed Consent (3.10).

ISO/TS 17975:2015(E)
indel insertion (3.19) or/and deletion (3.10) ISO/TS 20428:2017(E)
indicator digit leading digit of a GTIN-14 item identification number used to differentiate multiple levels of packaging or to

indicate a variable measure item

ISO/IEC 24724:2011(E)
indirect CRL

iCRL

revocation list that at least contains revocation information about certificates issued by authorities other than

that which issued this CRL

ISO/TS 22600-3:2009(E)
indirectly identifying data data that can identify a single person only when used together with other indirectly identifying data

NOTE Indirect identifiers can reduce the population to which the person belongs, possibly down to one if used in

combination.

EXAMPLE Postcode, sex, age, date of birth.

ISO/TS 25237:2008(E)
individual single discrete entity

Note 1 to entry: This includes a distinct person or organization.

Note 2 to entry: The term may refer to a person who is a subject of care (3.32), a patient, a data subject (3.6), a

client, a consumer or any other person.

ISO/TS 17975:2015(E)
individual provider any person who provides or is a potential provider of a health care service

Note 1 to entry: An individual provider is an individual person and is not considered to be a group of providers.

Note 2 to entry: Not all health care providers are recognized by professional bodies. It is for this reason the term

health care professional has not been used to describe them. All health care professionals are providers, but not

all providers are health care professionals.

ISO/TS 18530:2014(E)
individual provider health careperson who provides or is a potential provider of a health care service

NOTE An individual provider is an individual person and is not considered to be a group of providers. Not all health

care providers are recognized by professional bodies. It is for this reason that the term health care professional has not

been used to describe them. All health care professionals are providers, but not all providers are health care professionals.

ISO/TS 27527:2010(E)
individual provider identification unique number or code issued for the purpose of identifying an individual provider ISO/TS 18530:2014(E)
information data in context that enable interpretation with meaning and relevance ISO/TR 17119:2005(E)
information knowledge concerning such things as facts, concepts, objects, events, ideas

[SOURCE: ISO 1087‑2:2000]

ISO/TS 13972:2015(E)
information any type of knowledge that can be exchanged ISO/TS 21547:2010(E)
information data set within a context of meaning ISO/TS 25237:2008(E)
information access service (IAS) A component of infrared link management protocol (IrLMP). ISO/IEEE 11073-30200:2004(E)
information access service (IAS) A component of Infrared Link Management Protocol (IrLMP)

that provides for simple retrieval of device capability and configuration information.

ISO/IEEE 11073-30300:2004(E)
information governance processes by which an organization obtains assurance that the risks to its information, and thereby the

operational capabilities and integrity of the organization, are effectively identified and managed

ISO/TR 11633-1:2009(E)
information governance processes by which an organization obtains assurance that the risks to its information, and thereby the

operational capabilities and integrity of the organization, are effectively identified and managed

ISO/TR 11633-2:2009(E)
information governance processes by which an organization obtains assurance that the risks to its information and thereby the

operational capabilities and integrity of the organization, are effectively identified and managed

[SOURCE: ISO 27799:2008]

ISO/TS 13972:2015(E)
information governance processes by which an organization obtains assurance that the risks to its information, and thereby the operational capabilities and integrity of the organization, are effectively identified and managed

[ISO 27799:2008, definition 3.2.8]

ISO/TS 14265:2011(E)
information governance processes by which an organization obtains assurance that the risks to its information, and thereby the

operational capabilities and integrity of the organization, are effectively identified and managed

ISO/TS 14441:2013(E)
information model A structured specification, expressed graphically and/or narratively, of the information requirements of a

domain. An information model describes the classes of information required and the properties of those

classes, including attributes, relationships, and states. Examples in HL7 are the Domain Reference Information

Model, Reference Information Model, and Refined Message Information Model.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
information model structured specification of the information requirements of a project ISO/TS 27790:2009(E)
information object An abstract data model applicable to the communication of vital signs information

and related patient data. The attributes of an information object definition describe its properties. Each information object definition does not represent a specific instance of real-world data, but rather a class of

data that share the same properties.

ISO/IEEE 11073-10201:2004(E)
information object provision of an abstract data model applicable to the communication of vital signs information and related

patient data

NOTE The attributes of an information object definition describe its properties. Each information object definition

does not represent a specific instance of real-world data, but rather a class of data that share the same properties.

ISO/TS 27790:2009(E)
information privacy rights and obligations of individuals and organizations with respect to the collection, use, retention,

disclosure and disposal of personal information

[SOURCE: Adapted from the definition of privacy in the Generally Accepted Privacy Principles of the

American Institute of Certified Public Accountants and the Chartered Accountants of Canada]

ISO/TS 14441:2013(E)
information processing entity anything that processes information and contains the concept of datatype, including other standards,

specifications, data handling facilities and services

ISO 21090:2011(E)
information security preservation of confidentiality, integrity and availability of information ISO 27789:2013(E)
information security preservation of confidentiality, integrity and availability of information

NOTE Other properties, particularly accountability of users, but also authenticity, non-repudiation, and reliability, are

often mentioned as aspects of information security, but could be considered as derived from the three core properties in

the definition.

ISO/TR 11633-1:2009(E)
information security preservation of confidentiality, integrity and availability of information

NOTE Other properties, particularly accountability of users, but also authenticity, non-repudiation, and reliability, are

often mentioned as aspects of information security, but could be considered as derived from the three core properties in

the definition.

ISO/TR 11633-2:2009(E)
information security preservation of confidentiality, integrity and availability of information

Note 1 to entry: In addition, other properties, such as authenticity, accountability, non-repudiation, and reliability

can also be involved.

[SOURCE: ISO/IEC 27000:2012, definition 2.30]

ISO/TS 14441:2013(E)
information security protection of information from (accidental or intentional) unauthorized access, use, disclosure, disruption,

modification or destruction

ISO/TS 21547:2010(E)
information security policy document that states, in writing, how an organization plans to protect its physical and information technology

assets

ISO/TS 21547:2010(E)
information service ability of a system to provide a defined set of output information based on a defined set of input information

[EN 12967-1 to 3[7]]

ISO/TR 20514:2005(E)
information service element Instances in the medical data information base (MDIB). ISO/IEEE 11073-10201:2004(E)
information system organized collection of hardware, software, supplies, policies, procedures and people that stores,

processes and provides access to information

ISO/TS 18530:2014(E)
information system organized collection of hardware, software, supplies, policies, procedures and people that stores, processes and provides access to information ISO/TS 22220:2011(E)
information system organized set of people, procedures and equipment that enable, for decision making with stated objectives,

the collection and storage of those data that describe an actual situation and its evolution, their processing

into information and the transmission of this information

[http://www.metaglossary.com/meanings/501967/]

ISO/TS 27527:2010(E)
Informational Consent consent provided for the Collection (3.4), Use (3.33), Disclosure (3.8), or any data processing activities of

personal information (3.25)

Note 1 to entry: As opposed to consent (3.5) for treatment or care, this includes Denial (3.7) by the data subject

(3.6) of certain data processing activities, or constraints and conditions that the data subject might place on

those activities.

ISO/TS 17975:2015(E)
informative functional profile registered functional profile that has successfully completed formal public scrutiny via the HL7 consensus process ISO 10781:2015(E)
informative functional profile registered functional profile that has successfully completed formal public scrutiny via the HL7

consensus process

ISO/HL7 16527:2016(E)
informed consent consent granted on the basis of knowledge ISO/TS 14265:2011(E)
Informed Consent Informational Consent (3.20) process that provides the data subject (3.6) with explanations that will

help that data subject in making educated decisions about whether to begin or continue participating in

data Collection (3.4), Use (3.33) or Disclosure (3.8) of personal information (3.25)

Note 1 to entry: Can also refer to the outcome of the process of Informed Consent.

Note 2 to entry: Informed Consent is an ongoing, interactive process over the lifetime of the data rather than a

one-time information session.

Note 3 to entry: This was adapted from ICH “Informed Consent” by changing the phrase from “in a trial” to “in

data Collection, use …”

ISO/TS 17975:2015(E)
Infrared Data Association (IrDA) An industry organization that has developed a set of infrared

data communications specifications. The abbreviation is commonly used to refer to the set of specifications.

ISO/IEEE 11073-30300:2004(E)
Infrared Link Access Protocol (IrLAP) The link access protocol specified by the Infrared Data

Association (IrDA) that provides for reliable, ordered transfer of data between two devices.

ISO/IEEE 11073-30300:2004(E)
Infrared Link Management Protocol (IrLMP) The link management protocol specified by Infrared

Data Association (IrDA) that supports multiplexing of the Infrared Link Access Protocol (IrLAP) layer

and simple retrieval of device capability and configuration information.

ISO/IEEE 11073-30300:2004(E)
ingredient material used in the preparation of a medicinal/pharmaceutical product NOTE The ingredient is part of a Medicinal Product, either alone or in combination with one or more ingredients. The ingredient is also a component of a pharmaceutical product. Ingredient is equal to the detailed description of a substance, a substance playing the role of an ingredient in a product. ISO 11615:2012(E)
ingredient substance included as a component in a product

NOTE In this context product refers to pharmaceutical product.

[ENV 13607]

ISO 21549-7:2007(E)
inheritance mechanism by which more specific elements incorporate structure and behaviour of more general elements ISO 21090:2011(E)
inheritance In a generalization relationship, the subclass inherits all properties from the superclass, including attributes,

relationships, and states, unless otherwise specified.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
inheritance mechanism by which more specific elements incorporate structure and behaviour of more general elements ISO/TS 27790:2009(E)
inherited criterion one of a set of conformance criteria listed in a parent function that is inherited by all its children functions ISO 10781:2015(E)
inherited criterion conformance criteria listed in a header function that will be inherited by all its children functions, and

conformance criteria listed in a parent function that are inherited by all its children functions

ISO/HL7 16527:2016(E)
input device an analog and digital device used to configure and control the telelearning system or to provide audio, video or data information to the telelearning system ISO TS 16058:2004(E)
insertion addition of one or more nucleotide base pairs into a DNA sequence ISO/TS 20428:2017(E)
inspection examination of a product design, product, process or installation and determination of its conformity

with specific requirements or, on the basis of professional judgment, with general requirements

Note 1 to entry: Inspection of a process may include inspection of persons, facilities, technology and methodology.

[SOURCE: ISO/IEC 17000:2004, definition 4.3]

ISO/TS 14441:2013(E)
instance A case or an occurrence. For example, an instance of a class is an object. ISO 21731:2006(E) & ANSI/HL7 RIM R1
instance The realization of an abstract concept or specification, e.g., object instance, application

instance, information service element instance, virtual medical device (VMD) instance, class instance, operating

instance.

ISO/IEEE 11073-10201:2004(E)
instance realization of an abstract concept or specification

EXAMPLES Object instance, application instance, information service element instance, VMD instance, class

instance, operating instance.

ISO/TS 27790:2009(E)
instance of a concept member of the extension (A.3.2.8) of a concept (A.3.2.1) ISO 17115:2007(E)
integrity property that data has not been altered or destroyed in an unauthorized manner

[ISO 7498‑2]

ISO 21091:2013(E)
Integrity property of protecting the accuracy and completeness of assets ISO 27789:2013(E)
integrity proof that the message content has not been altered, deliberately or accidentally, in any way during transmission

NOTE Adapted from ISO 7498-2:1989.

ISO/TS 17090-1:2002(E)
integrity proof that the message content has not altered, deliberately or accidentally in any way, during transmission ISO/TS 21547:2010(E)
integrity property that information is not altered in any way, deliberately or accidentally ISO/TS 22600-2:2006(E)
integrity proof that the message content has not altered, deliberately or accidentally in any way during transmission

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
integrity property of data whose accuracy and consistency are preserved regardless of changes made ISO/TS 27790:2009(E)
integrity (of data) the property of data whose accuracy and consistency are preserved regardless of changes made ISO/TS 18308:2004(E)
intended site general body site at which a pharmaceutical product is intended to be administered ISO 11239:2012(E)
intensive care unit (ICU) The unit within a medical facility in which patients are managed using multiple

modes of monitoring and therapy.

ISO/IEEE 11073-10201:2004(E)
interaction combination of the specific elements that are needed to support the functional requirements defined within the

use case model

ISO/TS 27790:2009(E)
interchange format The representation of the data elements and the structure of the message containing

those data elements while in transfer between systems. The interchange format consists of a data set of

construction elements and a syntax. The representation is technology specific.

ISO/IEEE 11073-10201:2004(E)
interchange format representation of the data elements and the structure of the message containing those data elements while in

transfer between systems

NOTE The interchange format consists of a data set of construction elements and a syntax. The representation is

technology-specific.

ISO/TS 27790:2009(E)
interface specifier for the externally-visible operations of class, without specification of internal structure ISO 21090:2011(E)
Interface a boundary across which two systems communicate ISO TS 16058:2004(E)
interface the shared boundary between two functional units defined by various characteristics pertaining to the

functions, physical interconnections, signal exchanges and other characteristics as appropriate

[ENV 12443:1996]

ISO/TR 17119:2005(E)
interface description language

IDL

specification language used to describe a software component’s interface in a language-neutral way, enabling communication between software components that do not share a language ISO/HL7 27951:2009(E)
interface description language (IDL) specification language used to describe a software component’s interface in a language-neutral way, enabling communication between software components that do not share a language [(1) OMG; 2002] ISO/HL7 27951:2009(E)
intermediate packaging level of packaging between the outer packaging and the immediate container ISO 11239:2012(E)
intermediate packaging container between the outer packaging and the immediate container ISO 11615:2012(E)
international coding scheme identifier unique permanent identifier of a coding scheme registered for use in information interchange under the terms

of ISO/IEC 7826-1 and ISO/IEC 7826-2

[ENV 13607]

ISO 21549-7:2007(E)
international non-proprietary name INN official non-proprietary or generic name given to a pharmaceutical substance, as designated by the World Health Organization ISO 11615:2012(E)
interoperability the ability of two or more systems (computers, communication devices, networks, software, and other information

technology components) to interact with one another and exchange information according to a prescribed method

in order to achieve predictable results

ISO TR 16056-1:2004(E)
interoperability the ability of two or more systems (computers, communication devices, networks, software, and other information

technology components) to interact with one another and exchange information according to a prescribed method

in order to achieve predictable results

ISO TR 16056-2:2004(E)
Interoperability the ability of two or more systems (computers, communication devices, networks, software, and other information

technology components) to interact with one another and exchange information according to a prescribed method in order to achieve predictable results.

ISO TS 16058:2004(E)
interoperability Idealized scheme where medical devices of differing types, models, or manufacturers

are capable of working with each other, whether connected to each other directly or through a communication

system.

ISO/IEEE 11073-10201:2004(E)
interoperability ability of two or more systems or components to exchange information and to use the information that has

been exchanged

[IEEE Standard Computer Dictionary]

ISO/TS 27790:2009(E)
interoperability testing an assessment of the ability of two or more systems to interact with one another and exchange usable electronic

data

NOTE As conformity to the specifications alone does not guarantee interoperability of systems, interoperability testing is

required to assess the ability of two or more systems to interact with one another and exchange usable electronic data.

Interoperability testing does not include assessment of performance, robustness or reliability nor does it measure the conformity

of an implementation. Two systems can be interoperable but still not compliant to the standard or specification.

ISO TR 16056-1:2004(E)
interoperability testing an assessment of the ability of two or more systems to interact with one another and exchange usable electronic

data

NOTE As conformity to the specifications alone does not guarantee interoperability of systems, interoperability testing is

required to assess the ability of two or more systems to interact with one another and exchange usable electronic data.

Interoperability testing does not include assessment of performance, robustness or reliability nor does it measure the conformity

of an implementation. Two systems can be interoperable but still not compliant to the standard or specification.

ISO TR 16056-2:2004(E)
interoperability testing an assessment of the ability of two or more systems to interact with one another and exchange usable electronic data ISO TS 16058:2004(E)
interpretive device device (cart, computer) analysing the ECG signal ISO 11073-91064:2009(E)
interstitial fluid (ISF) The thin layer of fluid that surrounds the body’s cells. ISO/IEEE 11073-10425:2016(E)
interventional equipment medical device for use in surgical procedures EXAMPLES — surgical prostheses (hip implant, pacemaker, prosthetic valve) — surgical instruments (drill, needle, scissors, clamp) — fixation devices (nail, screw, plate, rod, pin) — tubular devices (catheter, drain, tube) — connecting material (suture, clip) — imaging devices (endoscope, microscope, X-ray, ultrasound equipment) — surgical agents (electricity, liquid nitrogen, laser) — substance (air, ionizing ray) — chemical (drug, anaesthetic agents) — animal organs and tissues NOTE Most terms concerning interventional equipment can be found in the application field of the definitions of Council Directive 93/42/EEC concerning medical devices or in the International Classification of Clinical Services (ICCS) section “Medical and surgical supplies”. ISO 1828:2012(E)
invariant rule about the features of a class which must always be true ISO 21090:2011(E)
invented name name for an innovative Medicinal Product as authorized by a Medicines Regulatory Agency in a jurisdiction NOTE Synonym to “trade name” of a Medicinal Product. ISO 11615:2012(E)
inversion chromosome rearrangement in which a segment of a chromosome is reversed end to end ISO/TS 20428:2017(E)
investigational code sponsor code code assigned by a regulatory authority to a sponsor’s investigational new drug application prior to the initiation of a clinical trial ISO 11616:2012(E)
Investigational Medicinal Product pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, used for an unauthorized indication, or used to gain further information about the authorized form ISO 11615:2012(E)
investigational medicinal product pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form ISO 11616:2012(E)
Investigational Medicinal Product pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, used for an unauthorized indication, or used to gain further information about the authorized form

[SOURCE: ISO 11615:2012, 3.1.28]

ISO/TS 19256:2016(E)
Investigational Medicinal Product Batch Identifier (I)BAID_1 unique identifier allocated to a specific batch of an (Investigational) Medicinal Product, which appears on the outer packaging of the (Investigational) Medicinal Product NOTE 1 It is constructed by using the batch number assigned by the manufacturer and the expiration date. NOTE 2 This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of an (Investigational) Medicinal Product at the package level. ISO 11615:2012(E)
Investigational Medicinal Product Batch Identifier (I)BAID_2 unique identifier allocated to a specific batch of an (Investigational) Medicinal Product, which appears on the immediate packaging, where this is not the outer packaging

NOTE 1 It is constructed by using the batch number assigned by the manufacturer and the expiration date.

NOTE 2 This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of an (Investigational) Medicinal Product based at the level of the immediate container.

ISO 11615:2012(E)
Investigational Medicinal Product Identifier unique identifier allocated to an Investigational Medicinal Product supplementary to any existing identifier as ascribed by a Medicines Regulatory Agency in a jurisdiction or a sponsor of a clinical trial

Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products worldwide.

[SOURCE: ISO 11615:2012, 3.1.31]

ISO/TS 19256:2016(E)
Investigational Medicinal Product Identifier IMPID unique identifier allocated to an Investigational Medicinal Product supplementary to any existing identifier as ascribed by a Medicines Regulatory Agency in a jurisdiction or a sponsor of a clinical trial NOTE This is for indexing purposes and to contribute to improving patient safety by allowing for the unique Identification of Medicinal Products worldwide. ISO 11615:2012(E)
Investigational Medicinal Product Package Identifier IPCID unique identifier allocated to an Investigational Medicinal Product at package level supplementary to any existing identifier as ascribed by a Medicines Regulatory Agency in a jurisdiction or a sponsor of a clinical trial

NOTE This is for indexing purposes and to contribute to improving patient safety by allowing for the unique Identification of Medicinal Products worldwide.

ISO 11615:2012(E)
irreversibility situation when, for any passage from identifiable to pseudonymous, it is computationally unfeasible to trace

back to the original identifier from the pseudonym

ISO/TS 25237:2008(E)
ISO OID organization code unique worldwide organization code defined and managed following the ISO/IEC 9834 series of International

Standards

ISO 21549-8:2010(E)
isotope variants of a chemical element that differ by molecular mass ISO 11238:2012(E)
item single distinct part of the visually readable data ISO 20301:2006(E)
jurisdiction geographical area or subject matter to which the Medicines Regulatory Agency applies ISO 11615:2012(E)
jurisdiction geographical area or subject matter to which the pharmaceutical legislative authority applies ISO 11616:2012(E)
key sequence of symbols that controls the operations of encipherment and decipherment

[ISO 7498‑2]

ISO 21091:2013(E)
key sequence of symbols which controls the operations of encipherment and decipherment

[ISO 7498-2:1989, definition 3.3.32]

ISO/TS 13606-4:2009(E)
key sequence of symbols that controls the operations of encipherment and decipherment

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
key sequence of symbols that controls the operations of encipherment and decipherment

ISO 7498-2:1989, definition 3.3.32.

ISO/TS 21547:2010(E)
key sequence of symbols that controls the operations of encipherment and decipherment

[ISO 7498-2, definition 3.3.32]

ISO/TS 22600-1:2006(E)
key sequence of symbols that controls the operations of encipherment and decipherment

[ISO 7498-2, definition 3.3.32]

ISO/TS 22600-2:2006(E)
key sequence of symbols that controls the operations of encipherment and decipherment

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
key sequence of symbols which controls the operations of encipherment (3.21) and decipherment (3.17)

[ISO 7498-2:1989, definition 3.3.32]

ISO/TS 25237:2008(E)
key agreement method for negotiating a key value online without transferring the key, even in an encrypted form, e.g. the

Diffie-Hellman technique

NOTE See ISO/IEC 11770-1 for more information on key agreement mechanisms.

ISO/TS 22600-3:2009(E)
key management generation, storage, distribution, deletion, archiving and application of keys in accordance with a

security policy

[ISO 7498‑2]

ISO 21091:2013(E)
key management generation, storage, distribution, deletion, archiving and application of keys in accordance with a security policy

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
key management generation, storage, distribution, deletion, archiving and application of keys in accordance with a security

policy (3.2.22)

ISO 7498-2:1989, definition 3.3.33.

ISO/TS 21547:2010(E)
key management generation, storage, distribution, deletion, archiving and application of keys in accordance with a security

policy

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
key management

cryptographic key management

generation, storage, distribution, deletion, archiving and application of keys in accordance with a security

policy (3.43)

[ISO 7498-2:1989, definition 3.3.33]

ISO/TS 25237:2008(E)
kind-of-property common defining aspect of mutually comparable properties EXAMPLE Colour, mass, amount-of-substance concentration. NOTE 1 The hyphens are used to clarify that the modifier “kind” should be seen as part of a connected whole. NOTE 2 A kind-of-property may be related to nominal scale (e.g. green, blue), ordinal scale (e.g. small, large), differential scale [e.g. 10 °C (i.e. 10 °C more than an arbitrary zero)], or rational scale (length 2 or 5 m); the last two types are related to kind-of-quantity. ISO 11240:2012(E)
kind-of-quantity aspect common to mutually comparable quantities NOTE 1 The hyphens are used to clarify that the modifier “kind” should be seen as part of a connected whole. NOTE 2 This concept is necessary for the definition of a measurable quantity, along with a system and often a component. NOTE 3 Quantities of the same kind within a given system of quantities have the same quantity dimension. However, quantities of the same dimension are not necessarily of the same kind. The division of the concept of “quantity” according to “kind-of-quantity” is to some extent arbitrary. EXAMPLE 1 The quantities diameter, circumference and wavelength are generally considered to be quantities of the same kind, namely of the kind-of-quantity called length. EXAMPLE 2 The quantities number of entities, relative substance concentration, and mass fraction are, by convention, not regarded as being of the same kind, although they have the same quantity dimension. NOTE 4 Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
knowledge database system in which knowledge on a specific topic is specified as set of declarative statements, hierarchical organization of such statements, and relationships between declarative statements, which serves as the underpinning of decision support systems ISO/TS 19256:2016(E)
knowledge management range of practices used by organizations to identify, create, represent and distribute knowledge to support

learning and decision making

ISO/TR 13054:2012(E)
knowledge resource collection of knowledge about a subject area collected for a purpose and made available to a user through

some means

ISO 13119:2012(E)
laboratory information system

LIS

information system which can provide services to one or more analytical instruments ISO 18812:2003(E)
large indel insertion or deletion up to ~1 kb ISO/TS 20428:2017(E)
latency In a communications scenario, the time delay between sending a signal from one device and

receiving it by another device.

ISO/IEEE 11073-10201:2004(E)
latency communicationstime delay between the sending of a signal from one device and its reception by another

device

ISO/TS 27790:2009(E)
lead Commonly refers to two different things: It may be used to refer to the combination of an electrode

and associated lead wire, used for a certain ECG recording. Alternatively, it may be used to refer to the

signal obtained by tracing the voltage between two electrodes or linear combinations thereof. The latter

definition is used throughout this standard.

ISO/IEEE 11073-10406:2012(E)
lead wire A cable connected between an electrode and the agent device. ISO/IEEE 11073-10406:2012(E)
legacy data data that were collected and maintained using a “previous” system, but are now preserved on a “current”

system

ISO 13606 -1:2008(E)
legal status of supply jurisdictional rule as to whether a Medicinal Product is subject to a medical prescription before it may be supplied to a patient or consumer ISO 11615:2012(E)
lesion abnormal morphologic structure EXAMPLES Cyst, foreign body, exostosis, polyp. NOTE 1 A lesion shall be described without reference to human anatomy (4.8.2) or any specific diagnosis such as embolism, hypertension, priapism, myocarditis. NOTE 2 A lesion may be the result of inheritance, disease, trauma, or previous surgical procedures. NOTE 3 The Oxford English Dictionary provides another similar definition: region in an organ or tissue which has suffered damage through injury or disease. ISO 1828:2012(E)
level of specialization property of a concept (A.3.2.1) reflecting the number of and detail of characteristics (A.3.2.4) in its

intension (A.3.2.9)

NOTE A specific concept (A.3.2.16) has a high level of specialization and a fine granularity; a generic concept

(A.3.2.15) has low level of specialization and coarse granularity.

ISO 17115:2007(E)
lifecycle 〈information resource〉 sequence of events that mark the development and use of an information resource

NOTE Adapted from ISO 15836:2009, definition 3.1.2.

EXAMPLE Conception of an invention, creation of a draft, revision of an article, publication of a book, acquisition by

a library, transcription to magnetic disk, migration to optical storage, translation into English and derivation of a new work

(e.g. a film).

ISO 13119:2012(E)
Lifecycle evolution of a system, product, service, project or other human-made entity from conception through

retirement

ISO/TR 17791:2013(E)
lifecycle [of information resource] sequence of events that mark the development and use of an information resource

EXAMPLE Conception of an invention, creation of a draft, revision of an article, publication of a book,

acquisition by a library, transcription to magnetic disk, migration to optical storage, translation into English and

derivation of a new work (e.g. a movie).

[SOURCE: ISO 15836:2003]

ISO/TS 13972:2015(E)
lightweight directory access protocol

LDAP

standard access protocol for directories allowing public or controlled access to certificates and other

information needed in a PKI

ISO 21091:2013(E)
lightweight directory access protocol

LDAP

standard access protocol for directories allowing public or controlled access to certificates and other

information needed in a PKI

ISO/TS 22600-3:2009(E)
likely benign alterations with strong evidence against pathogenicity

Note 1 to entry: Targeted testing of at-risk family members not recommended.

ISO/TS 20428:2017(E)
likely pathogenic alterations with strong evidence in favor of pathogenicity ISO/TS 20428:2017(E)
linear component linear portion of a GS1 Composite symbol, which encodes the primary identification of an item ISO/IEC 24724:2011(E)
linkage ability to join together two or more entities or parts. It may be physical, electrical or relational ISO 21549-3:2014(E)
linkage ability to join together two or more entities or parts

NOTE A linkage can be physical, electrical or relational.

ISO 21549-7:2007(E)
linkage flag indicator encoded in a GS1 DataBar or GS1-128 linear component to signal if a 2D component accompanies

the linear component

ISO/IEC 24724:2011(E)
linkage information data set that provides the complete information to locate the resource of a certain part of a distributed record ISO 21549-8:2010(E)
linkage of information objects process allowing a logical association to be established between different information objects ISO/TS 25237:2008(E)
linked reply A command response that requires more than one protocol data unit (PDU) to communicate

information. For example, a single command to retrieve an entire log file may result in many linked

response PDUs to provide the requested information.7

ISO/IEEE 11073-20101:2004(E)
list A form of collection whose members are ordered, and need not be unique. ISO 21731:2006(E) & ANSI/HL7 RIM R1
literary expression A representation of a model in text. The literary expression seeks to balance the need for a rigorous,

unambiguous description of the model with the need for a rendition that can be easily read and interpreted

by individuals who understand the general concepts underlying object-oriented models, but who may not

be schooled in formal model definition languages.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
Loadlist subset of one or more worklists specifically assigned to an analytical instrument ISO 18812:2003(E)
local area network (LAN) A communication network to interconnect a variety of intelligent

devices (e.g., personal computers, workstations, printers, file storage devices) that can transmit data over a

limited area, typically within a facility.

ISO/IEEE 11073-30200:2004(E)
local area network (LAN) A communication network to interconnect a variety of intelligent

devices (e.g., personal computers [PCs], workstations, printers, file storage devices) that can transmit data

over a limited area, typically within a facility. See also: service access point (SAP).

ISO/IEEE 11073-30300:2004(E)
local area network (LAN) A communications network to interconnect a variety of intelligent

devices (e.g., personal computers, workstations, printers, and file storage devices) that can transmit data

over a limited area, typically within a facility.

ISO/IEEE 11073-30400:2012(E)
logical information model information model that specifies the structures and relationships between information but is independent of

any particular technology or implementation environment

NOTE Information models are commonly classified from high-level abstract models through to concrete technology

implementation models. The ISO Health Informatics Profiling Framework (ISO/TR 17119[1]) defines three levels of

specificity for information models and other artefacts viz conceptual, logical and physical. Logical information models

provide detailed specifications for components of the model (e.g. container, section and link classes in a UML object

model of an EHR) and the relationships between the components, without any technological constraints. A logical

information model is therefore independent of any particular implementation technology. A physical information model on

the other hand, includes technological constraints to enable the building of a particular implementation of the logical model

(e.g. an EHR system built for a particular hardware and software platform).

