SIST EN ISO 1828:2012
(Main)Health informatics - Categorial structure for terminological systems of surgical procedures (ISO 1828:2012)
Health informatics - Categorial structure for terminological systems of surgical procedures (ISO 1828:2012)
This International Standard specifies the minimal characteristics of a categorial structure for terminological systems of surgical procedures and the minimal domain constraints to support interoperability, comparability and the exchange of meaningful information on surgical procedures, independently of the language, insofar as the significant differences are specified by the system.
Medizinische Informatik - Kategoriale Struktur für Klassifikationen und Kodierungssysteme für chirurgische Prozeduren (ISO 1828:2012)
Informatique de santé - Structure catégorielle pour les systèmes terminologiques des interventions chirurgicales (ISO 1828:2012)
L'ISO 1828:2012 spécifie les caractéristiques minimales d'une structure catégorielle destinée aux systèmes terminologiques d'interventions chirurgicales et les contraintes du domaine minimales nécessaires pour appuyer l'interopérabilité, la comparabilité et l'échange d'informations signifiantes sur les interventions chirurgicales, indépendamment du langage, dans la mesure où les différences significatives sont spécifiées par le système.
L'ISO 1828:2012 est applicable aux systèmes terminologiques d'interventions chirurgicales de toutes les disciplines chirurgicales. Elle ne traite que de la partie terminologique, telle que définie dans l'ISO 1087-1:2000, des systèmes terminologiques des interventions chirurgicales.
L'ISO 1828:2012 est destinée à être utilisée avec des applications informatiques, dont elle fera partie intégrante, ou avec le dossier de santé électronique.
Zdravstvena informatika - Kategorijska struktura za terminološke sisteme (klasifikacijo in kodiranje) kirurških postopkov (ISO 1828:2012)
Ta mednarodni standard določa minimalne značilnosti kategorijske strukture za terminološke sisteme kirurških postopkov in minimalne domenske omejitve za podporo interoperabilnosti, primerljivosti in izmenjave uporabnih podatkov o kirurških postopkih, neodvisno od jezika, v primerih, ko bistvene razlike določa sistem.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 1828:2012
01-november-2012
1DGRPHãþD
SIST EN 1828:2003
Zdravstvena informatika - Kategorijska struktura za terminološke sisteme
(klasifikacijo in kodiranje) kirurških postopkov (ISO 1828:2012)
Health informatics - Categorial structure for terminological systems of surgical
procedures (ISO 1828:2012)
Medizinische Informatik - Kategoriale Struktur für Klassifikationen und
Kodierungssysteme für chirurgische Prozeduren (ISO 1828:2012)
Informatique de santé - Structure catégorielle pour les systèmes terminologiques des
interventions chirurgicales (ISO 1828:2012)
Ta slovenski standard je istoveten z: EN ISO 1828:2012
ICS:
35.040 Nabori znakov in kodiranje Character sets and
informacij information coding
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 1828:2012 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 1828:2012
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SIST EN ISO 1828:2012
EUROPEAN STANDARD
EN ISO 1828
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2012
ICS 35.240.80 Supersedes EN 1828:2002
English Version
Health informatics - Categorial structure for terminological
systems of surgical procedures (ISO 1828:2012)
Informatique de santé - Structure catégorielle pour les Medizinische Informatik - Kategoriale Struktur für
systèmes terminologiques des interventions chirurgicales Klassifikationen und Kodierungssysteme für chirurgische
(ISO 1828:2012) Prozeduren (ISO 1828:2012)
This European Standard was approved by CEN on 14 September 2012.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1828:2012: E
worldwide for CEN national Members.
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SIST EN ISO 1828:2012
EN ISO 1828:2012 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 1828:2012
EN ISO 1828:2012 (E)
Foreword
This document (EN ISO 1828:2012) has been prepared by Technical Committee CEN/TC 251 “Health
informatics", the secretariat of which is held by NEN, in collaboration with Technical Committee ISO/TC 215
"Health informatics".
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 March 2013, and conflicting national standards shall be withdrawn at
the latest by March 2013.
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.
