EN 12264:2005

Health informatics - Categorial structures for systems of concepts

1.1   Main purpose
The purpose of this European Standard is to establish the characteristics and the conformance rules required to synthetically describe the organisation and content of a terminological system in health. This European Standard has been developed to allow the production of specific standards on categorial structures for particular healthcare subject fields with the minimum requirements to support meaningful exchange of information.
This European Standard is applicable to:
- facilitate the construction of new terminological systems in a regular form which will increase their coherence and expressiveness;
- facilitate maintenance of terminological systems;
- increase consistency and coherence of existing terminological system;
- allow systematic cross-references between items of different types of terminological systems;
- facilitate convergence among terminological systems;
- make explicit the overlap between different health care domains terminological systems;
- provide elements for negotiation about integration of different terminological systems into information systems between the respective developers;
- enable the systematic evaluation of terminological systems.
1.2   Target groups
The target groups for this European Standard are:
- designers of specialised standard healthcare terminological categorial structures;
- developers of healthcare terminological systems including classifications and coding systems;
- producers of services for terminological systems and designers of software including natural language processing;
- information modellers, knowledge engineers, and standards developers building models for health information management systems;
- developers of information systems that require an explicit system of concepts;
- developers of mark-up standards for representation of healthcare documents
(continued)

Medizinische Informatik - Kategoriale Struktur für Begriffssysteme

Informatique de santé - Structures catégorielles des systèmes de concepts

1.1   Objectifs principaux
Le présent document a pour objectif d'établir les caractéristiques et les règles de conformité nécessaires pour décrire synthétiquement l'organisation et le contenu d'un système terminologique dans le domaine de la santé.
Ce document a été développé pour permettre la production de normes particulières relatives aux structures catégorielles pour des domaines de santé spécifiques et avec des exigences minimales pour venir à l'appui d'un échange d'informations significatives.
Ce document est applicable pour :
-   faciliter la construction de nouveaux systèmes terminologiques avec une régularité qui augmentera leur cohérence et leur expressivité ;
-   faciliter la maintenance des systèmes terminologiques ;
-   augmenter la régularité et la cohérence du système terminologique existant ;
-   permettre des références croisées systématiques entre des articles des différents types de systèmes terminologiques (vocabulaires contrôlés, systèmes de codage, classifications, terminologies cliniques, thésaurus et nomenclatures) ;
-   faciliter la convergence des systèmes terminologiques ;
-   expliciter les recoupements entre des systèmes terminologiques de différents domaines de la santé ;
-   fournir des éléments de négociation entre les responsables de développement respectifs  sur l'intégration de différents systèmes terminologiques à des systèmes d'information ;
-   permettre l'évaluation systématique des systèmes terminologiques.
1.2   Groupes cible
Les groupes cibles du présent document sont :
-   les responsables de la conception de structures catégorielles des terminologies de santé normalisées de spécialités ;
-   les développeurs de systèmes terminologiques de santé y compris les classifications et les systèmes de codage ;
-   les prestataires de services sur les systèmes terminologiques et les responsables de l'élaboration de logiciels incluant ceux qui travaillent sur le langage naturel.

Zdravstvena informatika – Kategorijske strukture sistemov konceptov

General Information

• Status: Published
• Publication Date: 14-Jun-2005
• Withdrawal Date: 30-Dec-2005
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 1 - Information models
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 10-Mar-2021
• Mandate: M/255 - Standardization mandate to CEN, CENELEC and ETSI in the field of health care informatics
• Ref Project: SIST EN 12264:2005 - Health informatics - Categorial structures for systems of concepts

Relations

• Replaces: ENV 12264:1997 - Medical informatics - Categorical structures of systems of concepts - Model for representation of semantics
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2005
1DGRPHãþD
SIST ENV 12264:2003
Zdravstvena informatika – Kategorijske strukture sistemov konceptov
Health informatics - Categorial structures for systems of concepts
Medizinische Informatik - Kategoriale Struktur für Begriffssysteme
Informatique de santé - Structures catégorielles des systemes de concepts
Ta slovenski standard je istoveten z: EN 12264:2005
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 12264
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2005
ICS 35.240.80
English version
Health informatics - Categorial structures for systems of
concepts
Informatique de santé - Structures catégorielles des Medizinische Informatik - Kategoriale Struktur für
systèmes de concepts Begriffssysteme
This European Standard was approved by CEN on 29 April 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12264:2005: E
worldwide for CEN national Members.