ISO/TR 20514:2005(E)
logical information model information model that specifies the structures and relationships between data elements but is

independent of any particular technology or implementation environment

[SOURCE: ISO/TR 17119:2005]

ISO/TS 13972:2015(E)
long-term preservation act of maintaining information in a correct and independently understandable form over a long time ISO/TS 21547:2010(E)
lower layers Layer 1 to Layer 4 of the International Organization for Standardization (ISO)/open

systems interconnection (OSI) reference model. These layers cover mechanical, electrical, and general communication

protocol specifications.

ISO/IEEE 11073-10201:2004(E)
machine readable code code, readable by a machine, that contains information used to establish a relationship between a

physical object such as a medicinal product package and data sources such as medical, production,

logistical and/or reimbursement coding systems

ISO/TS 16791:2014(E)
machine readable code code, readable by a machine, that contains information used to establish a relationship between a physical

object such as a medical product package and data sources such as medical, production, logistical and/or

reimbursement coding systems

ISO/TS 18530:2014(E)
magistral medicinal product

extemporaneous medicinal product

intended to be used for one and only one subject of care

NOTE 1 A magistral/extemporaneous medicinal product is also a pharmaceutical product.

NOTE 2 The term extemporaneous medicinal product is not be used, as it is more appropriate in describing a medicine

processed during the administration of a medicinal product, especially when a mixture is made just before, e.g.,

intravenous administration.

[ENV 13607] [ENV 12610]

ISO 21549-7:2007(E)
magistral medicinal product

extemporaneous medicinal product

medicinal product manufactured in a pharmacy or a pharmacy department based on a recipe and intended to

be used for one and only one subject of care

NOTE A magistral medicinal product is also a pharmaceutical product.

[ENV 12610 (modified)]

ISO/TR 22790:2007(E)
major industry identifier

MII

code that identifies the sector/industry within which the data card is intended for use

NOTE The designated MII for healthcare is 80.

ISO 21549-2:2004(E)
major record identifier identifier linked to a primary record relating to a record person in a data card and a given healthcare delivery

system

ISO 21549-2:2004(E)
management information base (MIB) A type of database used to manage the devices in a

communications network. It comprises a collection of objects in a (virtual) database used to manage entities

in a network.

ISO/IEEE 11073-30400:2012(E)
management information base (MIB) aggregator A generic term for a device that combines multiple

downstream MIB ports and multiplexes them on to one upstream MIB port.

ISO/IEEE 11073-30400:2012(E)
management information base (MIB) interface An informal name for the ISO/IEEE 11073-30200:2004. ISO/IEEE 11073-30400:2012(E)
manager A node receiving data from one or more agent systems. Some examples of managers include a

cellular phone, health appliance, set top box, or a computer system.

ISO/IEEE

11073-10420

manager A node receiving data from one or more agent systems. Some examples of managers include a

cellular phone, health appliance, set top box, or a computer system.

ISO/IEEE 11073-00103:2015(E)
manager Device that receives data in a manager-agent communicating system. ISO/IEEE 11073-10201:2004(E)
manager A node receiving data from one or more agent systems. Some examples of managers include a

cellular phone, health appliance, set top box, or computer system.

ISO/IEEE 11073-10406:2012(E)
manager A node receiving data from one or more agent systems. Some examples of managers

include a cellular phone, health appliance, set top box, or a computer system.

ISO/IEEE 11073-10407:2010(E)
manager A node receiving data from one or more agent systems. Some examples of managers

include a cellular phone, health appliance, set top box, or a computer system.

ISO/IEEE 11073-10408:2010(E)
manager A node receiving data from one or more agent systems. Some examples of managers

include a cellular phone, health appliance, set top box, or a computer system.

ISO/IEEE 11073-10415:2010(E)
manager A node receiving data from one or more agent systems. Some examples of managers include

a cellular phone, health appliance, set top box, or a computer system.

ISO/IEEE 11073-10421:2012(E)
manager A node receiving data from one or more agent systems. Some examples of managers include a

cellular phone, health appliance, set top box, or a computer system.

ISO/IEEE 11073-10425:2016(E)
manager A node receiving data from one or more agent systems. Some examples of managers include a

cellular phone, health appliance, set top box, or a computer system.

ISO/IEEE 11073-10472:2012(E)
manager A node receiving data from one or more agent systems. Examples of managers include a cellular

phone, health appliance, set top box, or computer system.

ISO/IEEE 11073-20601:2016(E)
manager device that receives data in a manager/agent communicating system ISO/TS 27790:2009(E)
manager A node receiving data from one or more agent systems. Some examples of managers include a

cellular phone, health appliance, set top box, or computer system.

ISO_IEEE_11073-10417_2015
manager-agent model Communication model where one device (i.e., agent) provides data and

another device (i.e., manager) receives data.

ISO/IEEE 11073-10201:2004(E)
mandatory If an attribute is designated as mandatory, all message elements which make use of this attribute must

contain a non-null value or they must have a default that is not null.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
mandatory association An association with a multiplicity minimum greater than zero on one end. A fully mandatory association is

one with a multiplicity minimum greater than zero on both ends.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
manufactured dose form pharmaceutical dose form of a manufactured item as manufactured and, where applicable, before transformation into the pharmaceutical product ISO 11239:2012(E)
manufactured dose form pharmaceutical dose form of a manufactured item as manufactured and, where applicable, before transformation into the pharmaceutical product EXAMPLE Powder for solution for injection.

NOTE The manufactured dose form is identical to the administrable dose form in cases where no transformation of the manufactured item is necessary (i.e. where the manufactured item is equal to the pharmaceutical product).

ISO 11615:2012(E)
manufactured dose form pharmaceutical dose form as presented in the packaging by the manufacturer, before any necessary transformation has been carried out to yield the administered dose form EXAMPLE Powder for solution for injection. NOTE In many instances, there is no transformation necessary and the manufactured dose form is equal to the administered dose form. ISO 11616:2012(E)
manufactured item qualitative and quantitative composition of a product as contained in the packaging of the medicinal product NOTE 1 A medicinal product may contain one or more manufactured items. NOTE 2 In many instances, the manufactured item is equal to the pharmaceutical product. However, there are instances where the manufactured item(s) must undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal. NOTE 3 The manufactured item is not in direct contact with the outer packaging except where the outer packaging also serves as the immediate container ISO 11239:2012(E)
manufactured item qualitative and quantitative composition of a product as contained in the packaging of the Medicinal Product

NOTE 1 A Medicinal Product may contain one or more manufactured items.

NOTE 2 In many instances the manufactured item is equal to the pharmaceutical product. However, there are instances where the manufactured item(s) undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.

NOTE 3 The manufactured item is not in direct contact with the outer packaging except where the outer packaging also serves as the immediate container.

ISO 11615:2012(E)
manufacturer natural or legal person with responsibility for the design, manufacture, packaging or labelling of a health

software product, assembling a system, or adapting a health software product before it is placed on the

market and/or put into service, regardless of whether these operations are carried out by that person himself

or on his behalf by a third party

ISO/TR 27809:2007(E)
manufacturer natural or legal person with responsibility for the design, manufacture, packaging or labelling of a health

informatics product, assembly of a system or adaptation of a health informatics product before it is placed on

the market and/or put into service, regardless of whether these operations are carried out by that person or on

that person’s behalf by a third party

[adapted from ISO 14971]

ISO/TS 25238:2007(E)
manufacturing process of production for a substance or medicinal product from the acquisition of all materials through all processing stages ISO 11238:2012(E)
manufacturing authorization manufacture of the Medicinal Products within a jurisdiction subject to the holding of an authorization NOTE Such authorization may be required for both total and partial manufacture and for the various processes of dividing up, packaging or presentation. However, such authorization may not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorized in a jurisdiction to carry out such processes. ISO 11615:2012(E)
manufacturing authorization date date when the manufacturing authorization was granted ISO 11615:2012(E)
manufacturing authorization holder organization that holds the authorization for the manufacturing process ISO 11615:2012(E)
manufacturing/manufacture process of production from the acquisition of all materials through all processing stages, including final

packaging

ISO/TS 16791:2014(E)
mapping alternative representation of the same concept expressed in a different code from a different code system EXAMPLES Concept mapping, code mapping. NOTE Because units of measurement represent defined physical quantities, this mapping is always exact. The mapped terms represent exactly the same concept. ISO 11240:2012(E)
mapping assigning an element in one set to an element in another set through semantic correspondence (2.6.2)

NOTE It is the relation with the best semantic correspondence between an element in one set and an element in another

set.

ISO 17115:2007(E)
mapping assigning an element in one set to an element in another set through semantic correspondence (2.16)

[ISO 17115:2007, definition 2.6.1]

ISO/TS 22789:2010(E)
marketing authorization authorization issued from a Medicines Regulatory Agency that a Medicinal Product may be placed on the market ISO 11615:2012(E)
marketing authorization authorization issued from a Medicines Reulatory Agency that a Medicinal Product may be placed on the

market

[SOURCE: ISO 11615:2012, 3.1.40]

ISO/TS 16791:2014(E)
Marketing Authorization Holder organization that holds the authorization for marketing a Medicinal Product in a jurisdiction ISO 11615:2012(E)
marketing authorization holder organization that holds the authorization for marketing a medicinal product in a jurisdiction

[SOURCE: ISO 11615:2012, 3.1.38, — modified, “for marketing a medicinal product in a jurisdiction”

added]

ISO/TS 16791:2014(E)
marketing authorization holder organization that holds the authorization for marketing a medicinal product in a jurisdiction

[SOURCE: ISO 11615:2012, 3.1.41]

ISO/TS 19256:2016(E)
marketing authorization number identifier assigned by a Medicines Regulatory Agency to a Medicinal Product ISO 11615:2012(E)
marketing authorization number identifier assigned by a Medicines Regulatory Agency to a medicinal product

[SOURCE: ISO 11615:2012, 3.1.42]

ISO/TS 19256:2016(E)
marketing authorization procedure authorization procedure formal procedure applied by a Medicines Regulatory Agency to grant a marketing authorization, amend an existing one, extend its duration or to withdraw it NOTE Marketing authorisation procedure and authorisation procedure are synonymous. ISO 11615:2012(E)
marketing start date date when the authorized Medicinal Product is marketed in a jurisdiction NOTE The date of actual marketing of a Medicinal Product is always after a marketing authorization has been granted by a Medicines Regulatory Agency ISO 11615:2012(E)
marketing stop date date when the marketing of the authorized Medicinal Product is stopped in a jurisdiction ISO 11615:2012(E)
mass An intrinsic property of matter that can be measured using the effect of the gravitational field on an

object.

ISO/IEEE

11073-10420

mass An intrinsic property of matter that can be measured using the effect of the gravitational field

on an object.

ISO/IEEE 11073-10415:2010(E)
master data management enablement of a program that provides for an organization’s data definitions, source locations, ownership and

maintenance rules

ISO/TS 29585:2010(E)
material any entity that has mass, occupies space and consists of one or more substances ISO 11238:2012(E)
material substance or specified substance of which a certain component is made

NOTE This applies to a Medicinal Product package item (container), package (component) and device.

ISO 11615:2012(E)
material measure something that reproduces or supplies one or more quantities, each with an assigned quantity value EXAMPLES Ruler, standard weight, volume measure. ISO 11240:2012(E)
maturity 〈of an information system〉 state of a system, demonstrated by special characteristics and behaviour, that

permits it to operate better in accordance with its business goals as a result of transformation and adoption

NOTE Adapted from OSIMM.

ISO/TR 13054:2012(E)
maturity model means of and scale for evaluating and assessing the current state of maturity

NOTE Adapted from OSIMM.

ISO/TR 13054:2012(E)
mean arterial pressure value of the integral of one cycle of the blood pressure curve divided by the

period between successive heart beats.

ISO/IEEE 11073-10407:2010(E)
measurement process of experimentally obtaining one or more quantity values that can reasonably be attributed to a quantity NOTE 1 Measurement does not apply to nominal properties. NOTE 2 Measurement implies comparison of quantities and includes counting of entities. NOTE 3 Measurement presupposes a description of the quantity commensurate with the intended use of a measurement result, a measurement procedure, and a calibrated measuring system operating according to the specified measurement procedure, including the measurement conditions. NOTE 4 Measurement usually involves using a measuring instrument, such as a ruler or scale, which is calibrated to compare the object to some standard, such as a metre or a kilogram. NOTE 5 Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
measurement point physical location on an administration device where the quantity of the medication being delivered is measured ISO 11615:2012(E)
measurement procedure detailed description of a measurement according to one or more measurement principles (i.e. phenomena, observables) and to a given measurement method, based on a measurement model and including any calculation to obtain a measurement result NOTE 1 A measurement procedure is usually documented in sufficient detail to enable an operator to perform a measurement. NOTE 2 A measurement procedure can include a statement concerning a target measurement uncertainty. NOTE 3 A measurement procedure is sometimes called a standard operating procedure, abbreviated SOP. EXAMPLE Lowering of the concentration of glucose in blood in a fasting rabbit is an observable that can be applied to the measurement of insulin concentration in a preparation. Together with a description of the measurement method this can be used to define a measurement procedure. NOTE 4 Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
media access control (MAC) The data link sublayer that is responsible for transferring data to and from

the physical layer.

ISO/IEEE 11073-30400:2012(E)
median beat typical heart beat used for measurement and analysis in standard 12-lead ECG

Note 1 to entry: This is a waveform with the median value of waveforms excluding the abnormal beats for each

lead.

ISO/TS 22077-2:2015(E)
medical data information base (MDIB) The concept of an object-oriented database storing (at least)

vital signs information.

ISO/IEEE 11073-10201:2004(E)
medical device any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease; — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; — investigation, replacement or modification of the anatomy or of a physiological process; — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. [EC Directive on Medical Devices 2007/47] ISO 11615:2012(E)
medical device any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease; — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; — investigation, replacement or modification of the anatomy or of a physiological process; — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means [EC Directive 2007/47 on Medical Devices] NOTE This definition is applicable for the purposes of this and related standards alone (ISO 11238, ISO 11239, ISO 11240, ISO 11615 and this International Standard). ISO 11616:2012(E)
medical device A device, apparatus, or system used for patient monitoring, treatment, or therapy,

which does not normally enter metabolic pathways. For the purposes of this standard, the scope of medical

devices is further limited to patient-connected medical devices that provide support for electronic

communications.

ISO/IEEE 11073-10201:2004(E)
medical device any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

— investigation, replacement, modification, or support of the anatomy or of a physiological process,

— supporting or sustaining life,

— control of conception,

— disinfection of medical devices,

— providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and

b) which does not achieve its primary intended action in or on the human body by pharmacological,

immunological or metabolic means, but which may be assisted in its intended function by such means

ISO/TR 17791:2013(E)
medical device any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,

material or other similar or related article:

a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of

the specific purpose(s) of:

⎯diagnosis, prevention, monitoring, treatment or alleviation of disease;

⎯diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

⎯investigation, replacement, modification, or support of the anatomy or of a physiological process;

⎯supporting or sustaining life;

⎯control of conception;

⎯disinfection of medical devices;

⎯providing information for medical or diagnostic purposes by means of in vitro examination of

specimens derived from the human body;

b) which does not achieve its primary intended action in or on the human body by pharmacological,

immunological or metabolic means, but which may be assisted in its intended function by such means

NOTE This definition is drawn from the Global Harmonization Task Force (GHTF) [8]. However, with regard to the

coverage of software, there are some differences in definition in different countries which this Technical Report addresses

in Annex A.

ISO/TR 27809:2007(E)
medical device device, apparatus or system used for patient monitoring, patient treatment or therapy, which does not normally

enter metabolic pathways

NOTE For the purposes of this document, the scope of medical devices is further limited to those patient-connected

medical devices which provide support for electronic communications.

ISO/TS 27790:2009(E)
medical device communications (MDCs): A general term used to describe the networking

and connectivity standards that enable medical devices to communicate in interoperable ways.

ISO/IEEE 11073-30400:2012(E)
medical device system (MDS) Abstraction for system comprising one or more medical functions. In

the context of this standard, the term is specifically used as an object-oriented abstraction of a device that

provides medical information in the form of objects that are defined in this standard.

ISO/IEEE 11073-10201:2004(E)
medical information bus (MIB) The informal name for the ISO/IEEE 11073 family of standards. ISO/IEEE 11073-30200:2004(E)
medical information bus (MIB) The informal name for the ISO/IEEE 11073 family of standards. ISO/IEEE 11073-30300:2004(E)
medical information bus (MIB): An informal name for the ISO/IEEE 11073 family of standards.

Now deprecated.

ISO/IEEE 11073-30400:2012(E)
medical knowledge field of knowledge pertaining to the structure, function or dysfunction of the human body and how these can be influenced by external or internal factors and interventions ISO 13119:2012(E)
medical knowledge field pertaining to the structure, function, or dysfunction of the human body and how it can be influenced by external or internal factors and interventions

Note 1 to entry: Medical does not imply “physician”, all health professionals have medical knowledge according

to this definition.

ISO/TS 13972:2015(E)
medication concepts formally defined medicinal products in terms of their characteristics and relationships with other concepts ISO/TS 19256:2016(E)
medication history record keeping of the specificities of the prescribed/dispensed/OTC medicinal product (identification, brand, type, form, quantity, dosage, etc.); this record contains the medication still in use as well as the medication no longer in use

[SOURCE: IHE Pharmacy – Technical Framework Specification, modified]

ISO/TS 19256:2016(E)
medication order documented instruction on intended therapy for an individual person with a medicinal product issued by an

authorized health professional

NOTE A medication order contains information on the medicinal product(s), the intended dosage instruction and the

period of time during which the medication was intended to be given.

ISO/TR 22790:2007(E)
medication record record related to an individual person, which includes information about prescribed medicinal products, the

intended dosage instruction and the period of time during which the medication was intended to be given

NOTE 1 A medication record should preferably contain information not only on medicinal products prescribed for

community dispensation and home care but also medication ordered for administration to in-patients in hospital care.

NOTE 2 A medication record should be updated even when no prescription is issued to reflect current dosage and

possible withdrawal of prescribed medication.

NOTE 3 A medication record considered here is part of the more general concept Electronic Health Record and as

such other information should be associated to the core information in the definition such as date and place of recording,

responsible person, signature etc.

ISO/TR 22790:2007(E)
medicinal appliance device or piece of equipment which may be used by human beings or administered to animals for treating or

preventing disease, with the view to making medical diagnosis, to restore, correct or modify physiological

functions or to alleviate handicap

NOTE In order to be prescribable a medicinal appliance should fall within the purpose of prescribing as accepted by

local rules/traditions in the area. The purpose of prescribing may be a requirement for formal reimbursement, restrictions

on general sale of the appliance or need for labelling the appliance with individual instructions for use.

EXAMPLE Syringes, spacers for inhalation, diagnostic kits for pregnancy, bandages, catheters, nappies for

incontinence, orthopaedic shoes, colostomy bags, wheel chairs, pneumatic mattresses.

[ENV 13607]

ISO 21549-7:2007(E)
medicinal appliance device or piece of equipment that may be used by human beings or administered to animals for treating or

preventing disease, with the view to making medical diagnosis, to restore, correct or modify physiological

functions or to alleviate handicap

NOTE In order to be prescribable a medicinal appliance should fall within the purpose of prescribing as accepted by

local rules/traditions in the area. The production of a prescription may also be required for formal reimbursement,

restrictions on general sale of the appliance or need for labelling the appliance with individual instructions for use.

EXAMPLE Syringes, spacers for inhalation, diagnostic kits for pregnancy, bandages, catheters, nappies for

incontinence, orthopaedic shoes, colostomy bags, wheel chairs, pneumatic mattresses.

[ENV 12610]

ISO/TR 22790:2007(E)
medicinal product any substance or combination of substances which may be administered to human beings or animals for treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify physiological functions ISO 11238:2012(E)
medicinal product any substance or combination of substances, which may be administered to human beings or animals for treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify physiological functions [ENV 13607:2000; ENV 12610:1997] NOTE 1 A medicinal product may consist of one or more manufactured items and one or more pharmaceutical products. NOTE 2 In certain jurisdictions, a medicinal product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis. ISO 11239:2012(E)
medicinal product any substance, or combination of substances, which may be administered to human beings for treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify physiological functions NOTE 1 A medicinal product may contain one or more manufactured items and one or more pharmaceutical products. NOTE 2 In certain jurisdictions a medicinal product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis. NOTE 3 Adapted from ENV 13607:2000 and ENV 12610:1997. ISO 11240:2012(E)
Medicinal Product any substance or combination of substances that may be administered to human beings (or animals) for treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify physiological functions

NOTE 1 A Medicinal Product may contain one or more manufactured items and one or more pharmaceutical products.

NOTE 2 In certain jurisdictions a Medicinal Product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis.

NOTE 3 The provisions in this standard apply to proprietary medicinal products for human use intended to be placed on the market and to industrially manufactured medicinal products, the marketing of which has been authorized by a Medicines Regulatory Agency. However, the provisions do not apply to medicinal products prepared according to prescription, i.e. prepared in a pharmacy from a prescription intended for a specific patient; medicinal products prepared in accordance with an official formula, i.e. prepared in a pharmacy in accordance with the instructions in a pharmacopoeia and intended to be given direct to the patient by the pharmacy; medicinal products intended for research and development trials (see 3.1.28 Investigational Medicinal Product); intermediate products intended for subsequent processing by an authorized manufacturer. [ENV 13607 and ENV 12610]

ISO 11615:2012(E)
medicinal product any substance or combination of substances, which may be administered to human beings for treating or preventing disease with the view to making a medical diagnosis or to restore, correct or modify physiological functions [ENV 13607, ENV 12610] NOTE 1 A medicinal product may contain one or more manufactured items and one or more pharmaceutical products. NOTE 2 In certain jurisdictions, a medicinal product may also be defined as any substance or combination of substances that may be used to make a medical diagnosis. ISO 11616:2012(E)
medicinal product substance or combination of substances, which can be administered to human beings for treating or preventing disease, making a medical diagnosis or to restore, correct or modify physiological functions ISO 17523:2016(E)
medicinal product any substance or combination of substances, which may be administered to human beings or animals for

treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify

physiological functions

NOTE Some medicinal products are prescribed as a combination of a medicinal product and a medicinal appliance.

Such combinations are regarded in this part of ISO 21549 as medicinal products.

[ENV 13607]

ISO 21549-7:2007(E)
medicinal product any substance or combination of substances, which may be administered to human beings or animals for

treating or preventing disease, with the view to making medical diagnosis or to restore, correct or modify

physiological functions

NOTE Some medicinal products are prescribed as a combination of a medicinal product and a medicinal appliance.

Such combinations are regarded in this Technical report as medicinal products. [ENV 12610]

ISO/TR 22790:2007(E)
medicinal product any substance or combination of substances that can be administered to human beings for treating

or preventing disease, with the view of making a medical diagnosis or to restore, correct, or modify

physiological functions

Note 1 to entry: The same definition applies for animal health.

[SOURCE: ISO 11615:2012, 3.1.49, — modified, “(or animals” removed; notes 1-2 removed and a new note

1 to entry added.]

ISO/TS 16791:2014(E)
medicinal product any substance or combination of substances that may be administered to human beings (or animals) for treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify physiological functions

Note 1 to entry: A medicinal product can contain one or more manufactured items and one or more pharmaceutical products.

Note 2 to entry: In certain jurisdictions a medicinal product can also be defined as any substance or combination of substances which might be used to make a medical diagnosis.

Note 3 to entry: Medicinal Product MPID XXXX87456 Slaapdiep tablet / Slaapdiep20 mg tablets National – has a name dedicated to a specific jurisdiction. (the code number is just an illustration, not a real identifier).

[SOURCE: ISO 11615:2012, 3.1.49, modified]

ISO/TS 19256:2016(E)
Medicinal Product Dictionary System system that is specifically designed to support the prescription, dispensing and administration of medications in healthcare based on an accurate listing, description and identification of medicinal products ISO/TS 19256:2016(E)
Medicinal Product Identifier unique identifier allocated to a medicinal product supplementary to any existing authorization number as ascribed by a Medicines Regulatory Agency in a jurisdiction

Note 1 to entry: This is for indexing purposes and to contribute to improved patient safety by allowing for the unique identification of medicinal products worldwide.

[SOURCE: ISO 11615:2012, 3.1.50]

ISO/TS 19256:2016(E)
Medicinal Product Identifier MPID unique identifier allocated to a Medicinal Product supplementary to any existing authorization number as ascribed by a Medicines Regulatory Agency in a jurisdiction

NOTE This is for indexing purposes and to contribute to improved patient safety by allowing for the unique Identification of Medicinal Products worldwide.

ISO 11615:2012(E)
Medicinal Product name name as authorized by a Medicines Regulatory Agency

NOTE This may be either an invented name not liable to be confused with the common name, or a common or a scientific name accompanied by a trade mark or any other applicable descriptor.

ISO 11615:2012(E)
medicinal product package

package

delivery unit of a medicinal product in an outer container

[ENV 12610]

ISO 21549-7:2007(E)
medicinal product package

package

delivery unit of a medicinal product in an outer container

[ENV 12610]

ISO/TR 22790:2007(E)
Medicinal Product Package Identifier unique identifier allocated to a packaged medicinal product supplementary to any existing authorization number as ascribed by a Medicines Regulatory Agency in a jurisdiction

Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products worldwide.

[SOURCE: ISO 11615:2012, 3.1.52]

ISO/TS 19256:2016(E)
Medicinal Product Package Identifier PCID unique identifier allocated to a packaged Medicinal Product supplementary to any existing authorization number as ascribed by a Medicines Regulatory Agency in a jurisdiction

NOTE This is for indexing purposes and to contribute to improving patient safety by allowing for the unique Identification of Medicinal Products worldwide.

ISO 11615:2012(E)
Medicines Regulatory Agency institutional body that, according to the legal system under which it has been established, is responsible for the granting of marketing authorization for Medicinal Products

NOTE In certain jurisdictions, the role of the institutional body which according to the legal system grants the marketing authorization of Medicinal Products may be complemented by an additional institutional body responsible for the evaluation and supervision of Medicinal Products. For example, in the EU the European Commission is the institutional body that grants the marketing authorization of Medicinal Products and the European Medicines Agency is the body responsible for the evaluation and supervision of Medicinal Products.

ISO 11615:2012(E)
message textual body of information ISO 11073-91064:2009(E)
message element unit of structure within a message type ISO/TS 27790:2009(E)
message type organization of message elements that is specified in a hierarchical message definition ISO/TS 27790:2009(E)
metadata data that defines and describes other data ISO 13119:2012(E)
metadata data that define object class and property for the information collected ISO 13606 -1:2008(E)
metadata data that define and describes other data

[ISO/IEC 11179-3:2003, definition 3.2.18]

ISO 13606-2:2008(E)
metadata data that defines and describes other data

[SOURCE: ISO/IEC 11179‑1:2004]

ISO/TS 13972:2015(E)
metadata data describing context, content and structure of records and their management through time

ISO 15489-1:2001, definition 3.12.

ISO/TS 21547:2010(E)
metadata information stored in the data dictionary which describes the content of a document

NOTE In a data warehouse context, metadata are data structure, constraints, types, formats, authorizations,

privileges, relationships, distinct values, value frequencies, keywords, interpretative notes and users of the database

sources loaded in the data warehouse and the data warehouse itself. Metadata help users, developers and administrators

manage and interpret information.

ISO/TS 29585:2010(E)
methodology Methods or rules followed in a particular discipline. ISO 21731:2006(E) & ANSI/HL7 RIM R1
metric An object that models different forms of measurements. ISO/IEEE 11073-20601:2016(E)
metrology science of measurement and its application NOTE Metrology includes all theoretical and practical aspects of measurement, whatever the measurement uncertainty and field of application. [ISO/IEC Guide 99:2007, definition 2.2] ISO 11240:2012(E)
microheterogeneity substances isolated together that contain minor differences in glycosylation, or post-translational modification such as glycosylation or sequence heterogeneity ISO 11238:2012(E)
mixture substance type of polydisperse substance that is a combination of single substances isolated together or produced in the same synthetic process ISO 11238:2012(E)
model A representation of a domain that uses abstraction to express the relevant concepts. ISO 21731:2006(E) & ANSI/HL7 RIM R1
model representation of a domain that uses abstraction to express the relevant concepts ISO/TS 13972:2015(E)
model abstraction used to express the relevant concepts and interdependencies of a project ISO/TS 27790:2009(E)
modeling construction of abstract representations in the course of design, for example to represent the logical

structure of software applications before coding

[SOURCE: http://www.omg.org/gettingstarted/what_is_uml.htm]

ISO/TS 13972:2015(E)
modifier string which, when added to a term, changes the meaning of the term in the clinical sense

EXAMPLES “Clinical stage” or “severity of illness”.

ISO/TS 17117:2002(E)
moiety entity within a substance that has a complete and continuous molecular structure ISO 11238:2012(E)
molecular fragment portion of a molecule that has one or more sites of attachment to other fragments or moieties ISO 11238:2012(E)
molecular structure unambiguous representation of the arrangement of atoms ISO 11238:2012(E)
molecular weight mass of one molecule of a homogenous substance or the average mass of molecules that comprise a heterogeneous substance ISO 11238:2012(E)
monitor A medical device designed to acquire, display, record, and/or analyze patient data and to alert

caregivers of events needing their attention.

ISO/IEEE 11073-10201:2004(E)
MPID medicinal product identifier ISO 11239:2012(E)
MPID

medicinal product identifier

identifier allocated to a medicinal product supplementary to any existing authorization number as

ascribed by a medicines regulatory authority in a jurisdiction

[SOURCE: ISO 11615:2012, 3.1.50, — modified, “unique” removed; note removed.]

