1、August 2016 English price group 13No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 01.020; 35.240.80!%Yla“2547362www
2、.din.deDIN EN ISO 16278Health informatics Categorial structure for terminological systems of human anatomy (ISO 16278:2016);English version EN ISO 16278:2016,English translation of DIN EN ISO 16278:2016-08Medizinische Informatik Kategoriale Struktur fr terminologische Systeme der Anatomie des Mensch
3、en (ISO 16278:2016);Englische Fassung EN ISO 16278:2016,Englische bersetzung von DIN EN ISO 16278:2016-08Informatique de sant Structure catgorielle des systmes terminologiques de lanatomie humaine (ISO 16278:2016);Version anglaise EN ISO 16278:2016,Traduction anglaise de DIN EN ISO 16278:2016-08Supe
4、rsedesDIN EN 15521:2008-02www.beuth.deDocument comprises 24 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.08.16 DIN EN ISO 16278:2016-08 2 A comma is used as the decimal marker. National foreword This document (EN ISO 16278:2
5、016) has been prepared by Technical Committee ISO/TC 215 “Health informatics” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 251 “Health informatics” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (D
6、IN Standards Committee Medicine), Working Committee NA 063-07-03 AA Terminologie. In consideration of the decision of the Board 1/2004, the German version of this standard contains only the original English version of Annex A from EN ISO 16278:2016 (ISO 16278:2016). The DIN Standards corresponding t
7、o the International Standards referred to in this document are as follows: ISO 15225 DIN EN ISO 15225 ISO 18104 DIN EN ISO 18104 Amendments This standard differs from DIN EN 15521:2008-02 as follows: a) the form has been brought in line with the minimally revised European Standard adopted by ISO; b)
8、 in the title, “terminologies systems” has been changed to “terminological systems”; c) some minor editorial changes have been made. Previous editions DIN EN 15521: 2008-02 National Annex NA (informative) Bibliography DIN EN ISO 15225, Medical devices Quality management Medical device nomenclature d
9、ata structure DIN EN ISO 18104, Health informatics Categorical structures for representation of nursing diagnoses and nursing actions in terminological systems EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16278 March 2016 ICS 35.240.80 Supersedes EN 15521:2007English Version Health infor
10、matics - Categorial structure for terminological systems of human anatomy (ISO 16278:2016) Informatique de sant - Structure catgorielle des systmes terminologiques de lanatomie humaine(ISO 16278:2016) Medizinische Informatik - Kategoriale Struktur fr terminologische Systeme der Anatomie des Menschen
11、 (ISO 16278:2016) This European Standard was approved by CEN on 15 January 2016. 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 b
12、ibliographical 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 res
13、ponsibility 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 R
14、epublic 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 COMIT EUROPEN DE NO
15、RMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16278:2016 EForeword 4Introduction 51 Scope .62 Terms and definiti
16、ons .73 Categorial structure for terminologies of human anatomy description 83.1 Principles .83.2 Anatomical categories (2.7) .93.3 Precise goal of the categorial structure (2.10) .113.4 List of anatomical relations (2.8) .123.5 List of minimal anatomical domain constraints (2.9) 144 Conformance 14A
17、nnex A (informative) A reference ontology for biomedical informatics: the Foundational Model of Anatomy .15Bibliography .21Contents PageEN ISO 16278:2016 (E) DIN EN ISO 16278:2016-08 2European foreword .3European foreword This document (EN ISO 16278:2016) has been prepared by Technical Committee ISO
18、/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 Sept
19、ember 2016, and conflicting national standards shall be withdrawn at the latest by September 2016. 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 pa
20、tent rights. This document supersedes EN 15521:2007. 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, Finlan
21、d, 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. Endorsement notice The text of ISO
22、 16278:2016 has been approved by CEN as EN ISO 16278:2016 without any modification. EN ISO 16278:2016 (E) DIN EN ISO 16278:2016-08 3 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Inte
23、rnational 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 wi
24、th 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
25、, 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
26、 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 declaration
27、s 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 on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about I
28、SOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 215, Health informatics.EN ISO 16278:2016 (E) DIN EN ISO 16278:2016-08 4 IntroductionThis International Standa
29、rd specifies a categorial structure for terminologies of human anatomy. Computer-based processing and the interchange of medical or clinical information requires various kinds of terminological systems to represent that information, such as controlled vocabularies, classifications, nomenclatures, te
30、rminologies and thesauri, with or without coding schemes.The specific terminological issues in the field of health informatics are the following: large number of different terminological systems are available in different clinical specialties; large overlap among the subject fields involved; large n
31、umber 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
32、of computer-based medical records and administrative information systems in Electronic Health Records (EHR) require rationalization 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 sende
33、r EHR and not only the string of characters embedded in it.It is not possible to impose a rigid, uniform, standardized, natural language clinical terminology on healthcare professional providers. Nevertheless, standards need to be provided for guiding the development of terminologies in the differen
34、t sub domains of healthcare to allow semantic interoperability between them. To this end, a domain specific semantic representation has been developed (EN 12264) and applied in a series of specific initiatives, including European Pre standards (ENV), European Standards (EN) and International Standar
35、ds (ISO) on various subject fields to describe a set of categorial structures in partially overlapping subject fields. Human anatomy is central to medical terminology (surgical procedures, carcinoma staging, annotation of radiological findings, disease, clinical laboratory and so forth) and also to
36、many scientific and bio-informatics study beyond the scope of clinical medicine. In the US, the University of Washington has developed in the public domain an anatomical terminology for EHR named the Digital Anatomist Foundational Model of Anatomy (FMA for short), a reference ontology for biomedical
37、 informatics.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 healthcare terminological systems with a full concept system or ontology that in
38、 turn will support multipurpose 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 version of ISO 17115.Adequate field testing in several countries, rev
39、ision and integration have provided the comprehensive basis for this International Standard.EN ISO 16278:2016 (E) DIN EN ISO 16278:2016-08 5 1 ScopeThis International Standard defines the characteristics required to synthetically describe the organization and content of human anatomy within a termin
40、ological system. It is intended primarily for use with computer-based applications such as clinical electronic health records, decision support and for various bio-medical research purposes.This International Standard will serve to facilitate the construction of new terminological systems in a regul
41、ar form which will increase their coherence and expressiveness, facilitate maintenance of human anatomy within terminological systems, increase consistency and coherence of existing terminological system, allow systematic cross-references between items of human anatomy in different types of terminol
42、ogical systems, facilitate convergence among human anatomy within terminological systems, make explicit the overlap for human anatomy between different health care domains terminological systems, provide elements for negotiation about integration of different terminological systems into information
43、systems between the respective developers, and enable the systematic evaluation of human anatomy within terminological systems.The International Standard itself is not suitable or intended for use by, individual clinicians or hospital administrators.The target groups for this International Standard
44、are the following: designers of specialized 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 pr
45、ocessing; information modellers, knowledge engineers, and standards developers building models for health information management systems; developers of information systems that require an explicit representation of healthcare terminological systems; developers of marked-up standards for representati
46、on of healthcare documents.This International Standard does not include categorial structure that might be necessary for the description of developmental anatomy during the human life cycle, which includes prenatal development, post-natal growth and aging.This International Standard has been develop
47、ed 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.EN ISO 16278:2016 (E) DIN EN ISO 16278:2016-08 6 It is not the purpose of this International Standard to standardize the end user classification of hu
48、man anatomy terminology or to conflict with the concept systems embedded in national practice and languages.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1human anatomybiological science that concerns the discovery, analysis and representation of the structural organization of the human bodyNote 1 to entry: Human anatomy thus defined encompasses the material objects from the granularity level
