ISO/TR TECHNICAL REPORT 80002-2 Firstedition 2017-06 Medicaldevicesoftware Part 2: Validation of software for medical devicequality systems Logicielsdedispositifs medicaux- Partie2:Validation deslogicielspour les systemesde qualitedes dispositifs medicaux Reference number IEC IS0/TR80002-2:2017(E) IS02017 IS0/TR80002-2:2017(E) Contents Page Foreword .iv Introduction. 1 Scope. ..1 2 Normative references 3 Terms and definitions .1 4 Software validation discussion 4.1 Definition .1 4.2 Confidence-buildingactivities:Tools in thetoolbox .1 4.3 Critical thinking. .2 5 Softwarevalidationandcriticalthinking .2 5.1 Overview 2 5.2 Determine if the software is in scope. 6 5.2.1 Document ahigh-level definition of theprocess anduse ofthe software 6 5.2.2 Regulatoryuseassessment 5.2.3 Processes and software extraneous tomedicaldevice regulatoryrequirements...6 5.3 Developmentphase. 5.3.1 Validation planning. 5.3.2 Define. 7 5.3.3 Implement, test and deploy .11 5.4 Maintainphase. 13 5.4.1 Enteringthemaintenancephase .13 5.4.2 Planningfor maintenance ..14 5.4.3 Typesofmaintenancewithinthemaintainphase. .15 5.4.4 Processchanges:Changetoriskcontrolmeasures 5.4.5 Emergencychange .15 5.4.6 Maintaining for intended use ..16 5.5 Retirement phase.. ..16 6 Documentation .16 7 Prerequisiteprocesses ..17 AnnexA(informative)Toolbox .18 AnnexB(informative)Riskmanagementandrisk-basedapproach .24 AnnexC (informative)Examples. .28 Bibliography .84 IS0 2017-All rights reserved ili IS0/TR80002-2:2017(E) Foreword IsO(theInternational OrganizationforStandardization)isaworldwidefederationofnationalstandards bodies (iso member bodies).The work of preparing International Standards is normally carried out through Iso technical committees.Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with Iso, also take part in the work. ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersof electrotechnicalstandardization. The procedures used to develop this document and those intended for its further maintenance are described intheIsO/IECDirectives, Part1.Inparticular the different approval criterianeeded for the different types of Iso documents should be noted.This document was drafted in accordance with the editorialrulesoftheIso/lEcDirectives,Part2(seewww.iso.org/directives). Attentionisdrawntothepossibilitythat someoftheelementsof thisdocumentmaybethesubjectof patentrights.IsO should not beheld responsiblefor identifyingany orall such patent rights.Details of anypatent rights identified during thedevelopmentof thedocument will be in theIntroduction and/or on the Iso list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitutean endorsement. For an explanation on thevoluntary nature of standards, the meaning of Iso specific terms and expressions related to conformity assessment, as well as information about IsO's adherence to the World Trade Organization (WTO)principles in theTechnical Barriers toTrade (TBT)see thefollowing URL:www.iso.org/iso/foreword.html. This document was prepared byTechnical Committee ISo/TC 210, Quality management and correspondinggeneralaspects formedical devices,incollaboration withTechnical CommitteeIEc/TC62, usedin medical practice,in accordancewithIso/IEC mode of cooperation 4. Alistofall partsin theIS080002series canbefoundon theISOwebsite. iv IS02017-All rights reserved