IEC_62304-2015.pdf

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 rights reserved.Unless otherwise specified,no par t of this publication may be reproduced or utilized in any for m or by any means,electronic or mechanical,including photocopying and microfilm,without per mission in writing fr om 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 r ights to this publication,please contact the address below or your local IEC member National Committee for further infor mation.IEC Centr al Office Tel.:+41 22 919 02 11 3,rue de Varemb Fax:+41 22 919 03 00 CH-1211 Geneva 20 inf oiec.ch Switzerland www.iec.ch About t he IEC The International Electr otechnical Commission(IEC)is the leading global organization that prepar es and publishes Inter national Standards for all electr ical,electronic and related technologies.A bout 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 cor rigenda or an amendment might have been published.IEC Cat alogue-webstore.iec.ch/cat alogue The stand-alone application for consulting the entire bibliographical information on IEC International Standards,Technical Specifications,Technical R eports and other documents.A v ailable for PC,Mac OS,A ndroid Tablets and iPad.IEC publications search-w w w.iec.ch/searchpub The adv anced search enables to find IEC publications by a variety of criteria(reference number,text,technical committee,).It also gives information on projec ts,replaced and withdrawn publications.IEC Just Published-webstore.iec.ch/justpublished Stay up to date on all new IEC publications.Just Published details all new publications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.A v ailable online and also once a month by email.Elect ropedia-w w w.elect ropedia.org The worlds leading online dic tionary of elec tronic and electrical terms containing more than 30 000 terms and definitions in English and French,with equiv alent terms in 15 additional languages.Also known as the International Elec trotechnical Vocabulary (IEV)online.IEC Glossar y-st d.iec.ch/glossary More than 60 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002.Some entries hav e been collected from earlier publications of IEC TC 37,77,86 and CISPR.IEC Customer Service Cent re-webstore.iec.ch/csc If y ou wish to giv e us y our feedback on this publication or need further assistance,please contact the Customer Serv ice Centre:csciec.ch.Copyright International Electrotechnical Commission IEC 62304 Edit ion 1.1 2015-06 CONSOLIDA TED VERSION Medical dev ice software 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 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.6INTRODUCTION 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 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*SOFTWARE 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.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