ISO/TS 16791:2014(E)
MPID medicinal product identifier unique identifier allocated to a medicinal product supplementary to any existing authorization number as ascribed by a medicines regulatory agency in a jurisdiction NOTE This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products worldwide. ISO 11239:2012(E)
multiplicity In the information model, multiplicity is a specification of the minimum and maximum number of objects from

each class that can participate in an association. Multiplicity is specified for each end of the association.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
multipoint conference conference between three or more terminals, which may be on the LAN or on the circuit switched network ISO TR 16056-1:2004(E)
multipoint conference conference between three or more terminals, which may be on the LAN or on the circuit switched network ISO TR 16056-2:2004(E)
multipoint conference a conference between three or more terminals, which may be on the LAN or on the circuit switched network ISO TS 16058:2004(E)
multipoint control unit

MCU

endpoint on the LAN which enables three or more terminals and gateways to participate in a multipoint conference

NOTE The MCU includes a mandatory MC and optional MPs.

ISO TR 16056-1:2004(E)
multipoint control unit

MCU

endpoint on the LAN which enables three or more terminals and gateways to participate in a multipoint conference

NOTE The MCU includes a mandatory MC and optional MPs.

ISO TR 16056-2:2004(E)
multipoint controller

MC

An entity that provides for the control of three or more terminals in a multipoint conference ISO TR 16056-1:2004(E)
multipoint controller

MC

An entity that provides for the control of three or more terminals in a multipoint conference ISO TR 16056-2:2004(E)
multipoint processor

MP

entity that provides for the processing of audio, video, and/or data streams in a multipoint conference

NOTE The MP provides for the mixing, switching, or other processing of media streams under the control of the MC.

ISO TR 16056-1:2004(E)
multipoint processor

MP

entity that provides for the processing of audio, video, and/or data streams in a multipoint conference

NOTE The MP provides for the mixing, switching, or other processing of media streams under the control of the MC.

ISO TR 16056-2:2004(E)
multi-substance material multiple substances and/or specified substances of diverse origin used as a component in the formulation of a medicinal product ISO 11238:2012(E)
namespace A namespace is a part of the model in which names are defined and used, where each name has a unique

meaning.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
non-body substance-TM substance-TM (3.3.2) that is not originated in body

EXAMPLE Cold of <greater yang cold damage pattern>.

ISO/TS 16277-1:2015(E)
non-regulated health professional person employed by a healthcare organization who is not a health professional

EXAMPLES Receptionist or secretary who organizes appointments, or a business manager who is responsible for

validating patient health insurance.

NOTE The fact that the employee is not authorized by a body independent of the employer in his professional capacity

does, of course, not imply that the employee is not professional in conducting his services.

ISO/TS 17090-1:2002(E)
non-repudiation service providing proof of the integrity and origin of data (both in an unforgeable relationship), which can be

verified by any party

[ISO/TS 17090-1:2002, definition 3.2.21]

ISO 13606 -1:2008(E)
non-repudiation service providing proof of the integrity and origin of data (both in an unforgeable relationship), which can be

verified by any party

[ISO 17090-1:2008, definition 3.2.21]

ISO 13606-5:2010(E)
non-repudiation service providing proof of the integrity and origin of data (both in an unforgeable relationship), which can be verified

by any party

NOTE Adapted from ASTM [13].

ISO/TS 17090-1:2002(E)
non-repudiation the capacity for any actor to obtain proof that confirms the integrity and origin of a data item and cannot be forged ISO/TS 18308:2004(E)
non-repudiation service that provides proof of the integrity and origin of data (both in an unforgivable relationship) which can

be verified by any party

NOTE In a wider meaning, non-repudiation means there is unforgivable evidence that a specific action has occurred.

ISO/TS 21547:2010(E)
non-repudiation service that provides proof of the integrity and origin of data (both in an unforgeable relationship) which can be

verified by any party

ISO/TS 22600-2:2006(E)
non-repudiation service providing proof of the integrity and origin of data (both in an unforgeable relationship) which can be

verified by any party

ISO/TS 22600-3:2009(E)
NTSC Standard standard for television broadcasting established by the National Television Standards Committee (NTSC)

NOTE Used in North America, Japan and some other countries. NTSC format: Lines / frame: 525; Frames per second (fps):

30; Interlace ratio: 2:1; Aspect ratio: 4:3; Color matrix equation: Y = 0.3*R + 0.59*G + 0.11*B; I = 0.6*R . 0.28*G – 0.32*B; Q =

0.21*R . 0.52*G + 0.31 * B; where R = red, G = green, and B = blue.

ISO TR 16056-1:2004(E)
NTSC Standard standard for television broadcasting established by the National Television Standards Committee (NTSC)

NOTE Used in North America, Japan and some other countries. NTSC format: Lines / frame: 525; Frames per second (fps):

30; Interlace ratio: 2:1; Aspect ratio: 4:3; Color matrix equation: Y = 0.3*R + 0.59*G + 0.11*B; I = 0.6*R . 0.28*G – 0.32*B; Q =

0.21*R . 0.52*G + 0.31 * B; where R = red, G = green, and B = blue.

ISO TR 16056-2:2004(E)
nucleic acid substance type of substance that can be defined by a linear sequence of nucleosides typically linked through phosphate esters ISO 11238:2012(E)
numerical quantity value numerical value of a quantity numerical value number in the expression of a quantity value, other than any number serving as the reference NOTE 1 A number may serve as a “reference”. This can be explained by a dimensionless unit which appears as a number. For example, the unit (1) or a “pair” (2), a “dozen” (12) or 1 percent (0,01), ppm etc. NOTE 2 Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
object An instance of a class. A part of an information system containing a collection of related data (in the form

of attributes) and procedures (methods) for operating on that data.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
object In object-oriented modeling, a particular instantiation of a class. The instantiation realizes

attributes, methods, and events from the class.

ISO/IEEE

11073-10420

object A concept, an abstraction, or a thing with crisp boundaries and a meaning for the problem at

hand.

ISO/IEEE 11073-10201:2004(E)
object In object-oriented modeling, a particular instantiation of a class. The instantiation realizes

attributes, methods, and events from the class.

ISO/IEEE 11073-10407:2010(E)
object In object-oriented modeling, a particular instantiation of a class. The instantiation realizes

attributes, methods, and events from the class.

ISO/IEEE 11073-10408:2010(E)
object In object-oriented modeling, a particular instantiation of a class. The instantiation realizes

attributes, methods, and events from the class.

ISO/IEEE 11073-10415:2010(E)
object In object-oriented modeling, a particular instantiation of a class. The instantiation realizes

attributes, methods, and events from the class.

ISO/IEEE 11073-10421:2012(E)
object In object-oriented modeling, a particular instantiation of a class. The instantiation realizes

attributes, methods, and events from the class.

ISO/IEEE 11073-10425:2016(E)
object In object-oriented modeling, a particular instantiation of a class. The instantiation realizes

attributes, methods, and events from the class.

ISO/IEEE 11073-10472:2012(E)
object A unit that represents some functionality or item in a device whose properties are described by

attributes. Metric objects represent measurements (such as blood pressure, weight, or temperature), the

medical device system (MDS) represents the device, persistent metric store (PM-store) objects represent

the permanent storage mechanisms on an agent, and scanners represent a control and reporting mechanism.

ISO/IEEE 11073-20601:2016(E)
object instance of a class ISO/TS 27790:2009(E)
object In object-oriented modeling, a particular instantiation of a class. The instantiation realizes

attributes, methods, and events from the class.

ISO_IEEE_11073-10417_2015
object attributes Data that, together with methods, define an object. ISO/IEEE 11073-10201:2004(E)
object attributes data that, together with methods, define an object ISO/TS 27790:2009(E)
object class A descriptor used in association with a group of objects with similar properties (i.e.,

attributes), common behavior (i.e., operations), common relationships to other objects, and common

semantics.

ISO/IEEE 11073-10201:2004(E)
object class descriptor used in association with a group of objects with similar properties (attributes), common behaviour

(operations), common relationships to other objects and common semantics

ISO/TS 27790:2009(E)
object diagram Diagram showing connections between objects in a system. ISO/IEEE 11073-10201:2004(E)
object diagram diagram showing connections between objects in a system ISO/TS 27790:2009(E)
object identifier

OID

unique alphanumeric/numeric identifier registered under the ISO registration standard to reference a

specific object or object class

ISO 21091:2013(E)
object identifier

OID

globally unique identifier for an information object ISO 27789:2013(E)
object identifier number permanently assigned to an object for reference to uniquely identify it from all other objects in a collection ISO/HL7 27951:2009(E)
object identifier

OID

unique alphanumeric/numeric identifier registered under the ISO registration standard to reference a specific

object or object class

NOTE The object identifier is a name for a certificate policy that is recorded in a field of each certificate issued in

conformance with the policy.

ISO/TS 22600-3:2009(E)
object identity The feature that the existence of an object is independent of any values associated with the object. ISO 21731:2006(E) & ANSI/HL7 RIM R1
object method A procedure or process acting upon the attributes and states of an object class. ISO/IEEE 11073-10201:2004(E)
object method action that can be invoked on a resource

EXAMPLE A file system may have read, write and execute object methods.

ISO/TS 22600-3:2009(E)
object method procedure or process acting upon the attributes and states of an object class ISO/TS 27790:2009(E)
object: In object-oriented modeling, a particular instantiation of a class. The instantiation realizes

attributes, methods, and events from the class.

ISO/IEEE 11073-10406:2012(E)
object-based Any method, language, or system that supports object identity, classification, and encapsulation. An

object-based system does not support specialization . Ada is an example of an object-based implementation

language.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
object-oriented analysis Method of analysis where the problem domain is modelled in the form of

objects and their interactions.

ISO/IEEE 11073-10201:2004(E)
object-oriented analysis method of analysis where the problem domain is modelled in the form of objects and their interactions ISO/TS 27790:2009(E)
obj-handle See: handle. ISO/IEEE

11073-10420

obj-handle See: handle. ISO/IEEE 11073-10406:2012(E)
obj-handle See: handle. ISO/IEEE 11073-10407:2010(E)
obj-handle See: handle. ISO/IEEE 11073-10408:2010(E)
obj-handle See: handle. ISO/IEEE 11073-10415:2010(E)
obj-handle See: handle. ISO/IEEE 11073-10421:2012(E)
obj-handle See: handle. ISO/IEEE 11073-10425:2016(E)
obj-handle See: handle. ISO/IEEE 11073-10472:2012(E)
obj-handle See: handle. ISO_IEEE_11073-10417_2015
observational attribute An attribute value that may change during the life of an association. The value

may be sent in a scan or segment data event report. When a set of observational attribute values are

received, these values are combined with the available context information (i.e., all related dynamic and

static attribute values) to represent the observation at the observation time. Unlike dynamic and static

attribute values, the observational attribute values are combined only once with context information (i.e.,

the observational attribute values are not reused when any new attribute values are received in the future).

ISO/IEEE 11073-20601:2016(E)
occlusion Total obstruction of the infusion set that prevents administering insulin. ISO_IEEE_11073-10417_2015
octet A group of eight adjacent bits. ISO/IEEE 11073-30200:2004(E)
octet A group of eight adjacent bits. ISO/IEEE 11073-30300:2004(E)
octet A group of eight adjacent bits. ISO/IEEE 11073-30400:2012(E)
off label use use of a medicine for an unapproved indication or in an unapproved age group, or in a unapproved dosage or in an unapproved route of administration ISO/TS 19256:2016(E)
official name name given by an official registration authority ISO 11238:2012(E)
OID

object identifier

globally unique value associated with an object to unambiguously identify it ISO/TS 16791:2014(E)
one-way function (mathematical) function f which is easy to compute, but which, for a general value y in the range, it is

computationally difficult to find a value x in the domain such that f(x) y

NOTE There may be a few values y for which finding x is not computationally difficult.

ISO/TS 22600-3:2009(E)
online analytical processing

OLAP

set of applications developed for facilitating the collection, analysis and reporting of multidimensional data

NOTE See Reference [7].

ISO/TS 29585:2010(E)
ontology organization of concepts for which a rational argument can be made

NOTE Adapted from ISO/TS 17117.

ISO/TR 13054:2012(E)
ontology organization of concepts for which a rational argument can be made

EXAMPLE A hierarchy of qualifiers would be a qualifier ontology.

NOTE Colloquially, this term is used to describe a hierarchy constructed for a specific purpose.

ISO/TS 17117:2002(E)
open system A set of protocols allowing computers of different origins to be linked together. ISO/IEEE 11073-10201:2004(E)
OpenEHR template directly, locally usable data creation/validation artifact that is semantically a constraint/choice of

archetypes and which will often correspond to a whole form or screen

[SOURCE: ISO/TR 20514:2005]

ISO/TS 13972:2015(E)
operation service that an instance of the class may be requested to perform

NOTE An operation has a name and a list of arguments with assigned names and types, and returns a value of the

type specified.

ISO 21090:2011(E)
operation A function or transformation that may be applied to or by objects in a class (sometimes also

called service).

ISO/IEEE 11073-10201:2004(E)
operation function or transformation that may be applied to or by objects in a class

NOTE Sometimes also called service.

ISO/TS 27790:2009(E)
Opt-in process or type of policy whereby the data subject is required to take a separate action to express

specific, explicit or prior consent (3.5) for a specific type of processing

ISO/TS 17975:2015(E)
Opt-out process or type of policy whereby the data subject (3.6) is required to take a separate action in order to

withhold or withdraw consent (3.5) from a specific type of processing

Note 1 to entry: In the case of Opt-out, Implied Consent (3.18) exists for the collecting organization to process the

personal information (3.25) unless the individual (3.19) explicitly denies or withdraws permission. Opt-out is also

a process provided by a data collecting organization in order for a data subject to deny or withdraw permission

to perform a specific type of processing.

ISO/TS 17975:2015(E)
Order set of one or more analytical instrument investigation requests submitted to an analytical instrument ISO 18812:2003(E)
organization unique framework of authority within which a person or persons act, or are designated to act towards some

purpose

NOTE Groupings or subdivisions of an organization may also be considered as organizations where there is a need

to identify them for information interchange.

ISO 21549-7:2007(E)
organization health caregroup or business entity involved in the direct or indirect provision of health care services to an

individual or to a population

NOTE 1 Groups or subdivisions of an organization, such as departments, can also be considered as organizations

where there is a need to identify them.

NOTE 2 Effectively, a health care organization relies on the activity performed by health care professionals, employed,

contracting, or with temporary informal though functional relationships between them: within health care organizations, the

final effectors are health care professionals. A health care team is a kind of health care organization.

NOTE 3 A free-standing self employed solo practising health care professional is considered as the only member of

his/her own health care organization.

NOTE 4 Adapted from EN 13606-5.

ISO/TS 27527:2010(E)
organization group of people who have their own structure rules and culture in order to work together to achieve goals

and/or to provide services through processes, equipment and technology, etc.

ISO/TS 29585:2010(E)
OSI reference model model that divides and defines the functions of communication equipment, such as computers, into a

seven layer structure based on the design policy of Open Systems Interconnection (OSI) established by

ISO for network structuring, in order to facilitate heterogeneous network data transfer

ISO/TS 13972:2015(E)
other names name(s) by which the patient has been known at some time [HL7] ISO/TS 25237:2008(E)
outer container container that serves as an external layer of a package

[ENV 12610]

ISO 21549-7:2007(E)
outer packaging external container in which a medicinal product is supplied EXAMPLE Box. NOTE 1 The manufactured item or pharmaceutical product is not in direct contact with the outer packaging except where the outer packaging also serves as the immediate container. NOTE 2 An alternative, compatible definition of outer packaging is given in Directive 92/27/EEC: “packaging into which is placed the immediate packaging”. ISO 11239:2012(E)
outer packaging external container in which a Medicinal Product is supplied EXAMPLES Box, carton.

NOTE 1 The manufactured item or pharmaceutical product is not in direct contact with the outer packaging except where the outer packaging also serves as the immediate container.

NOTE 2 An alternative, compatible definition of outer packaging is given in Directive 92/27/EEC.

ISO 11615:2012(E)
outer packaging external container in which a medicinal product is supplied

Note 1 to entry: Corresponds frequently to “secondary packaging” (see Annex B).

[SOURCE: ISO 11615:2012, 3.1.55 — modified, examples and notes removed; new note added.]

ISO/TS 16791:2014(E)
overreading process whereby a cardiologist or a cardiology fellow reviews the computer-generated interpretation of an ECG in order to verify the accuracy or to make changes to the interpretation text ISO 11073-91064:2009(E)
package item (container) individual, distinct item(s) contained in a Packaged Medicinal Product which act as containers for manufactured item(s) for sale or distribution ISO 11615:2012(E)
Packaged Medicinal Product Medicinal Product in a container being part of a package, representing the entirety that has been packaged for sale or supply ISO 11615:2012(E)
packaged medicinal product medicinal product in a container being part of a package, representing the entirety that has been

packaged for sale or supply

Note 1 to entry: Corresponds frequently to “primary packaging” (see Annex B).

[SOURCE: ISO 11615:2012, 3.1.57 — modified, note 1 to entry added.]

ISO/TS 16791:2014(E)
packaged medicinal product medicinal product in a container being part of a package, representing the entirety that has been packaged for sale or supply

[SOURCE: ISO 11615:2012, 3.1.57]

ISO/TS 19256:2016(E)
packaged pharmaceutical product qualitative and quantitative composition of the pharmaceutical product as contained in the package of the medicinal product NOTE In many instances the packaged pharmaceutical medicinal product will be equal to the medicinal product. However, there are instances where, for example, the packaged pharmaceutical product(s) must be reconstituted before it can be administered to the patient (powder and solvent for solution for injection). EXAMPLE Each vial of Fabrazyme contains a nominal value of 35 mg of agalsidase beta (packaged pharmaceutical product). After reconstitution with 7,2 ml of water for injections, each vial of Fabrazyme contains 5 mg/ml (35 mg/7 ml) of agalsidase beta (pharmaceutical product after reconstitution) ISO 11616:2012(E)
packaging hierarchy relationship between a medicinal product package and its grouping in larger/smaller quantities

Note 1 to entry: See Annex B for illustration of “primary packaging”, “secondary packaging”, etc.

ISO/TS 16791:2014(E)
parameter synonym for data item, in particular when used to adapt a computation, or the operation or appearance

of a software application for a particular purpose

ISO/TS 13972:2015(E)
parent organism organism from which biological source material is derived ISO 11238:2012(E)
part anatomical origin and location of source material within an organism ISO 11238:2012(E)
participants data exporters and data importers ISO/TS 27790:2009(E)
pathogenic characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention ISO/TS 20428:2017(E)
pathological process-TM process occurring as consequence or induction of clinical finding-TM (3.1.6)

EXAMPLE <qi movement stagnation>, <qi movement disturbance>, <inhibited qi transformation>, <water qi

intimidating the heart>.

ISO/TS 16277-1:2015(E)
patient synonym for a subject of care ISO 13606 -1:2008(E)
patient subject of care ISO 13606-2:2008(E)
patient

client

individual who is a subject of care

NOTE 1 Adapted from ISO/TS 18308[3].

NOTE 2 The terms “patient” and “client” are synonymous but the usage of one or other of these terms tends to differ

between different groups of health professionals. Clinicians working in a hospital setting and medical practitioners in most

settings tend to use the term “patient” whereas allied health professionals tend to use the term “client”.

ISO/TR 20514:2005(E)
patient any person who is subject to a health software product

NOTE In this document that shall be taken to include healthy persons where applicable (e.g. a healthy person

accessing a knowledge data base to obtain health-related information).

ISO/TR 27809:2007(E)
patient

consumer

person who is the receiver of health related services and who is an actor in a health information system ISO/TS 17090-1:2002(E)
Patient an individual person that is a subject of care ISO/TS 18308:2004(E)
patient any person who is subject to, or who utilizes, a health software product

NOTE In this Technical Specification, this is taken to include healthy persons, where applicable (e.g. a healthy

person accessing a knowledge database to obtain health-related information).

ISO/TS 25238:2007(E)
patient individual person who is a subject of care ISO/TS 27790:2009(E)
patient healthcard healthcare data card, containing data related to a unique record person, intended for use within the healthcare

domain

NOTE The term patient is not intended to determine that the record person is currently a subject of care.

ISO 21549-1:2004(E)
patient safety prevention of harm caused by errors of commission and omission

[SOURCE: Aspden, Corrigan, Wolcott, et al., 2004]

ISO/TS 13972:2015(E)
patient/consumer person who is the receiver of health-related services and an actor in a health information system ISO/TS 21547:2010(E)
pattern-TM condition which represents a typical constellation of symptoms or complete clinical presentation of

patients including symptoms at a given moment in time and is a known or assumed dysfunction of body

function-TM(3.3.3.2), body structure-TM (3.3.1) or body substance-TM (3.3.2.1)

EXAMPLE <heart yang collapse pattern> is a pattern marked by sudden profuse sweating and cold skin,

reversal cold of limbs, feeble breathing, palpitations, clouding or loss of consciousness, pale complexion and

hardly perceptible pulse.[1] <greater yang cold damage pattern> is a pattern caused by pathogenic cold attacking

the greater yang meridian, chiefly manifested by fever, chills, absence of sweat and floating pulse, also called the

greater yang cold damage.[1]

Note 1 to entry: pattern-TM (3.2.1) indicates a set of signs and symptoms at a given moment in time that can be

captured by body system-TM (3.3.1.1) and their derivatives based on TM-CJK.

Note 2 to entry: This concept (3.1.1) may be expressed by pattern, syndrome, or disease pattern in English, 证 or

證 in Chinese and Japanese and 증 in Korean in TM-CJK related literature.

Note 3 to entry: This concept (3.1.1) is subcategories of clinical findings-TM and it can be used for

characterizing category (3.1.3) with semantic link(3.1.10) such as hasAssociatedPattern-TM(3.4.5) and

hasAssociatedFinding-TM(3.4.6).

ISO/TS 16277-1:2015(E)
payment guarantor organization responsible for the total or partial reimbursement or payment of the price of the medicinal product

[ENV 13607]

ISO 21549-7:2007(E)
payment guarantor organization responsible for the total or partial reimbursement or payment of the price of the medicinal product ISO/TR 22790:2007(E)
PCID

medicinal product package identifier

identifier allocated to a packaged medicinal product supplementary to any existing authorization

number as ascribed by a medicines regulatory agency in a jurisdiction

[SOURCE: ISO 11615:2012, 3.1.53, — modified, “unique” removed; note removed.]

Note 1 to entry: See Annex C for relationship between MPID, PCID, and GTIN.

ISO/TS 16791:2014(E)
peak expiratory flow maximum flow measured at the mouth during an expiration delivered with

maximal force starting immediately after achieving maximum lung inflation.

ISO/IEEE 11073-10421:2012(E)
peak expiratory flow monitor A medical device used to measure the respiratory function of those

managing respiratory conditions such as asthma.

ISO/IEEE 11073-10421:2012(E)
performance indicator measure that supports evaluation of an aspect of performance and its change over time ISO/TS 29585:2010(E)
permission approval for performing an operation on one or more RBAC protected objects ISO/TS 22600-3:2009(E)
persisted stored on a permanent basis ISO/TS 14265:2011(E)
persistent data data which are stored on a permanent basis ISO 13606 -1:2008(E)
persistent data data which are stored on a permanent basis ISO 13606-5:2010(E)
persistent data data stored on a permanent basis

[SOURCE: ISO/IEC 11179‑1:2004]

ISO/TS 13972:2015(E)
persistent data data in a final form intended as a permanent record, such that any subsequent modification is recorded

together with the original data

ISO/TS 29585:2010(E)
person identification process for establishing an association between an information object and a physical person ISO/TS 25237:2008(E)
personal best This value is determined by a healthcare professional or based on predicted average peak

flow and is typically the highest peak expiratory flow (PEF) reading an individual can obtain while in peak

condition.

ISO/IEEE 11073-10421:2012(E)
personal data any information relating to an identified or identifiable natural person (“data subject”)

[Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of

individuals with regard to the processing of personal data and on the free movement of such data]

ISO/TS 25237:2008(E)
personal digital assistant (PDA) The name given to the class of consumer electronic devices that

handle functions such as management of calendars, contact lists, and task lists.

ISO/IEEE 11073-30300:2004(E)
personal health data any personal data relevant to the health of an identified or identifiable natural person ISO/TS 27790:2009(E)
personal health device A device used in personal health applications. ISO/IEEE

11073-10420

personal health device A device used in personal health applications.

NOTE—For the purposes of this document, the scope of medical devices is further limited to patient-connected

medical devices that provide support for electronic communications. This narrow definition is not intended to exclude

or contradict broader definitions for medical devices that might exist.4

ISO/IEEE 11073-00103:2015(E)
personal health device A device used in personal health applications. ISO/IEEE 11073-10406:2012(E)
personal health device A device used in personal health applications. ISO/IEEE 11073-10407:2010(E)
personal health device A device used in personal health applications. ISO/IEEE 11073-10408:2010(E)
personal health device A device used in personal health applications. ISO/IEEE 11073-10415:2010(E)
personal health device A device used in personal health applications. ISO/IEEE 11073-10421:2012(E)
personal health device A device used in personal health applications. ISO/IEEE 11073-10472:2012(E)
personal health device A device used in personal health applications. ISO/IEEE 11073-20601:2016(E)
personal health device A device used in personal health applications. ISO_IEEE_11073-10417_2015
personal health device (PHD) A device used in personal health applications. ISO/IEEE 11073-10425:2016(E)
personal health information

PHI

information about an identifiable person that relates to the physical or mental health of the individual,

or to provision of health services to the individual

Note 1 to entry: Such information may include a) information about the registration of the individual for the

provision of health services, b) information about payments or eligibility for health care in respect to the individual,

c) a number, symbol or particular assigned to an individual to uniquely identify the individual for health purposes,

d) any information about the individual that is collected in the course of the provision of health services to the

individual, e) information derived from the testing or examination of a body part or bodily substance, and f)

identification of a person (e.g. a health professional) as provider of healthcare to the individual.

Note 2 to entry: Personal health information does not include information that, either by itself or when combined

with other information available to the holder, is anonymized, i.e. the identity of the individual who is the subject

of the information cannot be ascertained from the information.

ISO/TS 14441:2013(E)
personal health information

PHI

information about an identifiable person (3.15) that relates to the physical or mental health of the

individual (3.19) or to provision of health services to the individual

[SOURCE: ISO 27799:2008, 3.1.9]

Note 1 to entry: Such information might include the following:

a) information about the registration of the individual for the provision of health services;

b) information about payments or eligibility for health care in respect to the individual;

c) a number, symbol or particular assigned to an individual to uniquely identify the individual for health purposes;

d) any information about the individual that is collected in the course of the provision of health services to

the individual;

e) information derived from the testing or examination of a body part or bodily substance;

f) identification of a person (e.g. a health professional) as provider of healthcare to the individual.

Note 2 to entry: Personal health information does not include information that, either by itself or when combined

with other information available to the holder, is anonymised, i.e. the identity (3.17) of the individual who is the

subject of the information cannot be ascertained from the information.

ISO/TS 17975:2015(E)
personal health record health record for which the subject of care or a legal representative of the subject of care is the data controller ISO 13606 -1:2008(E)
personal identifier information with the purpose of uniquely identifying a person within a given context ISO/TS 25237:2008(E)
personal information information relating to an identified or identifiable natural person

[SOURCE: EU Directive 95/46/EC, MEDSEC]

Note 1 to entry: To determine whether a data subject (3.6) is identifiable, take account of all the means which can

reasonably be used by the entity holding the data, or by any other party, to identify that individual.

ISO/TS 17975:2015(E)
personal telehealth device See: personal health device. ISO/IEEE

11073-10420

personal telehealth device See: personal health device. ISO/IEEE 11073-10406:2012(E)
personal telehealth device See: personal health device. ISO/IEEE 11073-10407:2010(E)
personal telehealth device See: personal health device. ISO/IEEE 11073-10408:2010(E)
personal telehealth device See: personal health device. ISO/IEEE 11073-10415:2010(E)
personal telehealth device See: personal health device. ISO/IEEE 11073-10421:2012(E)
personal telehealth device See: personal health device. ISO/IEEE 11073-10425:2016(E)
personal telehealth device See: personal health device. ISO/IEEE 11073-10472:2012(E)
personal telehealth device See: personal health device. ISO/IEEE 11073-20601:2016(E)
personal telehealth device See: personal health device. ISO_IEEE_11073-10417_2015
pharmaceutical dose form physical manifestation of a product that contains the active ingredient(s) and/or inactive ingredient(s) that are intended to be delivered to the patient NOTE “Pharmaceutical dose form” can refer to the administrable dose form or the manufactured dose form, depending on the product that it is describing. ISO 11239:2012(E)
pharmaceutical product qualitative and quantitative composition of a medicinal product in the dose form approved for administration in line with the regulated product information ISO 11238:2012(E)
pharmaceutical product qualitative and quantitative composition of a medicinal product in the dose form authorized for administration by a medicines regulatory agency and as represented with any corresponding regulated product information NOTE 1 A medicinal product may contain one or more pharmaceutical products.

NOTE 2 In many instances the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item(s) must undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.

ISO 11239:2012(E)
pharmaceutical product qualitative and quantitative composition of a medicinal product in the dose form authorized for administration by a regulatory authority and as represented with any corresponding regulated product information NOTE A medicinal product may contain one or more pharmaceutical products. ISO 11240:2012(E)
pharmaceutical product qualitative and quantitative composition of a Medicinal Product in the dose form approved for administration in line with the regulated product information

NOTE 1 A Medicinal Product can contain one or more pharmaceutical products.

NOTE 2 In many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item must undergo a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.

