EN ISO 15225-2016 en Medical devices - Quality management - Medical device nomenclature data structure《医疗器械质量管理-医疗设备命名的数据结构(ISO 15225 2016)》.pdf

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1、BSI Standards PublicationBS EN ISO 15225:2016Medical devices Qualitymanagement Medical devicenomenclature data structureBS EN ISO 15225:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO15225:2016. It supersedes BS EN ISO 15225:2010 which iswithdrawn.The U

2、K participation in its preparation was entrusted to TechnicalCommittee CH/210/3, General terminology and symbols for MedicalDevices.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovision

3、s of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 82368 8ICS 01.040.11; 01.040.35; 11.040.01; 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This Br

4、itish Standard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15225 April 2016 ICS 01.040.11; 01.040.35; 11.040.01; 35.

5、240.80 Supersedes EN ISO 15225:2010 English version Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016) Dispositifs mdicaux - Management de la qualit - Structure des donnes de nomenclature des dispositifs mdicaux(ISO 15225:2016) Medizinprodukte - Qualit

6、tsmanagement - Datenstruktur fr die Nomenklatur von Medizinprodukten (ISO 15225:2016) This European Standard was approved by CEN on 9 June 2016. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the

7、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 and CENELEC member. This European Standard exists in three official versions (Eng

8、lish, French, German). A version in any other language made by translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bod

9、ies and national electrotechnical committees 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,

10、 Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members

11、. Ref. No. EN ISO 15225:2016 EBS EN ISO 15225:2016EN ISO 15225:2016 (E) 3 European foreword This document (EN ISO 15225:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” in collaboration with Technical Committee CEN/C

12、LC/TC 3 “Quality management and corresponding general aspects for medical devices” 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 October 2016, and confli

13、cting national standards shall be withdrawn at the latest by October 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 patent rights. This docume

14、nt supersedes EN ISO 15225:2010. 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 R

15、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 the United Kingdom. Endorsement notice The text of ISO 15225:2016 has been

16、 approved by CEN as EN ISO 15225:2016 without any modification. BS EN ISO 15225:2016ISO 15225:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle of structure 34.1 General . 34.2 Term . 44.2.1 Description 44.2.2 Term name 44.2.3 Term definition 4

17、4.2.4 Term code 44.2.5 Links to relevant collective term(s) (see 4.3) . 44.2.6 Links to synonym(s) . 44.2.7 Links to multiple-linked synonym(s) . 44.3 Collective term 54.4 Nomenclature structure example . 54.5 Synonyms . 54.6 Multiple-linked synonyms. 54.7 Abbreviations and acronyms 65 Data file dic

18、tionary . 65.1 General . 65.2 Term data file 65.3 Collective term data file . 7Annex A (informative) Examples for generation of generic device group terms and synonyms . 8Annex B (informative) Example of term record .10Annex C (informative) Examples of collective terms 11Annex D (informative) Exampl

19、es of top-level collective term nodes .12Bibliography .13 ISO 2016 All rights reserved iiiContents PageBS EN ISO 15225:2016ISO 15225:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepari

20、ng 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 lia

21、ison 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 Dir

22、ectives, 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 s

23、ome 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 decla

24、rations 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 ab

25、out ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.The committee responsible for this document is ISO/TC 210, Quality management and corresponding general aspects for medical devices.This third edition of this

26、 International Standard based on experience gained from utilization of the second edition cancels and replaces the second edition (ISO 15225:2010), which has been technically revised. The following major changes have been made: Template terms have been removed as the hierarchy within the GMDN is now

27、 managed with the use of collective terms. Device category has been removed as this provides no benefit for navigation and its value has now been superseded by the use of collective terms. The prefix preferred has been removed from term in the document and the word term now denotes the primary ident

28、ifier for generic device groups of medical devices. Collective terms can now be used by medical device regulators and other users to select larger groups of medical devices and analyse larger sets of data. Terms however remain the only way to identify generic device groups of medical devices. Device

29、 type data specification has been removed as it is outside the scope of the GMDN dataset, but remains a concept to which GMDN data are linked.iv ISO 2016 All rights reservedBS EN ISO 15225:2016ISO 15225:2016(E)IntroductionThis International Standard is intended to assist competent authorities, confo

30、rmity assessment bodies, healthcare providers and manufacturers in the submission and exchange of information. It is intended that the information covered by this International Standard be available in the public domain.This third edition of this International Standard is based on experience gained

31、from utilization of the second edition. The requirements contained in this International Standard are applicable to the development and updating of an international nomenclature and have been prepared specifically for construction of the Global Medical Device Nomenclature (GMDN). ISO 2016 All rights

