EN ISO 13120:2019
(Main)Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML) (ISO 13120:2019)
Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML) (ISO 13120:2019)
The main purpose of ClaML is to formally represent the content and hierarchical structure of healthcare classification systems in a markup language for the safe exchange and distribution of data and structure between organizations and dissimilar software products.
The scope of healthcare classification systems covered by this document encompasses terminologies, and is constrained to traditional paper-based systems (like ICD-10) and systems built according to categorial structures and a cross thesaurus (like ICNP)[2]. ClaML is intended for representation of healthcare classification systems in which classes have textual definitions, hierarchical ordering, named hierarchical levels (such as "chapter", "section"), inclusion and exclusion criteria, and codes. It is not intended to cover any formal representation, neither for definition or composition of concepts, nor for specification of classification rules. Systems with such formal specifications can at best be partially represented using ClaML, and are hence out of scope. Most of the notes and examples in this document relate to ICD. This is because ICD is the most common classification system in the scope of this document. As a highly complex classification system it is an inexhaustible source for examples of nearly any kind. But all these notes and examples represent also other similar classification systems, if applicable, which are usually less complex. An overview of currently known classification systems using ClaML is provided in a separate document which is electronically available (see 7.3).
This document is not intended to:
a) provide a normative syntax on how a healthcare classification system is to be constructed;
b) define link types between elements in a healthcare classification system (this is left to the developers of healthcare classification systems);
c) provide a representation for direct viewing or printing.
Medizinische Informatik - Syntax zur Darstellung des Inhalts von Klassifikationssystemen für das Gesundheitswesen - Klassifikationsauszeichnungssprache (ClaML) (ISO 13120:2019)
Der Hauptzweck der Klassifikationsauszeichnungsklasse (ClaML) ist die formale Darstellung des Inhalts und
der hierarchischen Struktur von Klassifikationssystemen der Gesundheitsversorgung in einer Auszeichnungssprache
(en: markup language), um den sicheren Austausch und die Verbreitung von Daten und
Struktur zwischen Organisationen und verschiedenen Softwareprodukten zu ermöglichen.
Der Anwendungsbereich von Klassifikationssystemen der Gesundheitsversorgung, welche durch dieses
Dokument abgedeckt werden, umfasst Terminologien und ist beschränkt auf traditionelle, papierbasierte
Systeme (wie z. B. die ICD-10) und Systeme, die nach kategorialen Strukturen und einem Cross-Thesaurus
aufgebaut sind (wie z. B. die ICNP) [2]. ClaML ist für die Darstellung von Klassifikationssystemen für die
Gesundheitsversorgung vorgesehen, deren Klassen Textdefinitionen, eine hierarchische Ordnung, benannte
hierarchische Ebenen (wie z. B. “Kapitel”, “Abschnitt”), Einschluss- bzw. Ausschlusskriterien und Codes
enthalten. Sie ist nicht zur Abdeckung jeglicher formaler Darstellungen vorgesehen, weder zur Definition
oder Zusammensetzung von Konzepten noch zur Festlegung von Klassifikationsregeln. Systeme mit derartigen
formalen Festlegungen können bestenfalls teilweise durch ClaML dargestellt werden und liegen
deshalb außerhalb des Anwendungsbereiches. Die meisten Anmerkungen und Beispiele in diesem Dokument
beziehen sich auf die ICD. Dies liegt daran, dass die ICD das gängigste Klassifikationssystem im
Anwendungsbereich dieses Dokument ist. Als hochkomplexes Klassifikationssystem ist sie eine
unerschöpfliche Quelle für Beispiele fast jeder Art. All diese Anmerkungen und Beispiele gelten jedoch,
sofern anwendbar, auch für andere vergleichbare Klassifikationssysteme, die allerdings meist weniger
komplex sind. Ein Überblick über die derzeit bekannten Klassifikationssysteme der Gesundheitsversorgung
auf Basis von ClaML wird in einem gesonderten Dokument bereitgestellt, das elektronisch verfügbar ist
(siehe 7.3).