Contents
Page
Foreword .3
1 Scope .5
2 Normative references .6
3 Terms and Definitions .6
4 Categorial structure description.13
5 Conformance of a categorial structure to the document.13
Bibliography.14

Foreword
This European Standard (EN 12264:2005) has been prepared by 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 December 2005, and conflicting national standards shall be withdrawn
at the latest by December 2005.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard : Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
Introduction
Computer-based processing and interchange of medical or clinical information require various kinds of
terminological systems of concepts to represent that information, such as controlled vocabularies,
classifications, nomenclatures, terminologies and thesauri, with or without coding schemes.

The specific terminological issues in the field of health informatics are:

- large number of different terminological systems are available in different clinical specialties;

-large overlap among the subject fields involved;

-large number of codes and rubrics, typically in the order of magnitude of 10,000 to 100,000 entries, in
commonly used terminological systems;

- increasing need for re-use of coded data in different health-care contexts;

- polysemy across different clinical specialties and sometimes within them.

The integration of computer-based medical records and administrative information systems in Electronic
Health Records (EHR) requires rationalisation in the field, and a uniform way to represent the meaning of
medical concepts to ensure that the receiver EHR of a message will catch the meaning introduced by the
sender EHR and not only the string of characters embedded in it. It is not possible to impose a rigid uniform
standardised natural language clinical terminology on healthcare providers.

Instead a domain specific semantic model has been envisioned and applied in a series of specific European
standards (EN) and international standards (ISO) on various subject fields to describe a set of categorial
structures in partially overlapping subject fields: a European standard for surgical procedures (EN 1828), an
ISO standard on integration of a reference model for nursing (EN ISO 18104) and an ISO technical
specification on medical devices. There are also several European Pre standards (ENV) for: clinical laboratory
measurements (ENV 1614), medical devices (ENV 12611), vital signs (EN ISO:IEEE 11073-10101 - Part
10101: Nomenclature), point-of-care medical device communication (EN ISO:IEEE 11073-10101 - Part 10101:
Nomenclature), medicinal products (ENV 12610), nursing (ENV 14032) and continuity of care (ENV 13940).

This European Standard specifies the terminology and categorical structure description to be used for
systems of concepts. Field testing in several countries, revision and integration have provided the
comprehensive basis for this document.
1 Scope
1.1 Main purpose
The purpose of this European Standard is to establish the characteristics and the conformance rules required
to synthetically describe the organisation and content of a terminological system in health. This European
Standard has been developed to allow the production of specific standards on categorial structures for
particular healthcare subject fields with the minimum requirements to support meaningful exchange of
information.
This European Standard is applicable to:

- facilitate the construction of new terminological systems in a regular form which will increase their coherence
and expressiveness;
- facilitate maintenance of terminological systems;
- increase consistency and coherence of existing terminological systems;

- allow systematic cross-references between items of different types of terminological systems;
- facilitate convergence among terminological systems;
- make explicit the overlap between different health care domains terminological systems;
- provide elements for negotiation about integration of different terminological systems into information
systems between the respective developers;
- enable the systematic evaluation of terminological systems.

1.2 Target groups
The target groups for this European Standard are:
- designers of specialised standard healthcare terminological categorial structures;
- developers of healthcare terminological systems including classifications and coding systems;
- producers of services for terminological systems and designers of software including applications for natural
language processing;
- information modellers, knowledge engineers, and standards developers building models for health
information management systems;

- developers of information systems that require an explicit system of concepts;

- developers of mark-up standards for representation of healthcare documents.