This document supersedes EN 1828:2002.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
3
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SIST EN ISO 1828:2012
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SIST EN ISO 1828:2012
INTERNATIONAL ISO
STANDARD 1828
First edition
2012-09-15
Health informatics — Categorial
structure for terminological systems of
surgical procedures
Informatique de santé — Structure catégorielle pour les systèmes
terminologiques des interventions chirurgicales
Reference number
ISO 1828:2012(E)
©
ISO 2012
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SIST EN ISO 1828:2012
ISO 1828:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
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 2012 – All rights reserved
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SIST EN ISO 1828:2012
ISO 1828:2012(E)
Contents Page
Foreword .iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description of categorial structure for terminological systems of surgical procedures . 5
4.1 General . 5
4.2 Goal of the terminological system for which the categorial structure is set . 5
4.3 Categories . 5
4.4 List of the representations of relations . 5
5 Domain constraint requirements . 5
6 UML (Unified Modeling Language) Diagram . 6
Annex A (informative) Definitions from ISO 17115:2007, 2.7, Terminological systems . 8
Annex B (informative) Categorial structures of the most recent and/or more widespread terminological
systems (in use or in progress) of surgical procedures . 9
Annex C (informative) Excerpt of EN 15521:2007 giving definitions of the entities of the category human
anatomy (see 3.8.2) . 11
Bibliography .14
© ISO 2012 – All rights reserved iii
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SIST EN ISO 1828:2012
ISO 1828:2012(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 1828 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 251, Health informatics, in collaboration with ISO Technical Committee ISO/TC 215, Health informatics,
in accordance with the agreement on technical cooperation between ISO and CEN (Vienna Agreement).
The preparation of this International Standard brought to light an urgent need to review the family of terminological
standards ISO 704, ISO 1087, ISO 17115 and EN 12264 in order to clarify the relations between concept,
generic concept, specific concept, object, class, instance, designation and formal representation. This also
applies to the forthcoming edition of ISO/TR 24156 (all parts).
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SIST EN ISO 1828:2012
ISO 1828:2012(E)
Introduction
The driving factor behind this International Standard is the fact that terminological systems for surgical procedures
are used for a wide range of purposes. Some of the main applications include, for instance, being incorporated
as an integral part of a computerized health care record for use in discharge summary information, for clinical
research, peer review, quality assurance, reimbursement, workload assessment, resource management,
utilization comparisons, public health management and epidemiological surveys. Unlike diagnoses, for which
the International Classification of Diseases (ICD) is an accepted de facto standard, there are at least as many
coding systems for surgical procedures as there are developed countries and, very often, several such coding
systems for different usages or for different surgical disciplines in each country. On the other hand, most of the
countries are unable to satisfy such applications for they lack such terminological systems or use terminological
systems from other countries. This hampers the exchange of meaningful health information, for instance for
international statistical comparisons.
Five types of health care terminological systems are defined in ISO 17115: classifications, coding scheme,
coding systems, reference terminologies and clinical terminologies.
Defining a surgical procedure is considered difficult because there are neither specific criteria to define it nor
specific criteria to define the limit between what a surgical procedure is and what it is not.
Within this International Standard, terminological systems of surgical procedures are defined in the following way:
— In this International Standard, a terminological system of surgical procedures is considered to have been
defined as such by its owner/developer in order to cover surgical procedures. The owner/developer decides
what can be considered a surgical procedure and then defines the content of the terminological system.
Terminological systems for surgical procedures group the different types of terminological systems including
terminological systems defined by ISO 17115:2007, 2.7: classifications, coding scheme, coding systems,
reference terminology and clinical terminology.
ENV 1828:1995 started by identifying the categories of terms in existing procedure classifications within and
outside Europe and also the natural language used in surgical reports. It defined the categorial structure
which contains the definition of a set of categories of terms and the internal relations that combine them into a
conceptual system.
EN 1828:2002 has been widely tested and/or applied in national and European projects (The Nordic NCSP, the
French CCAM, for the revision of UK OPCS and by three German-speaking countries (Austria, Germany and
Switzerland) as well as outside Europe in Australia (ACHI and ICHI) and Canada (CCI).
EN 1828:2002 was based on the assessment of different existing health care terminological systems. They are
made available in the bibliography as the material on which the standard was based. The main terminological
systems of surgical procedures developed since that edition of the standard have been added as well.
WHO-FIC (World Health Organization Family of International Classification) are currently implementing a
project called ICHI (International Classification of Health Intervention) which is intended to be based on a
concept system that is conformant to this International Standard. SNOMED CT IHTSDO has planned to align
the surgical procedures within SNOMED CT with this International Standard.
International standardization efforts by CEN and ISO related to electronic health records and semantic
interoperability have resulted in a number of categorial structures which are a step towards supporting health
care terminological systems with a full concept system or ontology that in turn will support multiple uses and
safe communication. In the present categorial structure standard, several of the definitions of basic terms
related to categorial structures have been updated to comply with the most recent edition of ISO 17115. This
is the first revision of a categorial structure standard developed by CEN or ISO since 1995, and one of several
that are to be reviewed in the next five years. These revisions are being processed in collaboration between
CEN/TC 251 and ISO/TC 215.