Dieses Dokument ist nicht dafür gedacht:
a) eine normative Syntax hinsichtlich des Aufbaus eines Klassifikationssystems der Gesundheitsversorgung
bereitzustellen;
b) Zusammenhänge zwischen Elementen von Klassifikationssystemen der Gesundheitsversorgung zu
definieren (dies obliegt den Entwicklern von Klassifikationssystemen der Gesundheitsversorgung);
c) ein direktes Darstellungs- und Druckformat bereitzustellen.
Informatique de santé - Syntaxe de représentation du contenu des systèmes de classification des soins de santé - Langage de balisage de la classification (ClaML) (ISO 13120:2019)
Le langage de balisage de classification (ClaML) vise principalement à représenter de manière formelle le contenu et la structure hiérarchique des systèmes de classification des soins de santé dans un langage de balisage pour l'échange et la diffusion sécurisés des données et de la structure entre les organismes et les produits logiciels dissemblables.
Le domaine d'application des systèmes de classification des soins de santé couvert par le présent document comprend les terminologies et se limite aux systèmes papier traditionnels (par exemple CIM-10) et aux systèmes compositionnels élaborés selon des structures catégorielles et un thésaurus croisé (par exemple ICNP).[2] Le langage de balisage de classification ClaML est destiné à la représentation de systèmes de classification des soins de santé dont les classes comportent des définitions textuelles, une hiérarchisation, des niveaux hiérarchiques nommés [tels que «chapter» (chapitre), «section» (section)], des critères d'inclusion et d'exclusion ainsi que des codes. Il n'est pas destiné à couvrir la représentation formelle d'aucune sorte, ni la définition de concepts, ni la spécification des règles de classification. Les systèmes contenant ces spécifications formelles ne peuvent être au mieux que partiellement représentés à l'aide de ClaML et ne sont donc pas couverts par le domaine d'application. La plupart des notes et des exemples du présent document sont relatifs au système CIM. En effet, le système de classification CIM est le plus courant dans le domaine d'application du présent document. Ce système de classification étant d'une grande complexité, il constitue une source inépuisable d'exemples de toutes sortes ou presque. Cependant, l'ensemble de ces notes et exemples représentent également d'autres systèmes de classification similaires généralement moins complexes, le cas échéant. Une vue d'ensemble des systèmes de classification actuels utilisant ClaML est fournie dans un document séparé, disponible sous forme électronique (voir 7.3).
Le présent document n'a pas pour objet de:
a) fournir une syntaxe normative sur la manière dont un système de classification des soins de santé doit être construit;
b) définir les types de liens entre les éléments d'un système de classification des soins de santé. Cette tâche appartient aux concepteurs des systèmes de classification des soins de santé;
c) fournir une représentation permettant une visualisation ou une impression directe.
Zdravstvena informatika - Sintaksa predstavitve vsebine klasifikacijskih sistemov v medicini - Označevalski jezik za klasifikacijo (ClaML) (ISO 13120:2019)
Glavni namen ClaML je, da formalno predstavlja vsebino in hierarhično strukturo klasifikacijskih sistemov na področju zdravstva z označevalskim jezikom za varno izmenjavo ter distribucijo podatkov in struktur med organizacijami ter različnimi programskimi izdelki.
