1、Health SoftwarePart 1: General requirements for product safetyBS EN 82304-1:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 82304-1 September 2017 ICS 35.240.80 English Version Health Software - Part 1: General
2、 requirements for product safety (IEC 82304-1:2016) Logiciels de sant - Partie 1: Exigences gnrales pour la scurit des produits (IEC 82304-1:2016) Gesundheitssoftware - Teil 1: Allgemeine Anforderungen fr die Produktsicherheit (IEC 82304-1:2016) This European Standard was approved by CENELEC on 2016
3、-12-01. 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 standards may be o
4、btained on application to the CEN-CENELEC Management Centre 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 notifie
5、d to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Gre
6、ece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisati
7、on Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 82304-1:2017 E National forewordThis British
8、Standard is the UK implementation of EN 82304-1:2017. It is identical to IEC 82304-1:2016. It supersedes BS IEC 82304-1:2016, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/62/1, .A list of organizations represented on this committee can be obtaine
9、d on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 51806 5ICS 35.240.80Compliance with a
10、 British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2017.Amendments/corrigenda issued since publicationDate Text affected31 December 2017 This corrigendum renumbers BS IEC 8
11、2304-1:2016 as BS EN 82304-1:2017BRITISH STANDARDBS EN 82304-1:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 82304-1 September 2017 ICS 35.240.80 English Version Health Software - Part 1: General requirements for product safety (IEC 82304-1:2016) Logiciels de sant - Partie 1: Exigences gn
12、rales pour la scurit des produits (IEC 82304-1:2016) Gesundheitssoftware - Teil 1: Allgemeine Anforderungen fr die Produktsicherheit (IEC 82304-1:2016) This European Standard was approved by CENELEC on 2016-12-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which st
13、ipulate 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 standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member. This Eur
14、opean 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 notified to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC m
15、embers are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands,
16、Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Ce
17、ntre: Avenue Marnix 17, B-1000 Brussels 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 82304-1:2017 E BS EN 82304-1:2017EN 82304-1:2017 2 European foreword The text of document 62A/1140/FDIS, future edition 1 of IEC 82304-1, p
18、repared by IEC/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 and approved by CENELEC as EN 82304-1:2017. The following dates are fixed: latest date by which the document
19、has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2018-03-01 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2020-09-01 Attention is drawn to the possibility that some of the elements
20、of this document may be the subject of patent rights. CENELEC shall not be 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. Endorsement notice The text
21、of the International Standard IEC 82304-1:2016 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: IEC 60601 (series) NOTE Harmonized as EN 60601 (series). IEC 60601-1:20
22、05 NOTE Harmonized as EN 60601-1:2006. IEC 61907:2009 NOTE Harmonized as EN 61907:2010. IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015. IEC 80001-1:2010 NOTE Harmonized as EN 80001-1:2011. ISO 9000:2015 NOTE Harmonized as EN ISO 9000:2015. ISO 13485:2015 NOTE Harmonized as EN ISO 13485:2016. IS
23、O 14971:2007 NOTE Harmonized as EN ISO 14971:2012. BS EN 82304-1:2017EN 82304-1:2017 2 European foreword The text of document 62A/1140/FDIS, future edition 1 of IEC 82304-1, prepared by IEC/SC 62A “Common aspects of electrical equipment used in medical practice“ of IEC/TC 62 “Electrical equipment in
24、 medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 82304-1:2017. 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) 2018-03-01 l
25、atest date by which the national standards conflicting with the document have to be withdrawn (dow) 2020-09-01 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC shall not be held responsible for identifying any or all such p
26、atent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association. Endorsement notice The text of the International Standard IEC 82304-1:2016 was approved by CENELEC as a European Standard without any modification. In th
27、e official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60601 (series) NOTE Harmonized as EN 60601 (series). IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006. IEC 61907:2009 NOTE Harmonized as EN 61907:2010. IEC 62366-1:2015 NOTE Harmonized as E
