Health Informatics - Harmonized data types for information interchange (ISO 21090:2011)

This International Standard provides a set of datatype definitions for representing and exchanging basic concepts that are commonly encountered in healthcare environments in support of information exchange in the healthcare environment; specifies a collection of healthcare-related datatypes suitable for use in a number of health-related information environments; declares the semantics of these datatypes using the terminology, notations and datatypes defined in ISO/IEC 11404, thus extending the set of datatypes defined in that standard; ? provides UML definitions of the same datatypes using the terminology, notation and types defined in Unified Modelling Language (UML) version 2.0; specifies an XML (Extensible Mark-up Language) based representation of the datatypes. The requirements which underpin the scope reflect a mix of requirements gathered primarily from HL7 Version 3 and ISO/IEC 11404, and also from CEN/TS 14796, ISO 13606 (all parts) and past ISO work on healthcare datatypes. This International Standard can offer a practical and useful contribution to the internal design of health information systems, but is primarily intended to be used when defining external interfaces or messages to support communication between them.

Medizinische Informatik - Harmonisierte Datentypen für den Datenaustausch im Gesundheitswesen (ISO 21090:2011)

Informatique de santé - Types de données harmonisées pour une interchangeabilité d'informations (ISO 21090:2011)

L'ISO 21090:2011
fournit un jeu de définitions de types de données permettant de représenter et d'échanger les concepts de base couramment rencontrés dans les environnements de santé pour assurer l'interchangeabilité d'informations relevant du domaine des soins de santé;
spécifie un recueil de types de données de santé pouvant être utilisées dans un certain nombre d'environnements d'informations de santé;
déclare la sémantique de ces types de données sur la base de la terminologie, des notations et des types de données définis dans l'ISO/CEI 11404, augmentant ainsi le jeu de types de données défini dans la présente Norme internationale;
fournit les définitions UML de ces mêmes types de données sur la base de la terminologie, de la notation et des types définis dans le Unified Modeling Language (UML: langage de modélisation unifié) version 2.0;
définit une représentation basée sur le langage XML [Extensible Markup Language (langage de balisage) extensible] des types de données.
Le domaine d'application constitue une combinaison des exigences compilées principalement de la Version 3 d'HL7 et de l'ISO/CEI 11404, et également de celles issues de la CEN/TS 14796, de l'ISO 13606 (toutes les parties) et des travaux antérieurs de l'ISO sur les types de données de soins de santé.
L'ISO 21090:2011 peut contribuer de manière pratique et utile à la conception interne des systèmes d'information de santé mais elle est principalement destinée à être utilisée pour la définition des interfaces externes ou des messages destinés à prendre en charge leur communication interne.

Zdravstvena informatika - Vrste harmoniziranih podatkov za izmenjavo informacij (ISO 21090:2011)

Ta mednarodni standard zagotavlja sklop definicij vrst podatkov za predstavitev in izmenjavo osnovnih konceptov, s katerimi se običajno srečujemo v zdravstvenih okoljih, kot podpora izmenjavi informacij v zdravstvenem okolju; določa zbirko z zdravstvom povezanih vrst podatkov, primernih za uporabo v več z zdravstvom povezanih informacijskih okoljih; navaja pomene teh vrst podatkov z uporabo terminologij, oznak in vrst podatkov, določenih v ISO/IEC 11404, in s tem razširja sklop vrst podatkov, opredeljenih v tem standardu; zagotavlja definicije UML istih vrst podatkov z uporabo terminologije, oznak in vrst, določenih v poenotenem jeziku modeliranja (UML) različice 2.0; določa predstavitev vrst podatkov, temelječo na XML (razširljivem označevalnem jeziku). Zahteve, ki podpirajo področje uporabe, odražajo mešanico zahtev, združenih predvsem iz HL7 različice 3 in ISO/IEC 11404 ter prav tako iz CEN/TS 14796, ISO 13606 (vseh delov) in preteklim delom o vrstah zdravstvenih podatkov ISO. Ta mednarodni standard lahko ponudi praktičen in uporaben prispevek k načrtu notranjosti informacijskih sistemov v zdravstvu, vendar je prvotno namenjen uporabi, kadar določamo zunanje vmesnike ali sporočila v podporo komunikaciji med njimi.