Obseg klasifikacijskih sistemov na področju zdravstva, zajet v tem dokumentu, vključuje terminologije in je omejen na tradicionalne papirne sisteme (kot je ICD-10) ter sisteme, zgrajene v skladu s kategorijskimi strukturami in navzkrižnim tezavrom (kot ICNP) [2]. ClaML je namenjen predstavitvi klasifikacijskih sistemov na področju zdravstva, v katerih razredi vključujejo besedilne definicije, hierarhično urejanje po hierarhičnih ravneh (kot so »poglavje«, »razdelek«), merila za vključitev in izključitev ter šifre. Ni namenjen za kakršno koli formalno predstavitev, prav tako ne za opredelitev ali sestavo pojmov, niti za določitev klasifikacijskih pravil. Sistemi s takšnimi formalnimi specifikacijami so lahko s ClaML v najboljšem primeru delno predstavljeni in so torej zunaj področja uporabe. Večina opomb in primerov v tem dokumentu se nanaša na ICD. To je zato, ker je ICD najpogostejši klasifikacijski sistem na področju uporabe tega dokumenta. Kot zelo zapleten klasifikacijski sistem je neizčrpen vir primerov skoraj vseh vrst. Toda vsi ti napotki in primeri predstavljajo tudi druge podobne klasifikacijske sisteme, kot je ustrezno, ki so običajno manj zapleteni. Pregled trenutno znanih klasifikacijskih sistemov, ki uporabljajo ClaML, je podan v ločenem dokumentu, ki je na voljo v elektronski obliki (glej 7.3).
Namen tega dokumenta ni:
a) zagotoviti normativno sintakso o tem, kako naj bo zgrajen klasifikacijski sistem na področju zdravstva;
b) določiti vrste povezav med elementi v klasifikacijskem sistemu na področju zdravstva (to je prepuščeno razvijalcem klasifikacijskih sistemov na področju zdravstva);
c) zagotoviti predstavitev za neposreden ogled ali tiskanje.
General Information
Relations
Overview
EN ISO 13120:2019 (ISO 13120:2019) specifies the Classification Markup Language (ClaML) - a syntax for formally representing the content and hierarchical structure of healthcare classification systems. ClaML is an XML‑based format (now defined by an XML Schema Definition (XSD) and aligned with HTML) designed to support safe exchange and distribution of classification data and structure between organizations and dissimilar software products.
ClaML covers traditional paper‑based classification systems (for example ICD‑10) and categorial systems built with a cross‑thesaurus structure (for example ICNP). It represents classes that include textual definitions, hierarchical ordering, named levels (such as “chapter” or “section”), inclusion/exclusion criteria, and codes. It is explicitly not intended to represent formal concept definitions, compositional concept models, or classification rules.
Key Topics and Technical Requirements
- Scope and limits: Supports terminologies and traditional classification systems; excludes full formal concept composition and rule specification.
- XML Schema (XSD): Replaces the previous DTD with an XSD to validate ClaML documents. XSD files and informative annexes are made available via the ISO Standards Maintenance Portal.
- HTML alignment: ClaML syntax has been aligned with HTML to facilitate safe inclusion of formatted text and anchors.
- Semantic model: Detailed semantic descriptions for elements such as Classification, Class, Rubric, Modifier, Identifier, Title, History, Super/SubClass relationships, and more.
- Conformance and implementation profile: Guidance on how to implement ClaML, including suggested attribute values and examples (Annex A–C are informative).
- Not intended for printing/viewing: ClaML is a structural exchange format, not a layout or presentation format.
Applications and Who Uses It
- Health informatics teams maintaining national or organizational classification releases (ICD, ICNP, etc.).
- EHR vendors and software developers implementing import/export, lookup, and coding tools.
- Terminologists and clinical coders who manage code lists, inclusion/exclusion notes, and hierarchical relationships.
- Health statistics authorities and public health organizations exchanging standardized classification content across systems.
- Interoperability architects using ClaML for consistent, machine‑readable distribution of classification versions and updates.
Practical uses include standardized exchange of code sets, automated ingestion into clinical systems, version control of classifications, and enabling mapping workflows between classification systems.
Related Standards and Notes
- Prepared by ISO/TC 215 (Health informatics) and endorsed as EN ISO 13120:2019 (supersedes the 2013 edition).
- ClaML complements other health informatics standards for terminology services and interoperability but does not define how classifications are constructed or linked - those decisions remain with system developers and standards bodies.
