1、BSI Standards PublicationMedical device softwarePart 3: Process reference model of medical device software life cycle processes (IEC 62304)PD IEC/TR 80002-3:2014National forewordThis Published Document is the UK implementation of IEC/TR 80002-3:2014.The UK participation in its preparation was entrus
2、ted by Technical Com-mittee 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 committee can be obtained onrequest to its secretary.This publication does not purport to
3、include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 85976 2ICS 11.040.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This
4、 Published Document was published under the authority of theStandards Policy and Strategy Committee on 31 July 2014.Amendments/corrigenda issued since publicationDate Text affectedPUBLISHED DOCUMENTPD IEC/TR 80002-3:2014IEC TR 80002-3 Edition 1.0 2014-06 INTERNATIONAL STANDARD Medical device softwar
5、e Part 3: Process reference model of medical device software life cycle processes (IEC 62304) INTERNATIONAL ELECTROTECHNICAL COMMISSION U ICS 11.040.01 PRICE CODE ISBN 978-2-8322-1616-3 Warning! Make sure that you obtained this publication from an authorized distributor. PD IEC/TR 80002-3:2014 2 IEC
6、 TR 80002-3:2014 IEC 2014 CONTENTS FOREWORD . 3 INTRODUCTION . 5 0.1 Background . 5 0.2 Organization of this technical report 5 1 Scope 6 2 Normative references 6 3 Terms and definitions 6 4 Medical device software life cycle processes . 7 4.1 Software development process . 7 Software development pl
7、anning . 7 4.1.1Software requirements analysis . 8 4.1.2Software architectural design . 8 4.1.3Software detailed design . 9 4.1.4Software unit implementation and verification 9 4.1.5Software integration and integration testing . 10 4.1.6Software system testing . 10 4.1.7Software release . 11 4.1.84.
8、2 Software maintenance 11 Purpose . 11 4.2.1Outcomes 11 4.2.24.3 Software risk management 12 Purpose . 12 4.3.1Outcomes 12 4.3.24.4 Software configuration management . 13 Purpose . 13 4.4.1Outcomes 13 4.4.24.5 Software problem resolution 14 Purpose . 14 4.5.1Outcomes 14 4.5.2Annex A (informative) De
9、velopment of this technical report . 16 Annex B (informative) Mapping between IEC 62304:2006 and ISO/IEC 12207:2008 18 Bibliography 28 Figure A.1 Requirements in process elements of IEC 62304:2006 and ISO/IEC 12207:2008 . 16 Figure A.2 Development of process outcomes for medical device software deve
10、lopment PRM 17 Table A.1 Direct process mappings between IEC 62304:2006 and ISO/IEC 12207:2008 . 17 Table B.1 Mapping between process outcomes of the PRM and the requirements of IEC 62304:2006, including their safety classes, and the requirements of ISO/IEC 12207:2008 (1 of 9) . 19 PD IEC/TR 80002-3
11、:2014IEC TR 80002-3:2014 IEC 2014 3 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL DEVICE SOFTWARE Part 3: Process reference model of medical device software life cycle processes (IEC 62304) FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standard
12、ization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes Intern
13、ational Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter 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
14、in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between th
15、e two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications hav
16、e the form of recommendations for international use and are accepted by IEC National Committees in that sense. While all reasonable 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 misi
17、nterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding natio
18、nal 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 c
19、arried out by independent certification bodies. 6) All users should ensure that they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National
20、Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is dra
21、wn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not
22、 be held responsible for identifying any or all such patent rights. The main task of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical report when it has collected data of a different kind from that which is norm
23、ally published as an International Standard, for example “state of the art“. IEC TR 80002-3, which is a technical report, has been prepared by a Joint Working Group of subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipme
24、nt in medical practice, and ISO technical committee 210: Quality management and corresponding general aspects for medical devices. It is published as a double logo standard. PD IEC/TR 80002-3:2014 4 IEC TR 80002-3:2014 IEC 2014 The text of this technical report is based on the following documents: E
25、nquiry draft Report on voting 62A/918/DTR 62A/928/RVC Full information on the voting for the approval of this technical report can be found in the report on voting indicated in the above table. In ISO, the technical report has been approved by 14 P members out of 16 having cast a vote. This publicat
26、ion has been drafted in accordance with the ISO/IEC Directives, Part 2 and in accordance with ISO/IEC 24774, Systems and software engineering Life cycle management Guidelines for process description. A list of all parts of the IEC 80002 series, published under the general title Medical device softwa
27、re, can be found on the IEC website. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be recon
28、firmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later date. PD IEC/TR 80002-3:2014IEC TR 80002-3:2014 IEC 2014 5 INTRODUCTION 0.1 Background Software is often an integral part of medical device technology. Establishing the safe
29、ty and effectiveness of a medical device containing software requires well designed software that fulfils its purpose without causing any unacceptable risks. Following an internationally approved set of software development practices provides one way of achieving this. This technical report (TR) pro