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SIST EN ISO 1828:2012
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SIST EN ISO 1828:2012
INTERNATIONAL STANDARD ISO 1828:2012(E)
Health informatics — Categorial structure for terminological
systems of surgical procedures
1 Scope
This International Standard specifies the minimal characteristics of a categorial structure for terminological
systems of surgical procedures and the minimal domain constraints to support interoperability, comparability
and the exchange of meaningful information on surgical procedures, independently of the language, insofar as
the significant differences are specified by the system.
NOTE 1 Further characteristics or more detailed value sets can be used for specific purposes.
NOTE 2 Categorial structures support interoperability by providing common frameworks within which to develop
terminological systems that can be related to each other, and to analyse the properties of different terminological systems
in order to derive relationships between them.
This International Standard is applicable to terminological systems of surgical procedures in all surgical
disciplines. It covers only the terminology part, as defined in ISO 1087-1:2000, of the terminological systems
of surgical procedures.
It is intended to be used by:
— organizations involved with the development or maintenance of terminological systems for surgical
procedures, namely for multipurpose terminological systems on a national or international level;
— organizations developing and maintaining software tools that allow natural clinical language expressions
analysis, generation and mapping to the main existing terminological systems of surgical procedures.
This International Standard is intended to be used as an integrated part of computer-based applications and
for electronic health care records. It is of limited value for manual use.
This International Standard is not suitable for, nor intended for use by, individual clinicians or hospital
administrators. It is not the purpose of this International Standard to standardize the end user terminological
system or to conflict with the concept systems embedded in national practice and languages.
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.
EN 12264, Health informatics — Categorial structures for systems of concepts
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
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.
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SIST EN ISO 1828:2012
ISO 1828:2012(E)
3.2
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.
3.3
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.
3.4
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.
3.5
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.
3.6
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.
3.7
goal
statement on situations and applications for which the categorial structure is intended and its limits of use
3.8 Categories of health care entities for terminological systems of surgical procedures
3.8.1
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.
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SIST EN ISO 1828:2012
ISO 1828:2012(E)
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.
3.8.2
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.
3.8.3
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.
3.8.4
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”.
3.9 List of authorized representations of relations
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SIST EN ISO 1828:2012
ISO 1828:2012(E)
3.9.1
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.
3.9.2
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.
3.9.3
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).
3.9.4
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).
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ISO 1828:2012(E)
NOTE 2 This representation of relation is a hasPart type relation.
4 Description of categorial structure for terminological systems of surgical procedures
4.1 General
A categorial structure for a terminological system of surgical procedures (3.1) claiming conformance to this
International Standard shall provide the information described in 3.8, 3.9 and 4.2 and shall comply with the five
minimal domain constraint requirements specified in Clause 5.
The categorial structures for terminological systems of surgical procedures shall be in accordance with the
categorial structure specified in EN 12264 and in ISO 17115 (see 3.1).
To describe a categorial structure for terminological systems of surgical procedures, the following information
shall be provided:
— categories that organize the health care entities for this terminological system of surgical procedures and
subdivide their representation in the domain;
— list of the representations of relations authorized by domain constraints;
— goal of the terminological system of surgical procedures for which the categorial structure is set.
4.2 Goal of the terminological system for which the categorial structure is set
The goal of each terminological system for surgical procedures shall be defined by the users and make
statement on situations and applications for which the categorial structure is intended and the limits of use.
EXAMPLE Controlled vocabulary, production for clinicians or comparison with another terminological system for
coding centres.
To be conformant with this International Standard, each terminological system for surgical procedures shall
state its goal. To be conformant with EN 12264, each terminological system of health care and biomedical
science shall also state that it is conformant to the categorial structure standard EN 12264 outside the limits of
use in the subject field of surgical procedures.
4.3 Categories
Categories organize the health care entities for this terminological system of surgical procedures and subdivide
their representation in the domain as defined in 3.8.
4.4 List of the representations of relations
The list of the representations of relations is authorized by domain constraints as defined in 3.9.
5 Domain constraint requirements
The list of minimal domain constraints required by the goal of the categorial structure shall contain among
the different authorized representations of relations (3.9) and the different related authorized categories
(3.8) the ones which are valid and necessary for the precise goal (4.2) of a categorial structure (3.1) for a
terminological system of surgical procedures.
5.1 Each surgical procedure terminological phrase shall, as a minimum, consist of a surgical deed (3.8.1)
and have the semantic link hasObject (3.9.1).
5.2 Each surgical procedure terminological phrase shall contain the category human anatomy (3.8.2), in
relation to the semantic link hasObject (3.9.1) or hasSite (3.9.2) when the object does not belong to the
category human anatomy but to the category lesion (3.8.3) or to the category interventional equipment
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