Keywords: ClaML, ISO 13120, health informatics, classification markup language, healthcare classification systems, ICD‑10, ICNP, XML Schema, XSD, terminology exchange.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2019
Nadomešča:
SIST EN ISO 13120:2013
Zdravstvena informatika - Sintaksa predstavitve vsebine klasifikacijskih sistemov
v medicini - Označevalski jezik za klasifikacijo (ClaML) (ISO 13120:2019)
Health informatics - Syntax to represent the content of healthcare classification systems -
Classification Markup Language (ClaML) (ISO 13120:2019)
Medizinische Informatik - Syntax zur Darstellung des Inhalts medizinischer
Klassifikationssysteme - Klassifikations-Auszeichnungssprache (ClaML) (ISO
13120:2019))
Informatique de santé - Syntaxe de représentation du contenu des systèmes de
classification des soins de santé - Langage de marquage de la classification (ClaML)
(ISO 13120:2019)
Ta slovenski standard je istoveten z: EN ISO 13120:2019
ICS:
35.060 Jeziki, ki se uporabljajo v Languages used in
informacijski tehniki in information technology
tehnologiji
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.
EN ISO 13120
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 13120:2013
English Version
Health informatics - Syntax to represent the content of
healthcare classification systems - Classification Markup
Language (ClaML) (ISO 13120:2019)
Informatique de santé - Syntaxe de représentation du Medizinische Informatik - Syntax zur Darstellung des
contenu des systèmes de classification des soins de Inhalts medizinischer Klassifikationssysteme -
santé - Langage de balisage de la classification (ClaML) Klassifikations-Auszeichnungssprache (ClaML) (ISO
(ISO 13120:2019) 13120:2019)
This European Standard was approved by CEN on 16 November 2018.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13120:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 13120:2019) 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 November 2019, and conflicting national standards
shall be withdrawn at the latest by November 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 13120:2013.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 13120:2019 has been approved by CEN as EN ISO 13120:2019 without any modification.
INTERNATIONAL ISO
STANDARD 13120
Second edition
2019-04
Health informatics — Syntax to
represent the content of healthcare
classification systems — Classification
Markup Language (ClaML)
Informatique de santé — Syntaxe de représentation du contenu des
systèmes de classification des soins de santé — Langage de balisage
de la classification (ClaML)
Reference number
ISO 13120:2019(E)
©
ISO 2019
ISO 13120:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 13120:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 Conformance . 2
6 Conventions . 2
7 Classification markup language . 2
7.1 Basis of the syntax . 2
7.2 HTML inclusion . 2
7.3 Electronic inserts . 3
7.4 Informative addenda . 3
7.5 ClaML implementation profile . . 4
7.6 XML Schema Definition. 4
7.7 Semantic description of the Classification Markup Language .12
7.7.1 ClaML .12
7.7.2 Classification .12
7.7.3 Meta .14
7.7.4 Identifier .16
7.7.5 Title .17
7.7.6 Authors .17
7.7.7 Author .18
7.7.8 Variants .18
7.7.9 Variant .19
7.7.10 ClassKinds . .19
7.7.11 ClassKind .20
7.7.12 UsageKinds .20
7.7.13 UsageKind .21
7.7.14 Usage .21
7.7.15 RubricKinds .22
7.7.16 RubricKind .22
7.7.17 Display .23
7.7.18 Modifier .24
7.7.19 ModifierClass .25
7.7.20 Class .26
7.7.21 ModifiedBy .27
7.7.22 ExcludeModifier .29
7.7.23 ValidModifierClass .30
7.7.24 Rubric .31
7.7.25 Label .32
7.7.26 Extended XHTML anchor element (a) .33
7.7.27 History .35
7.7.28 SuperClass .35
7.7.29 SubClass .36
7.7.30 Fragment .37
7.7.31 Include .38
7.7.32 IncludeDescendants .39
Annex A (informative) Examples of usage of ClaML .41
Annex B (informative) Suggested usage of ClaML attribute values .45
ISO 13120:2019(E)
Annex C (informative) Different ways of modification .47
Bibliography .58
iv © ISO 2019 – All rights reserved
ISO 13120:2019(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
This second edition cancels and replaces the first edition (ISO 13120:2013), which has been technically
revised. The main changes compared to the previous edition are as follows:
— Alignment of the Classification Markup Language (ClaML) to HTML;
— Replacement of the format ‘Document Type Definition’ (DTD) by an ‘XML Schema Definition’
(XSD);
— Provision of XSD files and further informative Annexes on the ISO Standards Maintenance Portal;
— Addition of a new Annex C on ‘Different ways of modification’;
— Complete editorial revision.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
ISO 13120:2019(E)
Introduction
Healthcare classification systems are developed and distributed in a variety of informal formats, such
as MS Word, with little consistency in approach between developers. Exchanging data from these
systems or attempting to parse the informal text into a more formal structure, say for publishing
purposes, presents many challenges because mistakes are easily made and difficult to detect. For
example, the accidental deletion of a tab can transform a sibling rubric into a parent. Text files with
comma-separated value fields are another mechanism widely used for storing and transferring data,
but as a solution here are limited by insufficient formal structuring capabilities.