30、vides a framework of life cycle processes supporting the safe design and maintenance of medical device software called the process reference model (PRM). The process descriptions in this PRM are fully compliant with the requirements of ISO/IEC 24774:2010, Systems and software engineering Life cycle
31、management Guidelines for process description. This TR presents the PRM for medical device software development as a result of integrating requirements from IEC 62304:2006 and from the international standard of software life-cycle processes ISO/IEC 12207:2008. This TR is aimed at medical device soft
32、ware developers who can use it for realizing the set of requirements they have to achieve to be compliant with IEC 62304:2006 in the scope of the safety class of the medical device software they are developing. Each process outcome with a corresponding safety class is a requirement in IEC 62304:2006
33、. The process outcomes without a corresponding safety class are based only on ISO/IEC 12207:2008. These process outcomes provide additions that are beneficial when achieving the purpose of the process and could be regarded as a valuable contribution to safety-critical software development. The PRM m
34、ay also be used to provide a common basis for different models and methods for process assessment, ensuring that the results of the assessments can be reported in a common context. Assessors who are concerned with examining medical device software processes can use the PRM as an agreed list of IEC 6
35、2304 process outcomes to inform audit check listing and reporting. The process descriptions in the PRM incorporate a statement of the purpose of the process which describes at a high level the overall objectives of performing the process, together with the set of outcomes which demonstrate the succe
36、ssful achievement of the process purpose. These process outcomes are the software life cycle process requirements the statements of the overall goal of performing the process. In any process description, the set of process outcomes are necessary and sufficient to achieve the purpose of the process.
37、A manufacturer of a medical device software system is required to assign a software safety class (A, B, or C) according to the possible effects on the patient, operator, or other people resulting from a hazard to which the software system contributes, described in greater detail in IEC 62304:2006. T
38、he software safety classes are assigned based on severity as follows: Class A: no injury or damage to health is possible; Class B: non-serious injury is possible; Class C: death or serious injury is possible. 0.2 Organization of this technical report This TR is organized to follow the structure of I
39、EC 62304. Annex A describes the development of the TR in greater detail. Annex B provides a mapping from IEC 62304 clauses together with their safety classes to the corresponding ISO/IEC 12207:2008 processes. The life cycle processes of the PRM for medical device software development are described i
40、n terms of process name, process purpose and the corresponding process outcomes. The outcomes marked with an “ISO/IEC 12207” at the end of the outcome statement are derived from ISO/IEC 12207:2008, with no directly corresponding requirement in IEC 62304. Users of this PRM who wish to examine only th
41、e IEC 62304 requirements can elect to disregard the outcomes that are based only on ISO/IEC 12207:2008. PD IEC/TR 80002-3:2014 6 IEC TR 80002-3:2014 IEC 2014 MEDICAL DEVICE SOFTWARE Part 3: Process reference model of medical device software life cycle processes (IEC 62304) 1 Scope This part of IEC 8
42、0002, which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes. They have been aligned with the software development life cycle
43、processes of ISO/IEC 12207:2008 and are presented herein in full compliance with ISO/IEC 24774:2010. The content of these three standards provides the foundation of this TR. This TR does not address: areas already covered by existing related standards, e.g. the international standards that relate to
44、 the four standards used to build this TR (see Bibliography); FDA guidance documents; or software development tools. This TR describes the PRM for medical device software development and is limited in scope to the life cycle processes described in IEC 62304:2006. The process names correspond to thos
45、e of IEC 62304:2006. The mappings provided in Annex B are essential for the alignment between IEC 62304:2006 (which is based on ISO/IEC 12207:1995) and ISO/IEC 12207:2008, developed to address the detailed normative relationship between the two standards. This technical report is not intended to be
46、used as the basis of regulatory inspection or certification assessment activities. 2 Normative references 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 und
47、ated references, the latest edition of the referenced document (including any amendments) applies. IEC 62304:2006, Medical device software Software life cycle processes ISO/IEC 12207:2008, Systems and software engineering Software life cycle processes 3 Terms and definitions For the purposes of this
48、 document, the terms and definitions given in IEC 62304:2006 apply. NOTE To be consistent with the requirements for developing a PRM, the guidelines set forth in ISO/IEC 24774 were followed. Having a dedicated software risk management process enables the software developers to realize the set of req
49、uirements they have to adhere to when developing software for medical devices. This PRM also enables the medical device software developers to determine the requirements necessary to develop software for a specific safety class. The PRM presented in this TR includes only the software risk management requirements of ISO 14971 that are a part of IEC 62304. The software risk management terminology is therefore derived directly from ISO 14971. For the purposes of this TR, the software development-re
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