General Information

Status
Published
Public Enquiry End Date
31-Jul-2008
Publication Date
08-Mar-2011
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
28-Feb-2011
Due Date
05-May-2011
Completion Date
09-Mar-2011

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SLOVENSKI STANDARD
SIST EN ISO 21090:2011
01-april-2011
Zdravstvena informatika - Vrste harmoniziranih podatkov za izmenjavo informacij
(ISO 21090:2011)
Health Informatics - Harmonized data types for information interchange (ISO
21090:2011)
Medizinische Informatik - Harmonisierte Datentypen für den Datenaustausch im
Gesundheitswesen (ISO 21090:2011)
Informatique de santé - Types de données harmonisées pour une interchangeabilité
d'informations (ISO 21090:2011)
Ta slovenski standard je istoveten z: EN ISO 21090:2011
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 21090:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21090:2011

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SIST EN ISO 21090:2011


EUROPEAN STANDARD
EN ISO 21090

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2011
ICS 35.240.80
English Version
Health Informatics - Harmonized data types for information
interchange (ISO 21090:2011)
Informatique de santé - Types de données harmonisées Medizinische Informatik - Harmonisierte Datentypen für den
pour une interchangeabilité d'informations (ISO Datenaustausch im Gesundheitswesen (ISO 21090:2011)
21090:2011)
This European Standard was approved by CEN on 12 February 2011.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21090:2011: E
worldwide for CEN national Members.

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SIST EN ISO 21090:2011
EN ISO 21090:2011 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 21090:2011
EN ISO 21090:2011 (E)
Foreword
This document (EN ISO 21090:2011) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of
which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by August 2011, and conflicting national standards shall be withdrawn at
the latest by August 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 21090:2011 has been approved by CEN as a EN ISO 21090:2011 without any modification.

3

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SIST EN ISO 21090:2011

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SIST EN ISO 21090:2011

INTERNATIONAL ISO
STANDARD 21090
First edition
2011-02-15


Health informatics — Harmonized data
types for information interchange
Informatique de santé — Types de données harmonisées pour une
interchangeabilité d'informations




Reference number
ISO 21090:2011(E)
©
ISO 2011

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SIST EN ISO 21090:2011
ISO 21090:2011(E)
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©  ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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Published in Switzerland

ii © ISO 2011 – All rights reserved

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SIST EN ISO 21090:2011
ISO 21090:2011(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Abbreviated terms.4
5 Conformance .5
5.1 General .5
5.2 Direct conformance.5
5.3 Indirect conformance.7
6 Datatypes overview .9
6.1 What is a datatype?.9
6.2 Definitions of datatypes.9
6.3 Datatype names and re-use of common datatype names.10
6.4 Mapping to this datatypes International Standard.10
6.5 Conformance with ISO/IEC 11404.10
6.6 Reference to UML 2.11
6.7 Modelling of datatypes.11
7 Datatypes .15
7.1 General properties.15
7.2 Top level model .20
7.3 Basic datatypes .22
7.4 Text and binary datatypes .33
7.5 Coded datatypes (terminology) .48
7.6 Identification and location datatypes.61
7.7 Name and address datatypes.72
7.8 Quantity datatypes .93
7.9 Collections of datatypes.121
7.10 Continuous set datatypes.136
7.11 Uncertainty datatypes.155
7.12 Structured text .158
Annex A (normative) XML representation.180
Annex B (normative) UML support types.183
Annex C (informative) RM-ODP viewpoint mappings .186
Annex D (informative) HL7 V3 Abstract Data Types mapping.187
Annex E (informative) Schema for XML representation.194
Bibliography.195
© ISO 2011 – All rights reserved iii

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SIST EN ISO 21090:2011
ISO 21090:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 21090 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2011 – All rights reserved

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SIST EN ISO 21090:2011
ISO 21090:2011(E)
Introduction
Assistance from the Infrastructure and Messaging Committee in HL7 and the support of Connecting for Health
have been instrumental in the preparation of this International Standard, which is a shared document between
Health Level Seven (HL7) and ISO, and has been produced according the terms of the agreement between
HL7, CEN and ISO (JIC, see http://www.global-e-health-standards.org/), which ensures that the content is
fully available through ISO, CEN and HL7 publication channels.
© ISO 2011 – All rights reserved v

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SIST EN ISO 21090:2011

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SIST EN ISO 21090:2011
INTERNATIONAL STANDARD ISO 21090:2011(E)