In the interests of safely exchanging and distributing the content and hierarchical structure of
healthcare classification systems, this document presents a simple XML specification, ClaML, for
exchange and distribution of healthcare classification systems. XML is the chosen format for this syntax
as: a) XML provides the necessary structuring elements, and b) there are many readily available XML
parsers in existence.
This document builds on EN 14463:2008 and ISO 13120:2013.
In this version of the syntax representing ClaML 3.0.0 there had been performed a lot of structural
and content-related changes to solve known problems with ClaML 2.0.0 according to experiences out of
practical use and to serve additional demands of classification developers and end users. Major changes
are the replacement of the DTD (Document Type Definition) by an XSD (XML Schema Definition) and
the alignment with HTML by inclusion of XHTML 1.1.
ClaML is intended to serve as the core representation from which all publication forms can be derived.
It contains information of a depth sufficient to uniquely identify and describe the structure and relevant
elements of healthcare classification systems. This document does not intend to prescribe to developers
how healthcare classification systems should be structured, nor does it define or explain the meaning
of the structuring elements. ClaML is not meant to be a direct format for viewing or printing the content
of a healthcare classification system. Views and prints are to be derived from this representation by
post processing.
ClaML is targeted at:
[1]
a) developers of first generation healthcare classification systems to assist in the construction,
maintenance and publication (both in paper and electronic formats) of their particular healthcare
classification systems;
b) developers of information systems to assist in the inclusion of mechanisms for unambiguous
loading of healthcare classification systems into their applications;
c) organizations responsible for updating healthcare classification systems;
d) institutions receiving updated healthcare classification systems.
vi © ISO 2019 – All rights reserved
INTERNATIONAL STANDARD ISO 13120:2019(E)
Health informatics — Syntax to represent the content of
healthcare classification systems — Classification Markup
Language (ClaML)
1 Scope
The main purpose of ClaML is to formally represent the content and hierarchical structure of healthcare
classification systems in a markup language for the safe exchange and distribution of data and structure
between organizations and dissimilar software products.
The scope of healthcare classification systems covered by this document encompasses terminologies,
and is constrained to traditional paper-based systems (like ICD-10) and systems built according to
[2]
categorial structures and a cross thesaurus (like ICNP) . ClaML is intended for representation of
healthcare classification systems in which classes have textual definitions, hierarchical ordering,
named hierarchical levels (such as “chapter”, “section”), inclusion and exclusion criteria, and codes. It
is not intended to cover any formal representation, neither for definition or composition of concepts,
nor for specification of classification rules. Systems with such formal specifications can at best be
partially represented using ClaML, and are hence out of scope. Most of the notes and examples in this
document relate to ICD. This is because ICD is the most common classification system in the scope of
this document. As a highly complex classification system it is an inexhaustible source for examples of
nearly any kind. But all these notes and examples represent also other similar classification systems,
if applicable, which are usually less complex. An overview of currently known classification systems
using ClaML is provided in a separate document which is electronically available (see 7.3).