ISO 11615:2012(E)
pharmaceutical product qualitative and quantitative composition of a medicinal product in the dose form authorized for administration by a regulatory authority, and as represented with any corresponding regulated product information NOTE 1 A medicinal product may contain one or more pharmaceutical products. NOTE 2 In many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item undergoes a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal. ISO 11616:2012(E)
pharmaceutical product product consisting of one or more ingredients

[ENV 13607]

ISO 21549-7:2007(E)
pharmaceutical product product consisting of one or more ingredients

NOTE 1 A pharmaceutical product may have a different pharmaceutical form from the final intended medicinal product.

NOTE 2 This Technical Report does not make a distinction between a bulk product, an intermediate or a final product.

EXAMPLE 1 An amount of penicillin powder and physiologic solution to be mixed together are both pharmaceutical

products. They are both part of a medicinal product, e.g. Combicillin 1 g.

EXAMPLE 2 Adepal (Fr) is a medicinal product with two types of tablets containing ethinyloestradiol and

progresterone in different ratio composition. Each of these tablets are pharmaceutical products. They are both part of this

medicinal product.

ISO/TR 22790:2007(E)
pharmaceutical product qualitative and quantitative composition of a medicinal product in the dose form authorized for administration by a regulatory authority, and as represented with any corresponding regulated product information

Note 1 to entry: A medicinal product can contain one or more pharmaceutical products.

Note 2 to entry: In many instances, the pharmaceutical product is equal to the manufactured item. However, there are instances where the manufactured item undergoes a transformation before being administered to the patient (as the pharmaceutical product) and the two are not equal.

Note 3 to entry: For example: Pharmaceutical Product PhPID: L4M456897456123 Sweetopam 20mg tablet (the code number is just an illustration, not a real identifier).

[SOURCE: ISO 11616:2012, 3.1.19, modified]

ISO/TS 19256:2016(E)
pharmaceutical product identifier globally unique identifier assigned to the pharmaceutical product(s)

[SOURCE: ISO 11616:2012, 3.1.22]

ISO/TS 19256:2016(E)
Pharmaceutical Product Identifier PhPID unique identifier for a pharmaceutical product ISO 11615:2012(E)
pharmacovigilance process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines

NOTE Pharmacovigilance is a key public health function which comprises:

— collecting and managing data on the safety of medicines;

— looking at the data to detect “signals” (any new or changing safety issue);

— evaluating the data and making decisions with regard to safety issues;

— acting to protect public health (including regulatory action);

— communicating with stakeholders;

— auditing of both the outcomes of action taken and the key processes involved. Those directly involved in pharmacovigilance include:

— patients as the users of medicines;

— doctors, pharmacists, nurses and all other healthcare professionals working with medicines and regulatory authorities responsible for monitoring the safety of medicines;

— pharmaceutical companies, and companies importing or distributing medicines.

ISO 11615:2012(E)
pharmacovigilance the process and science of monitoring the safety of medicines and taking action to reduce risks and increase benefits from medicines

NOTE 1 It is a key public health function.

EXAMPLE Pharmacovigilance includes:

— collecting and managing data on the safety of medicines;

— looking at the data to detect “signals” (any new or changing safety issue) and evaluating the data and making decisions with regard to safety issues; — acting to protect public health (including regulatory action) and communicating with stakeholders;

— auditing, both of the outcomes of action taken and of the key processes involved.

NOTE 2 Those directly involved in pharmacovigilance include:

— patients as the users of medicines; — doctors, pharmacists, nurses and all other healthcare professionals working with medicines and regulatory authorities responsible for monitoring the safety of medicines;

— pharmaceutical companies and companies importing or distributing medicines.

ISO 11616:2012(E)
pharmacovigilance science and activities relating to the detection, assessment, understanding and prevention of adverse

effects or any other medicine-related problem

[SOURCE: WHO]

ISO/TS 16791:2014(E)
pharmacovigilance process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines

[SOURCE: ISO 11615:2012, 3.1.59, modified]

ISO/TS 19256:2016(E)
PHI disclosure divulging of, or provision of access to, personal health information

Note 1 to entry: Adapted from ISO/TS 25237:2008, definition 3.20.

ISO/TS 14441:2013(E)
PhPID pharmaceutical product identifier ISO 11239:2012(E)
PhPID

pharmaceutical product identifier

identifier for a pharmaceutical product

Note 1 to entry: Pharmaceutical product: qualitative and quantitative composition of the pharmaceutical product

as administered to the patient in line with the regulated product information.

[SOURCE: ISO 11615:2012, 3.1.60 — modified, “unique” removed; note 1 to entry added.]

ISO/TS 16791:2014(E)
PhPID pharmaceutical product identifier unique identifier assigned to the pharmaceutical product(s) ISO 11239:2012(E)
PHPID pharmaceutical product identifier globally unique identifier assigned to the pharmaceutical product(s) ISO 11616:2012(E)
physical characteristics description of the height, weight, width, depth, volume, colour and shape of an item ISO 11615:2012(E)
physical form physical state, either gas, liquid or solid, and the type of organization for solid matter ISO 11238:2012(E)
physical model or design model instantiation of a logical model that respects specific technological constraints, normally for use in

building a specific system or product.

[SOURCE: ISO/TR 20514:2005 and ISO/TR 17119:2005]

ISO/TS 13972:2015(E)
physical unit of measurement unit of measurement that is defined using a physical quantity NOTE 1 Its definition relates measured quantities to the base quantities through a set of well-defined equations. NOTE 2 Physical units and their related scales are defined independently of the measurement procedure and the measured components. They relate to an internationally standardized system of units and equations governing the mathematical relations between those units. ISO 11240:2012(E)
point of care (POC) The environment immediately surrounding a patient. ISO/IEEE 11073-30300:2004(E)
Point of Care (PoC) The area in which clinicians and patients are in close physical proximity

and in which specific care, treatments, medical procedures, and/or monitoring are provided to the patient.

ISO/IEEE 11073-30400:2012(E)
point-of-care (POC) device device: A medical device typically used in patient care areas. In the context of

the National Committee for Clinical Laboratory Standards Point-of-Care Connectivity; Approved Standard

(NCCLS POCT1), a device that is capable of performing blood chemistry and other measurements in

patient-care areas.

ISO/IEEE 11073-30300:2004(E)
point-of-care (POC) device interface (PDI): Specifies the interface (principally output) of a POC

device or its docking station to an access point (AP).

NOTE—This term is used extensively in the National Committee for Clinical Laboratory Standards Point-of-Care Connectivity;

Approved Standard (NCCLS POCT1) and is equivalent to an ISO/IEEE 11073 device communications controller

(DCC).

ISO/IEEE 11073-30300:2004(E)
point-of-service (POS) clinical system system that is used at the point of care or service in the provision of clinical services to the subject of

care

EXAMPLE Electronic Medical Record (EMR), Pharmacy Management System (PMS), Hospital Information

System (HIS), Public Health Information System (PHIS).

ISO/TS 14441:2013(E)
point-to-point protocol protocol defined in RFC 1661, the Internet standard for transmitting network layer datagrams (e.g. IP packets) over

serial point-to-point links

ISO TR 16056-1:2004(E)
point-to-point protocol protocol defined in RFC 1661, the Internet standard for transmitting network layer datagrams (e.g. IP packets) over

serial point-to-point links

ISO TR 16056-2:2004(E)
Policy set of legal, political, organizational, functional and technical obligations for communication and cooperation ISO 27789:2013(E)
policy set of legal, political, organizational, functional and technical obligations for communication and cooperation

[ISO/TS 22600-1:2006, definition 2.13]

ISO/TS 13606-4:2009(E)
policy set of legal, political, organizational, functional and technical obligations for communication and cooperation

[ISO/TS 22600-1:2006, definition 2.13]

ISO/TS 14265:2011(E)
policy set of legal, political, organizational, functional and technical obligations for communication and cooperation ISO/TS 22600-1:2006(E)
policy set of legal, political, organizational, functional and technical obligations for communication and cooperation ISO/TS 22600-2:2006(E)
policy set of legal, political, organizational, functional and technical obligations or omissions for communication and

cooperation

ISO/TS 22600-3:2009(E)
policy agreement written agreement where all involved parties commit themselves to a specified set of policies

[ISO/TS 22600-1:2006, definition 2.14]

ISO/TS 14265:2011(E)
policy agreement written agreement where all involved parties commit themselves to a specified set of policies ISO/TS 22600-1:2006(E)
policy agreement written agreement where all involved parties commit themselves to a specified set of policies ISO/TS 22600-2:2006(E)
policy agreement written agreement where all involved parties commit themselves to a specified set of policies ISO/TS 22600-3:2009(E)
policy decision point

PDP

system entity that evaluates an applicable policy and renders an authorization decision

NOTE 1 This term is defined differently in RFC 3198 [45].

NOTE 2 This term corresponds to “Access Decision Function” (ADF) in ISO/IEC 10181-3:1996.

ISO/TS 22600-3:2009(E)
policy enforcement point

PEP

system entity that performs access control, by making decision requests and enforcing authorization decisions

NOTE 1 This term is defined in a joint effort by the IETF Policy Framework Working Group and the Distributed

Management Task Force (DMTF)/Common Information Model (CIM) in RFC 3198.

NOTE 2 This term corresponds to “Access Enforcement Function” (AEF) in ISO/IEC 10181-3:1996.

ISO/TS 22600-3:2009(E)
policy mapping recognizing that, when a CA in one domain certifies a CA in another domain, a particular certificate policy in

the second domain may be considered by the authority of the first domain to be equivalent to (but not

necessarily identical to in all respects) a particular certificate policy in the first domain

ISO/TS 22600-3:2009(E)
polydisperse substance substance containing multiple related molecular components ISO 11238:2012(E)
polydispersity measure of the range of molecular masses in a polymer substance ISO 11238:2012(E)
polymer substance type of polydisperse substance that contains structural repeating units linked by covalent bonds ISO 11238:2012(E)
post-coordinated concept representation compositional concept representation (2.4.1) using more than one concept (A.3.2.1) from one or many

formal systems (2.5.1), combined using mechanisms within or outside the formal systems

EXAMPLE Problem.Main = “Fracture”, Problem.Location = Femur within a template for a problem description.

NOTE Combining concepts from disparate terminologies can cause problems with overlapping and/or conflicting

concepts. Typically, the mechanisms for making compositional concept representations (2.4.1) are specified in an

information model (e.g. as templates for a certain type of concept).

ISO 17115:2007(E)
post-translational modification modification of a protein that typically occurs in vivo during or after translation ISO 11238:2012(E)
precoordinated concept representation compositional concept representation (2.4.1) within a formal system (2.5.1), with an equivalent single

unique identifier

EXAMPLE Problem = Fracture that hasLocation Femur. This is an example of how a precoordinated concept is

represented.

NOTE The identifier (code, term, etc.) may be within or outside the terminology system in question.

ISO 17115:2007(E)
predicted average peak flow The value of peak expiratory flow that is calculated based on the user’s

age, height, and sex to serve as a benchmark for the user’s measurements.

ISO/IEEE 11073-10421:2012(E)
prefix word or symbol for attachment to the name or symbol of a unit in order to form units that are multiples or submultiples of that unit NOTE For more details, see chapter 3.1 of the International System of Units (SI)[27]. ISO 11240:2012(E)
prenatal/fetal biomaterial sample of fetuses before birth

Note 1 to entry: Prenatal/fetal DNA sequencing: Reading the DNA of foetuses to diagnose Mendelian disease of unborn child.

ISO/TS 20428:2017(E)
prescriber healthcare professional authorized to issue electronic prescriptions ISO 17523:2016(E)
prescriber healthcare person authorized to issue prescriptions

[ENV 13607]

ISO 21549-7:2007(E)
prescriber healthcare person authorized to issue prescriptions ISO/TR 22790:2007(E)
prescribing process in which an authorized healthcare professional, the prescriber, issues a prescription information object

Note 1 to entry: Typically, the healthcare professional is a medical specialist or a general practitioner but this differs across legislations. In some countries, pharmacists or nurse practitioners are also authorized to prescribe.

ISO 17523:2016(E)
prescribing process of creating a prescription

[ENV 13607]

ISO 21549-7:2007(E)
prescribing process of creating a prescription ISO/TR 22790:2007(E)
prescribing process of creating a prescription ISO/TS 19256:2016(E)
prescription set of values of attributes that is produced as the output of a prescription act

Note 1 to entry: A prescription is a set of instructions written by a prescriber that authorizes a medicinal product or treatment to be given to a patient. It is a) an instruction by an authorized healthcare professional, b) a request to dispense by an authorized healthcare professional and c) advice to a patient on his/her medication treatment or d) an instruction to administer by an authorized healthcare professional.

Note 2 to entry: The word “prescription” is sometimes used when referring to the act of prescribing, “prescription process”. To avoid confusion with the term “prescription” as an information object, throughout this International Standard, the word “prescription” is reserved for the information object. For the act of prescribing, the term “prescribing” is used.

ISO 17523:2016(E)
prescription direction created by an authorized healthcare person, to instruct a dispensing agent regarding the preparation

and use of a medicinal product or medicinal appliance to be taken or used by a subject of care

NOTE The term “prescription” alone should be avoided as it is colloquially used at random for the following terms:

new prescription message, prescription set and prescription item. Further, it is also used to describe a prescription form.

The use of the terms prescription set, prescription item and new prescription message where appropriate is recommended.

[ENV 13607]

ISO 21549-7:2007(E)
prescription direction created by an authorized healthcare person, to instruct a dispensing agent regarding the preparation

and use of a medicinal product or medicinal appliance to be taken or used by a subject of care

[ENV 13607]

NOTE The term prescription alone should be avoided as it is colloquially used at random for the following terms used

in prescription message standards: new prescription message, prescription set and prescription item. Further, it is also

used to describe a prescription paper form. The use of the terms prescription set, prescription item and new prescription

message, where appropriate, is recommended.

ISO/TR 22790:2007(E)
prescription direction created by an authorized healthcare person, to instruct a dispensing agent regarding the preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of care

Note 1 to entry: The term “prescription” alone is best avoided as it is colloquially used at random for the following terms: new prescription message, prescription set and prescription item. Further, it is also used to describe a prescription form. The use of the terms prescription set, prescription item and new prescription message where appropriate is recommended.

ISO/TS 19256:2016(E)
prescription item specification created by an authorized healthcare person, to instruct a dispensing agent regarding the

preparation and use of single medicinal product/medicinal appliance or to inform other parties following

dispensing regarding the preparation and use of a single dispensed medicinal product/medicinal appliance

NOTE A prescription item may contain administrative details needed for dispensing or derived from dispensing, but

not contain information about the prescriber or the subject of care for whom the prescription item is prescribed or to whom

it has been dispensed.

[ENV 13607]

ISO 21549-7:2007(E)
prescription item specification created by an authorized healthcare person, to instruct a dispensing agent regarding the

preparation and use of single medicinal product/medicinal appliance or to inform other parties following

dispensing regarding the preparation and use of a single dispensed medicinal product/medicinal appliance

NOTE A prescription item may contain administrative details needed for dispensing or derived from dispensing, but

does not contain information about the prescriber or the subject of care for whom the prescription item is prescribed or to

whom it has been dispensed.

ISO/TR 22790:2007(E)
prescription product abstract level of a medicinal product that contains the elements for prescribing a medicine at a generic level, which are necessary to dispense the appropriate medicine

EXAMPLE Salbutamol aerosol 100 μg/dose 200 doses volumatic. The addition ‘volumatic’ is not included in the pharmaceutical product, but is necessary in the description of the prescribed medicine to express that the product with the ‘volumatic’ (and not e.g. the autohaler) is meant.

Note 1 to entry: The level of abstraction needed for generic prescription can vary between the healthcare settings

ISO/TS 19256:2016(E)
prescription set collection of one or more prescription item(s) prescribed and/or dispensed as a unit

[ENV 13607]

ISO 21549-7:2007(E)
prescription set collection of one or more prescription item(s) prescribed and/or dispensed as a unit ISO/TR 22790:2007(E)
presentation data value (PDV) The union of the sets of values in all possible abstract syntaxes. ISO/IEEE 11073-20101:2004(E)
primary identifiers set of unique IDMP identifiers allocated supplementary to any existing authorization number as ascribed by a Medicines Regulatory Agency in a jurisdiction NOTE This is for indexing purposes and to contribute to improving patient safety by allowing for the unique Identification of Medicinal Products worldwide. ISO 11615:2012(E)
primary rate interface

PRI

ISDN service comprising 23 B (bearer) channels operating at 64 Kbps each and one D (data) channel operating at

16 Kbps

ISO TR 16056-1:2004(E)
primary rate interface

PRI

ISDN service comprising 23 B (bearer) channels operating at 64 Kbps each and one D (data) channel operating at

16 Kbps

ISO TR 16056-2:2004(E)
primary station As defined by the infrared link access protocol (IrLAP), the station on the data link

that assumes responsibility for the organization of data flow and for unrecoverable data link error conditions.

It issues commands to the secondary stations and gives them permission to transmit.

ISO/IEEE 11073-30200:2004(E)
primary station As defined by Infrared Link Access Protocol (IrLAP), the station on the data link

that assumes responsibility for the organization of data flow and for unrecoverable data link error conditions.

It issues commands to the secondary stations and gives them permission to transmit.

ISO/IEEE 11073-30300:2004(E)
primary use of personal data use of personal data for delivering healthcare ISO/TS 25237:2008(E)
principal actor able to realize specific scenarios (user, organization, system, device, application, component, object) ISO/TS 22600-1:2006(E)
principal actor able to realize specific scenarios (user, organization, system, device, application, component, object) ISO/TS 22600-2:2006(E)
principal actor able to realise specific scenarios (user, organization, system, device, application, component, object) ISO/TS 22600-3:2009(E)
privacy freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue or

illegal gathering and use of data about that individual

[ISO/IEC 2382-8:1998, definition 08.01.23]

ISO 13606
privacy freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue or

illegal gathering and use of data about that individual

[ISO/IEC 2382-8:1998, definition 08.01.23]

ISO 13606 -1:2008(E)
privacy freedom from intrusion into the private life or affairs of an individual when that intrusion results from

undue or illegal gathering and use of data about that individual

[ISO/IEC 2382‑8]

ISO 21091:2013(E)
privacy freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue or illegal gathering and use of data about that individual

[ISO/IEC 2382-8:1998, definition 08.01.23]

ISO/TS 14265:2011(E)
privacy freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue or illegal

gathering and use of data about that individual

[ISO/IEC 2382-8:1998]

ISO/TS 17090-1:2002(E)
Privacy freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue or

illegal gathering and use of data about that individual

ISO/TS 18308:2004(E)
privacy freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue or

illegal gathering and use of data about that individual

ISO/IEC 2382-8:1998, definition 08.01.23.

ISO/TS 21547:2010(E)
privacy freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue or

illegal gathering and use of data about that individual

[ISO/IEC 2382-8:1998, definition 08-01-23]

ISO/TS 25237:2008(E)
privacy freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue or

illegal gathering and use of data about that individual

ISO/TS 27790:2009(E)
privacy breach situation where PHI is processed in an unlawful manner or in violation of one or more relevant privacy

policies

ISO/TS 14441:2013(E)
privacy breach situation where personal information (3.25) is collected, accessed, used or disclosed in an unlawful

manner or in violation of one or more relevant privacy policies

[SOURCE: ENV 12924:1996, adapted from security breach.]

ISO/TS 17975:2015(E)
privacy control technical and organizational measures aimed at mitigating risks that could result in privacy breaches

Note 1 to entry: Privacy controls include policies, procedures, guidelines, practices or organizational structures,

which can be administrative, technical, management or legal in nature.

Note 2 to entry: Control is also used as a synonym for safeguard or countermeasure.

ISO/TS 14441:2013(E)
privacy control technical and organizational measures aimed at mitigating risks that could result in privacy

breaches (3.26)

Note 1 to entry: Privacy controls include policies, procedures, guidelines, practices or organizational structures,

which can be administrative, technical, management or legal in nature.

Note 2 to entry: Control is also used as a synonym for safeguard or countermeasure.

ISO/TS 17975:2015(E)
privacy policy specification of objectives, rules, obligations and privacy controls with regard to the processing of PHI

in a particular setting

ISO/TS 14441:2013(E)
privacy policy specification of objectives, rules, obligations and privacy controls (3.27) with regard to the processing

of personal information (3.25) in a particular setting

ISO/TS 17975:2015(E)
privacy policy

privacy protection policy

document that states, in writing, principles of data protection used by an organization

NOTE It can be national as is the NHS Care Record Guarantee or local, made by an organization.

ISO/TS 21547:2010(E)
privacy preferences specific or implied choices made by an individual about how his/her PHI should be processed ISO/TS 14441:2013(E)
privacy principles set of shared values governing the privacy protection of the PHI when processed in ICT systems ISO/TS 14441:2013(E)
privacy principles set of shared values governing the privacy protection of the personal information (3.25) over its

information management lifetime

ISO/TS 17975:2015(E)
privacy protection implementation of appropriate safeguards to ensure the security and confidentiality of data records, as well as

to protect the records against threats or hazards that could result in substantial embarrassment, harm,

inconvenience or unfairness to any person

ISO/TS 21547:2010(E)
privacy risk assessment analysis of the risks of privacy breach involved in an envisaged processing operation

Note 1 to entry: This analysis, also known as privacy impact assessment, is achieved to (a) ensure processing

conforms to applicable legal, regulatory and policy requirements regarding privacy, (b) determine the risks and

effects of processing PHI, and (c) examine and evaluate privacy controls and alternative processes for handling

PHI to mitigate identified privacy risks.

ISO/TS 14441:2013(E)
privacy safeguarding requirements criteria to be fulfilled when implementing privacy controls designed to help mitigate risks of privacy

breaches

ISO/TS 14441:2013(E)
private key key that is used with an asymmetric cryptographic algorithm and whose possession is restricted

(usually to only one entity)

[ISO/IEC 10181‑1]

ISO 21091:2013(E)
private key key that is used with an asymmetric cryptographic algorithm and whose possession is restricted (usually to only

one entity)

[ISO 10181-1:1996]

ISO/TS 17090-1:2002(E)
private key key that is used with an asymmetric cryptographic algorithm and whose possession is restricted (usually to

only one entity)

[ISO/IEC 10181-1, definition 3.3.10]

ISO/TS 22600-1:2006(E)
private key key that is used with an asymmetric cryptographic algorithm and whose possession is restricted (usually to

only one entity)

[ISO/IEC 10181-1, definition 3.3.10]

ISO/TS 22600-2:2006(E)
private key key that is used with an asymmetric cryptographic algorithm and whose possession is restricted (usually to

only one entity)

[ISO/IEC 10181-1:1996]

ISO/TS 22600-3:2009(E)
Privilege capacity assigned to an entity by an authority ISO 27789:2013(E)
privilege capacity assigned to an entity by an authority ISO/TS 13606-4:2009(E)
privilege capacity assigned to an entity by an authority according to the entity’s attribute ISO/TS 22600-1:2006(E)
privilege capacity assigned to an entity by an authority according to the entity’s attribute ISO/TS 22600-2:2006(E)
privilege capacity assigned to an entity by an authority according to the entity’s attribute ISO/TS 22600-3:2009(E)
privilege asserter privilege holder using their attribute certificate or public-key certificate to assert privilege ISO/TS 22600-2:2006(E)
privilege asserter privilege holder using their attribute certificate or public key certificate to assert privilege ISO/TS 22600-3:2009(E)
privilege management infrastructure

PMI

infrastructure able to support the management of privileges in support of a comprehensive authorization

service and in relationship with a Public Key Infrastructure

ISO/TS 22600-2:2006(E)
privilege management infrastructure

PMI

infrastructure able to support the management of privileges in support of a comprehensive authorization

service and in relationship with a public key infrastructure

ISO/TS 22600-3:2009(E)
privilege policy policy that outlines conditions for privilege verifiers to provide/perform sensitive services to/for qualified

privilege asserters

NOTE Privilege policy relates attributes associated with the service as well as attributes associated with privilege

asserters.

ISO/TS 22600-2:2006(E)
privilege policy policy that outlines conditions for privilege verifiers to provide/perform sensitive services to/for qualified

privilege asserters

NOTE Privilege policy relates attributes associated with the service, as well as attributes associated with privilege

asserters.

ISO/TS 22600-3:2009(E)
privilege verifier entity verifying certificates against a privilege policy ISO/TS 22600-2:2006(E)
privilege verifier entity verifying certificates against a privilege policy ISO/TS 22600-3:2009(E)
Problem an entity in which an assessment is made and a plan or intervention is initiated ISO/TS 18308:2004(E)
problem domain The field of health care under consideration in a modeling process. ISO/IEEE 11073-10201:2004(E)
problem-oriented (includes issues and conditions) an organisational approach to recording and using health information based on problems or issues of concern

to the patient and/or carers

ISO/TS 18308:2004(E)
procedure specified way to carry out an activity or a process

[SOURCE: ISO 9000:2005, definition 3.4.5]

ISO/TS 14441:2013(E)
procedure number tracking or identification number assigned by a Medicines Regulatory Agency in relation to a specific medicines regulatory process ISO 11615:2012(E)
procedure type type of legal process applied to authorize or maintain a Medicinal Product marketing authorization EXAMPLES Centralised, decentralised, national, mutual recognition. ISO 11615:2012(E)
processing obtaining, recording, holding, altering, retrieving, destroying or disclosing data

[UK Data Protection Act: 1998]

ISO/TS 14265:2011(E)
processing material type of material essential to the manufacturing process that is not incorporated into the resultant material ISO 11238:2012(E)
processing of personal data

processing

operation or set of operations performed upon personal data, whether or not by automatic means

Note 1 to entry: Operations can include Collection (3.4), recording, organization, storage, adaptation or alteration,

retrieval, consultation, Use (3.33), Disclosure (3.8) by transmission, dissemination or otherwise making available,

alignment or combination, blocking, erasure or destruction.

ISO/TS 17975:2015(E)
processing of personal data any operation or set of operations that is performed upon personal data, whether or not by automatic means,

such as collection, recording, organization, storage, adaptation or alteration, retrieval, consultation, use,

disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking,

erasure or destruction

[Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of

individuals with regard to the processing of personal data and on the free movement of such data]

ISO/TS 25237:2008(E)
processing of personal data

processing

any operation or set of operations that is performed upon personal data, whether or not by automatic means,

such as collection, recording, organization, storage, adaptation or alteration, retrieval, consultation, use

ISO/TS 27790:2009(E)
processing of PHI any operation or set of operations performed upon PHI (e.g. collection, storage, access, analysis, linkage,

communication, disclosure and retention)

ISO/TS 14441:2013(E)
processor natural or legal person, public authority, agency or any other body that processes personal data on behalf of

the controller

[Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of

individuals with regard to the processing of personal data and on the free movement of such data]

ISO/TS 25237:2008(E)
processor natural or legal person, public authority, agency or any other body that processes personal data on behalf of

the controller

ISO/TS 27790:2009(E)
product short form for Medicinal Product or Investigational Medicinal Product ISO 11615:2012(E)
product entire entity of software proffered to a user including instructions for use and, where applicable, training ISO/TR 27809:2007(E)
product result of a process

Note 1 to entry: Four generic product categories are noted in ISO 9000:2005: services (e.g. transport); software

(e.g. computer program, dictionary); hardware (e.g. engine, mechanical part); processed materials (e.g. lubricant).

Many products comprise elements belonging to different generic product categories. Whether the product is then

called service, software, hardware or processed material depends on the dominant element.

Note 2 to entry: The statement of conformity can be regarded as a product of attestation.

Note 3 to entry: Adapted from ISO 9000:2005, 3.4.2.

ISO/TS 14441:2013(E)
product entire entity proffered to a user, including instructions for use and training, where applicable ISO/TS 25238:2007(E)
product classification categorization or grouping of Medicinal Products based on specific properties EXAMPLES Pharmacological classification, classification by therapeutic effect. ISO 11615:2012(E)
Profile restricted subset of a standard intended for a particular purpose ISO 18812:2003(E)
profile a brief description, outline or overview ISO/TR 17119:2005(E)
profile set of automatically generated data characterizing a category of individuals that is intended to be applied

to an individual, namely for the purpose of analysing or predicting personal preferences, behaviours

and attitudes

ISO/TS 14441:2013(E)
property inherent state- or process-descriptive feature of a system, including any pertinent to a component being determined NOTE There can be a set of data elements (system, component, kind-of-property) common to a set of particular properties. EXAMPLE Substance concentration of glucose in blood plasma. ISO 11240:2012(E)
property Any attribute, association, method, or state model defined for a class or object. ISO 21731:2006(E) & ANSI/HL7 RIM R1
property inherent state- or process-descriptive feature of a system including any pertinent to a component

being determined or set of data elements (systems, component, kind-of-property) common to a set of

particular properties

ISO/TS 13582:2015(E)
protein sequence order and identity of amino acids within a protein sub-unit ISO 11238:2012(E)
protein substance type of substance with a defined sequence of alpha-amino-acids connected through peptide bonds ISO 11238:2012(E)
protein sub-unit linear sequence of amino acid residues connected through peptide bonds ISO 11238:2012(E)
protocol A standard set of rules describing the transfer of data between devices. It specifies the format

of the data and specifies the signals to start, control, and end the transfer.

ISO/IEEE 11073-10201:2004(E)
protocol standard set of rules describing the transfer of data between devices, specifying the format of the data and the

signals to start, control and end the transfer

ISO/TS 27790:2009(E)
protocol data unit (PDU) Information delivered as a unit between peer entities that contains control

information and, optionally, data.

ISO/IEEE 11073-30200:2004(E)
protocol data unit (PDU) Information delivered as a unit between peer entities that contains control

information and, optionally, data.

ISO/IEEE 11073-30300:2004(E)
protocol number 〈clinical trial〉 identification or tracking number assigned to the clinical trial protocol ISO 11615:2012(E)
provider health care person or organization who is involved in or associated with the delivery of health care to a

subject of care, or caring for the well-being of a subject of care

NOTE A provider in this context includes not only health care providers, but also those directly involved in the

provision of services to patients.

