EN 62304-2006 en Medical device software - Software life-cycle processes (Incorporating Corrigendum November 2008 Incorporates Amendment A1 2015)《医疗器械用软件 软件寿命过程 2006》.pdf

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1、BRITISH STANDARDBS EN62304:2006Medical devicesoftware Softwarelife-cycle processesICS 11.040.01; 35.080; 35.240.80g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43

2、g55g3g47g36g58Incorporating corrigendumNovember 2008BS EN 62304:2006 +A1:2015Incorporating corrigendum November 2008BS EN 62304:2006+A1:2015ISBN 978 0 580 83868 2Amendments/corrigenda issued since publicationDate Comments31 May 2011 Implementation of CENELEC corrigendum November 2008; modification o

3、f CENELEC Foreword and addition of Annex ZZ30 November 2015 Implementation of IEC amendment 1:2015 with CENELEC endorsement A1:2015. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2006 The British Standards Institution 2015. Publ

4、ished by BSI Standards Limited 2015National forewordThis British Standard is the UK implementation of EN 62304:2006+A1:2015, incorporating corrigendum November 2008. It is identical to IEC 62304:2006, incorporating amendment 1:2015. It supersedes BS EN 62304:2006, which will be withdrawn on 31 July

5、2018. The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by .The UK participation in its preparation was entrusted by Te

6、chnical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to includ

7、e all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARD EN 62304 NORME EUROPENNE EUROPISCHE NORM July 2006 CENELEC European Committee for Electrotechnical Standa

8、rdization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 62304:2006 E

9、ICS 11.040 English version Medical device software - Software life-cycle processes (IEC 62304:2006) Logiciels de dispositifs mdicaux - Processus du cycle de vie du logiciel (CEI 62304:2006) Medizingerte-Software - Software-Lebenszyklus-Prozesse (IEC 62304:2006) This European Standard was approved by

10、 CENELEC on 2006-06-01. 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 bibliographical references concerning such national st

11、andards may be obtained on application to the Central Secretariat or to any CENELEC 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 CENELEC member into its own language and n

12、otified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxe

13、mbourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Incorporating corrigendum November 2008EN 62304:2006+A1October 2015 2 Foreword The text of document 62A/523/FDIS, future edition 1 of IEC 62304, prepared by a joi

14、nt working group of SC 62A, Common aspects of electrical equipment used in medical practice, of IEC technical committee 62, Electrical equipment in medical practice, and ISO Technical Committee 210, Quality management and corresponding general aspects for medical devices, was submitted to the IEC-CE

15、NELEC parallel vote and was approved by CENELEC as EN 62304 on 2006-06-01. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2007-03-01 latest date by which the national standar

16、ds conflicting with the EN have to be withdrawn (dow) 2009-06-01 In this standard the following print types are used: requirements and definitions: in roman type; informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is al

17、so in a smaller type; terms used throughout this standard that have been defined in Clause 3 and also given in the index: IN SMALL CAPITALS. An asterisk (*) as the first character of a title or at the beginning of a paragraph indicates that there is guidance related to that item in Annex B. Table C.

18、5 was prepared by ISO/IEC JTC 1/SC 7, Software and system engineering. _ Endorsement notice The text of the International Standard IEC 62304:2006 was approved by CENELEC as a European Standard without any modification. This European Standard has been prepared under a mandate given to CENELEC by the

19、European Commission and the European Free Trade Association and covers essential requirements of EC Directives 93/42/EEC, 90/385/EC and 98/79/EC. See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. BS EN 62304:2006EN 62304:2006 (E)The contents of the corrigendum of November 2008 have been in

20、cluded in this copy.- 2 -BS EN 62304:2006+A1:2015EN 62304:2006+A1:2015 (E)EN 62304:2006/A1:2015 3 IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015. IEC 82304-1 NOTE Harmonized as EN 82304-1 1)1) At draft stage. EN 62304:2006/A1:2015 3 IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015. IEC 82304

21、-1 NOTE Harmonized as EN 82304-1 1)1) At draft stage. - 3 -BS EN 62304:2006+A1:2015EN 62304:2006+A1:2015 (E)EN 62304:2006/A1:2015 2 European Foreword The text of document 62A/1007/FDIS, future IEC 62304:2006/A1, prepared by SC 62A “Common aspects of electrical equipment used in medical practice“ of

22、IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62304:2006/A1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national stand

23、ard or by endorsement (dop) 2016-05-01 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-07-31 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be

24、 held responsible for identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC,

25、 98/79/EC, 90/385/EEC see informative Annex ZZ, included in EN 62304:2006/corrigendum Nov. 2008. Endorsement notice The text of the International Standard IEC 62304:2006/A1:2015 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the fo