1.3 Topics outside the scope
This European Standard has been developed for use as an integrated part of computer-based applications
and for the electronic healthcare record. It would be of limited value for manual use.
This European Standard itself is not suitable for or intended for use by individual clinicians or hospital
administrators.
It is not the purpose of this European Standard to standardise the end user classification or to conflict with the
concept systems embedded in national practice and languages.
This European Standard is applicable to any healthcare terminology in any healthcare terminological system.
2 Normative references
Not applicable.
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
concept
unit of knowledge created by a unique combination of characteristics (3.2)

NOTE Concepts are not necessarily bound to particular languages. They are, however, influenced by the social or
cultural background often leading to different categorisations.[ISO 1087-1:2000]

3.2
characteristic
abstraction of a property of an object (3.3) or of a set of objects (3.3)
[ISO 1087-1:2000]
NOTE Characteristics are used for describing concepts (3.1) or of members of a set of objects (3.3) which form
the extension (3.27) of a concept (3.1)

3.3
object
anything perceivable or conceivable
NOTE 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).

[ISO 1087-1:2000]
3.4
concept system
system of concepts
set of concepts (3.1) structured according to the relations among them

[ISO 1087-1:2000]
3.5
formal representation
system of symbols which stand for concepts (3.1) and/or the relations between them and which is governed
by explicit rules
3.6
concept representation
formal representation (3.5) of a concept (3.1)

NOTE Informally, we often talk of ’concepts’ when we mean ’concept representations’. However, this leads to
confusion when precise meanings are required. Concepts arise out of human individual and social conceptualisation
of the world around them. Concept representations are artefacts constructed of symbols and often manifest in
computer programs. Because they are artefacts, we can be precise about the functioning and capabilities of concept
representations. It is more difficult to be clear about the yet poorly understood function of human conceptualisation.

3.7
concept system representation
formal representation (3.5) of a system of concepts (3.4)

NOTE Informally, we often talk of ’concept systems’ when we mean ’concept system representations’. However,
this leads to confusion when precise meanings are required. Concepts arise out of human individual and social
conceptualisation of the world around them. Concept system representations are artefacts constructed of symbols
and often manifest in computer programs. Because they are artefacts, we can be precise about the functioning and
capabilities of concept systems representation. It is more difficult to be clear about the yet poorly understood function
of human conceptualisation.
3.8
concept name
term (3.36) which uniquely designates a concept (3.1) within a concept system (3.4)

3.9
concept representation name
(3.36) which uniquely designates a (3.7)
term concept representation
3.10
hierarchical relation
relation between two concepts (3.1) which may be either a generic relation (3.11) or a partitive relation
(3.7)
[ISO 1087-1:2000]
3.11
generic relation
genus / species relation
subtype relation
relation between two concepts (3.1) where the intention (3.26) of one of the concepts (3.1) includes that of
the other concept (3.1) and at least one additional delimiting characteristic (3.25)

[ISO 1087-1:2000]
NOTE 1 A generic relation exists between the concepts (3.1) 'word' and 'pronoun', 'vehicle' and 'car', 'person' and
'child'.
NOTE 2 All instances of a concept in the extension (3.27) of the second are included in the extension of the first.
3.12
individuation relation
relation between a concept (3.1) and the members of its extension (3.27)
NOTE It is a relation between concept (3.1) and object (3.3)
3.13
partitive relation
part / whole relation
relation between two concepts (3.1) where one of the concepts (3.1) constitutes the whole and the other
concept (3.1) a part of that whole

[ISO 1087-1:2000]
NOTE A partitive relation exists between the concepts (3.1) 'week' and 'day', 'molecule' and 'atom'.
3.14
associative relation
pragmatic relation
relation between two concepts (3.1) having a non-hierarchical thematic connection by virtue of experience

[ISO 1087-1:2000]
EXAMPLE An associative relation exists between the concepts (3.1) 'education' and 'teaching', 'baking' and 'oven'.
3.15
superordinate concept
broader concept
concept (3.1) which is either a generic concept (3.17) or a comprehensive concept (3.19)

[ISO 1087-1:2000]
3.16
subordinate concept
narrower concept
concept (3.1) which is either a specific concept (3.18) or a partitive concept (3.20)

[ISO 1087-1:2000]
3.17
generic concept
concept (3.1) in a generic relation (3.11) having the narrower intention (3.26)

[ISO 1087-1:2000]
3.18
specific concept
(3.1) in a (3.11) having the broader (3.26)
concept generic relation intention

[ISO 1087-1:2000]
3.19
comprehensive concept
concept (3.1) in a partitive relation (3.13) viewed as th
...