ISO/TS 27527:2010(E)
provider identifier

health care provider identifier

HCPI

health care unique number or code issued for the purpose of uniquely identifying a health care provider ISO/TS 27527:2010(E)
pseudonym personal identifier that is different from the normally used personal identifier

NOTE 1 This may be either derived from the normally used personal identifier in a reversible or irreversible way, or

alternatively be totally unrelated.

NOTE 2 Pseudonym is usually restricted to mean an identifier that does not allow the derivation of the normal personal

identifier. Such pseudonymous information is thus functionally anonymous.

ISO/TS 25237:2008(E)
pseudonymization process applied to PHI which replaces identity information with an alias

Note 1 to entry: Pseudonymization allows, for example, a subject of care to use a resource or service without

disclosing his or her identity, while still being held accountable for that use. After pseudonymization, it may still

be possible to determine the subject of care’s identity based on the alias and/or to link the subject’s actions to one

another and as a consequence, to the subject of care.

ISO/TS 14441:2013(E)
pseudonymization pseudonymization

particular type of anonymization (3.1) that both removes the association with a data subject (3.6) and

adds an association between a particular set of characteristics relating to the data subject and one or

more pseudonyms

[SOURCE: ISO/TS 25237:2008, 3.39]

Note 1 to entry: Pseudonymization allows, for example, a data subject (3.6) to use a resource or service without

disclosing his or her identity (3.17), while still being held accountable for that Use (3.33). After pseudonymization,

it might still be possible to determine the data subject’s identity based on the alias and/or to link the data subject’s

actions to one another and, as a consequence, to the data subject (3.6) himself.

ISO/TS 17975:2015(E)
pseudonymization particular type of anonymization that both removes the association with a data subject and adds an

association between a particular set of characteristics relating to the data subject and one or more

pseudonyms

ISO/TS 25237:2008(E)
public key key that is used with an asymmetric cryptographic algorithm and that can be made publicly available

[ISO/IEC 10181‑1]

ISO 21091:2013(E)
public key key that is used with an asymmetric cryptographic algorithm and that can be made publicly available

[ISO 10181-1:1996]

ISO/TS 17090-1:2002(E)
public key key that is used with an asymmetric cryptographic algorithm and that can be made publicly available

[ISO/IEC 10181-1, definition 3.3.11]

ISO/TS 22600-1:2006(E)
public key key that is used with an asymmetric cryptographic algorithm and that can be made publicly available

[ISO/IEC 10181-1, definition 3.3.11]

ISO/TS 22600-2:2006(E)
public key key that is used with an asymmetric cryptographic algorithm and that can be made publicly available

[ISO/IEC 10181-1:1996]

ISO/TS 22600-3:2009(E)
public key certificate

PKC

certificate that binds an identity and a public key

[RFC 3280]

ISO 21091:2013(E)
public key certificate

PKC

X.509 public key certificates (PKCs) which bind an identity and a public key; the identity may be used to support

identity-based access control decisions after the client proves that it has access to the private key that corresponds

to the public key contained in the PKC

NOTE Adapted from IETF/RFC 2459.

ISO/TS 17090-1:2002(E)
public key certificate

PKC

certificate that binds an identity and a public key

NOTE The identity may be used to support identity-based access control decisions after the client proves that they

have access to the private key that corresponds to the public key contained in the PKC.

ISO/TS 22600-2:2006(E)
public key certificate X.509 public key certificates (PKCs) [X.509], binding an identity and a public key

NOTE The identity may be used to support identity-based access control decisions after the client proves that it has

access to the private key that corresponds to the public key contained in the PKC.

ISO/TS 22600-3:2009(E)
public key infrastructure

PKI

structure of hardware, software, people, processes and policies that uses digital signature technology

to provide relying parties with a verifiable association between the public component of an asymmetric

key pair with a specific subject

ISO 21091:2013(E)
public key infrastructure

PKI

infrastructure used in the relation between a key holder and a relying party which allows a relying party to use

a certificate relating to the key holder for at least one application using a public key dependent security service

and which includes a certification authority, a certificate data structure, means for the relying party to obtain

current information on the revocation status of the certificate, a certification policy and methods to validate the

certification practice

[ISO 17090-1:2008, definition 3.3.18]

ISO/TS 13606-4:2009(E)
public key infrastructure

PKI

infrastructure used in the relation between a key holder and a relying party that allows a relying party to use a

certificate relating to the key holder for at least one application using a public key dependent security service and

that includes a certification authority, a certificate data structure, means for the relying party to obtain current

information on the revocation status of the certificate, a certification policy and methods to validate the certification

practice

ISO/TS 17090-1:2002(E)
public key infrastructure

PKI

infrastructure used in the relation between a key holder and a relying party that allows a relying party to use a

certificate relating to the key holder for at least one application using a public-key-dependent security service

NOTE PKI includes a certification authority, a certificate data structure, means for the relying party to obtain current

information on the revocation status of the certificate, a certification policy and methods to validate the certification practice.

ISO/TS 22600-3:2009(E)
pulse The frequency of the cardiac cycle as reported by the blood pressure monitor. ISO/IEEE 11073-10407:2010(E)
pulse code modulation technique of used for the digital sampling of sound

NOTE The input waveform with a bandwidth up to 4.0 KHz is sampled at the recommended rate of 8,000 samples per

second. Each sample is converted to one of 212 digital values and then compressed on either the A-law or the -law. This

sampling scheme is adequate for voice communication.

ISO TR 16056-1:2004(E)
pulse code modulation technique of used for the digital sampling of sound

NOTE The input waveform with a bandwidth up to 4.0 KHz is sampled at the recommended rate of 8,000 samples per

second. Each sample is converted to one of 212 digital values and then compressed on either the A-law or the -law. This

sampling scheme is adequate for voice communication.

ISO TR 16056-2:2004(E)
pulse pressure The systolic pressure minus the diastolic pressure. ISO/IEEE 11073-10407:2010(E)
qualified certificate certificate whose primary purpose is identifying a person with a high level of assurance in public non-repudiation

services

NOTE The actual mechanisms that will decide whether a certificate should or should not be considered to be a “qualified

certificate” in regard to any legislation are outside the scope of this Technical Specification.

ISO/TS 17090-1:2002(E)
qualifier string which, when added to a term, changes the meaning of the term in a temporal or administrative sense

EXAMPLES “History of ” or “recurrent”.

ISO/TS 17117:2002(E)
qualitative composition composition of all the constituents of the investigational or authorized Medicinal Product, if applicable, after reconstitution and functioning of the constituents of:

— the substance and specified substance description;

— the constituent(s) of the excipients, whatever their nature or the quantity used, including colouring matter, preservatives, adjuvants, stabilizers, thickeners, emulsifiers, flavouring and aromatic substances, etc.

ISO 11615:2012(E)
quality degree to which all the properties and characteristics of a product, process, or service satisfy the

requirements which ensue from the purpose for which that product, process, or service is to be used

[SOURCE: ISO 9001:2008]

ISO/TS 13972:2015(E)
quality degree to which all the properties and characteristics of a product, process or service satisfy the requirements which ensue from the purpose for which that product, process or service is to be used

[SOURCE: ISO 9000:2015, 3.6.2, modified]

ISO/TS 19256:2016(E)
Quality Management System (QMS) Framework described by the ISO 9000 family of standards and comprised of the three core elements:

quality control, quality assurance and quality improvement

ISO/TS 13972:2015(E)
quality of service

QoS

set of network technologies that enable a network to handle data traffic with a minimum amount of negative effects

in a network environment used by many other users

NOTE Subscribers of QoS specify requirements in service-level agreements (SLAs) regarding throughput, packet loss,

latency, and jitter.

ISO TR 16056-1:2004(E)
quality of service

QoS

set of network technologies that enable a network to handle data traffic with a minimum amount of negative effects

in a network environment used by many other users

NOTE Subscribers of QoS specify requirements in service-level agreements (SLAs) regarding throughput, packet loss,

latency, and jitter.

ISO TR 16056-2:2004(E)
quality of service (QoS) Necessary parameters associated with the support of medical data transfer across

a wireless (or wired) infrastructure system. QoS requirements depend largely on the nature (i.e., waveform

vs. simple text) and criticality of the data being transported, and they are generally classified as reliability,

latency, priority, and bandwidth requirements.

ISO/IEEE 11073-00103:2015(E)
quality of service (QoS) The four negotiated parameters for a link: signaling speed, maximum turnaround

time, data size, and disconnect threshold.

ISO/IEEE 11073-30200:2004(E)
quality of service (QoS) Four negotiated parameters constituting the QoS for a link: signaling

speed, maximum turnaround time, data size, and disconnect threshold.

ISO/IEEE 11073-30300:2004(E)
quantitative composition amounts of substance and specified substance constituents of the investigational or authorized Medicinal Product expressed in a ratio scale

NOTE 1 It is necessary for the quantitative composition of the substance(s) or the specified substance descriptions of the finished investigational or authorized Medicinal Products (depending on the pharmaceutical form concerned) to specify the mass, or the number of units of biological activity, either per dosage unit or per unit of mass or volume, of each substance or specified substance.

NOTE 2 Substance or specified substance descriptions present in the form of compounds or derivatives are always designated quantitatively by their total mass and, if necessary or relevant, by the mass of active entity, or entities, of the molecule. NOTE 3 See also strength (3.1.76).

ISO 11615:2012(E)
quantity property of a phenomenon, body, or substance, where the property has a magnitude that can be expressed as a number and a unit EXAMPLE Mass of a given object at a given point in time. NOTE 1 The unit serves as a reference. NOTE 2 Quantity is more specific in relation to property.

NOTE 3 A reference can be a unit of measurement, a measurement procedure, a reference material, or a combination of such. NOTE 4 Adapted from ISO/IEC Guide 99.

ISO 11240:2012(E)
quantity value value of a quantity number and unit (reference) together expressing magnitude of a quantity

NOTE 1 A quantity value expresses the magnitude of a quantity. This expression consists of a numerical value together with a unit of measurement. The unit of measurement represents a quantitative scale of reference that relates the measured (or estimated) quantity value to one or more reference quantity values. The numerical value is the result of comparing the measured quantity to this reference scale.

NOTE 2 The word “magnitude” is not defined in ISO/IEC Guide 99. However, this definition of quantity value indicates that “magnitude” is expressed as a quantity value; i.e. a quantity value is an expression of a magnitude and the same magnitude might be expressed in many quantity values.

NOTE 3 A reference can be a unit of measurement, a measurement procedure, a reference material, or a combination of such.

ISO 11240:2012(E)
quantity value value of a quantity number and unit (reference), together expressing magnitude of a quantity

NOTE 1 A quantity value expresses the magnitude of a quantity. This expression consists of a numerical value together with a unit of measurement. The unit of measurement represents a quantitative scale of reference that relates the measured (or estimated) quantity value to one or more reference quantity values. The numerical value is the result of comparing the measured quantity to this reference scale.

NOTE 2 The word “magnitude” is not defined in ISO/IEC Guide 99. However, this definition of quantity value indicates that “magnitude” is expressed as a quantity value, i.e. a quantity value is an expression of a magnitude and the same magnitude might be expressed in many quantity values.

NOTE 3 A reference can be a unit of measurement, a measurement procedure, a reference material, or a combination of such.

ISO 11616:2012(E)
quarter common intermediate format

QCIF

represents 176 pixels/line by 144 lines/image for luminance and 88 pixels/line by 72 lines/image for chrominance

NOTE See also CIF.

ISO TR 16056-1:2004(E)
quarter common intermediate format

QCIF

represents 176 pixels/line by 144 lines/image for luminance and 88 pixels/line by 72 lines/image for chrominance

NOTE See also CIF.

ISO TR 16056-2:2004(E)
radio frequency (RF) (A) (Loosely) The frequency in the portion of the electromagnetic spectrum that is between the audio-frequency portion and the infrared portion. (B) A frequency useful for radio

transmission.

NOTE—The present practicable limits of radio frequency are roughly 10 kHz to 100 000 MHz. Within this frequency

range, electromagnetic radiation may be detected and amplified as an electric current at the wave frequency.10

ISO/IEEE 11073-30200:2004(E)
radio frequency (RF) (A) (Loosely) The frequency in the portion of the electromagnetic spectrum

that is between the audio-frequency portion and the infrared portion. (B) A frequency useful for radio

transmission.

NOTE to (B)—The present practicable limits of RF are roughly 10 kHz to 100 000 MHz. Within this frequency range

electromagnetic radiation may be detected and amplified as an electric current at the wave frequency.

ISO/IEEE 11073-30300:2004(E)
radio frequency interference (RFI) See: radio interference. ISO/IEEE 11073-30200:2004(E)
radio frequency interference (RFI) See: radio interference (RI). ISO/IEEE 11073-30300:2004(E)
radio interference Degradation of the reception of a wanted signal caused by radio frequency (RF)

disturbance.

NOTES

1—RF disturbance is an electromagnetic disturbance having components in the RF range.

2—The words “interference” and “disturbance” are often used indiscriminately. The expression “radio frequency interference”

is also commonly applied to an RF disturbance or an unwanted signal.

ISO/IEEE 11073-30200:2004(E)
radio interference (RI) Degradation of the reception of a wanted signal caused by radio frequency

(RF) disturbance. Synonym: radio frequency interference (RFI).

NOTES

1—RF disturbance is an electromagnetic disturbance having components in the RF range.

2—The English words interference and disturbance are often used indiscriminately. The expression radio frequency

interference (RFI) is also commonly applied to an RF disturbance or an unwanted signal.

ISO/IEEE 11073-30300:2004(E)
radiopharmaceutical kit preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration

NOTE In the context of a radiopharmaceutical kit, which is to be radio-labelled after supply by the manufacturer, the active substance/specified substance is considered to be that part of the formulation which is intended to carry or bind the radio-nuclide.

ISO 11616:2012(E)
read type type of run in the sequencing instrument

Note 1 to entry: It can be either single-end or paired-end.

Note 2 to entry: Single-end: Single read runs the sequencing instrument reads from one end of a fragment to the other end.

Note 3 to entry: Paired-end: Paired end runs read from one end to the other end, and then start another round of reading from the opposite end.

ISO/TS 20428:2017(E)
real time These programs must guarantee a response within strict time constraints (operational deadlines

from event to system response), e.g., continuous transmission (streaming) of data in an electrocardiography

(ECG) measurement.

ISO/IEEE 11073-00103:2015(E)
real-time streaming protocol

RTSP

application-level protocol that establishes and controls one or more time-synchronized streams of continuous

media

NOTE RTSP has been designed to serve up multimedia from a cluster of hosts and acts as a network remote control for

multimedia servers.

ISO TR 16056-1:2004(E)
real-time streaming protocol

RTSP

application-level protocol that establishes and controls one or more time-synchronized streams of continuous

media

NOTE RTSP has been designed to serve up multimedia from a cluster of hosts and acts as a network remote control for

multimedia servers.

ISO TR 16056-2:2004(E)
real-time transport protocol

RTP

data communication protocol capable of delivering real-time data such as live or interactive audio and video over IP

packet-switched networks

NOTE RTP runs over UDP and uses its multiplexing and error checking features.

ISO TR 16056-1:2004(E)
real-time transport protocol

RTP

data communication protocol capable of delivering real-time data such as live or interactive audio and video over IP

packet-switched networks

NOTE RTP runs over UDP and uses its multiplexing and error checking features.

ISO TR 16056-2:2004(E)
recipient natural or legal person, public authority, agency or any other body to whom data are disclosed ISO/TS 25237:2008(E)
record entire data file to be transmitted, including the ECG data and associated information, such as patient identification, demographic and other clinical data ISO 11073-91064:2009(E)
Record aggregate of fields describing one aspect of the complete message ISO 18812:2003(E)
record collection of data ISO 21549-1:2004(E)
record collection of data ISO 21549-2:2004(E)
record collection of data ISO 21549-7:2007(E)
record recorded information, in any form, including data in computer systems, created or received and

maintained by an organization or person in the transaction of business or the conduct of affairs and

kept as evidence of such activity

ISO/TS 18530:2014(E)
record recorded information, in any form, including data in computer systems, which is created or received and maintained by an organization or person in the transaction of business or the conduct of affairs and kept as evidence of such activity ISO/TS 22220:2011(E)
record collection of data ISO/TS 27790:2009(E)
record component part of the electronic health record extract of a single subject of care, represented as a node within a

hierarchical data structure conforming to this part of ISO 13606

ISO 13606 -1:2008(E)
Record Component part of the electronic health record extract of a single subject of care, represented as a node within a

hierarchical data structure conforming to the ISO 13606 series of International Standards

ISO 13606-3:2009(E)
record component part of the electronic health record extract of a single subject of care, represented as a node within a

hierarchical data structure conforming to ISO 13606

[ISO 13606-1:2008, definition 3.43]

ISO 13606-5:2010(E)
record entry a semantically indivisible clinical statement which may be structurally large or small, but which loses meaning

if broken up

ISO/TS 18308:2004(E)
record entry semantically indivisible clinical statement that may be structurally large or small, but which loses meaning if

broken up

ISO/TS 27790:2009(E)
record person individual about whom there is an identifiable record containing person-related data ISO 21549-1:2004(E)
record person individual about whom there is an identifiable record containing person-related data ISO 21549-2:2004(E)
record person individual about whom there is an identifiable record containing person-related data ISO 21549-7:2007(E)
recording technique technique to put visually readable data onto the card surface or to write data in non-volatile memories ISO 20301:2006(E)
record-keeping system information system that captures, manages and provides access to records through time

NOTE 1 Adapted from the NHS Code of Practice.

NOTE 2 The EHR-system is a typical record-keeping system.

ISO/TS 21547:2010(E)
records recorded information, in any form, including data in computer systems, created or received and maintained by

an organization or person in the transaction of business or the conduct of affairs and kept as evidence of such

activity

[ISO 22220:2009, definition 3.5]

ISO/TS 27527:2010(E)
records management field of management responsible for the efficient and systematic control of the creation, receipt, maintenance, use and disposition of records, including processes for capturing and maintaining evidence of and information about business activities and transactions in the form of records ISO 27789:2013(E)
records management field of management responsible for the efficient and systematic control of the creation, receipt, maintenance,

use and disposition of records

NOTE Adapted from the NHS Code of Practice.

ISO/TS 21547:2010(E)
reference information that provides the unambiguous identification of a certain part of a distributed record ISO 21549-8:2010(E)
reference beat reference/representative ECG cycle computed through any (but not specified) algorithm comprising the P, QRS and the ST-T waves ISO 11073-91064:2009(E)
reference ID (REFID) A unique, symbolic, and programmatic form for the term. The form is correlated

to the context-free code (i.e., terms are by definition context-free with respect to all other terms); in this

standard, terms are prefixed with “MDC_” for consistency.

ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
reference information information that provides identifiers that allow an outside system to refer unambiguously to the particular

information

ISO/TS 21547:2010(E)
Reference Information Model

RIM

The HL7 information model from which all other information models (e.g., R-MIMs) and messages are

derived.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
reference information model single information model that covers the domain of activity being addressed by a standards developing

organization using this methodology

ISO/TS 27790:2009(E)
Reference Information Model (RIM) The HL7 information model from which all other information models, e.g., RMIMS, and messages are derived. ISO/HL7 27932:2009(E)
reference information model (RIM) HL7 information model from which all other information models, e.g., RMIMS, and messages are derived ISO/HL7 27951:2009(E)
reference information model
RIM
HL7 information model from which all other information models, e.g., RMIMS, and messages are derived ISO/HL7 27951:2009(E)
reference material material, sufficiently homogeneous and stable with reference to specified properties, which has been established to be fit for its intended use in measurement or in examination of nominal properties NOTE 1 Some reference materials have assigned quantity values that are metrologically traceable to a measurement unit outside a system of units. Such materials include vaccines to which International Units (IU) have been assigned by the World Health Organization (WHO).

NOTE 2 Adapted from ISO/IEC Guide 99.

ISO 11240:2012(E)
Reference Model for Open Distributed Processing (RM-ODP) standardized approach to design and governance of information systems, in particular systems

involving data communications between organizations that have different computing platforms.

[SOURCE: ITU-T Rec. X.901-X.904 | ISO/IEC 10746]

ISO/TS 13972:2015(E)
reference sequence digital nucleic acid sequence database, assembled by scientists as a representative example of human genome ISO/TS 20428:2017(E)
reference strength strength of substance(s) and/or specified substance(s) used as a reference from which the strength of an investigational or authorized Medicinal Product is described EXAMPLE 1 Where an ingredient is present in the form of a salt or hydrate, the quantitative composition may be expressed in terms of the mass [or biological activity in International (or other) units where appropriate] of the active moiety (base, acid or anhydrous material), e.g. ‘60 mg toremifene (as citrate)’ or ‘toremifene citrate equivalent to 60 mg toremifene’ will have ‘toremifene citrate’ as the active ingredient and ‘toremifene’ as the reference substance. EXAMPLE 2 Where the active ingredient is an ester or pro-drug the quantitative composition may be stated in terms of the quantity of that ester or pro-drug; e.g. 75 mg of fosphenytoin, which is equivalent to 50 mg of phenytoin. ‘Phenytoin’ is therefore the reference substance.

NOTE The strength of the substance(s) and/or specified substance(s) shall be described as a quantity of the substance present in a given unit of the pharmaceutical product or manufactured item.

ISO 11615:2012(E)
reference strength substance(s) and/or specified substance(s) used as a reference to form the basis of strength of an investigational or authorized medicinal product NOTE The reference strength refers to the strengths of the base, in case the strength of the substance is expressed as the salt or water for hydration. ISO 11616:2012(E)
reference strength substance(s) and/or specified substance(s) used as a reference to form the basis of strength of an investigational or authorized medicinal product

Note 1 to entry: The reference strength refers to the strengths of the base, in case the strength of the substance is expressed as the salt or water for hydration.

[SOURCE: ISO 11616:2012, 3.1.26]

ISO/TS 19256:2016(E)
reference terminology set of atomic level designations structured to support representations of both simple and compositional

concepts independent of human language (within machine)

NOTE 1 Reference terminology is designed to uniquely represent concepts (A.2.3.1).

NOTE 2 The terminology lists the concepts and specifies their structure, relationships and, if present, their systematic

and formal definitions (2.4.3).

ISO 17115:2007(E)
reference terminology model domain concept model (3.1) that is optimised for terminology management ISO 18104:2003(E)
Refined Message Information Model (RMIM) An information structure that represents the requirements for a set of messages. ISO/HL7 27932:2009(E)
refined message information model (RMIM) information structure used in HL7 Version 3 messaging that represents the requirements for a set of messages ISO/HL7 27951:2009(E)
refined message information model
RMIM
information structure used in HL7 Version 3 messaging that represents the requirements for a set of messages ISO/HL7 27951:2009(E)
registered functional profile functional profile that has successfully completed HL7 EHR Work Group registration process and review ISO 10781:2015(E)
registered functional profile functional profile that has successfully completed HL7 EHR WG registration process and review ISO/HL7 16527:2016(E)
registered jack (RJ)-45 (A) AT&T Registered Jack designation for the eight-pin modular connectors

that meet the requirements of IEC 60603-7:1996 [B5]7 and ISO/IEC 8877:1992 [B8]. (B) An eight-pin modular

telephone plug.

NOTE 1—Also called a programmable connection, an RJ-45 plug is generally used on four-wire circuits, but it can be

used on eight-wire circuits.8

NOTE 2—Definition (B) reflects colloquial usage. Standards referencing this term should point to the precise

standardized connector specification.

ISO/IEEE 11073-30400:2012(E)
registration act of giving a record a unique identity in a record keeping system ISO/TS 18530:2014(E)
registration act of giving a record a unique identity in a record keeping system ISO/TS 22220:2011(E)
registration act of giving a record a unique identity in a record-keeping system

[ISO 22220:2009, definition 3.6]

ISO/TS 27527:2010(E)
registration authority

RA

entity that is responsible for identification and authentication of certificate subjects, but that does not sign or issue

certificates (i.e. an RA is delegated certain tasks on behalf of a CA)

[IETF/RFC 2527]

ISO/TS 17090-1:2002(E)
registration number 〈clinical trial〉 identifier assigned to a clinical trial by a Medicines Regulatory Agency in a jurisdiction for tracking purposes ISO 11615:2012(E)
registry collection of all the official records relating to something, or the place where they are kept ISO/TS 27790:2009(E)
regulated document any document issued by a Medicines Regulatory Agency in the context of the regulatory process to grant, maintain or update the authorization of a Medicinal Product or in the regulatory process of the authorization and supervision of clinical trials EXAMPLES Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL). ISO 11615:2012(E)
regulated health professional person who is authorized by a nationally recognized body to be qualified to perform certain health services

EXAMPLES Physicians, registered nurses and pharmacists.

NOTE 1 The types of registering or accrediting bodies differ in different countries and for different professions. Nationally

recognized bodies include local or regional governmental agencies, independent professional associations and other formally

and nationally recognized organizations. They may be exclusive or non-exclusive in their territory.

NOTE 2 A nationally recognized body in this definition does not imply one nationally controlled system of professional

registration but, in order to facilitate international communication, it would be preferable for one nationwide directory of

recognized health professional registration bodies to exist.

ISO/TS 17090-1:2002(E)
regulatory agency (or authorities) Geopolitical entities have established agencies/authority responsible for regulating products used in health care. The agencies are collectively referred to as regulatory agencies. ISO/HL7 27932:2009(E)
relaying agent party agreed to be acting as an intermediary, communicating messages between the requesting and

requested healthcare parties in both directions when direct communication is not possible as the

requested healthcare party’s identity is not known, being dependent on individual patient’s choice

[SOURCE: ENV 13607]

ISO 21549-4:2014(E)
release characteristics description of the modified timing by which an active ingredient is made available in the body after administration of the pharmaceutical product, in comparison with a conventional, direct release of the active ingredient EXAMPLES Delayed, extended, none. ISO 11239:2012(E)
relying party recipient of a certificate who acts in reliance on that certificate and/or digital signature verified using

that certificate

[RFC 3647]

ISO 21091:2013(E)
relying party recipient of a certificate who acts in reliance on that certificate and/or digital signature verified using that certificate

[IETF/RFC 2527]

ISO/TS 17090-1:2002(E)
relying party recipient of a certificate who acts in reliance on that certificate and/or digital signature verified using that

certificate

ISO/TS 22600-3:2009(E)
repeat field field containing one or more data elements, each of which is to be treated as having equal priority or standing ISO 18812:2003(E)
replication digital duplication where there is no change to the information ISO/TS 21547:2010(E)
repository place where something is safely kept ISO/TS 27790:2009(E)
representation of relation semantic link formal relation between two or more categories derived from corresponding relations between instances of the respective categories EXAMPLE hasLocation (with inverse islocationOf):isCauseOf (with inverse hasCause). NOTE 1 This includes all relations except Is_a, has_part relation. NOTE 2 The definition is authorized by a domain constraint. NOTE 3 Adapted from ISO 17115. ISO 1828:2012(E)
Request request for a single laboratory service and a corresponding analytical instrument procedure to be carried out in respect of a specified subject of investigation ISO 18812:2003(E)
residual data remaining original ECG data after “proper” subtraction of the reference beat where the adjective “proper” refers to accurate beat alignment ISO 11073-91064:2009(E)
Result set of information including all essential or useful data relevant to the result of a single analytical instrument investigation and a corresponding analytical instrument procedure ISO 18812:2003(E)
resultant material material that is the result of a critical process ISO 11238:2012(E)
review verification of the suitability, adequacy and effectiveness of selection and determination activities,

and the results of these activities, with regard to fulfilment of specified requirements by an object of

conformity assessment

[SOURCE: ISO/IEC 17000:2004, definition 5.1]

ISO/TS 14441:2013(E)
RFID

radio frequency identification

wireless non-contact system that uses radio-frequency electromagnetic fields to transfer data from a

tag attached to an object, for the purposes of automatic identification and tracking

ISO/TS 16791:2014(E)
rhythm data full original ECG data, or the decompressed and reconstructed ECG data at reduced resolution ISO 11073-91064:2009(E)
ribonucleic acid

RNA

polymer of ribonucleotides occurring in a double-stranded or single-stranded form

[SOURCE: ISO 22174:2005, 3.1.3]

ISO/TS 20428:2017(E)
risk combination of the probability of an event and its consequence

[ISO/IEC Guide 73:2002, definition 3.1.1]

ISO/TR 11633-1:2009(E)
risk combination of the probability of an event and its consequence

[ISO/IEC Guide 73:2002, definition 3.1.1]

ISO/TR 11633-2:2009(E)
Risk combination of the probability of occurrence of harm and the severity of that harm ISO/TR 17791:2013(E)
risk combination of the probability of occurrence of harm and the severity of that harm

[ISO/IEC Guide 51:1999, definition 3.2] [7]

ISO/TR 27809:2007(E)
risk combination of the probability of an event and its consequence

Note 1 to entry: Adapted from ISO Guide 73:2009, definition 1.1.

ISO/TS 14441:2013(E)
risk combination of the likelihood of occurrence of harm and the severity of that harm

[adapted from ISO/IEC Guide 51:1999]

See Clause 4.

ISO/TS 25238:2007(E)
risk analysis systematic use of available information to identify hazards and to estimate the risk ISO/TS 25238:2007(E)
risk applicability relationship, relevancy and appropriateness of risk in a particular context ISO/TR 17791:2013(E)
risk assessment overall process of risk analysis and risk evaluation

[ISO/IEC Guide 73:2002, definition 3.3.1]

ISO/TR 11633-1:2009(E)
risk assessment overall process of risk analysis and risk evaluation

[ISO/IEC Guide 73:2002, definition 3.3.1]

ISO/TR 11633-2:2009(E)
risk assessment overall process of risk analysis and risk evaluation

Note 1 to entry: Adapted from ISO Guide 73:2009, definition 3.4.1.