32、 reserved vBS EN ISO 15225:2016BS EN ISO 15225:2016Medical devices Quality management Medical device nomenclature data structure1 ScopeThis International Standard specifies rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data

33、used by regulatory bodies on an international level between interested parties, e.g. regulatory authorities, manufacturers, suppliers, healthcare providers and end users.This International Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system

34、 designers setting up databases that utilize the nomenclature system described herein.The requirements contained in this International Standard are applicable to the development and maintenance of an international nomenclature for medical device identification.This International Standard does not in

35、clude the nomenclature itself, which is provided as a separate data file.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in the document and are indispensable for its application. For dated references, only the edition cited applies. For undated referen

36、ces, the latest edition of the referenced document (including any amendments) applies.ISO/IEC 8859-1:1998, Information technology 8-bit single-byte coded graphic character sets Part 1: Latin alphabet No. 13 Terms and definitionsFor the purposes of this document, the following terms and definitions a

37、pply1).3.1charactermember of a set of elements used for the organization, control or representation of dataSOURCE: ISO/IEC 8859-1:1998, 4.33.2codesystem of alpha, alphanumeric or numeric characters and rules by which information is represented, communicated, or both3.3collective termterm provides a

38、multi-hierarchical structure to search for appropriate generic device group terms by using broad common features or characteristics1) In this International Standard, many terms are used which have their basis in regulatory statutes, e.g.“medical device”, “custom made medical device” and “manufacture

39、r”. These terms are defined in the respective jurisdictions where the nomenclature is used.INTERNATIONAL STANDARD ISO 15225:2016(E) ISO 2016 All rights reserved 1BS EN ISO 15225:2016ISO 15225:2016(E)3.4conceptunit of knowledge created by a unique combination of characteristicsSOURCE: ISO 1087-1:2000

40、, 3.2.1, modified Note 1 to entry has been deleted.3.5definitionformal concise statement of the meaning of a term3.6device intended for clinical investigationdevice intended for use in a designed and planned systematic study in or on human subjects to verify safety, performance, or both3.7device int

41、ended for performance evaluationdevice intended by the manufacturer to be subject to performance evaluation studies in laboratories for medical analyses or other appropriate environments3.8device typeidentification of a manufacturers specific kind of products, i.e., for similar usage or series of co

42、mparable modelsNote 1 to entry: This data element is not included in the GMDN nomenclature, but is coded in various ways outside of the nomenclature and linked to terms.3.9filenamed set of records stored or processed as a unitSOURCE: ISO/IEC 2382:2015, 21214143.10generic device groupset of devices h

43、aving the same or similar intended use and common technology, identified by a term3.11Global Medical Device NomenclatureGMDNnomenclature based on the structure of this International Standard, which provides information in the form of a code to indicate the generic descriptor within which a device ty

44、pe can be identifiedNote 1 to entry: By reference to this globally accepted, generic medical device nomenclature, other particular devices which have substantially similar generic features but which come from another source can be identified, for reasons of data exchange between competent authoritie

45、s and others, for the exchange of post-market vigilance information and for inventory purposes.3.12GMDN agencyorganization representing the interests of regulatory agencies, manufacturers and healthcare providers to ensure the continued relevance and effectiveness of the GMDN, and is responsible for

46、 the development, control and distribution of the GMDN2 ISO 2016 All rights reservedBS EN ISO 15225:2016ISO 15225:2016(E)3.13identifierone or more characters used to identify or name a data element and possibly to indicate certain properties of that data elementSOURCE: ISO/IEC 2382-4:19992), 04.09.0

47、2, modified Note has been deleted.3.14multiple-linked synonymalternative name(s) for a synonym term linked to more than one GMDN Term3.15nameverbal designation of an individual conceptSOURCE: ISO 1087-1:2000, 3.4.2, modified The preferred term in ISO 1087-1:2000 (appellation) is not used in this Int

48、ernational Standard.3.16nomenclatureterminology structured systematically according to pre-established naming rulesSOURCE: ISO 1087-1:2000, 3.5.3, modified Note 1 to entry has been deleted.3.17product identifiermarker to indicate which terms can and cannot be used for product identification3.18synon

49、ymalternative name for a termEXAMPLE A proprietary or common name for a device.3.19termbasic data entity within the GMDN datasetNote 1 to entry: A term consists of a code, name and definition. It is the data representation of a generic device group.4 Principle of structure4.1 GeneralThe nomenclature shall consist of terms, collective terms, synonyms and multiple-linked synonyms. All elements have codes and names, and terms additionally have definitions. All terms should be given in the singular form.The no