28、N 62366-1:2015. IEC 80001-1:2010 NOTE Harmonized as EN 80001-1:2011. ISO 9000:2015 NOTE Harmonized as EN ISO 9000:2015. ISO 13485:2015 NOTE Harmonized as EN ISO 13485:2016. ISO 14971:2007 NOTE Harmonized as EN ISO 14971:2012. EN 82304-1:2017 3 Annex ZA (normative) Normative references to internation
29、al publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the
30、referenced document (including any amendments) applies. NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
31、 here: www.cenelec.eu. Publication Year Title EN/HD Year IEC 62304 2006 Medical device software - Software life-cycle processes EN 62304 2006 - - + corrigendum Nov. 2008 + A1 2015 + A1 2015 BS EN 82304-1:2017This page deliberately left blank 2 IEC 82304-1:2016 IEC 2016 CONTENTS FOREWORD . 3 INTRODUC
32、TION . 5 1 Scope 6 1.1 Purpose 6 1.2 Field of application 6 1.3 Compliance . 6 2 Normative references 6 3 Terms and definitions 7 4 * HEALTH SOFTWARE PRODUCT requirements 10 4.1 General requirements and initial RISK ASSESSMENT 10 4.2 HEALTH SOFTWARE PRODUCT use requirements . 11 4.3 VERIFICATION of
33、HEALTH SOFTWARE PRODUCT use requirements 11 4.4 Updating HEALTH SOFTWARE PRODUCT use requirements . 12 4.5 System requirements 12 4.6 VERIFICATION of system requirements 12 4.7 Updating HEALTH SOFTWARE PRODUCT system requirements . 12 5 * HEALTH SOFTWARE Software life cycle processes 13 6 * HEALTH S
34、OFTWARE PRODUCT VALIDATION . 13 6.1 VALIDATION plan 13 6.2 Performing VALIDATION 13 6.3 VALIDATION report 14 7 HEALTH SOFTWARE PRODUCT identification and ACCOMPANYING DOCUMENTS 14 7.1 * Identification . 14 7.2 ACCOMPANYING DOCUMENTS . 14 7.2.1 General . 14 7.2.2 Instructions for use 15 7.2.3 Technic
35、al description . 17 8 Post-market activities for the HEALTH SOFTWARE PRODUCT . 18 8.1 General . 18 8.2 SOFTWARE MAINTENANCE 18 8.3 Re-VALIDATION . 19 8.4 Post-market communication on the HEALTH SOFTWARE PRODUCT . 19 8.5 Decommissioning and disposal of the HEALTH SOFTWARE PRODUCT . 19 Annex A (inform
36、ative) Rationale . 20 A.1 General . 20 A.2 Requirements for HEALTH SOFTWARE PRODUCTS 21 A.3 Rationale for particular clauses and subclauses 22 Bibliography 26 Figure A.1 HEALTH SOFTWARE application domains and scope of related standards 22 Figure A.2 IEC 82304-1: HEALTH SOFTWARE PRODUCT processes 23
37、 Table A.1 Examples of software (SW) in or not in the scope of this document 21 2 IEC 82304-1:2016 IEC 2016 CONTENTS FOREWORD . 3 INTRODUCTION . 5 1 Scope 6 1.1 Purpose 6 1.2 Field of application 6 1.3 Compliance . 6 2 Normative references 6 3 Terms and definitions 7 4 * HEALTH SOFTWARE PRODUCT requ
38、irements 10 4.1 General requirements and initial RISK ASSESSMENT 10 4.2 HEALTH SOFTWARE PRODUCT use requirements . 11 4.3 VERIFICATION of HEALTH SOFTWARE PRODUCT use requirements 11 4.4 Updating HEALTH SOFTWARE PRODUCT use requirements . 12 4.5 System requirements 12 4.6 VERIFICATION of system requi
39、rements 12 4.7 Updating HEALTH SOFTWARE PRODUCT system requirements . 12 5 * HEALTH SOFTWARE Software life cycle processes 13 6 * HEALTH SOFTWARE PRODUCT VALIDATION . 13 6.1 VALIDATION plan 13 6.2 Performing VALIDATION 13 6.3 VALIDATION report 14 7 HEALTH SOFTWARE PRODUCT identification and ACCOMPAN
40、YING DOCUMENTS 14 7.1 * Identification . 14 7.2 ACCOMPANYING DOCUMENTS . 14 7.2.1 General . 14 7.2.2 Instructions for use 15 7.2.3 Technical description . 17 8 Post-market activities for the HEALTH SOFTWARE PRODUCT . 18 8.1 General . 18 8.2 SOFTWARE MAINTENANCE 18 8.3 Re-VALIDATION . 19 8.4 Post-mar
41、ket communication on the HEALTH SOFTWARE PRODUCT . 19 8.5 Decommissioning and disposal of the HEALTH SOFTWARE PRODUCT . 19 Annex A (informative) Rationale . 20 A.1 General . 20 A.2 Requirements for HEALTH SOFTWARE PRODUCTS 21 A.3 Rationale for particular clauses and subclauses 22 Bibliography 26 Fig
42、ure A.1 HEALTH SOFTWARE application domains and scope of related standards 22 Figure A.2 IEC 82304-1: HEALTH SOFTWARE PRODUCT processes 23 Table A.1 Examples of software (SW) in or not in the scope of this document 21 BS EN 82304-1:2017IEC 82304-1:2016 IEC 2016 3 INTERNATIONAL ELECTROTECHNICAL COMMI
43、SSION _ HEALTH SOFTWARE Part 1: General requirements for product safety FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote inter
44、national co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafte
45、r referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also particip
46、ate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an in
47、ternational consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all rea
48、sonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply I
49、EC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certif