ISO/TS 14441:2013(E)
risk class classification of a health software product according to the underlying risk it might present to the safety of

patients

ISO/TS 25238:2007(E)
risk management coordinated activities to direct and control an organization with regard to risk

NOTE Risk management typically includes risk assessment, risk treatment, risk acceptance and risk communication.

[ISO/IEC Guide 73:2002, definition 3.1.7]

ISO/TR 11633-1:2009(E)
risk management coordinated activities to direct and control an organization with regard to risk

NOTE Risk management typically includes risk assessment, risk treatment, risk acceptance and risk communication.

[ISO/IEC Guide 73:2002, definition 3.1.7]

ISO/TR 11633-2:2009(E)
risk management systematic application of management policies, procedures and practices to the tasks of analyzing,

evaluating and controlling risk

ISO/TR 17791:2013(E)
risk management coordinated activities to direct and control an organization with regard to risk

[SOURCE: ISO Guide 73:2009, definition 2.1]

Note 1 to entry: Risk management generally includes risk assessment, risk treatment, risk acceptance, risk

communication, risk monitoring and risk review.

ISO/TS 14441:2013(E)
risk sharing form of risk treatment involving the agreed distribution of risk with other parties ISO/TR 17791:2013(E)
risk treatment process of selection and implementation of measures to modify (typically reduce) risk

NOTE Adapted from ISO/IEC Guide 73:2002.

ISO/TR 11633-1:2009(E)
risk treatment process of selection and implementation of measures to modify (typically reduce) risk

NOTE Adapted from ISO/IEC Guide 73:2002.

ISO/TR 11633-2:2009(E)
risk treatment process to modify risk ISO/TR 17791:2013(E)
risk treatment process of selection and implementation of measures to modify risk

Note 1 to entry: Adapted from ISO Guide 73:2009, definition 3.8.1.

ISO/TS 14441:2013(E)
RJ-45 (A) AT&T Registered Jack designation for the eight-pin modular connectors that meet the

requirements of IEC 60603-7:1996 and ISO/IEC 8877:1992. (B) An eight-pin modular telephone plug.

NOTES

1—Also called a programmable connection, an RJ-45 plug is generally used on four-wire circuits, but can be used on

eight-wire circuits.

2—Definition (B) reflects colloquial usage. Standards referencing this term should point to the precise standardized connector

specification.

ISO/IEEE 11073-30200:2004(E)
role set of behaviours that is associated with a task

[ISO/TS 17090-1:2002, definition 3.2.24]

ISO 13606 -1:2008(E)
role name of a set of behaviours which is associated with a task

NOTE Adapted from ISO 17090-1.

ISO 13606-5:2010(E)
role set of competences and/or performances associated with a task ISO 21091:2013(E)
role 1. A function or position.

2. A Reference Information Model class that defines the competency of an Entity class. Each role is played

by one Entity (the Entity that is in the role) and is usually scoped by another.

3. In UML, each end of an association is designated as a role to reflect the function that class plays in the

association.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
Role set of competences and/or performances associated with a task ISO 27789:2013(E)
role set of competences and/or performances associated with a task ISO/TS 13606-4:2009(E)
role set of behaviours that is associated with a task ISO/TS 17090-1:2002(E)
Role the name of a set of behaviours that is associated with a task ISO/TS 18308:2004(E)
role set of behaviours that is associated with a task ISO/TS 21547:2010(E)
role set of competences and/or performances which is associated with a task ISO/TS 22600-1:2006(E)
role set of competences and/or performances which is associated with a task ISO/TS 22600-2:2006(E)
role set of competences and/or performances that are associated with a task

NOTE For managing role relationships between the entities, structural and functional roles can be defined.

[ISO/TS 21298:2008].

ISO/TS 22600-3:2009(E)
role assignment certificate certificate that contains the role attribute, assigning one or more roles to the certificate holder ISO/TS 22600-2:2006(E)
role assignment certificate certificate that contains the role attribute, assigning one or more roles to the certificate holder ISO/TS 22600-3:2009(E)
role certificate certificate that assigns privileges to a role rather than directly to individuals

NOTE Individuals assigned to that role, through an attribute certificate or public-key certificate with a subject directory

attributes extension containing that assignment, are indirectly assigned the privileges contained in the role certificate.

ISO/TS 22600-2:2006(E)
role certificate certificate that assigns privileges to a role rather than directly to individuals

NOTE Individuals assigned to that role, through an attribute certificate or public key certificate with a subject directory

attributes extension containing that assignment, are indirectly assigned the privileges contained in the role certificate.

ISO/TS 22600-3:2009(E)
role certificate certificate that assigns privileges to a role rather than directly to individuals

NOTE Individuals assigned to that role, through an attribute certificate or public key certificate with a subject directory

attributes extension containing that assignment, are indirectly assigned the privileges contained in the role certificate.

ISO/TS 22600-3:2009(E)
role name See association role name. ISO 21731:2006(E) & ANSI/HL7 RIM R1
role specification certificate certificate that contains the assignment of privileges to a role ISO/TS 22600-2:2006(E)
role specification certificate certificate that contains the role attribute, assigning one or more roles to the certificate holder ISO/TS 22600-3:2009(E)
role specification certificate certificate that contains the assignment of privileges to a role ISO/TS 22600-3:2009(E)
roll up method of regrouping and aggregating multidimensional data to move up the hierarchy into larger units

EXAMPLE Weekly count of patients aggregated by quarter or by year.

ISO/TS 29585:2010(E)
route of administration path by which the pharmaceutical product is taken into or makes contact with the body EXAMPLES Intravenous, oral, ocular, oromucosal. ISO 11239:2012(E)
route of administration path by which the pharmaceutical product is taken into or makes contact with the body EXAMPLES Oral, intravenous, oromucosal, ocular. ISO 11615:2012(E)
route of administration path by which the pharmaceutical product is taken into or makes contact with the body

EXAMPLE Oral, intravenous, oromucosal, ocular.

[SOURCE: ISO 11615:2012, 3.1.73]

ISO/TS 19256:2016(E)
RS-232 The serial interface defined in ANSI/TIA/EIA-232-F-1997. ISO/IEEE 11073-30200:2004(E)
Safety freedom from unacceptable risk ISO/TR 17791:2013(E)
safety freedom from unacceptable risk

[ISO/IEC Guide 51:1999, definition 3.1] [7]

ISO/TR 27809:2007(E)
safety freedom from unacceptable risk of harm

[SOURCE: ISO/IEC Guide 51:2014]

ISO/TS 13972:2015(E)
safety freedom from unacceptable risk of harm

[SOURCE: ISO/IEC Guide 51, 3.14, modified]

ISO/TS 19256:2016(E)
safety freedom from unacceptable risk of harm

[ISO/IEC Guide 51:1999]

ISO/TS 25238:2007(E)
salt ionic substances formed from the neutralization reaction of an acid and base ISO 11238:2012(E)
Sample one or more parts taken or to be taken from a system and intended to provide information on that system or on a subsystem, or to provide a basis for decision on either of these ISO 18812:2003(E)
sampling provision of a sample of the object of conformity assessment, according to a procedure

[SOURCE: ISO/IEC 17000:2004, definition 4.1]

ISO/TS 14441:2013(E)
sanctioned characteristic formal representation of a type of characteristics (A.3.2.5)

EXAMPLE 1 performedUsing <INSTRUMENT>; hasLocation <BodyPartOrImplantedDevice>.

EXAMPLE 2 “CauseOfInflammation canBe set{ bacteria, virus, parasite, autoimmune, chemical, physical }”, where

“canBe” is the semantic link (2.2.3), and “set{ bacteria, virus, parasite, autoimmune, chemical, physical }” is the

characterizing generic concept (2.3.3).

NOTE A sanctioned characteristic is typically made up of a combination of a semantic link and a characterizing generic

concept, and can be used in domain constraints (2.3.2).

ISO 17115:2007(E)
sanctioned characteristic formal representation of a type of characteristic (3.1.5)

[SOURCE: ISO 17115:2007, definition 2.3.1]

EXAMPLE {performedUsing} <Instrument>; {hasLocation} <BodyPartOrImplantedDevice>,

where “{performedUsing}” and “{hasLocation}” are the semantic links (3.1.10), and “<Instrument>” and

“<BodyPartOrImplantedDevice>” is the characterizing category (3.1.3).

Note 1 to entry: A sanctioned characteristic (3.1.9) is typically made up of a combination of a semantic link (3.1.10)

and a characterizing category (3.1.3), and can be used in domain constraints (3.1.7).

3.1.10

semantic link

formal representation of a directed associative relation or partitive relation between two concepts (3.1.1)

[SOURCE: ISO 17115:2007, definition 2.2.3]

EXAMPLE {hasLocation} (with inverse {isLocationOf}) and {isCauseOf} (with inverse {hasCause}).

Note 1 to entry: A semantic link (3.1.10) always has an inverse, i.e. another semantic link (3.1.10) with the opposite

direction. The inverse may or may not be explicitly stated.

ISO/TS 16277-1:2015(E)
sanctioned characteristic formal representation of a type of characteristic (2.6)

[ISO 17115:2007, definition 2.3.1]

EXAMPLE 1 performedUsing <INSTRUMENT>; hasLocation <BodyPartOrImplantedDevice>.

EXAMPLE 2 “CauseOfInflammation canBe set{bacteria, virus, parasite, autoimmune, chemical, physical}”, where

“canBe” is the semantic link (2.17), and “set{bacteria, virus, parasite, autoimmune, chemical, physical}” is the

characterizing category (2.4).

NOTE A sanctioned characteristic (2.15) is typically made up of a combination of a semantic link (2.17) and a

characterizing category (2.4), and can be used in domain constraints (2.11).

ISO/TS 22789:2010(E)
scanner An observer and “summarizer” of object attribute values. ISO/IEEE 11073-10201:2004(E)
scenario A formal description of a class of business activities including the semantics of business

agreements, conventions, and information content.

ISO/IEEE 11073-10201:2004(E)
scenario statement of healthcare-relevant events defined as a sequence of interactions ISO/TS 27790:2009(E)
scope of attestation range or characteristics of objects of conformity assessment covered by attestation

[SOURCE: ISO/IEC 17000:2004, definition 5.3]

ISO/TS 14441:2013(E)
secondary data use expression sometimes employed to describe the use of data for additional purposes other than the primary

reason for their collection, adding value to these data

ISO/TS 29585:2010(E)
secondary station As defined by the infrared link access protocol (IrLAP), any station on the data

link that does not assume the role of the primary station. It will initiate transmission only as a result of

receiving explicit permission to do so from the primary station.

ISO/IEEE 11073-30200:2004(E)
secondary station As defined by Infrared Link Access Protocol (IrLAP), any station on the data link

that does not assume the role of the primary station. It will initiate transmission only as a result of receiving

explicit permission to do so from the primary station.

ISO/IEEE 11073-30300:2004(E)
secondary use (of a healthcare record) any legitimate use of a healthcare record other than for the purpose of supporting the direct delivery of

healthcare services to the subject of care

ISO/TS 18308:2004(E)
secondary use of personal data any use different from primary use ISO/TS 25237:2008(E)
second-party conformity assessment activity the object

Note 1 to entry: Persons or organizations performing second-party conformity assessment activities include,

for example, purchasers or users of products, or potential customers seeking to rely on a supplier’s management

system, or organizations representing those interests.

[SOURCE: ISO/IEC 17000:2004, definition 2.3]

ISO/TS 14441:2013(E)
section aggregate of data elements related to one aspect of the electrocardiographic recording, measurement or interpretation ISO 11073-91064:2009(E)
security combination of availability, confidentiality, integrity and accountability

[ENV 13608-1]

ISO 21091:2013(E)
security combination of confidentiality, integrity and availability ISO 21549-2:2004(E)
security combination of security properties (such as availability, confidentiality, integrity and accountability) which

constitutes a guarantee that data items and, more generally, any kind of security object has not been altered,

modified, disclosed or withheld by any kind of security subject in an unauthorized manner with respect to the

security policy

[ITSEC]

ISO 21549-7:2007(E)
security combination of availability, confidentiality, integrity and accountability

[ENV 13608-1:2000]

ISO/TS 13606-4:2009(E)
security combination of availability, confidentiality, integrity and accountability

[ENV 13608-1]

ISO/TS 17090-1:2002(E)
security combination of availability, confidentiality, integrity and accountability

ENV 13608-1:2000.

ISO/TS 21547:2010(E)
security combination of availability, confidentiality, integrity and accountability

[ENV 13608-1]

ISO/TS 22600-1:2006(E)
security combination of availability, confidentiality, integrity and accountability

[ENV 13608-1]

ISO/TS 22600-2:2006(E)
security combination of availability, confidentiality, integrity and accountability ISO/TS 22600-3:2009(E)
security combination of confidentiality, integrity and availability ISO/TS 27790:2009(E)
security (of information) preservation of the confidentiality, integrity and availability of data ISO/TS 18308:2004(E)
security classification category to which personal information and material is assigned to denote the degree of damage that

unauthorized disclosure would cause a person or his/her relations and to denote the degree of protection

required

ISO/TS 21547:2010(E)
security policy plan or course of action adopted for providing computer security

[ISO/IEC 2382‑8]

ISO 21091:2013(E)
security policy plan or course of action adopted for providing computer security ISO 27789:2013(E)
security policy plan or course of action adopted for providing computer security

[ISO/IEC 2382-8:1998, definition 08.01.06]

ISO/TS 13606-4:2009(E)
security policy plan or course of action adopted for providing computer security

[ISO/IEC 2382-8:1998]

ISO/TS 17090-1:2002(E)
security policy plan or course of action adopted for providing computer security

ISO/IEC 2382-8:1998, definition 08.01.06.

EXAMPLE A set of laws, rules and practices that regulate how sensitive information is managed and distributed

within a specific system.

ISO/TS 21547:2010(E)
security policy plan or course of action adopted for providing computer security ISO/TS 22600-1:2006(E)
security policy plan or course of action adopted for providing computer security ISO/TS 22600-2:2006(E)
security policy plan or course of action adopted for providing computer security

[ISO/IEC 2382-8:1998]

ISO/TS 22600-3:2009(E)
security policy set of rules laid down by the security authority governing the use and provision of security services and

facilities

ISO/TS 22600-3:2009(E)
security policy plan or course of action adopted for providing computer security

[ISO/IEC 2382-8:1998, definition 08-01-06]

ISO/TS 25237:2008(E)
security service service, provided by a layer of communicating open systems, which ensures adequate security of the

systems or of data transfers

[ISO/IEC 7498]

ISO 21091:2013(E)
security service service, provided by a layer of communicating open systems, which ensures adequate security of the systems

or of data transfers

[ISO 7498-2:1989, definition 3.3.51]

ISO/TS 13606-4:2009(E)
security service service, provided by a layer of communicating open systems, which ensures adequate security of the systems or of

data transfers

[ISO 7498-2:1989]

ISO/TS 17090-1:2002(E)
security service service, provided by a layer of communicating open systems, which ensures adequate security of the systems

or of data transfers

ISO 7498-2:1989, definition 3.3.51.

ISO/TS 21547:2010(E)
security service service, provided by a layer of communicating open systems, which ensures adequate security of the systems

or of data transfers

[ISO 7498-2, definition 3.3.51]

ISO/TS 22600-1:2006(E)
security service service, provided by a layer of communicating open systems, which ensures adequate security of the systems

or of data transfers

[ISO 7498-2, definition 3.3.51]

ISO/TS 22600-2:2006(E)
security service service, provided by a layer of communicating open systems, which ensures adequate security of the systems

or of data transfers

[ISO 7498-2:1989]

ISO/TS 22600-3:2009(E)
security subject active entity, generally in the form of a person, process or device, that causes information to flow among

objects or changes the system state

Note 1 to entry: Technically, a process/domain pair.

ISO 21091:2013(E)
segment minimum decodable portion of a bar code symbol, consisting, in GS1 DataBar, of a symbol character and its

adjacent finder pattern

ISO/IEC 24724:2011(E)
semantic relating to meaning in language ISO 13606-2:2008(E)
semantic correspondence measure of similarity between two concepts

NOTE The opposite is semantic distance.

ISO 17115:2007(E)
semantic correspondence measure of similarity between two concepts

[ISO 17115:2007, definition 2.6.2]

ISO/TS 22789:2010(E)
semantic interoperability ability for data shared by systems to be understood at the level of fully defined domain concepts

[ISO/TS 18308:2004, definition 3.38]

ISO 13606 -1:2008(E)
semantic interoperability ability for data shared by systems to be understood at the level of fully defined domain concepts

[ISO/TS 18308:2004, definition 3.38]

ISO 13606-2:2008(E)
semantic interoperability ability for information shared by systems to be understood at the level of formally defined domain concepts

NOTE Adapted from ISO/TS 18308[3].

ISO/TR 20514:2005(E)
semantic interoperability ability for data shared by systems to be understood at the level of fully defined domain concepts

[SOURCE: ISO/TS 18308:2011]

ISO/TS 13972:2015(E)
semantic interoperability the ability for data shared by systems to be understood at the level of formally defined domain concepts ISO/TS 18308:2004(E)
semantic interoperability ability for data shared by systems to be understood at the level of formally defined domain concepts ISO/TS 27790:2009(E)
semantic link formal representation of a directed associative relation (A.3.2.23) or partitive relation (A.3.2.22) between

two concepts (A.3.2.1)

EXAMPLES hasLocation (with inverse isLocationOf); isCauseOf (with inverse hasCause).

NOTE 1 This includes all relations except the generic relation (A.3.2.21).

NOTE 2 A semantic link always has an inverse, i.e. another semantic link with the opposite direction.

NOTE 3 A semantic link can be part of a composite characteristic (2.2.1) where it describes the role of the

characterizing concept (2.2.2). Similarly, it describes the role of a characterizing generic concept (2.3.3) in a

sanctioned characteristic (A.3.1).

ISO 17115:2007(E)
semantic link formal representation of a directed associative relation (2.1) or partitive relation between two concepts (2.9)

[ISO 17115:2007, definition 2.2.3]

EXAMPLE hasLocation (with inverse isLocationOf) and isCauseOf (with inverse hasCause).

NOTE 1 This includes all relations except the generic relation.

NOTE 2 A semantic link (2.17) always has an inverse, i.e. another semantic link (2.17) with the opposite direction.

NOTE 3 A semantic link (2.17) can be part of a composite characteristic (2.7) where it defines the role of the

characterizing concept (2.5). Similarly, it defines the role of a characterizing category (2.4) in a sanctioned

characteristic (2.15).

ISO/TS 22789:2010(E)
Sensitivity measure of the potential or perceived potential to create harm to a data subject, or to be abused, or misused ISO 27789:2013(E)
sensitivity measure of importance assigned to information to denote its need for protection ISO/TS 13606-4:2009(E)
sensitivity characteristic of a resource that implies its value or importance ISO/TS 22600-2:2006(E)
sensitivity characteristic of a resource that implies its value or importance ISO/TS 22600-3:2009(E)
sequence read

read

fragmented nucleotide sequences which are used to reconstruct the original sequence for next generation sequencing technologies ISO/TS 20428:2017(E)
sequence variation

DNA sequence variation

variation

differences of DNA sequence among individuals in a population

Note 1 to entry: Variation implies CNV (3.7), deletion (3.10), insertion (3.19), indel (3.18), small indel (3.32), large indel (3.20), and SNP (3.31).

[SOURCE: ISO 25720:2009, 4.8]

ISO/TS 20428:2017(E)
serialization assigning a unique identifier (e.g. a number) to an item (e.g. pack, case or pallet)

Note 1 to entry: This identifier is stored on a database along with other information about the item (e.g.

manufacturer, batch info, etc). Serialization typically includes randomly selected, encrypted, numerical or alphanumeric

serial number.

ISO/TS 16791:2014(E)
service A specific behavior that a communication party in a specific role is responsible for exhibiting. ISO/IEEE 11073-10201:2004(E)
service number of processes, involving an organization in the provision of specific objectives

[EN 12967-1 to 3[7]]

NOTE See also 2.27.

ISO/TR 20514:2005(E)
service specific behaviour that a communication party in a specific role is responsible for exhibiting ISO/TS 27790:2009(E)
service access point (SAP) An address that identifies a user of the services of a protocol entity. ISO/IEEE 11073-30200:2004(E)
service access point (SAP) An address or port at which a connection to an upper layer protocol

entity can be established.

ISO/IEEE 11073-30300:2004(E)
service area countries/areas where the healthcare data card is intended to be used and where the healthcare service

obtained by using the card is provided

ISO 20301:2006(E)
service data unit (SDU) Information that is delivered as a unit between peer service access points

(SAPs). See: service access point.

ISO/IEEE 11073-30200:2004(E)
service data unit (SDU) Information that is delivered as a unit between peer service access points

(SAPs). See: service access point (SAP).

ISO/IEEE 11073-30300:2004(E)
service entity services provided by an organization or which an organization is able, or licensed, to provide ISO/TS 27527:2010(E)
set A form of collection which contains an unordered list of unique elements of a single type. ISO 21731:2006(E) & ANSI/HL7 RIM R1
set normal response mode (SNRM) A high-level data link control (HDLC) message sent by a bedside

communications controller (BCC) to a device communications controller (DCC) when a successful

connection to the network has occurred.

ISO/IEEE 11073-30300:2004(E)
set normal response mode (SNRM): A high-level data link control (HDLC) message sent by a bedside

communications controller (BCC) to a device communications controller (DCC) when a successful

connection to the network has occurred.

ISO/IEEE 11073-30200:2004(E)
shareable EHR EHR with a commonly agreed logical information model

NOTE 1 The shareable EHR per se is an artefact between a basic-generic EHR and the Integrated Care EHR (ICEHR)

which is a specialization of the shareable EHR. The shareable EHR is probably of little use without the additional clinical

characteristics thath are necessary for its effective use in an integrated care setting.

NOTE 2 Whilst the ICEHR is the target for interoperability of patient health information and optimal patient care, it is of

note that the large majority of EHRs in use at present are not even shareable let alone have the additional characteristics required to comply with the definition of an Integrated Care EHR. A definition of a basic-generic EHR has therefore been

included to acknowledge this current reality.

ISO/TR 20514:2005(E)
shareable electronic health record electronic health record with a standardized information model which is independent of electronic health

record systems and accessible by multiple authorized users

[adapted from ISO/TR 20514:2005, definition 2.33]

ISO 13606 -1:2008(E)
shareable electronic health record electronic health record with a standardized information model which is independent of electronic health

record systems and accessible by multiple authorized users

ISO 13606-2:2008(E)
shareable electronic health record electronic health record with a standardized information model which is independent of electronic health

record systems and is accessible by multiple authorized users

ISO 13606-5:2010(E)
SI International System of Units ISO 11239:2012(E)
sign&symptom-TM manifestation of a dysfunction classified only by TM-CJK

EXAMPLE <night sweating>, <cold sweating>, <floating pulse>, <slippery pulse>, <relaxed pulse>, <hollow

pulse>, <pale tongue>, <red tongue>, <yellow fur tongue>.

Note 1 to entry: sign&symptom (3.2.3) may be identifiable by the affected person or the health worker.[6]

Note 2 to entry: This concept (3.1.1) is subcategories of clinical findings-TM and it can be used for

characterizing category (3.1.3) with semantic link(3.1.10) such as hasAssociatedPattern-TM (3.4.5) and

hasAssociatedFinding-TM (3.4.6)

ISO/TS 16277-1:2015(E)
silencer DNA sequence that suppresses transcription ISO 11238:2012(E)
simple authentication authentication by means of simple password arrangements ISO/TS 22600-3:2009(E)
single nucleotide polymorphism

SNP

single nucleotide variation in a genetic sequence that occurs at appreciable frequency in the population

Note 1 to entry: Pronounced “snip”.

[SOURCE: ISO 25720:2009, 4.23]

ISO/TS 20428:2017(E)
single substance substance that can be described by a single representation or set of descriptive elements ISO 11238:2012(E)
situational criterion criterion that is required if the circumstances given are applicable ISO 10781:2015(E)
situational criterion criterion that is required if the circumstances given are applicable ISO/HL7 16527:2016(E)
small indel insertion or deletion of 2 ~100 nucleotides ISO/TS 20428:2017(E)
SoC

subject of care

person seeking to receive, receiving or having received health care ISO/TS 18530:2014(E)
soft lean mass The sum of the body water mass and protein mass. ISO/IEEE

11073-10420

solvate substance formed through association of a solvent molecule (e.g. water, alcohol) with another moiety. ISO 11238:2012(E)
somatic cell cells of the body in contrast to the germ line cells ISO/TS 20428:2017(E)
source material material from which a substance is derived, which is defined based on taxonomic and anatomical origins ISO 11238:2012(E)
source of authority

SOA

attribute authority (2.3) that a privilege verifier for a particular resource trusts as the ultimate authority to

assign a set of privileges

ISO/TS 22600-2:2006(E)
source of authority

SoA

attribute authority that a privilege verifier for a particular resource trusts as the ultimate authority to assign a

set of privileges, or a special type of attribute authority upon which a verifier endows unlimited privilege

NOTE The verifier trusts the source of authority to delegate that privilege to certificate holders, some of which may

further delegate that privilege to other certificate holders.

ISO/TS 22600-3:2009(E)
specialization taxonomic relationship between a more general class, interface or concept and a more specific class,

interface or concept where the more specific entity adds new features or redefines existing features by

constraining their possible behaviours

ISO 21090:2011(E)
specialization An association between two classes (designated superclass and subclass), in which the subclass is derived

from the superclass. The subclass inherits all properties from the superclass, including attributes, relationships,

and states, but also adds new ones to extend the capabilities of the superclass.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
specialization definition of a concept or class subordinate to a general concept or class ISO/TS 27790:2009(E)
specialize form a more specific concept (A.3.2.16) [by constraining the extension (A.3.2.8) of a more generic concept

(A.3.2.15)]

EXAMPLE 1 Infection that hasCause Bacteria can be specialized to Infection that hasCause.

EXAMPLE 2 Pneumococcus Hepatitis can be specialized to NonA-NonB-hepatitis.

NOTE 1 To specialize is to increase the intension and decrease the extension of a concept. The more specific

concept (A.3.2.16) has a larger intension (A.3.2.9), but a smaller extension than the general concept (A.3.2.3).

Specialization and generalization can be achieved in many ways, including replacing a semantic link with a more specific

semantic link (and vice versa for generalization).

NOTE 2 The more specific concept has a broader intension, but a narrower extension than the generic concept.

NOTE 3 Ways to specialize concepts include

— adding one or more composite characteristics (2.2.1),

— replacing the characterizing concept (2.2.2) in one or more characteristics (A.3.2.4) with a more specific concept

(A.3.2.16), and

— forming an intersection of two concepts (where the intersection is a specialization of both the “parents”).

NOTE 4 The opposite is generalize (2.1.2).

ISO 17115:2007(E)
specified requirement need or expectation that is stated

NOTE Specified requirements can be stated in normative documents such as regulations, standards and technical

specifications. Specific requirements are intended to define some feature of a real implementation and offer the possibility of

testing.

ISO TR 16056-1:2004(E)
specified requirement need or expectation that is stated

NOTE Specified requirements can be stated in normative documents such as regulations, standards and technical

specifications. Specific requirements are intended to define some feature of a real implementation and offer the possibility of

testing.

ISO TR 16056-2:2004(E)
specified requirement need or expectation that is stated ISO TS 16058:2004(E)
specified requirement need or expectation that is stated

Note 1 to entry: Specified requirements may be stated in normative documents such as regulations, standards

and technical specifications.

[SOURCE: ISO/IEC 17000:2004, definition 3.1]

ISO/TS 14441:2013(E)
specified substance group of elements which describe multi-substance materials and specify further information on substances and multi-substance materials relevant to the description of medicinal products ISO 11238:2012(E)
specified substance substance defined by groups of elements that describes multi-substance materials or specifies further information on substances relevant to the description of Medicinal Products

NOTE 1 This could include grade, units of measure, physical form, constituents, manufacturer, critical manufacturing processes (e.g. extraction, synthetic or recombinant processes), specification and the analytical methods used to determine whether a substance is in compliance with a specification. NOTE 2 There are four different groups of elements that can be used to define a given specified substance and specific relationships between each group of elements.

ISO 11615:2012(E)
specified substance group of elements that describe multiple substance materials and specify further information on substances and multi-substance materials relevant to the description of medicinal products

NOTE 1 This could include grade, units of measure, physical form, constituents, manufacturer, critical manufacturing processes (i.e. extraction, synthetic, recombinant processes), specification and the analytical methods used to determine whether a substance is in compliance with a specification. NOTE 2 There are four different groups of elements that can be used to define a given specified substance and specific relationships between each group of elements.

ISO 11616:2012(E)
sponsor individual, company, institution or organization, which takes responsibility for the initiation, management and/or financing of a clinical trial ISO 11615:2012(E)
sponsor individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial ISO 11616:2012(E)
sponsored healthcare provider health services provider who is not a regulated professional in the jurisdiction of his/her practice, but who is active

in his/her healthcare community and sponsored by a regulated healthcare organization

EXAMPLES A drug and alcohol education officer who is working with a particular ethnic group, or a healthcare aid worker in

a developing country.

ISO/TS 17090-1:2002(E)
SRIN

service relation instance number

attribute to a global service relation number (3.6) to identify an instance within a care process

EXAMPLE Such as an identification band, an order sheet, test-tube etc.

ISO/TS 18530:2014(E)
standard document, established by consensus and approved by a recognised body, which provides, for common and

repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the

optimum degree of order in a given context

[ISO/IEC Guide 2:2004, definition 3.2]

ISO 13606 -1:2008(E)
standard document, established by consensus and approved by a recognized body, that provides, for common and

repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the

optimum degree of order in a given context

[ISO/IEC Guide 2:2004, definition 3.2]

ISO 13606-5:2010(E)
standard document established by consensus and approved by a recognised body, that provides, for common and

repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the

optimum degree of order in a given context

NOTE Standards are based on the consolidated results of science, technology and experience, and aimed at the

promotion of optimum community benefits.

