1、BSI Standards PublicationBS EN ISO 16278:2016Health informatics Categorial structure forterminological systemsof human anatomy (ISO16278:2016)BS EN ISO 16278:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO16278:2016. It supersedes BS EN 15521:2007 which
2、 is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract
3、. Users are responsible for its correctapplication. The British Standards Institution 2016. Published by BSI StandardsLimited 2016ISBN 978 0 580 77282 5ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority
4、 of theStandards Policy and Strategy Committee on 31 March 2016.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16278 March 2016 ICS 35.240.80 Supersedes EN 15521:2007English Version Health informatics - Categorial structure for terminolo
5、gical 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 (ISO 16278:2016) This European Standard w
6、as 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 bibliographical references concerning such
7、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 l
8、anguage 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, Gre
9、ece, 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 NORMALISATION EUROPISCHES KOMITEE FR NORMUNG
10、 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 EBS EN ISO 16278:2016EN ISO 16278:2016 (E) 3 European foreword This document (EN ISO 16278:2016)
11、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 t
12、ext or by endorsement, at the latest by September 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 re
13、sponsible for identifying any or all such patent 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, Cypr
14、us, 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
15、 Kingdom. Endorsement notice The text of ISO 16278:2016 has been approved by CEN as EN ISO 16278:2016 without any modification. BS EN ISO 16278:2016ISO 16278:2016(E)Foreword ivIntroduction v1 Scope . 12 Terms and definitions . 23 Categorial structure for terminologies of human anatomy description 33
16、.1 Principles . 33.2 Anatomical categories (2.7) . 43.3 Precise goal of the categorial structure (2.10) 63.4 List of anatomical relations (2.8) 73.5 List of minimal anatomical domain constraints (2.9) . 94 Conformance . 9Annex A (informative) A reference ontology for biomedical informatics: the Foun
17、dational Model of Anatomy .10Bibliography .16 ISO 2016 All rights reserved iiiContents PageBS EN ISO 16278:2016ISO 16278:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internati
18、onal 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 IS
19、O, 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, Par
20、t 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
21、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 rec
22、eived (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 ISOs a
23、dherence 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.iv ISO 2016 All rights reservedBS EN ISO 16278:2016ISO 16278:2016(E)IntroductionThis Intern
24、ational Standard 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, nom
25、enclatures, terminologies 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 inv
26、olved; 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.Th
27、e integration 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 introduce
28、d by the sender 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 i
29、n the different 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 Interna
30、tional Standards (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
31、) and also to 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
32、for biomedical 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 on
33、tology that in 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
34、countries, revision and integration have provided the comprehensive basis for this International Standard. ISO 2016 All rights reserved vBS EN ISO 16278:2016BS EN ISO 16278:2016Health informatics Categorial structure for terminological systems of human anatomy1 ScopeThis International Standard defin
35、es the characteristics required to synthetically describe the organization and content of human anatomy within a terminological 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
36、purposes.This International Standard will serve to facilitate the construction of new terminological systems in a regular form which will increase their coherence and expressiveness, facilitate maintenance of human anatomy within terminological systems, increase consistency and coherence of existing
37、 terminological system, allow systematic cross-references between items of human anatomy in different types of terminological systems, facilitate convergence among human anatomy within terminological systems, make explicit the overlap for human anatomy between different health care domains terminolo
38、gical systems, provide elements for negotiation about integration of different terminological systems into information systems between the respective developers, and enable the systematic evaluation of human anatomy within terminological systems.The International Standard itself is not suitable or i
39、ntended for use by, individual clinicians or hospital administrators.The target groups for this International Standard are the following: designers of specialized standard healthcare terminological categorial structures; developers of healthcare terminological systems including classifications and c
40、oding 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 requ
41、ire an explicit representation of healthcare terminological systems; developers of marked-up standards for representation of healthcare documents.This International Standard does not include categorial structure that might be necessary for the description of developmental anatomy during the human li
42、fe cycle, which includes prenatal development, post-natal growth and aging.This International 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.INTERNATIONAL STANDARD ISO 1627
43、8:2016(E) ISO 2016 All rights reserved 1BS EN ISO 16278:2016ISO 16278:2016(E)It is not the purpose of this International Standard to standardize the end user classification of human anatomy terminology or to conflict with the concept systems embedded in national practice and languages.2 Terms and de
44、finitionsFor 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 objec
45、ts from the granularity level of the whole human body to that of cell parts, portions of body substances, and non-material entities such as surfaces, spaces, lines and points, that form the phenotypic organization of the human body. Although encompassed by the definition of anatomical structure (3.2
46、.9), biological macromolecules do not come under the purview of the science human anatomy.2.2anatomical entityentity that constitutes the structural organization of a particular human body2.3spatial dimensionnumber of dimensions of the entity in spaceEXAMPLE 1 Entities with spatial dimension of valu
47、e 3 are organs, cells and body cavity.EXAMPLE 2 Entities with spatial dimension of value 2: the plane of the esophagogastric junction and the surface of the parietal part of the head.EXAMPLE 3 Entities with spatial dimension of value 1: pectinate line, linea aspera and superior nuchal line.EXAMPLE 4
48、 Entities with spatial dimension of value 0: the pointed extremity of petrous part of temporal bone, pointed extremity of the orbit and the pointed extremity of the sacrum.2.4three-dimensional shapeshape of an anatomical entity of spatial dimension with value 3EXAMPLE Hollow cylinder.2.5terminologys
49、et of designations belonging to one special languageSOURCE: ISO 1087-1:20002.6anatomical termverbal designation of an anatomical entity (2.2)2.7anatomical categorytype of anatomical entity shared by all the individual instances in existence in the present, past and futureEXAMPLE The anatomical category liver is instantiated by this liver and all individual livers in existence in the present, past and future.Note 1 to entry: Anatomical categories may be more or less general. Where one anatomical category is subsumed by another, the is_a rela
