EN ISO 15225-2010 2500 Medical devices - Quality management - Medical device nomenclature data structure《命名 用于管理资料交流的医疗器械命名系统规范》.pdf

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1、BS EN ISO15225:2010ICS 01.04.11; 01.040.35; 11.040.01; 35.240.80NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDMedical devices Quality management Medical devicenomenclature datastructure (ISO15225:2010)Copyright European Committee for Standardization Provided b

2、y IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHSThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2010 BSI 2010ISBN 978 0 580 58066 6Amendments/corrigenda issued since publicationDate

3、 CommentsBS EN ISO 15225:2010National forewordThis British Standard is the UK implementation of EN ISO 15225:2010.It supersedes BS EN ISO 15225:2000 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/210/3, General terminology and symbols for MedicalDev

4、ices.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfro

5、m legal obligations.Copyright European Committee for Standardization Provided by IHS under license with CENNot for Resale-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15225 May 2010 ICS 11.040.01; 35.240.80 Supersedes EN ISO 15225:2000 English version Medical devices - Quality manage

6、ment - Medical device nomenclature data structure (ISO 15225:2010) Dispositifs mdicaux - Management de la qualit - Structure des donnes de nomenclature des dispositifs mdicaux (ISO 15225:2010) Medizinprodukte - Qualittsmanagement - Datenstruktur fr die Nomenklatur von Medizinprodukten (ISO 15225:201

7、0)This European Standard was approved by CEN on 27 February 2010. CEN and CENELEC 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 bibl

8、iographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN and CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the re

9、sponsibility of a CEN and CENELEC member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Cz

10、ech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CEN Management Centre: CENELEC Central Secretar

11、iat:Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels 2010 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO 15225:2010 ECopyright European Committee for Standardization Provided

12、by IHS under license with CENNot for Resale-,-,-BS EN ISO 15225:2010EN ISO 15225:2010 (E) 3 Foreword This document (EN ISO 15225:2010) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” in collaboration with Technical Commit

13、tee CEN/CLC/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 November 2010,

14、and conflicting national standards shall be withdrawn at the latest by November 2010. 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.

15、This document supersedes EN ISO 15225:2000. 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, France

16、, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15225:2010 has been approved by CEN as a EN ISO 15225:2

17、010 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHSBS EN ISO 15225:2010ISO 15225:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduct

18、ion.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Principle of structure 4 4.1 General .4 4.2 Device category .5 4.3 Collective term.5 4.4 Generic device group5 4.5 Device type.6 4.6 Nomenclature structure example 6 5 Requirements.7 5.1 Device category .7 5.2 Generic device group7

19、5.3 Device type.9 5.4 Collective term.9 6 Data file dictionary 9 6.1 General .9 6.2 Device category data file 9 6.3 Generic device group data file .9 6.4 Device type data file 10 6.5 Collective term data file 11 Annex A (informative) Device categories .12 Annex B (informative) Examples for generatio

20、n of generic device group terms and synonyms.15 Annex C (informative) Examples of generic device group records.18 Annex D (informative) Examples of collective terms 19 Bibliography20 Copyright European Committee for Standardization Provided by IHS under license with CENNot for Resale-,-,-BS EN ISO 1

21、5225:2010ISO 15225:2010(E) iv ISO 2010 All rights reservedForeword 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 committe

22、es. 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 Inte

23、rnational 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 S

24、tandards 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 su

25、bject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15225 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This second edition cancels and replaces the first edition (ISO

26、 15225:2000), which has been technically revised. It also incorporates the Amendment ISO 15225:2000/Amd.1:2004. Copyright European Committee for Standardization Provided by IHS under license with CENNot for Resale-,-,-BS EN ISO 15225:2010ISO 15225:2010(E) ISO 2010 All rights reserved vIntroduction T

27、his International Standard is intended to assist competent authorities, conformity 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. Th

28、is second edition of this International Standard is based on experience gained from utilization of the first edition. The following major changes have been made to the first edition: definitions have been added in Clause 3 for base concept, collective term, device category, device type, generic devi

29、ce group, Global Medical Device Nomenclature (GMDN), GMDN agency, multiple-linked synonym, product specifier and template specifier; Codes 13, 14 and 15 have been added in Annex A, and the descriptions have been updated with examples of new technologies; Annex D has been added containing examples of