This document is not intended to:
a) provide a normative syntax on how a healthcare classification system is to be constructed;
b) define link types between elements in a healthcare classification system (this is left to the
developers of healthcare classification systems);
c) provide a representation for direct viewing or printing.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 3166-1, Codes for the representation of names of countries and their subdivisions — Part 1: Country codes
ISO 639-1, Codes for the representation of names of languages — Part 1: Alpha-2 code
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
ISO 13120:2019(E)
4 Abbreviated terms
ClaML Classification Markup Language
DTD Document Type Definition
[4][5][6]
HTML HyperText Markup Language
ICD International Classification of Diseases
ICF International Classification of Functioning, Disability and Health
ICNP International Classification for Nursing Practice
OPS “Operationen und Prozedurenschlüssel”, the German procedure classification
WHO World Health Organization
[4][5][7]
XHTML Extensible HyperText Markup Language
[3]
XML Extensible Markup Language 1.0
XSD XML Schema Definition
5 Conformance
The normative part of this document is written in the form of an XML Schema Definition (XSD). Many
commercially available XML tools provide facilities to test the conformance of an XML document with
an XSD. Users of ClaML are encouraged to perform such a test before distributing their healthcare
classification systems in the format of this document.
6 Conventions
The font Courier New is used to denote XSD or XML content of ClaML. XML examples in this document
are only a partial representation of a ClaML file. For reasons of readability parts are left out at “.”.
In descriptive parts of this document bold text is used to denote elements and attributes defined in the
XSD. For names of elements Upper CamelCase is used (i.e. a single string, consisting of multiple words
without spaces, each starting with a capital); for names of attributes lowercase is used. Italic text in
quotation marks is used to denote attribute values.
NOTE Names of externally defined XHTML 1.1 elements are in lowercase.
7 Classification markup language
7.1 Basis of the syntax
The basis of the syntax is to represent the content of healthcare classification systems. The syntax
defined in this document is called Classification Markup Language. It is defined here in the form of
an XSD. The reference to this syntax will be headed to ClaML in this document. The version of ClaML
described in this document is version 3.0.0.
7.2 HTML inclusion
In the previous ClaML 2.0.0 version internally defined elements were used for representation of textual
content of a healthcare classification system. These elements originated from the DocBook standard.
Experiences with this version raised the wish to align ClaML to HTML for various reasons (e.g. HTML
2 © ISO 2019 – All rights reserved
ISO 13120:2019(E)
is more common, it enables easier transformation between different formats and it contains in ClaML
so far missing features for accessibility demands). Therefore for this version these elements have been
removed and replaced by inclusion of externally defined equivalent content of HTML. The module-
[5][7]
based XHTML 1.1 definition appeared to be the most suitable candidate for integration as it allows
the inclusion of the model (xhtml11-model-1.xsd) and modules (xhtml11-modules-1.xsd) schema files
into the same namespace of ClaML. This enables the use of these elements in a ClaML file without a
prefix. Extensions by redefinition of XHTML modules allow keeping ClaML specific functions. This
[6]
XHTML 1.1 inclusion should as well cover functionality of the HTML 5 specification in its basics,
which is not available as XML Schema Definition file. However, this partial inclusion does not meet
the official criteria for XHTML Host Language Document Type Conformance or XHTML Integration
Set Conformance. ClaML may therefore not be called “XHTML Host Language Conforming” or “XHTML
[7]
Integration Set Conforming” .
For further information on the specific use of XHTML 1.1 elements in ClaML refer to the notes on the
Label element in 7.7.25.1 and the extended XHTML anchor element (a) in 7.7.26.
7.3 Electronic inserts
The following electronic inserts are located in the ISO Standards Maintenance Portal 13120 folder:
http: //standards .iso .org/iso/13120/ed -2/en.
In the versions of ClaML published so far (EN 11463:2008, ISO 13120:2013), the DTD was only a regular
part of the text document. In this version 3.0.0 of the syntax, the XML Schema Definition as given in 7.6
is also provided as electronic insert. The ClaML3.0.0.xsd file has been uploaded to the ISO database and
is electronically available.