Health informatics — Harmonized data types for information
interchange
1 Scope
This International Standard
⎯ provides a set of datatype definitions for representing and exchanging basic concepts that are commonly
encountered in healthcare environments in support of information exchange in the healthcare
environment;
⎯ specifies a collection of healthcare-related datatypes suitable for use in a number of health-related
information environments;
⎯ declares the semantics of these datatypes using the terminology, notations and datatypes defined in
ISO/IEC 11404, thus extending the set of datatypes defined in that standard;
⎯ provides UML definitions of the same datatypes using the terminology, notation and types defined in
Unified Modelling Language (UML) version 2.0;
⎯ specifies an XML (Extensible Mark-up Language) based representation of the datatypes.
The requirements which underpin the scope reflect a mix of requirements gathered primarily from HL7
Version 3 and ISO/IEC 11404, and also from CEN/TS 14796, ISO 13606 (all parts) and past ISO work on
healthcare datatypes.
This International Standard can offer a practical and useful contribution to the internal design of health
information systems, but is primarily intended to be used when defining external interfaces or messages to
support communication between them.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO/IEC 4217, Codes for the representation of currencies and funds
ISO/IEC 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
ISO/IEC 8824 (all parts), Information technology — Abstract Syntax Notation One (ASN.1)
ISO/IEC 11404:2007, Information technology — General-Purpose Datatypes (GPD)
ISO/TS 22220, Health Informatics — Identification of subjects of health care
IETF RFC 1738, Uniform Resource Locators (URL)
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SIST EN ISO 21090:2011
ISO 21090:2011(E)
IETF RFC 1950, ZLIB Compressed Data Format Specification version 3.3
IETF RFC 1951, DEFLATE Compressed Data Format Specification version 1.3
IETF RFC 1952, GZIP file format specification version 4.3
IETF RFC 2045, Multipurpose Internet Mail Extensions (MIME) Part One: Format of Internet Message Bodies
IETF RFC 2046, Multipurpose Internet Mail Extensions (MIME) Part Two: Media Types
IETF RFC 2396, Uniform Resource Identifiers (URI): Generic Syntax
IETF RFC 3066, Tags for the Identification of Languages
1)
IETF RFC 3966, The tel URI for Telephone Numbers
FIPS PUB 180-1, Secure Hash Standard
2)
FIPS PUB 180-2, Secure Hash Standard
Open Group, CDE 1.1, Remote Procedure Call specification, Appendix A
HL7 V3 Standard, Data Types — Abstract Specification (R2)
3)
Regenstrief Institute, Inc. and the UCUM Organization, The Unified Code for Units of Measure
4)
W3C Recommendation, XML Signature Syntax and Processing
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
attribute
characteristic of an object that is assigned a name and a type
NOTE The value of an attribute can change during the lifetime of the object.
3.2
class
descriptor for a set of objects with similar structure, behaviour and relationships
3.3
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/.
2 © ISO 2011 – All rights reserved

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SIST EN ISO 21090:2011
ISO 21090:2011(E)
3.4
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
3.5
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.
3.6
conformance
fulfillment of a specified requirement; adherence of an information processing entity to the requirements of one
or more specific specifications or standards
3.7
datatype
set of distinct values, characterized by properties of those values, and by operations on those values
3.8
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.
3.9
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.
3.10
information processing entity
anything that processes information and contains the concept of datatype, including other standards,
specifications, data handling facilities and services
3.11
inheritance
mechanism by which more specific elements incorporate structure and behaviour of more general elements
3.12
interface
specifier for the externally-visible operations of class, without specification of internal structure
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SIST EN ISO 21090:2011
ISO 21090:2011(E)
3.13
invariant
rule about the features of a class which must always be true
3.14
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.
3.15
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
3.16
string character set
character set used in all string content throughout this International Standard
3.17
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.
4 Abbreviated terms
For the purposes of this document, the following abbreviated terms apply.
CEN Comité Européen de Normalisation (European Committee for Standardization)
CNE Coded no exceptions
CWE Coded with exceptions
GPD General-Purpose Datatypes
HL7 Health Level Seven, Inc.
IETF Internet Engineering Task Force
OID Object Identifier
OMG Object Management Group
UML Unified Modelling Language
W3C World Wide Web Consortium
XML Extensible Mark-up Language
4 © ISO 2011 – All rights reserved

