IEC_TR_80002-3-2014.pdf

IEC TR 80002-3 Edition 1.0 2014-06 INTERNATIONAL STANDARD Medical device software Part 3:Process reference model of medical device software life cycle processes(IEC 62304)IEC TR 80002-3:2014-06(en)Copyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,,downloaded on Nov-27-2014 by James Madison.No further reproduction or distribution is permitted.Uncontrolled when printed.THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2014 IEC,Geneva,Switzerland All rights reserved.Unless otherwise specified,no part of this publication may be reproduced or utilized in any form or by any means,electronic or mechanical,including photocopying and microfilm,without permission in writing from either IEC or IECs member National Committee in the country of the requester.If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,please contact the address below or your local IEC member National Committee for further information.IEC Central Office Tel.:+41 22 919 02 11 3,rue de Varemb Fax:+41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch Switzerland www.iec.ch About the IEC The International Electrotechnical Commission(IEC)is the leading global organization that prepares and publishes International Standards for all electrical,electronic and related technologies.About IEC publications The technical content of IEC publications is kept under constant review by the IEC.Please make sure that you have the latest edition,a corrigenda or an amendment might have been published.IEC Catalogue-webstore.iec.ch/catalogue The stand-alone application for consulting the entire bibliographical information on IEC International Standards,Technical Specifications,Technical Reports and other documents.Available for PC,Mac OS,Android Tablets and iPad.IEC publications search-www.iec.ch/searchpub The advanced search enables to find IEC publications by a variety of criteria(reference number,text,technical committee,).It also gives information on projects,replaced and withdrawn publications.IEC Just Published-webstore.iec.ch/justpublished Stay up to date on all new IEC publications.Just Published details all new publications released.Available online and also once a month by email.Electropedia-www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 30 000 terms and definitions in English and French,with equivalent terms in 14 additional languages.Also known as the International Electrotechnical Vocabulary(IEV)online.IEC Glossary-std.iec.ch/glossary More than 55 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002.Some entries have been collected from earlier publications of IEC TC 37,77,86 and CISPR.IEC Customer Service Centre-webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance,please contact the Customer Service Centre:csciec.ch.Copyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,,downloaded on Nov-27-2014 by James Madison.No further reproduction or distribution is permitted.Uncontrolled when printed.IEC TR 80002-3 Edition 1.0 2014-06 INTERNATIONAL STANDARD Medical device software 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.Copyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,,downloaded on Nov-27-2014 by James Madison.No further reproduction or distribution is permitted.Uncontrolled when printed.2 IEC 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 planning.7 4.1.1 Software requirements analysis.8 4.1.2 Software architectural design.8 4.1.3 Software detailed design.9 4.1.4 Software unit implementation and verification.9 4.1.5 Software integration and integration testing.10 4.1.6 Software system testing.10 4.1.7 Software release.11 4.1.84.2 Software maintenance.11 Purpose.11 4.2.1 Outcomes.11 4.2.24.3 Software risk management.12 Purpose.12 4.3.1 Outcomes.12 4.3.24.4 Software configuration management.13 Purpose.13 4.4.1 Outcomes.13 4.4.24.5 Software problem resolution.14 Purpose.14 4.5.1 Outcomes.14 4.5.2Annex A(informative)Development 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 development PRM.17 Table A.1 Direct process mappings between IEC 62