[ISO/IEC Guide 2:2004, definition 3.2]

ISO 21549-7:2007(E)
Standard A technical specification which addresses a business requirement, has been implemented in viable commercial products, and, to the extent practical, complies with recognized standards organizations such as ISO. ISO/HL7 27932:2009(E)
Standard technical specification which addresses a business requirement, has been implemented in viable commercial products, and, to the extent practical, complies with recognized standards organizations such as ISO ISO/HL7 27951:2009(E)
Standard technical specification which addresses a business requirement, has been implemented in viable commercial products, and, to the extent practical, complies with recognized standards organizations such as ISO ISO/HL7 27951:2009(E)
Standard document, established by consensus and approved by a recognized body, that provides, for common and

repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement

of the optimum degree of order in a given context

ISO/TR 17791:2013(E)
standard document, established by consensus and approved by a recognized body, which provides, for common and

repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the

optimum degree of order in a given context

[ISO/IEC Guide 2[4]]

ISO/TR 20514:2005(E)
standards developing organization any organization one of whose functions is to create and/or publish standards ISO/TS 27790:2009(E)
star schema dimensional modelling concept that refers to a collection of fact and dimension tables ISO/TS 29585:2010(E)
starting material type of material that is modified through a manufacturing process ISO 11238:2012(E)
state 〈of a process〉condition or situation during the lifecycle of an object during which it satisfies some condition,

performs some activity or waits for some event

[ISO/TS 18308:2004, definition 3.39]

ISO 13606 -1:2008(E)
state of a processcondition or situation during the lifecycle of an object during which it satisfies some condition,

performs some activity or waits for some event

[ISO/TS 18308:2004, definition 3.39]

ISO 13606-5:2010(E)
state A named condition of a class instance ( object) that can be tested by examination of the instance’s attributes

and associations.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
state (of a process) condition or situation during the lifecycle of an object during which it satisfies some condition, performs some

activity or waits for some event

[ISO/TS 18308:2004, definition 3.39]

ISO 13606-3:2009(E)
state (of a process) a condition or situation during the life of an object during which it satisfies some condition, performs some

activity, or waits for some event

ISO/TS 18308:2004(E)
state attribute An attribute describing the current state of an object. ISO 21731:2006(E) & ANSI/HL7 RIM R1
state diagram A graphical representation of a state transition model showing states as vertices (nodes) and state transitions

as directed arcs (arrows) between the nodes.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
state machine A description of the life cycle for instances of a class, defined by a state transition model. ISO 21731:2006(E) & ANSI/HL7 RIM R1
state of matter physical condition describing the molecular form of a product EXAMPLES Gas, liquid, semi-solid, solid. NOTE State of matter is used to group basic dose forms according to their physical properties. ISO 11239:2012(E)
state transition A change in the state of an object, as a result of a change in its attributes or associations. ISO 21731:2006(E) & ANSI/HL7 RIM R1
state transition model A graphical representation of the life cycle of a class. The model depicts all of the relevant states of a class,

and the valid transitions from state to state.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
state-TM series of abstract or physical actions over time or condition in certain time in body according to TM-CJK

Note 1 to entry: While <body system-TM> (3.3.1.1) has an explanatory framework for human body and health

problems, many individual findings also can be related to <state-TM> (3.3.3). It includes functional aspects like

<body state-TM> (3.3.3.1) among entities of <body system-TM> (3.3.1.1) and also <pathological process-TM>

(3.3.3.3) impairing the normal <body function-TM> (3.3.3.2) in TM-CJK.

ISO/TS 16277-1:2015(E)
static attribute An attribute value that does not change (its value remains fixed) during the life of an

association. The value is sent in the configuration event report. The value remains in effect until the system

exits the associated state.

NOTE—Do not confuse the use of static in this document with static as used in the C programming language.8

ISO/IEEE 11073-20601:2016(E)
stereochemistry relative spatial arrangement of atoms within molecules ISO 11238:2012(E)
stoichiometric substances that contain moieties in simple integral ratios ISO 11238:2012(E)
storage function of storing records for future retrieval and use ISO/TS 22220:2011(E)
storage function of storing records for future retrieval and use

[ISO/TS 22220:2009, definition 3.7]

ISO/TS 27527:2010(E)
strength content of the substance(s) or specified substance(s), expressed quantitatively per dosage unit, unit of presentation, per unit of volume or mass, according to the dose form

NOTE See also quantitative composition (3.1.69).

ISO 11615:2012(E)
strength quantitative composition amount of substance or specified substance expressed quantitatively per dosage unit, per unit of mass or volume, according to the dosage form

NOTE 1 It is necessary for the quantitative composition of the substance(s)/specified substance descriptions of the finished authorized/investigational medicinal products, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage unit or per unit of mass or volume, of each substance/specified substance.

NOTE 2 Substances/specified substance descriptions present in the form of compounds or derivatives are always designated quantitatively by their total mass and, if necessary or relevant, by the mass of active entity, or entities, of the molecule.

ISO 11616:2012(E)
strength

quantitative composition

amount of substance or specified substance expressed quantitatively per dosage unit, per unit of mass or volume, according to the dosage form

Note 1 to entry: It is necessary for the quantitative composition of the substance(s)/specified substance descriptions of the finished authorized/investigational medicinal products, depending on the pharmaceutical form concerned, to specify the mass, or the number of units of biological activity, either per dosage unit or per unit of mass or volume, of each substance/specified substance.

Note 2 to entry: Substances/specified substance descriptions present in the form of compounds or derivatives are always designated quantitatively by their total mass and, if necessary or relevant, by the mass of active entity, or entities, of the molecule.

[SOURCE: ISO 11616:2012, 3.1.29]

ISO/TS 19256:2016(E)
string character set character set used in all string content throughout this International Standard ISO 21090:2011(E)
strong authentication authentication by means of cryptographically derived credentials ISO/TS 22600-1:2006(E)
strong authentication authentication by means of cryptographically derived credentials ISO/TS 22600-3:2009(E)
structural role structural roles specify relations between entities in the sense of competence (RIM roles), often reflecting

organizational or structural relations (hierarchies)

[ISO/TS 21298:2008]

NOTE See also functional role (3.61).

ISO/TS 22600-3:2009(E)
structurally diverse substance type of polydisperse substance isolated from a single source that is a complex mixture which cannot be described as a mixture of a limited number of single substances ISO 11238:2012(E)
structure information information that imports knowledge about how other information is organized ISO/TS 21547:2010(E)
subclass A class that is the specialization of another class (superclass). ISO 21731:2006(E) & ANSI/HL7 RIM R1
subject entity whose public key is certified in the certificate ISO 21091:2013(E)
subject area A convenient aggregation of model classes used to partition large models into manageable subsets. ISO 21731:2006(E) & ANSI/HL7 RIM R1
subject field domain field of special knowledge [ISO 1087-1:2000, definition 3.1.2] NOTE The borderlines of a subject field are defined from a purpose-related point of view ISO 1828:2012(E)
subject of care person scheduled to receive, receiving, or having received healthcare ISO 13606 -1:2008(E)
subject of care person scheduled to receive, receiving or having received health care

NOTE Adapted from EN 14822-2:2005.

ISO 13606-2:2008(E)
subject of care

patient

person scheduled to receive, receiving, or having received health care ISO 13606-3:2009(E)
subject of care person scheduled to receive, receiving or having received healthcare ISO 13606-5:2010(E)
subject of care person scheduled to receive, receiving, or having received healthcare ISO 21091:2013(E)
subject of care person or defined groups of persons receiving or registered as eligible to receive healthcare services or

having received healthcare services

EXAMPLE Patient.

[ENV 12443:1996]

ISO 21549-7:2007(E)
subject of care person scheduled to receive, receiving or having received a health service ISO 27789:2013(E)
subject of care person seeking to receive, receiving, or having received healthcare ISO/TR 17791:2013(E)
subject of care one or more persons scheduled to receive, receiving or having received a health service

[ISO/TS 18308[3]]

NOTE 1 The terms “patient” and “client” are synonymous with subject of care in a health record context and are

commonly used instead of the more formal term “subject of care”.

NOTE 2 The term “consumer” is also often used as a synonym in this context. However, it is of note that a consumer

may not necessarily be a subject of care since it can be argued that it is possible for a consumer to have a health record

without ever having received a health care service.

ISO/TR 20514:2005(E)
subject of care person seeking to receive, receiving or having received healthcare

NOTE Adapted from EN 14822-2:2005.

ISO/TS 13606-4:2009(E)
subject of care

patient

one or more persons scheduled to receive, receiving, or having received a health service

Note 1 to entry: Adapted from ISO 18308:2011, definition 3.47.

ISO/TS 14441:2013(E)
subject of care person or defined groups of persons receiving or registered as eligible to receive healthcare services

(3.14) or having received healthcare services

[SOURCE: ENV 12443:1996]

ISO/TS 17975:2015(E)
subject of care one or more persons scheduled to receive, receiving, or having received a healthcare service ISO/TS 18308:2004(E)
subject of care any person who uses, or is a potential user of, a health care service

[SOURCE: ISO/TS 22220:2011, 3.2]

ISO/TS 20428:2017(E)
subject of care

SOC

subject of health care

any person who uses, or is a potential user of, a health care service

NOTE Subjects of care may also be referred to as patients, health care consumers or subjects of care.

ISO/TS 22220:2011(E)
subject of care one or more persons scheduled to receive, receiving, or having received a healthcare service ISO/TS 27790:2009(E)
subject of care identifier

SCI

unique number or code issued for the purpose of identifying a subject of (health) care ISO/TS 22220:2011(E)
subject of care identifier

healthcare identifier

identifier of a person for exclusive use by a healthcare system ISO/TS 25237:2008(E)
substance any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical ISO 11238:2012(E)
substance any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical

NOTE 1 substances can be either single substances, mixture substances or one of a group of specified substances. Single substances are defined using a minimally sufficient set of data elements divided into five types: chemical, protein, nucleic acid, polymer and structurally diverse. substances may be salts, solvates, free acids, free bases, mixtures of related compounds that are either isolated or synthesized together. Pharmacopoeial terminology and defining characteristics will be used when available and appropriate. Defining elements are dependent on the type of substance.

NOTE 2 Discrete existence refers to the ability of a substance to exist independently of any other substance. substances can either be well-defined entities containing definite chemical structures, synthetic (i.e. isomeric mixtures) or naturallyoccurring (i.e. conjugated oestrogens) mixtures of chemicals containing definite molecular structures, or materials derived from plants, animals, microorganisms or inorganic matrices for which the chemical structure may be unknown or difficult to define. substances may be salts, solvates, free acids, free bases, mixtures of related compounds that are either isolated or synthesized together.

ISO 11615:2012(E)
substance matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical

NOTE 1 Substances may be either single substances or mixture substances.

NOTE 2 Single substances are always defined using a minimally sufficient set of data elements divided into five types: chemical, protein, nucleic acid, polymer and structurally diverse. Substances may be salts, solvates, free acids, free bases, or mixtures of related compounds that are either isolated or synthesized together.

NOTE 3 Pharmacopeial terminology and defining characteristics are used when available and appropriate. Defining elements are dependent on the type of substance.

NOTE 4 Discrete existence refers to the ability of a substance to exist independently of any other substance. Substances may either be well-defined entities containing definite chemical structures, synthetic (i.e. isomeric mixtures) or naturallyoccurring (i.e. conjugated oestrogens) mixtures of chemicals containing definite molecular structures, or materials derived from plants, animals, microorganisms or inorganic matrices for which the chemical structure may be unknown or difficult to define.

ISO 11616:2012(E)
substance any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical

Note 1 to entry: Substances can be single substances, mixture substances or one of a group of specified substances. Single substances are defined using a minimally sufficient set of data elements divided into five types: chemical, protein, nucleic acid, polymer and structurally diverse. Substances may be salts, solvates, free acids, free bases or mixtures of related compounds that are either isolated or synthesized together. Pharmacopeial terminology and defining characteristics will be used when available and appropriate. Defining elements are dependent on the type of substance.

Note 2 to entry: Discrete existence refers to the ability of a substance to exist independently of any other substance. Substances can either be well-defined entities containing definite chemical structures, synthetic (i.e. isomeric mixtures) or naturally occurring (i.e. conjugated oestrogens) mixtures of chemicals containing definite molecular structures, or materials derived from plants, animals, microorganisms or inorganic matrices for which the chemical structure may be unknown or difficult to define. Substances may be salts, solvates, free acids, free bases and mixtures of related compounds that are either isolated or synthesized together.

[SOURCE: ISO 11238:2012, 2.1.58]

ISO/TS 19256:2016(E)
substance-TM continuous abstract or physical entity (3.1.8) that has no inherent shape according to TM-CJK ISO/TS 16277-1:2015(E)
sub-state An identifiable state of a class that has a more specific definition than, and is entirely encompassed within

the scope of, its super-state.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
substituent molecular fragment attached to a structural repeat unit of a polymer that typically replaces a hydrogen atom ISO 11238:2012(E)
Summary of Product Characteristics SMPC product labelling Medicinal Product information as authorized by a Medicines Regulatory Agency in a jurisdiction

NOTE 1 The product labelling content may not be changed except with the approval of the originating Medicines Regulatory Agency. The Summary of Product Characteristics is the basis of information for health professionals on how to use the Medicinal Product safely and effectively.

NOTE 2 Summary of Product Characteristics and product labelling are synonymous.

ISO 11615:2012(E)
superclass A class that is the generalization of one or more other classes (subclasses). ISO 21731:2006(E) & ANSI/HL7 RIM R1
super-state A state of a class that encompasses two or more independent sub-states. ISO 21731:2006(E) & ANSI/HL7 RIM R1
supporting organization officially registered organization which is providing services to a healthcare organization, but which is not providing

healthcare services

EXAMPLES Healthcare financing bodies such as insurance institutions, suppliers of pharmaceuticals and other goods.

ISO/TS 17090-1:2002(E)
supporting organization employee person employed by a supporting organization

EXAMPLES Medical records transcriptionists, healthcare insurance claims adjudicators and pharmaceutical order entry

clerks.

ISO/TS 17090-1:2002(E)
surgical deed deed which can be done by a medical practitioner to the patient’s body during the surgical procedure EXAMPLES Excising, destroying, dividing, puncturing.

NOTE 1 For the purposes of this International Standard, the surgical deed shall be described without reference to any specific human anatomy (3.8.2) or interventional equipment (3.8.4). NOTE 2 Surgical deed terms are presented by the neutral inflection of a verb as a present participle (e.g. removing). NOTE 3 Surgical deed categories do not include reason and outcome (e.g revascularization). NOTE 4 A surgical deed is part of a surgical procedure; major surgery is composed of a series of surgical deeds. A surgical deed in case of minor surgery can be considered itself as the essential component of a surgical procedure.

ISO 1828:2012(E)
symbol visually perceptible or machine-readable concept representation, used to transmit information independently of language ISO 11240:2012(E)
synchronized multimedia integration language

SMIL

enables simple authoring of interactive audiovisual presentations

NOTE SMIL is typically used for rich media/multimedia presentations, which integrate streaming audio and video with

images, text or any other media type.

ISO TR 16056-1:2004(E)
synchronized multimedia integration language

SMIL

enables simple authoring of interactive audiovisual presentations

NOTE SMIL is typically used for rich media/multimedia presentations, which integrate streaming audio and video with

images, text or any other media type.

ISO TR 16056-2:2004(E)
synchronous transmission data communications in which transmissions are sent at a fixed rate, with the sending and receiving devices

synchronized

ISO TR 16056-1:2004(E)
synchronous transmission data communications in which transmissions are sent at a fixed rate, with the sending and receiving devices

synchronized

ISO TR 16056-2:2004(E)
synonym alternate symbol or name for the same concept within a given language ISO 11240:2012(E)
synonym one or more words of the same language that have the same meaning in some or all senses

Note 1 to entry: A synonym replaces a word in a sentence and is of similar size to that word. It does not necessarily

explain the meaning intended. A synonym is not a shortened form of the original word, such as an abbreviation.

Note 2 to entry: Taken from Webster’s Dictionary, modified.

ISO/TS 17439:2014(E)
synonymy relation between or among terms in a given language representing the same concept

[SOURCE: ISO 1087‑1:2000]

Note 1 to entry: Appendicectomy and appendectomy.

Note 2 to entry: Terms which are interchangeable in all contexts are called synonyms; if they are interchangeable

only in some contexts, they are called quasi-synonyms.

ISO/TS 17439:2014(E)
syntax structure of expressions in a language, and the rules governing the structure of the language; the relationships

among characters or groups of characters, independent of their meanings or the manner of their interpretation

and use

ISO 21549-7:2007(E)
syntax (i.e., of an interchange format) The rules for combining the construction elements of the interchange

format.

ISO/IEEE 11073-10201:2004(E)
System an aggregation of end products and enabling products to achieve a given purpose ISO TS 16058:2004(E)
system The demarcated part of the perceivable universe, existing in time and space, that may be

regarded as a set of elements and relationships between these elements.

ISO/IEEE 11073-10201:2004(E)
system demarcated part of the perceivable universe, existing in time and space, that may be regarded as a set of

elements and relationships between these elements

ISO/TS 27790:2009(E)
system integrity property that a system performs its intended function in an unimpaired manner, free from deliberate or

accidental unauthorized manipulation of the system

ISO/TR 11633-1:2009(E)
system integrity property that a system performs its intended function in an unimpaired manner, free from deliberate or

accidental unauthorized manipulation of the system

ISO/TR 11633-2:2009(E)
system integrity property that a system performs its intended function in an unimpaired manner, free from deliberate or

accidental unauthorized manipulation of the system

[SOURCE: ISO 27799:2008, definition 3.2.14]

ISO/TS 14441:2013(E)
system of quantities set of quantities together with a set of non-contradictory equations relating those quantities NOTE Adapted from ISO/IEC Guide 99. ISO 11240:2012(E)
system of units set of base units and derived units, together with their multiples and submultiples, defined in accordance with given rules, for a given system of quantities [ISO/IEC Guide 99:2007, definition 1.13] ISO 11240:2012(E)
systematic name An organization of differentiating, relational descriptors that are unique for each term. ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
systolic pressure This maximum value of the arterial blood pressure as a result of the contraction

of the left ventricle. It is typically the first and the higher of the readings given as the blood pressure.

ISO/IEEE 11073-10407:2010(E)
T.120 family of ITU-T standards, ratified in 1996, that defines collaborative document sharing and whiteboard activities

NOTE The T.120 standards provide the audiographic portion of the H.320, H.323 and H.324 families. They also work

independently as an audiographic conference for a low-bandwidth channel. The whiteboard capability provides documentsharing

functions for multiple users so that they can simultaneously view and annotate a document with pens, highlighters and

drawing tools. This specification also allows data-only T.120 sessions when no video communications are required or provided.

In addition, T. 120 supports multipoint meetings in which the participants use different transmission media.

ISO TR 16056-1:2004(E)
T.120 family of ITU-T standards, ratified in 1996, that defines collaborative document sharing and whiteboard activities

NOTE The T.120 standards provide the audiographic portion of the H.320, H.323 and H.324 families. They also work

independently as an audiographic conference for a low-bandwidth channel. The whiteboard capability provides documentsharing

functions for multiple users so that they can simultaneously view and annotate a document with pens, highlighters and

drawing tools. This specification also allows data-only T.120 sessions when no video communications are required or provided.

In addition, T. 120 supports multipoint meetings in which the participants use different transmission media.

ISO TR 16056-2:2004(E)
T.121 ITU-T standard that provides a generic application template (GAT), which specifies a common set of guidelines for

building application protocols and the management facility that controls the resources used by the application

NOTE T.121 also describes how an application protocol, such as T.127 for file transfer, performs the following functions:

–  Registers itself with the conference.

–  Applies its capabilities locally and remotely.

–  Interoperates and negotiates capabilities with other applications.

To ensure application consistency, T.121 is a required standard for products developed under T.120. The ITU also recommends

that non-standard applications incorporate T.121 to provide product interoperability.

ISO TR 16056-1:2004(E)
T.121 ITU-T standard that provides a generic application template (GAT), which specifies a common set of guidelines for

building application protocols and the management facility that controls the resources used by the application

NOTE T.121 also describes how an application protocol, such as T.127 for file transfer, performs the following functions:

–  Registers itself with the conference.

–  Applies its capabilities locally and remotely.

–  Interoperates and negotiates capabilities with other applications.

To ensure application consistency, T.121 is a required standard for products developed under T.120. The ITU also recommends

that non-standard applications incorporate T.121 to provide product interoperability.

ISO TR 16056-2:2004(E)
T.122 ITU-T standard that defines the multipoint services, which allow one or more participants to send data as part of a

conference

NOTE These multipoint services are implemented by T.125, which provides the mechanism for transporting the data.

Together, the T.122 and T.125 standards make up the T.120 multipoint communication services (MCS).

ISO TR 16056-1:2004(E)
T.122 ITU-T standard that defines the multipoint services, which allow one or more participants to send data as part of a

conference

NOTE These multipoint services are implemented by T.125, which provides the mechanism for transporting the data.

Together, the T.122 and T.125 standards make up the T.120 multipoint communication services (MCS).

ISO TR 16056-2:2004(E)
T.123 ITU-T standard that defines the transport and sequencing of data, and for controlling the flow of data across

networks, including connect, disconnect, send, and receive functions

NOTE For data transport, T.123 defines a series of network interface profiles. Also, T.123 provides an error-correcting

mechanism that ensures accurate and reliable data delivery. T.123 Annex B, an addition to the T.123 data conferencing

standard, also defines the protocol for secure data conferencing.

ISO TR 16056-1:2004(E)
T.123 ITU-T standard that defines the transport and sequencing of data, and for controlling the flow of data across

networks, including connect, disconnect, send, and receive functions

NOTE For data transport, T.123 defines a series of network interface profiles. Also, T.123 provides an error-correcting

mechanism that ensures accurate and reliable data delivery. T.123 Annex B, an addition to the T.123 data conferencing

standard, also defines the protocol for secure data conferencing.

ISO TR 16056-2:2004(E)
T.124 ITU-T standard that provides the generic conference control (GCC) for initiating and administering multipoint data

conferences.

NOTE The GCC performs the following functions:

–  Serves as the information centre, directing users and data in and out of conferences and monitoring progress so that the

latest conference information is always available,

–  Maintains lists of conference participants and their applications; the GCC identifies compatible applications and features so

that products can interoperate, and

–  Tracks MCS resources so that conflicts do not occur when conference participants use multiple application protocols, such

as T.127 for file transfer and T.128 for application sharing.

ISO TR 16056-1:2004(E)
T.124 ITU-T standard that provides the generic conference control (GCC) for initiating and administering multipoint data

conferences.

NOTE The GCC performs the following functions:

–  Serves as the information centre, directing users and data in and out of conferences and monitoring progress so that the

latest conference information is always available,

–  Maintains lists of conference participant

–  Tracks MCS resources so that conflicts do not occur when conference participants use multiple application protocols, such

as T.127 for file transfer and T.128 for application sharing.

ISO TR 16056-2:2004(E)
T.125 ITU-T standard that specifies how data is transmitted within a conference

NOTE T.125 defines the private and broadcast channels that transport the data, and ensures accurate and efficient

communication among multiple users. T.125 also implements the multipoint services defined by T.122.

ISO TR 16056-1:2004(E)
T.125 ITU-T standard that specifies how data is transmitted within a conference

NOTE T.125 defines the private and broadcast channels that transport the data, and ensures accurate and efficient

communication among multiple users. T.125 also implements the multipoint services defined by T.122.

ISO TR 16056-2:2004(E)
T.126 ITU-T standard that specifies how an application sends and receives whiteboard information, in either compressed

or uncompressed form, for viewing and updating among multiple conference participants

NOTE The role of T.126 is to manage the multi-user workspace provided by the whiteboard.

ISO TR 16056-1:2004(E)
T.126 ITU-T standard that specifies how an application sends and receives whiteboard information, in either compressed

or uncompressed form, for viewing and updating among multiple conference participants

NOTE The role of T.126 is to manage the multi-user workspace provided by the whiteboard.

ISO TR 16056-2:2004(E)
T.127 ITU-T standard that defines how files are transferred simultaneously among conference participants

NOTE T.127 (also known as T.MBTF for Multipoint binary file transfer) enables one or more files to be selected and

transmitted in compressed or uncompressed form to all or selected participants during a conference.

ISO TR 16056-1:2004(E)
T.127 ITU-T standard that defines how files are transferred simultaneously among conference participants

NOTE T.127 (also known as T.MBTF for Multipoint binary file transfer) enables one or more files to be selected and

transmitted in compressed or uncompressed form to all or selected participants during a conference.

ISO TR 16056-2:2004(E)
T.128 ITU-T standard that specifies the program sharing protocol, defining how participants in a T.120 conference can

share local programs. Specifically, T.128 enables multiple conference participants to view and collaborate on

shared programs.

ISO TR 16056-1:2004(E)
T.128 ITU-T standard that specifies the program sharing protocol, defining how participants in a T.120 conference can

share local programs. Specifically, T.128 enables multiple conference participants to view and collaborate on

shared programs.

ISO TR 16056-2:2004(E)
T.134 protocol that provides point-to-point and multipoint distribution of text messages within the T.120 conference

NOTE It provides real-time or near-real-time text communications for those applications where audio communication is not

available.

ISO TR 16056-1:2004(E)
T.134 protocol that provides point-to-point and multipoint distribution of text messages within the T.120 conference

NOTE It provides real-time or near-real-time text communications for those applications where audio communication is not

available.

ISO TR 16056-2:2004(E)
T.135 protocol that allows a user to reserve and control multipoint conference resources

NOTE It defines conferencing reservation protocols in a T.120 environment, typically between a client application and a

scheduling system which reserves resources for multipoint control units (MCUs) or bridges.

ISO TR 16056-1:2004(E)
T.135 protocol that allows a user to reserve and control multipoint conference resources

NOTE It defines conferencing reservation protocols in a T.120 environment, typically between a client application and a

scheduling system which reserves resources for multipoint control units (MCUs) or bridges.

ISO TR 16056-2:2004(E)
T.136 protocol that specifies how Remote Device Control and configuration may be performed using T.120 as the

transport protocol

ISO TR 16056-1:2004(E)
T.136 protocol that specifies how Remote Device Control and configuration may be performed using T.120 as the

transport protocol

ISO TR 16056-2:2004(E)
T.140 protocol for multimedia application text conversation

NOTE The protocol for text chat within T.120, goes with T.134.

ISO TR 16056-1:2004(E)
T.140 protocol for multimedia application text conversation

NOTE The protocol for text chat within T.120, goes with T.134.

ISO TR 16056-2:2004(E)
T.AVC protocol that describes the control of audio and video capabilities present in a desktop or videoconference

NOTE This standard extends the capabilities offered by H.320.

ISO TR 16056-1:2004(E)
T.AVC protocol that describes the control of audio and video capabilities present in a desktop or videoconference

NOTE This standard extends the capabilities offered by H.320.

ISO TR 16056-2:2004(E)
T.RDC recommendation that provides control of remote audio and video devices during a conference

NOTE A relatively new recommendation, T.RDC is an extension of H.281 for far-end camera control.

ISO TR 16056-1:2004(E)
T.RDC recommendation that provides control of remote audio and video devices during a conference

NOTE A relatively new recommendation, T.RDC is an extension of H.281 for far-end camera control.

ISO TR 16056-2:2004(E)
tag identifier code for a semantic concept ISO/TS 22077-2:2015(E)
target resource being accessed ISO/TS 13606-4:2009(E)
target resource being accessed by a claimant ISO/TS 22600-1:2006(E)
target resource being accessed by a claimant

NOTE Its sensitivity is modelled in this document as a collection of attributes, represented as either ASN.1 attributes

or XML elements.

ISO/TS 22600-2:2006(E)
target resource being accessed by a claimant

NOTE Its sensitivity is modelled in this part of ISO/TS 22600 as a collection of attributes, represented as either

ASN.1 attributes or XML elements.

ISO/TS 22600-3:2009(E)
target capture method to capture genomic regions of interest from a DNA sample prior to sequencing ISO/TS 20428:2017(E)
target of evaluation

TOE

set of software, firmware and/or hardware possibly accompanied by guidance

[SOURCE: ISO/IEC 15408‑1:2009, definition 3.1.72]

ISO/TS 14441:2013(E)
target population type of patients or consumers for which the indication of a Medicinal Product is authorized ISO 11615:2012(E)
tautomer molecular structure capable of interconversion with an isomeric molecular structure that typically involves facile migration of a hydrogen atom between two adjacent atoms ISO 11238:2012(E)
taxonomy scientific organism classification system needed to describe the origin of source material in substances isolated from biological matrices ISO 11238:2012(E)
telehealth use of telecommunication techniques for the purpose of providing telemedicine, medical education, and health

education over a distance

NOTE See GATES 1994.

ISO TR 16056-1:2004(E)
telehealth use of telecommunication techniques for the purpose of providing telemedicine, medical education, and health

education over a distance

NOTE See GATES 1994.

ISO TR 16056-2:2004(E)
Telehealth the use of telecommunication techniques for the purpose of providing telemedicine, medical education, and health education over a distance ISO TS 16058:2004(E)
telemedicine use of advanced telecommunication technologies to exchange health information and provide health care services

across geographic, time, social and cultural barriers

NOTE See Reid 1996.

ISO TR 16056-1:2004(E)
telemedicine use of advanced telecommunication technologies to exchange health information and provide health care services

across geographic, time, social and cultural barriers

NOTE See Reid 1996.

ISO TR 16056-2:2004(E)
Telemedicine use of advanced telecommunication technologies to exchange health information and provide health care services across geographic, time, social and cultural barriers ISO TS 16058:2004(E)
template and which will often correspond to a whole form or screen

[Beale:2003[11]]

NOTE Templates in general have a one-to-many relationship with underlying concepts, each of which is described by

an archetype.