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SIST EN ISO 21090:2011
ISO 21090:2011(E)
5 Conformance
5.1 General
An information processing product, system, element or other entity may conform to this International Standard
either directly, by utilizing datatypes specified in this International Standard in a conforming manner, or
indirectly, by means of mappings between internal datatypes used by the entity and the datatypes specified in
this International Standard.
NOTE The term "information processing entity" is used as defined in 3.10, which is consistent with how it is used in
ISO/IEC 11404:2007, Clause 4. Specifically, this definition includes applications and also other standards and
specifications.
5.2 Direct conformance
5.2.1 Direct conformance definition
An information processing entity which conforms directly to this International Standard shall:
a) specify which of the datatypes specified in Clause 7 are provided by the entity and which are not;
b) define the value spaces of the healthcare datatypes used by the entity to be identical to the value spaces
specified by this International Standard;
c) specify to what extent the value spaces of the datatypes are constrained for use within its own context;
d) to the extent that the entity provides operations other than movement or translation of values, define
operations on the healthcare datatypes which can be derived from, or are otherwise consistent with, the
characterizing operations specified by this International Standard;
e) represent these datatypes using the Extensible Mark-up Language (XML) representation described
herein, when the datatypes are represented in XML;
f) optionally, publish a formal conformance profile making these statements clear, or reference one
published by some other information processing entity.
The above-mentioned requirements prohibit the use of a type-specifier defined in this International Standard
to designate any other datatype (but, see 6.3 concerning the scope of the datatype names). They make no
other limitation on the definition of additional datatypes in a conforming entity. For instance, a directly
conforming information processing entity could continue to use ISO/IEC 11404 general-purpose datatypes in
addition to these healthcare datatypes.
Requirement d) does not require all characterizing operations to be supported and permits the provision of
additional operations. The intention is to permit the addition of semantic interpretation to the datatypes, as
long as it does not conflict with the interpretations given in this International Standard. A conflict arises only
when a given characterizing operation could not be implemented or would not be meaningful, given the entity
provided operations on the datatype.
Examples of entities that could conform directly are language definitions or healthcare specifications whose
datatypes, and the notation for them, are those defined herein. In addition, the verbatim support by a software
tool or application package of the datatype syntax and definition facilities herein should not be precluded.
Information processing entities claiming direct conformance with this International Standard do not always
need to use the datatypes defined in this International Standard to represent the concepts, i.e. simply because
an address datatype is defined does not mean that the address datatypes must always be used for
representing addresses. However, the type defined within this International Standard shall be used where the
context is interoperability using these datatypes.
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SIST EN ISO 21090:2011
ISO 21090:2011(E)
Information processing entities claiming direct conformance with this International Standard may further
constrain the value domain of any of the datatypes within their context of use. The conformance statement
shall make clear how constraints are applied within the information processing entity and how values that do
not conform to the imposed constraints are handled.
Consistency of characterizing operations specified by conforming entities may be assessed by these criteria.
Where operations have the same name as the operation defined within this International Standard, they are
consistent if the operation can be invoked with the same parameters to return the same result. Other
parameters may be defined, but shall have default values or be defined using additional definitions of
operations with the same name but other parameter lists.
Information processing entities claiming direct conformance are not required to call any or all of the types
defined in this International Standard "types". Other terms such as "data structures" may be used.
5.2.2 Conformance statements
When an information processing entity claims direct conformance with this International Standard, it should
make a conformance statement.
It is anticipated that other standards bodies would make conformance statements with regard to this
International Standard both in a general sense and in the sense of adopting these datatypes for a particular
standard. In addition, it is anticipated that certain countries publish profiles of these datatypes on either an
advisory or a normative basis. Finally, vendors and purchasers of healthcare applications may well find use in
creating, sharing and publishing these conformance statements.
This International Standard makes no rules about either the form of the statement or how it is published, but it
should be clearly and formally presented and made available to all interested parties associated with the
scope of the information processing entity.
In addition to specifying that conformance statements shall contain formal statements pertaining to
5.2.1 a) to d), this International Standard makes additional rules about what they shall or should say or may
choose to do.
5.2.2.1 Direct conformance statements shall:
a) define which character set and encoding applies; the default is Unicode (see 6.7.5);
b) if an alternative mechanism for providing history and audit data is provided, define how it maps to the
history and audit information on datatypes (see 7.1.3);
c) make clear how attribute and collection cardinality are specified (see 7.1.5);
d) define how the attributes nullFlavor, updateMode and flavorId on ANY are managed (see 7.3.3);
e) if quantities are used, make clear exactly how and when the QTY attributes expression, originalText,
uncertainty and uncertaintyType are used;
f) make clear what methods may be used to provide alternative definitions for discrete set uniqueness
(see 7.9.3);
g) if the structured documents types are used, document the scope of the document context and clearly
define how references within this document context are resolved (see 7.12);
h) specify to what degree the XML format is adopted and define the namespace that is used (see A.1).
5.2.2.2 Direct conformance statements should:
a) define defaulting rules for language (see 7.4.2.3.7);
b) declare what languages are supported in the QTY.expression property (see 7.8.2.3.1);
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SIST EN ISO 21090:2011
ISO 21090:2011(E)
c) describe which codes may be used in QSC.code (see 7.10.8.3);
d) if the structured documents types are used, define how version tracking works in the contexts where it is
used (see 7.12.12.2.1).
5.2.2.3 Direct conformance
...

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