1、 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
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11、ntre: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
12、 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 Dem
13、o 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 N
14、ormative 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 implem
15、entation 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
16、 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