26、llowing notes have to be added for the standards indicated: Replace the existing references with the following: IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006. IEC 60601-1:2005/AMD1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013. IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996. IEC 606

27、01-1-4:1996/AMD1:1999 NOTE Harmonized as EN 60601-1-4:1996/A1:1999. IEC 60601-1-6 NOTE Harmonized as EN 60601-1-6. IEC 61508-3 NOTE Harmonized as EN 61508-3. IEC 61010-1:2010 NOTE Harmonized as EN 61010-1:2010. ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005. ISO 9001:2008 NOTE Harmonized as EN IS

28、O 9001:2008. ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2003. Foreword to amendment A1EN 62304:2006/A1:2015 3 IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015. IEC 82304-1 NOTE Harmonized as EN 82304-1 1)1) At draft stage. EN 62304:2006/A1:2015 3 IEC 62366-1:2015 NOTE Harmonized as EN 62366-1

29、:2015. IEC 82304-1 NOTE Harmonized as EN 82304-1 1)1) At draft stage. EN 62304:2006/A1:2015 2 European Foreword The text of document 62A/1007/FDIS, future IEC 62304:2006/A1, prepared by SC 62A “Common aspects of electrical equipment used in medical practice“ of IEC/TC 62 “Electrical equipment in med

30、ical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62304:2006/A1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-05-01

31、 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-07-31 Att ntion is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any

32、or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, 98/79/EC, 90/385/EEC see informative

33、Annex ZZ, included in EN 62304:2006/corrigendum Nov. 2008. Endorsement notice The text of the International Standard IEC 62304:2006/A1:2015 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the

34、 standards indicated: Replace the existing references with the following: IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006. IEC 60601-1:2005/AMD1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013. IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996. IEC 60601-1-4:1996/AMD1:1999 NOTE Har onized

35、as EN 60601-1-4:1996/A1:1999. IEC 60601-1-6 NOTE Harmonized as EN 60601-1-6. IEC 61508-3 NOTE Harmonized as EN 61508-3. IEC 61010-1:2010 NOTE Harmonized as EN 61010-1:2010. ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005. ISO 9001:2008 NOTE Harmonized as EN ISO 9001:2008. ISO 13485:2003 ISO 13485:

36、2003. EN 62304:2006/A1:2015 2 European Foreword The text of document 62A/1007/FDIS, future IEC 62304:2006/A1, prepared by SC 62A “Common aspects of electrical equipment used in medical practice“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote an

37、d approved by CENELEC as EN 62304:2006/A1:2015. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-05-01 latest date by which the national standards conflicting with th

38、e document have to be withdrawn (dow) 2018-07-31 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for identifying any or all such patent rights. This document has been prepared under

39、 a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, 98/79/EC, 90/385/EEC see informative Annex ZZ, included in EN 62304:2006/corrigendum Nov. 2008. Endor

40、sement notice The text of the International Standard IEC 62304:2006/A1:2015 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: Replace the existing references with the f

41、ollowing: IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006. IEC 60601-1:2005/AMD1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013. IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996. IEC 60601-1-4:1996/AMD1:1999 NOTE Harmonized as EN 60601-1-4:1996/A1:1999. IEC 60601-1-6 NOTE Harmonized as E

42、N 60601-1-6. IEC 61508-3 NOTE Harmonized as EN 61508-3. IEC 61010-1:2010 NOTE Harmonized as EN 61010-1:2010. ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005. ISO 9001:2008 NOTE Harmonized as EN ISO 9001:2008. ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2003. 76 Annex ZA (normative) Normative re

43、ferences to international publications with their corresponding European publications 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

44、 (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year ISO 14971 -F1)Medical devices - Application of risk management to medical devices EN ISO 14971 2000

45、F2)_ 1)Undated reference. 2)Valid edition at date of issue. BS EN 62304:2006EN 62304:2006 (E)- 4 -BS EN 62304:2006+A1:2015EN 62304:2006+A1:2015 (E)Annex ZZ (informative) Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by t

46、he European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directives 93/42/EEC, 90/385/EC and 98/79/EC. Compliance with this standard provides one means of conformity with the specified es

47、sential requirements of the Directives concerned. WARNING: Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard. _ 77 BS EN 62304:2006EN 62304:2006 (E)- 5 -BS EN 62304:2006+A1:2015EN 62304:2006+A1:2015 (E)BS EN 62304:2006+A1:2015IEC 62304:2006+A1:2015 (E) - 6 -CONTENTSForeword 8Introduction 101 Scope 1311 * Purpose 1312 * Field of application 1313 Relationship to other standards