30、 collective terms. 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). Copyright European Committee for Standar

31、dization Provided by IHS under license with CENNot for Resale-,-,-BS EN ISO 15225:2010Copyright European Committee for Standardization Provided by IHS under license with CENNot for Resale-,-,-BS EN ISO 15225:2010INTERNATIONAL STANDARD ISO 15225:2010(E) ISO 2010 All rights reserved 1Medical devices Q

32、uality management Medical device nomenclature data structure 1 Scope This International Standard provides rules and guidelines for a medical device nomenclature data structure, in order to facilitate cooperation and exchange of data used by regulatory bodies on an international level between interes

33、ted parties, e.g. regulatory authorities, manufacturers, suppliers, health care providers and end users. This International Standard includes guidelines for a minimum data set and its structure. These guidelines are provided for system designers setting up databases that utilize the nomenclature sys

34、tem 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 include the nomenclature itself, which is provided as a data file

35、. 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. ISO/IEC 8859-1:1998, Inf

36、ormation technology 8-bit single-byte coded graphic character sets Part 1: Latin alphabet No. 1 3 Terms and definitions For the purposes of this document, the following terms and definitions apply1). 3.1 base concept broadest representation of the generic device group, and the primary listing basis

37、of the GMDN GMDN Agency 3.2 character member of a set of elements used for the organization, control or representation of data ISO/IEC 8859-1:1998, definition 4.3 1) In this International Standard, many terms are used which have their basis in regulatory statutes, e.g. “medical device”, “custom made

38、 medical device” and “manufacturer”. These terms are defined in the respective jurisdictions where the nomenclature are used. Copyright European Committee for Standardization Provided by IHS under license with CENNot for Resale-,-,-BS EN ISO 15225:2010ISO 15225:2010(E) 2 ISO 2010 All rights reserved

39、3.3 code system of alpha, alphanumeric or numeric characters and rules by which information is represented, communicated, or both 3.4 collective term term used to describe broad common features or characteristics within which a number of generic device group terms are recognized, for regulatory or o

40、ther purposes NOTE Generic devices can be linked to one or more collective terms to indicate, for example, the following: common areas of intended use; the application of common technology; the use of specific hazardous or difficult materials; the application of a particular medical speciality; the

41、need for application of specific manufacturing processes; the presence of other common attributes with which to identify certain devices; the common descriptor of a broad device concept (i.e. a template term). 3.5 concept unit of knowledge created by a unique combination of characteristics ISO 1087-

42、1:2000, definition 3.2.1 3.6 definition formal concise statement of the meaning of a preferred term or template term 3.7 device category broadest grouping within the nomenclature 3.8 device intended for clinical investigation device intended for use in a designed and planned systematic study in or o

43、n human subjects to verify the safety, performance, or both 3.9 device intended for performance evaluation device intended by the manufacturer to be subject to performance evaluation studies in laboratories for medical analyses or other appropriate environments outside the manufacturers premises 3.1

44、0 device type identification of a manufacturers specific product NOTE The manufacturers specific product is the make and model. 3.11 file named set of records stored or processed as a unit ISO/IEC 2382-1:1993, definition 01.08.06 Copyright European Committee for Standardization Provided by IHS under

45、 license with CENNot for ResaleNo reproduction or networking permitted without license from IHSBS EN ISO 15225:2010ISO 15225:2010(E) ISO 2010 All rights reserved 33.12 foreign key relation one or a group of attributes that corresponds to a primary key in another relation ISO/IEC 2382-17:1999, defini

46、tion 17.04.15 3.13 generic device group set of devices having the same or similar intended use, common technology, or both 3.14 Global Medical Device Nomenclature GMDN nomenclature based on the structure of this International Standard, which provides information in the form of a code to indicate the

47、 generic descriptor within which a device type can be identified NOTE 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 exch

48、ange between competent authorities and others, for the exchange of post-market vigilance information and for inventory purposes. 3.15 GMDN agency organization representing the interests of regulatory agencies, manufacturers and healthcare providers to ensure the continued relevance and effectiveness

49、 of the GMDN, and is responsible for the development, control and distribution of the GMDN 3.16 identifier organization of data one or more characters used to identify or name a data element and possibly to indicate certain properties of that data element ISO/IEC 2382-4:1999, definition 04.09.02 3.17 multipl