Direct link: http: //standards .iso .org/iso/13120/ed -2/en/ClaML3 .0 .0 .xsd
Also a DTD and an XSD file of the previous version 2.0.0 have been generated to support users upgrading
to the new version. In the versions of ClaML published so far (EN 11463:2008, ISO 13120:2013), the
specification was only defined as DTD. So for this revision the old DTD needed to be translated into an
XSD first as basis for any further changes. Changes are much more comprehensible when comparing
the new ClaML 3.0.0 XSD to this file instead of the old DTD. This XSD file might as well be used as
replacement for the old DTD when dealing with ClaML 2.0.0-based healthcare classification systems.
The files are stored in the ed-1-en.zip file. File names: ClaML2.0.0.dtd and ClaML2.0.0.xsd.
Direct link: http: //standards .iso .org/iso/13120/ed -2/en/ed -1 -en .zip
7.4 Informative addenda
The following informative addenda are located in the ISO Standards Maintenance Portal 13120 folder:
http: //standards .iso .org/iso/13120/ed -2/en.
According to the substantial changes from the previous ClaML version 2.0.0 to this version 3.0.0 some
informative documents have been generated. These documents will help to better understand the
changes and facilitate the transfer of healthcare classification systems to the new version.
The “ClaML_XSD_2.0.0_TO_3.0.0” document illustrates the changes of the specification in detail and
shall help users to better understand them and facilitate an update to the new version. All changes
based on the ClaML 2.0.0 XSD are yellow highlighted. Insertions are displayed as red and underlined
text. Deletions are displayed as blue and striked-through text. The ClaML_XSD_2.0.0_TO_3.0.0.pdf file
has been uploaded to the ISO database and is electronically available.
Direct link: http: //standards .iso .org/iso/13120/ed -2/en/ClaML _XSD _2 .0 .0 _TO _3 .0 .0 .pdf
The “Inventory of classification systems using ClaML” document gives an overview of currently known
healthcare classification systems using ClaML. These might serve as example healthcare classification
systems when considering representing a new healthcare classification system in ClaML and gives a
better understanding of the scope of the syntax. The file is stored in the ed-1-en.zip file. File name:
Inventory_of_classification_systems_using_ClaML_2016-02-15.pdf.
ISO 13120:2019(E)
Direct link: http: //standards .iso .org/iso/13120/ed -2/en/ed -1 -en .zip
The “ClaML 2.0.0 structure” document displays the ClaML 2.0.0 structure in a diagram. The file is stored
in the ed-1-en.zip file. File name: ClaML2.0.0_structure.pdf.
Direct link: http: //standards .iso .org/iso/13120/ed -2/en/ed -1 -en .zip
The “ClaML 3.0.0 structure” document displays the ClaML 3.0.0 structure in a diagram. The ClaML3.0.0_
structure.pdf file has been uploaded to the ISO database and is electronically available.
Direct link: http: //standards .iso .org/iso/13120/ed -2/en/ClaML3 .0 .0 _structure .pdf
7.5 ClaML implementation profile
ClaML offers a wide range of possibilities for the representation of classification content. The defined
XML structure partially allows tree structures of endless depth. This generates serious problems
for end users when importing ClaML files. As healthcare classification systems nowadays contain a
huge amount of data, so do the resulting ClaML files. Therefore it is difficult for end users to oversee
what needs to be addressed in their import routines so that no important information of the files is
overlooked.
Hence classification system developers are highly encouraged to provide an implementation profile
with their ClaML files. Such an implementation profile should at a minimum address the following
questions:
— which elements and attributes are used in the current ClaML file;
— maximum expectable depth of the tree structure regarding potentially endless branches;
— subclassificiation structure (e.g. maximum level, use of multiple modifiers);
— notes on further necessary post-processing for generation of output formats.