ISO/TR 20514:2005(E)
template expression of a set of constraints on the RIM/RM or derived model used to apply additional constraints

to a portion of an instance of data which is expressed in terms of some other Static Model, to further

define and refine these existing models to specify a narrower and more focused scope

[SOURCE: HL7 V3 Templates. HL7 Version 3 Standard: Specification and Use of Reusable Constraint

Templates, Release 2 February 2008]

ISO/TS 13972:2015(E)
term designation of a defined concept in a special language by a linguistic expression

[SOURCE: ISO 1087‑1:2000]

ISO/TS 13972:2015(E)
term word or words corresponding to one or more concepts ISO/TS 17117:2002(E)
term designation of a defined concept in a special language by a linguistic expression

[SOURCE: ISO 1087‑1:2000, 3.4.3, modified]

ISO/TS 19256:2016(E)
term and definition harmonization activity leading to the establishment of a correspondence between two or more closely related or

overlapping concepts

Note 1 to entry: The purpose of concept harmonization is to improve communication. Concept harmonization

occurs where a term has professional, technical, scientific, social, economic, linguistic, cultural, or other

differences, in order to eliminate or reduce minor differences between them. (See ISO 860:2007.)

ISO/TS 17439:2014(E)
term entry linguistic representation of a concept being defined in the glossary

Note 1 to entry: In this Technical Specification, the word “term” is used to indicate term entry.

Note 2 to entry: A term can contain symbols and have variants, e.g. different forms of spelling.

ISO/TS 17439:2014(E)
term family group of defined terms that are related in that each assists in the definition of other members of the

group

EXAMPLE Health record, healthcare record, electronic health record. The health record could be considered

the least specific, healthcare records relate not to health in any context, but to the care provided in relation to

health and could be considered a synonym of medical record, while electronic health record implies a format

or functionality of the health record. Once health record is defined, it is easier to define healthcare record and

electronic health record, as it is not necessary to define the base from which the definition begins.

Note 1 to entry: Guidance is provided later in this Technical Specification on what terms are appropriate to a

family. It is acknowledged that further testing of this process will be required through the implementation of this

Technical Specification.

ISO/TS 17439:2014(E)
TermID controlled vocabulary term identifier concept identifier intended to be used as the preferred unique identifier for that concept in that code system and which is published by the author of a code system NOTE 1 The TermID remains constant over time, independent of the particular version of the knowledge resource. NOTE 2 Adapted from HL7 Core Principles. ISO 11616:2012(E)
terminal endpoint system, which provides for real-time, two-way communications with another terminal, gateway, or MCU

NOTE A terminal must provide audio and may also provide video and/or data.

ISO TR 16056-1:2004(E)
terminal endpoint system, which provides for real-time, two-way communications with another terminal, gateway, or MCU

NOTE A terminal must provide audio and may also provide video and/or data.

ISO TR 16056-2:2004(E)
terminological system ordered collection of concepts, in which each concept is expressed by terms, words or expressions

[SOURCE: NEN 7522, based on ISO/IEC 11179‑1:2004, definition 3.2.25]

ISO/TS 13972:2015(E)
terminological system structured human and machine-readable representation of concepts (3.1) required directly or indirectly

to describe certain domain and allow their subsequent retrieval or analysis

Note 1 to entry: Also the relationship of the terminology to the specifications for organizing, communicating, and

interpreting such a set of concepts.

[SOURCE: ISO 18104:2014, 4.9]

ISO/TS 18790-1:2015(E)
terminological system ordered collection of concepts, in which each concept is expressed by terms, words or expressions

[SOURCE: ISO/IEC 11179‑1:2015, 3.2.25, modified]

ISO/TS 19256:2016(E)
Terminology any organized set of codes, including the entities commonly referred to as “code sets”, “ontologies”, “vocabularies”, “classification systems”, etc.  [Article 2e; European Directive 2001/20/EC] ISO/HL7 27951:2009(E)
Terminology any organized set of codes, including the entities commonly referred to as “code sets”, “ontologies”, “vocabularies”, “classification systems”, etc. ISO/HL7 27951:2009(E)
terminology A synonym for nomenclature. ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
terminology set of terms representing a system of concepts within a specified domain

NOTE This implies a published purpose and scope from which one can determine the degree to which this representation

adequately covers the domain specified.

ISO/TS 17117:2002(E)
Test determination of a single analyte or a combination of values from other determinations or observations that constitute a measure of a single system attribute ISO 18812:2003(E)
testing determination of one or more characteristics of an object of conformity assessment, according to a

procedure

Note 1 to entry: “Testing” typically applies to materials, products or processes.

[SOURCE: ISO/IEC 17000:2004, definition 4.2]

ISO/TS 14441:2013(E)
testing of conformity determination of whether one or more characteristics of an object of conformity assessment fulfils specified

requirements, according to a procedure

NOTE .Testing. typically applies to materials, products or processes. The primary output of conformity testing is a test

report, which includes the specified requirements, the actual results of testing, and the conformity status (i.e., whether or not the

given product passed the test).

ISO TR 16056-1:2004(E)
testing of conformity determination of whether one or more characteristics of an object of conformity assessment fulfils specified

requirements, according to a procedure

NOTE .Testing. typically applies to materials, products or processes. The primary output of conformity testing is a test

report, which includes the specified requirements, the actual results of testing, and the conformity status (i.e., whether or not the

given product passed the test).

ISO TR 16056-2:2004(E)
testing of conformity determination of whether one or more characteristics of an object of conformity assessment fulfils specified requirements, according to a procedure ISO TS 16058:2004(E)
therapeutic indication intended use of the Medicinal Product as authorized by the Medicines Regulatory Agency in a jurisdiction NOTE For clinical trials, this refers to the intended use under investigation and as described in the clinical trial protocol. ISO 11615:2012(E)
therapeutic precautions a list of precautions relevant to a particular subject of care which includes allergies, adverse reactions, patient

preferences and prohibitions

ISO/TS 18308:2004(E)
third party party other than data originator, or data recipient, required to perform a security function as part of a

communication protocol

ISO 21091:2013(E)
third party party, other than data originator or data recipient, required to perform a security function as part of a

communication protocol

ISO/TS 17090-1:2002(E)
third party party other than the data originator, or data recipient, required to perform a security function as part of a

communication protocol

ISO/TS 22600-3:2009(E)
third-party conformity assessment activity conformity assessment activity that is performed by a person or body that is independent of the person

or organization that provides the object, and of user interests in that object

Note 1 to entry: Criteria for the independence of conformity assessment bodies and accreditation bodies are

provided in the International Standards and Guides applicable to their activities (see Bibliography).

[SOURCE: ISO/IEC 17000:2004, definition 2.4]

ISO/TS 14441:2013(E)
threat potential cause of an unwanted incident, which may result in harm to a system or organization

NOTE Adapted from ISO/IEC 13335-1.

ISO/TR 11633-1:2009(E)
threat potential cause of an unwanted incident, which may result in harm to a system or organization

NOTE Adapted from ISO/IEC 13335-1.

ISO/TR 11633-2:2009(E)
threat potential cause of an unwanted incident, which may result in harm to a system or organization

[SOURCE: ISO/IEC 27000:2012, definition 2.77]

ISO/TS 14441:2013(E)
time zero In the context of this document, time zero is the instant at which a user starts blowing into the

peak-flow monitor to record a measurement.

ISO/IEEE 11073-10421:2012(E)
timestamp An attribute or field in data that denotes the time of data generation. ISO/IEEE 11073-10201:2004(E)
timestamp attribute or field in data which denotes the time of data generation ISO/TS 27790:2009(E)
Tiny Transport Protocol (TinyTP) The transport protocol specified by Infrared Data Association

(IrDA) that provides multiple, concurrent, reliable, bidirectional communication streams on an IrDA link

with robust flow control.

ISO/IEEE 11073-30300:2004(E)
tolerable risk risk which is accepted in a given context based on the current values of society

[IEC 61508-4:1998]

ISO/TS 25238:2007(E)
top object The ultimate base class for all other objects belonging to one model. ISO/IEEE 11073-10201:2004(E)
top-down method or procedure that starts at the highest level of abstraction and proceeds towards the lowest level

[ENV 12443:1996]

ISO/TR 17119:2005(E)
traceability metrological traceability property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty

NOTE 1 For this definition, a “reference” can be a definition of a measurement unit through its practical realization, or a measurement procedure, or a measurement standard

NOTE 2 Metrological traceability requires an established calibration hierarchy.

NOTE 3 The expression “traceability to the SI” means “metrological traceability to a measurement unit of the International System of Units”.

NOTE 4 Adapted from ISO/IEC Guide 99.

ISO 11240:2012(E)
traceability ability to track forward the movement through specified stage(s) of the extended supply chain and trace

backward the history, application, or location of that which is under consideration

[SOURCE: Global Traceability Standard for Healthcare, GS1, 2009]

ISO/TS 16791:2014(E)
trademark distinctive sign or indicator used by an individual, business organization or other legal entity to identify that the associated products or services to consumers originate from a unique source, and to distinguish those products or services from those of other entities ISO 11615:2012(E)
transfer syntax Specification of the structure of data as they are communicated across a transport or

physical medium.

ISO/IEEE 11073-20101:2004(E)
transformation procedure that is carried out in order to convert a manufactured item that requires such a procedure into a pharmaceutical product, i.e. from its manufactured dose form to its administrable dose form

EXAMPLES Dilution, dissolution, suspension.

NOTE A transformation is not required when the manufactured item is equal to the pharmaceutical product.

ISO 11239:2012(E)
translation alternate rendition of the same content translated into a different language or orthography ISO 11240:2012(E)
Transmission Control Protocol/Internet Protocol (TCP/IP) A transport protocol that provides

reliable, bidirectional, stream-oriented network communication. TCP/IP is one of the foundation protocols

of the Internet.

ISO/IEEE 11073-30300:2004(E)
transport control protocol/internet protocol

TCP/IP

de facto standard ethernet protocols incorporated into 4.2BSD Unix

NOTE TCP/IP was developed by DARPA for internetworking and encompasses both network layer and transport layer

protocols. While TCP and IP specify two protocols at specific protocol layers, TCP/IP is often used to refer to the entire DoD

protocol suite based upon these, including telnet, FTP, UDP and RDP.

ISO TR 16056-1:2004(E)
transport control protocol/internet protocol

TCP/IP

de facto standard ethernet protocols incorporated into 4.2BSD Unix

NOTE TCP/IP was developed by DARPA for internetworking and encompasses both network layer and transport layer

protocols. While TCP and IP specify two protocols at specific protocol layers, TCP/IP is often used to refer to the entire DoD

protocol suite based upon these, including telnet, FTP, UDP and RDP.

ISO TR 16056-2:2004(E)
trigger event action or event causing a message to be sent ISO 18812:2003(E)
trust quality by which an entity can be said to “trust” a second entity when it (the first entity) makes the assumption

that the second entity will behave exactly as the first entity expects

NOTE This trust may apply only for some specific function. The key role of trust in this framework is to describe the

relationship between an authenticating entity and an authority; an entity should be certain that it can trust the authority to

create only valid and reliable certificates.

ISO/TS 22600-2:2006(E)
trust an entity can be said to “trust” a second entity when it (the first entity) makes the assumption that the second

entity will behave exactly as the first entity expects

NOTE This trust may apply only for some specific function. The key role of trust in this framework is to describe the

relationship between an authenticating entity and an authority; an entity shall be certain that it can trust the authority to

create only valid and reliable certificates.

ISO/TS 22600-3:2009(E)
trusted third party

TTP

third party which is considered trusted for purposes of a security protocol

[ENV 13608-1]

Note 1 to entry: This term is used in many ISO/IEC standards and other documents describing mainly the services

of a CA. The concept is however broader and includes services like time stamping and possibly escrowing.

ISO 21091:2013(E)
trusted third party

TTP

third party which is considered trusted for purposes of a security protocol

[ENV 13608-1]

NOTE This term is used in many ISO/IEC International Standards and other documents describing mainly the services of a

CA. The concept is, however, broader and includes services such as time-stamping and possibly escrowing.

ISO/TS 17090-1:2002(E)
trusted third party

TTP

third party which is considered to be trusted for purposes of a security protocol

[EN 13608-1:2007]

NOTE This term is used in many ISO/IEC standards and other documents describing mainly the services of a CA.

The concept is, however, broader and includes services like time stamping and possibly escrowing. TTPs provide basic

services, infrastructural services and value-added services.

ISO/TS 22600-3:2009(E)
tuple a component of a relation; e.g., a 2-tuple has two relational components. ISO/IEEE 11073-10101:2004(E)
UDI unique device identifier unique identifier assigned to a medicinal product as defined by the International Medical Device Regulators’ Forum (IMDRF) ISO 11616:2012(E)
uncertain significance alterations with limited and/or conflicting evidence regarding pathogenicity ISO/TS 20428:2017(E)
Unified Modeling Language (UML) A language for the creation of domain models. UML was created in order to unify several well-known

object-oriented modeling methodologies, including those of Booch, Rumbaugh, Jacobson, and others.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
unified modelling language

UML

standardized general-purpose modelling language used to specify semantic requirements for a

particular domain

ISO 14199:2015(E)
Uniform Resource Identifier compact sequence of characters which identifies an abstract or physical resource ISO 21549-8:2010(E)
Uniform Resource Locator standardized address used for referring to resources by their location ISO 21549-8:2010(E)
Uniform Resource Name location-independent standardized label identifying an object by its name serving as persistent, locationindependent

resource identifier

ISO 21549-8:2010(E)
unique nonredundant. ISO/IEEE 11073-10101:2004(E)
unit of measurement real scalar quantity, defined and adopted by convention, with which any other quantity of the same kind can be compared in order to express the ratio of the two quantities as a number

NOTE Depending on the nature of the reference scale, the unit of measurement expression may stand either for a physical unit of measurement that is related to a system of quantities (e.g. SI units) or for an arbitrarily defined unit of measurement, which might refer to a certain reference material, a standard measurement procedure, a material measure or even to a combination of those.

ISO 11239:2012(E)
unit of measurement measurement unit real scalar quantity, defined and adopted by convention, with which any other quantity of the same kind can be compared to express the ratio of the two quantities as a number

NOTE Depending on the nature of the reference scale, the unit of measurement expression may stand either for a physical unit of measurement that is related to a system of quantities (e.g. SI units) or for an arbitrarily defined unit of measurement, which may refer to a certain reference material, a standard measurement procedure, a material measure or even to a combination of those.

ISO 11240:2012(E)
unit of measurement real scalar quantity, defined and adopted by convention, with which any other quantity of the same kind can be compared in order to express the ratio of the two quantities as a number

NOTE Depending on the nature of the reference scale, the unit of measurement expression may stand either for a physical unit of measurement that is related to a system of quantities (e.g. SI units) or for an arbitrarily defined unit of measurement, which may refer to a certain reference material, a standard measurement procedure, a material measure or even to a combination of those.

ISO 11616:2012(E)
unit of measurement real scalar quantity, defined and adopted by convention, with which any other quantity of the same kind can be compared in order to express the ratio of the two quantities as a number

Note 1 to entry: Depending on the nature of the reference scale, the unit of measurement expression may stand either for a physical unit of measurement that is related to a system of quantities (e.g. SI units) or for an arbitrarily defined unit of measurement, which might refer to a certain reference material, a standard measurement procedure, a material measure or even to a combination of those.

[SOURCE: ISO 11239:2012, 3.1.27]

ISO/TS 19256:2016(E)
unit of presentation qualitative term describing the discrete countable entity in which a pharmaceutical product or manufactured item is presented, in cases where strength or quantity is expressed referring to one instance of this countable entity EXAMPLE 1 To describe strength: puff, spray, tablet “contains 100 mcg per spray” (unit of presentation = spray). EXAMPLE 2 To describe quantity: bottle, box, vial “contains 100 ml per bottle” (unit of presentation = bottle). NOTE A unit of presentation can have the same name as another controlled vocabulary, such as a basic dose form or a container, but the two concepts are not equivalent, and each has a unique controlled vocabulary term identifier. ISO 11239:2012(E)
unit of presentation qualitative term describing the discrete countable entity in which a pharmaceutical product or manufactured item is presented, in cases where strength or quantity is expressed referring to one instance of this countable entity EXAMPLE 1 To describe strength: a puff, spray or tablet “contains 100 µg per spray” (unit of presentation = spray). EXAMPLE 2 To describe quantity: a bottle, box or vial “contains 100 ml per bottle” (unit of presentation = bottle). NOTE A unit of presentation can have the same name as another controlled vocabulary, such as a basic dose form or a container, but the two concepts are not equivalent, and each has a unique controlled vocabulary term identifier. ISO 11615:2012(E)
unit of presentation qualitative term describing the unit in which the strength(s) of the manufactured item or pharmaceutical product is presented and described NOTE 1 This is often used specifically at the point of delivery to the patient in cases where a quantitative unit of measurement is not applicable. NOTE 2 A unit of presentation may have the same “display name” as in another controlled vocabulary, such as a pharmaceutical dose form, but the two concepts are not equivalent, and each has a unique controlled vocabulary term identifier. EXAMPLE A tablet, spray or puff “contains 100 µg per spray” (unit of presentation = spray). ISO 11616:2012(E)
unit of presentation discrete countable entity in which a pharmaceutical product or manufactured item is presented, in cases where strength or quantity is expressed referring to one instance of this countable entity

EXAMPLE 1 To describe strength: spray, “contains 100 mcg per spray” (unit of presentation = spray).

EXAMPLE 2 To describe quantity: bottle, “contains 100 ml per bottle” (unit of presentation = bottle).

Note 1 to entry: A unit of presentation can have the same name as another controlled vocabulary, such as a basic dose form or a container, but the two concepts are not equivalent, and each has a unique controlled vocabulary term identifier.

[SOURCE: ISO 11239:2012, 3.1.28, modified]

ISO/TS 19256:2016(E)
units of presentations qualitative term describing the discrete countable entity in which a pharmaceutical product or manufactured item is presented, in cases where strength or quantity is expressed referring to one instance of this countable entity EXAMPLE 1 To describe strength: a puff, spray or tablet “contains 100 mcg per spray” (unit of presentation = spray). EXAMPLE 2 To describe quantity: a bottle, box or vial “contains 100 ml per bottle” (unit of presentation = bottle). NOTE A unit of presentation can have the same name as another controlled vocabulary, such as a basic dose form or a container, but the two concepts are not equivalent, and each has a unique controlled vocabulary term identifier. ISO 11240:2012(E)
universal statement codes ECG interpretation codes ISO 11073-91064:2009(E)
unshielded twisted pair (UTP) The type of Category-5 (CAT-5) cabling used in ISO/IEEE 11073-

30200.

ISO/IEEE 11073-30300:2004(E)
Upload transmission of data from an AI to an LIS ISO 18812:2003(E)
upper layers Layer 5 to Layer 7 of the International Organization for Standardization (ISO)/open

systems interconnection (OSI) reference model. These layers cover application, presentation, and session

specifications and functionalities.

ISO/IEEE 11073-10201:2004(E)
upstream device A term used to differentiate the two ends of an Ethernet connection. The matching

term (identifying the other end of the Ethernet connection) is “downstream device.”

ISO/IEEE 11073-30400:2012(E)
Use <of health information> act of employing data or information for a specific purpose, for which access to

the data is required

Note 1 to entry: Use of data implies that the data has been collected, even if simply by viewing it.

ISO/TS 17975:2015(E)
User person, device or program that uses an EHR system for data processing or health information exchange ISO 27789:2013(E)
user datagram protocol unreliable networking layer that sits at the same level of the networking stack as TCP ISO TR 16056-1:2004(E)
user datagram protocol unreliable networking layer that sits at the same level of the networking stack as TCP ISO TR 16056-2:2004(E)
vaccine adjuvant component that potentiates the immune response to an antigen and/or modulates it towards the desired immune response ISO 11616:2012(E)
value set uniquely identifiable set of valid concept representations, where any concept representation can be

tested to determine whether or not it is a member

Note 1 to entry: A value set is intended to be a set in the formal sense, and so should contain only one code for

each uniquely identifiable concept that it contains.

[SOURCE: Adapted from TN903 HITSP specified metadata: element, description, HITSP Template Metadata

and the HL7 Templates DSTU Property name, MIF mapping. Adapted from HL7 Version 3 Core Principals]

ISO/TS 13972:2015(E)
valueSet that which represents a uniquely identifiable set of valid concept representations, where any concept

representation can be tested to determine whether or not it is a member of the value set

NOTE A concept representation can be a single concept code or a post-coordinated combination of codes.

ISO 21090:2011(E)
variable symbolic name associated with a data element or data item, often a data element or data item whose

content or value may change over time

ISO/TS 13972:2015(E)
verification reading unique identifier numbers and checking these in a database ISO/TS 16791:2014(E)
verifier entity responsible for performing or providing a sensitive service for/to qualified claimants

NOTE The verifier enforces the privilege policy. When validating certification paths, a verifier is a type of relying party.

ISO/TS 22600-3:2009(E)
version mechanism that takes into account that at the given effective date, some characteristics of the investigational or authorized Medicinal Product have changed and those changes may be traced during the entire life cycle of a product ISO 11615:2012(E)
video streaming method of delivery of multimedia data (eg audio, video, images, text, alphanumeric data, time-series, waveform

data) across the networks with a reasonable amount of QoS

NOTE The receiving system presents (displays or plays) the data while the data is being transmitted in the background.

Typically no storage of data occurs during streaming. The following protocols have been created by the IETF and W3C to

achieve data streaming:

–  RTP (Real-time Transport Protocol),

–  RTSP (Real-time Streaming Protocol), and

–  SMIL (Synchronized Multimedia Integration Language).

ISO TR 16056-1:2004(E)
video streaming method of delivery of multimedia data (e.g. audio, video, images, text, alphanumeric data, time-series, waveform

data) across the networks with a reasonable amount of QoS

NOTE The receiving system presents (displays or plays) the data while the data is being transmitted in the background.

Typically no storage of data occurs during streaming. The following protocols have been created by the IETF and W3C to

achieve data streaming:

–  RTP (Real-time Transport Protocol),

–  RTSP (Real-time Streaming Protocol), and

–  SMIL (Synchronized Multimedia Integration Language).

ISO TR 16056-2:2004(E)
videoconferencing electronic form of communications that permits people in different locations to engage in face-to-face audio and

visual communication. Also, a collection of technologies that integrate video with audio, data, or both to convey in

real-time over distance for meeting between dispersed sites

ISO TR 16056-1:2004(E)
videoconferencing electronic form of communications that permits people in different locations to engage in face-to-face audio and

visual communication. Also, a collection of technologies that integrate video with audio, data, or both to convey in

real-time over distance for meeting between dispersed sites

ISO TR 16056-2:2004(E)
Videoconferencing electronic form of communications that permits people in different locations to engage in face-to-face audio and visual communication. Also, a collection of technologies that integrate video with audio, data, or both to convey in real-time over distance for meeting between dispersed sites ISO TS 16058:2004(E)
view alternate presentation of data for a different user or purpose ISO 13606 -1:2008(E)
view alternate presentation of data for a different user or purpose

[SOURCE: ISO 13606‑1:2008]

ISO/TS 13972:2015(E)
View alternate presentation of data for a different user or purpose ISO/TS 18308:2004(E)
virtual medical device (VMD) An abstract representation of a medical-related subsystem of a medical

device system (MDS).

ISO/IEEE 11073-10201:2004(E)
virtual medical object (VMO): An abstract representation of an object in the Medical Package of the

domain information model (DIM).

ISO/IEEE 11073-10201:2004(E)
visually readable data data that are placed on the surface of the healthcare data card to be read visually by users ISO 20301:2006(E)
vital sign Clinical information, relating to one or more patients, that is measured by or derived from

apparatus connected to the patient or otherwise gathered from the patient.

ISO/IEEE 11073-10201:2004(E)
vital sign clinical information relating to one or more patients; measured by or derived from apparatus connected to the

patient, or otherwise gathered from the patient

ISO/TS 27790:2009(E)
vocabulary terminological dictionary which contains designations and definitions from one or more specific subject fields

NOTE Adapted from ISO 1087-1:2000

ISO 11240:2012(E)
vocabulary terminological dictionary which contains designations and definitions from one or more specific subject fields [ISO 1087-1:2000, definition 3.7.2] ISO 11615:2012(E)
vocabulary terminological dictionary which contains designations and definitions from one or more specific subject fields NOTE Adapted from ISO 1087-1:2000, definition 3.7.2. ISO 11616:2012(E)
vocabulary The set of valid values for a coded attribute or field. ISO 21731:2006(E) & ANSI/HL7 RIM R1
vocabulary domain The set of all concepts that can be taken as valid values in an instance of a coded attribute or field; a

constraint applicable to code values.

ISO 21731:2006(E) & ANSI/HL7 RIM R1
vocabulary domain qualifier Part of a vocabulary domain specification. The two existing qualifiers are extensibility and realm. ISO 21731:2006(E) & ANSI/HL7 RIM R1
voting decoding technique whereby decoded segment values are saved along with a count of the number of times

they have been decoded

NOTE Voting is used for decoding GS1 DataBar by segments such as when used with omnidirectional scanning.

ISO/IEC 24724:2011(E)
vulnerability weakness of an asset or group of assets that can be exploited by a threat

NOTE Adapted from ISO/IEC 13335-1.

ISO/TR 11633-1:2009(E)
vulnerability weakness of an asset or group of assets that can be exploited by a threat

NOTE Adapted from ISO/IEC 13335-1.

ISO/TR 11633-2:2009(E)
vulnerability weakness of an asset or control that can be exploited by a threat ISO/TS 14441:2013(E)
W3C The World Wide Web Consortium, an international industry consortium ISO 21731:2006(E) & ANSI/HL7 RIM R1
waveform Graphic data, typically vital signs data values varying with respect to time, usually presented

to the clinician in a graphical form.

ISO/IEEE 11073-10201:2004(E)
web access to DICOM persistent objects service enabling the web client system to retrieve DICOM persistent objects managed by a web enabled

DICOM server, through HTTP/HTTPs protocol

ISO 17432:2004(E)
web client system system using internet technologies (web, e-mail) interested in retrieving DICOM persistent objects from a web

enabled DICOM server, through HTTP/HTTPs protocol

ISO 17432:2004(E)
web enabled DICOM server system managing DICOM persistent objects and able to transmit them on request to the web client system ISO 17432:2004(E)
web ontology language

OWL

web-based language designed for use in applications that need to process the content of information ISO 14199:2015(E)
web ontology language – description logic

OWL-DL

family of knowledge representation languages or ontology languages for authoring ontololgies or

knowledge bases

ISO 14199:2015(E)
web services description language (WSDL) XML format for describing network services as a set of endpoints operating on messages containing either document-oriented or procedure-oriented information

NOTE The operations and messages are described abstractly, and then bound to a concrete network protocol and message format to define an endpoint. Related concrete endpoints are combined into abstract endpoints (services). WSDL is extensible to allow description of endpoints and their messages regardless of what message formats or network protocols are used to communicate, however, the only bindings described in this document describe how to use WSDL in conjunction with SOAP 1.1, HTTP GET/POST, and MIME. [(2) W3C; 2001]

ISO/HL7 27951:2009(E)
web services description language
WSDL
XML format for describing network services as a set of endpoints operating on messages containing either document-oriented or procedure-oriented information ISO/HL7 27951:2009(E)
weight The force that results from the exertion of gravity on an object. The weight is directly proportional

to the mass of the object. However, in the health care domain the term body weight is typically used to denote

the body mass of a person. This notation applies also to this standard.

ISO/IEEE

11073-10420

weight The force that results from the exertion of gravity on an object. The weight is directly

proportional to the mass of the object. However, in the health care domain the term body weight is typically

used to denote the body mass of a person. This notation applies also to this standard.

ISO/IEEE 11073-10415:2010(E)
whole exome sequencing

WES

technique for sequencing all the protein-coding genes in a genome ISO/TS 20428:2017(E)
whole genome sequencing

WGS

technique that determines the complete DNA sequence of an organism’s genome at a single time ISO/TS 20428:2017(E)
widget standalone visualization component (e.g. a heat map, gauge or geographic map) that can be integrated with a

data warehouse source and presented in an end-user dashboard

NOTE Custom widgets can be developed using a business intelligence vendor software development kit (SDK) and

managed via the widget library.

ISO/TS 29585:2010(E)
workflow depiction of the actual sequence of the operations or actions taken in a process

Note 1 to entry: A workflow reflects the successive decisions and activities in the performance of a process.

[SOURCE: ISO 18308:2011]

ISO/TS 13972:2015(E)
Worklist defined set of requested analytical instrument investigations that can be assigned to an analytical instrument ISO 18812:2003(E)
XML Extensible Markup Language (XML) is a simple, very flexible text format derived from SGML (ISO 8879). Originally designed to meet the challenges of large-scale electronic publishing, XML is also playing an increasingly important role in the exchange of a wide variety of data on the Web and elsewhere. ISO/HL7 27932:2009(E)
XML Schema XML Schemas express shared vocabularies and allow machines to carry out rules made by people. They provide a means for defining the structure, content and semantics of XML documents in more detail. ISO/HL7 27932:2009(E)
zone collection of all terminals, gateways, and MCUs managed by a single gatekeeper

NOTE A zone must include at least one terminal and may include LAN segments connected using routers.

ISO TR 16056-1:2004(E)
zone collection of all terminals, gateways, and MCUs managed by a single gatekeeper

NOTE A zone must include at least one terminal and may include LAN segments connected using routers.

ISO TR 16056-2:2004(E)
-law variant of the G.711 audio encoding used primarily in North America and Japan

NOTE See also G.711 and A-law.

ISO TR 16056-1:2004(E)
-law variant of the G.711 audio encoding used primarily in North America and Japan

NOTE See also G.711 and A-law.

ISO TR 16056-2:2004(E)