1、 IEC 62304 Edition 1.1 2015-06 CONSOLIDA TED V ER SION Medical dev ice software Software life cycle processes IEC 62304:2006-05+AMD1:2015-06 CSV(en)colourinsideCopyright International Electrotechnical Commission THIS PUBLICA TION IS COPYRIGHT PROTECTED Copyright 2015 IEC,Geneva,Switzerland All right
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11、ware Software life cycle processes INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040 ISBN 978-2-8322-2765-7 Warning!Make sure that you obtained this publication from an authorized distributor.colourinsideCopyright International Electrotechnical Commission Copyright International Electrotechnical
12、Commission IEC 62304 Edition 1.1 2015-06 REDLINE V ER SION Medical dev ice software Software life cycle processes IEC 62304:2006-05+AMD1:2015-06 CSV(en)colourinsideCopyright International Electrotechnical Commission 2 IEC 62304:2006 +AMD1:2015 CSV IEC 2015 CONTENTS FOREWORD.4INTRODUCTION.6INTRODUCTI
13、ON to Amendment 1.81Scope.91.1*Purpose.91.2*Field of application.91.3Relationship to other standards.91.4Compliance.92*Normative ref erences.103*Terms and def initions.104*General requirements.154.1*Quality management system.154.2*RISK MANAGEMENT.164.3*Sof tware saf ety classif ication.164.4*LEGACY
14、SOFTWARE.185Sof tware development PROCESS.195.1*Sof tware development planning.195.2*Sof tware requirements analysis.215.3*Sof tware ARCHITECTURAL design.235.4*Sof tware detailed design.245.5*SOFTWARE UNIT implementation and verif ication.255.6*Sof tware integration and integration testing.255.7*SOF
15、TWARE SYSTEM testing.275.8*Sof tware release.286Sof tware maintenance PROCESS.296.1*Establish sof tware maintenance plan.296.2*Problem and modif ication analysis.306.3*Modif ication implementation.317*Sof tware RISK MANAGEMENT PROCESS.317.1*Analysis of sof tware contributing to hazardous situations.
16、317.2RISK CONTROL measures.327.3VERIFICATION of RISK CONTROL measures.327.4RISK MANAGEMENT of sof tware changes.338*Sof tware conf iguration management PROCESS.338.1*Conf iguration identif ication.338.2*Change control.338.3*Conf iguration status accounting.349*Sof tware problem resolution PROCESS.349.1Prepare PROBLEM REPORTS.349.2Investigate the problem.359.3Advise relevant parties.359.4Use change control process.359.5Maintain records.359.6Analyse problems f or trends.359.7Verif y sof tware prob