7.6 XML Schema Definition
xmlns:xml="http://www.w3.org/XML/1998/namespace"
elementFormDefault="qualified" attributeFormDefault="unqualified">
schemaLocation="http://www.w3.org/2001/xml.xsd"/>
use="optional"/>
4 © ISO 2019 – All rights reserved
ISO 13120:2019(E)
maxOccurs="unbounded"/>
maxOccurs="unbounded"/>
maxOccurs="unbounded"/>
maxOccurs="unbounded"/>
maxOccurs="unbounded"/>
maxOccurs="unbounded"/>
default="default"/>
refer="Class-code-key">
ISO 13120:2019(E)
refer="Modifier-code-key">
refer="Modifier-code-key">
refer="Modifier-code-key">
refer="ClassKind-name-key">
6 © ISO 2019 – All rights reserved
ISO 13120:2019(E)
maxOccurs="unbounded"/>
use="optional"/>
use="optional"/>
use="optional"/>
use="optional"/>
use="optional"/>
use="optional"/>
maxOccurs="unbounded"/>
use="optional"/>
ISO 13120:2019(E)
maxOccurs="unbounded"/>
maxOccurs="unbounded"/>
use="optional"/>
maxOccurs="unbounded"/>
...
Frequently Asked Questions
EN ISO 13120:2019 is a standard published by the European Committee for Standardization (CEN). Its full title is "Health informatics - Syntax to represent the content of healthcare classification systems - Classification Markup Language (ClaML) (ISO 13120:2019)". This standard covers: The main purpose of ClaML is to formally represent the content and hierarchical structure of healthcare classification systems in a markup language for the safe exchange and distribution of data and structure between organizations and dissimilar software products. The scope of healthcare classification systems covered by this document encompasses terminologies, and is constrained to traditional paper-based systems (like ICD-10) and systems built according to categorial structures and a cross thesaurus (like ICNP)[2]. ClaML is intended for representation of healthcare classification systems in which classes have textual definitions, hierarchical ordering, named hierarchical levels (such as "chapter", "section"), inclusion and exclusion criteria, and codes. It is not intended to cover any formal representation, neither for definition or composition of concepts, nor for specification of classification rules. Systems with such formal specifications can at best be partially represented using ClaML, and are hence out of scope. Most of the notes and examples in this document relate to ICD. This is because ICD is the most common classification system in the scope of this document. As a highly complex classification system it is an inexhaustible source for examples of nearly any kind. But all these notes and examples represent also other similar classification systems, if applicable, which are usually less complex. An overview of currently known classification systems using ClaML is provided in a separate document which is electronically available (see 7.3). This document is not intended to: a) provide a normative syntax on how a healthcare classification system is to be constructed; b) define link types between elements in a healthcare classification system (this is left to the developers of healthcare classification systems); c) provide a representation for direct viewing or printing.
The main purpose of ClaML is to formally represent the content and hierarchical structure of healthcare classification systems in a markup language for the safe exchange and distribution of data and structure between organizations and dissimilar software products. The scope of healthcare classification systems covered by this document encompasses terminologies, and is constrained to traditional paper-based systems (like ICD-10) and systems built according to categorial structures and a cross thesaurus (like ICNP)[2]. ClaML is intended for representation of healthcare classification systems in which classes have textual definitions, hierarchical ordering, named hierarchical levels (such as "chapter", "section"), inclusion and exclusion criteria, and codes. It is not intended to cover any formal representation, neither for definition or composition of concepts, nor for specification of classification rules. Systems with such formal specifications can at best be partially represented using ClaML, and are hence out of scope. Most of the notes and examples in this document relate to ICD. This is because ICD is the most common classification system in the scope of this document. As a highly complex classification system it is an inexhaustible source for examples of nearly any kind. But all these notes and examples represent also other similar classification systems, if applicable, which are usually less complex. An overview of currently known classification systems using ClaML is provided in a separate document which is electronically available (see 7.3). This document is not intended to: a) provide a normative syntax on how a healthcare classification system is to be constructed; b) define link types between elements in a healthcare classification system (this is left to the developers of healthcare classification systems); c) provide a representation for direct viewing or printing.
EN ISO 13120:2019 is classified under the following ICS (International Classification for Standards) categories: 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 13120:2019 has the following relationships with other standards: It is inter standard links to EN ISO 13120:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 13120:2019 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
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