IEC-62304-2006-CheckList(可编辑修改word版)

1、IEC62304ReferenceSoftwareLifecycleProcessApplicableforClassAClassBClassCPRIMARYLIFECYCLEPROCESESS5SOFTWAREDEVELOPMENTProcess51DevelopmentPlanningActivity5.1.1SoftwaredevelopmentplantaskXXX5.1.2SoftwaredevelopmentplanreferencetoSYSTEMrequirementstaskXXX5.1.3SOUPmanagementplanningtaskXX5.1.4Softwarede

2、velopmentmeasuresplanningtaskXX5.1.5SoftwareintegrationandintegrationtestingplanningtaskXX5.1.6SoftwareVERIFICATIONplanningtaskXXX5.1.7SoftwareVERIFICATIONrequirementscoverageplanningtaskXX5.1.8SoftwareRISKMANAGEMENTplanningtaskXXX5.1.9DocumentationplanningtaskXXX5.1.10Softwareconfigurationmanagemen

3、tplanningtaskXXX5.1.11SoftwareconfigurationcontrolplanningtaskXX5.1.12SoftwareproblemresolutionplanningtaskX52RequirementsAnalysisActivity5.2.1DefinesoftwarerequirementsfromSYSTEMrequirementstaskXXX5.2.2EstablishsoftwarerequirementstaskXXX5.2.3SoftwarerequirementscontenttaskXXX5.2.4IncludeRISKCONTRO

4、LmeasuresinsoftwarerequirementstaskXX5.2.5UpdateRISKANALYSIStaskXXX5.2.6EnsurecompliancewithSYSTEMrequirementstaskXXX5.2.7UniquelyidentifysoftwarerequirementstaskXXX5.2.8UpdateSYSTEMrequirementstaskXXX5.2.9VerifysoftwarerequirementstaskXXX5.2.10DocumentsoftwarerequirementsVERIFICATIONtaskXXX53Archit

5、ecturalDesignActivity5.3.1TransformsoftwarerequirementsintoanARCHITECTUREtaskXXX5.3.2DocumentsoftwareARCHITECTUREtaskXXX5.3.3DocumentsoftwaresafetyclassificationofeachSOFTWAREITEMtaskXXX5.3.4DevelopanARCHITECTUREfortheinterfacesofSOFTWAREITEMStaskXX5.3.5SpecifySYSTEMhardwareandsoftwarerequiredbySOUP

6、itemtaskXX5.3.6SpecifyfunctionalandperformancerequirementsofSOUPitemtaskXX5.3.7IdentifysegregationnecessaryforSAFETYtaskXX5.3.8VerifysoftwareARCHITECTUREtaskXX5.3.9VerifyappropriatenessofsoftwaredevelopmentplantaskXX5.3.10DocumentresultsofsoftwareARCHITECTUREVERIFICATIONtaskXX5.4DetailedDesignActivi

7、ty5.4.1RefineSOFTWAREITEMSintoSOFTWAREUNITStaskXX5.4.2InheritanceofsoftwaresafetyclassificationtaskXX5.4.3DevelopdetaileddesignforeachSOFTWAREUNITtaskX5.4.4DevelopdetaileddesignforinterfacestaskX5.4.5VerifydetaileddesigntaskXX5.4.6AdditionaldetaileddesignVERIFICATIONtaskX5.4.7Documentresultsofdesign

8、VERIFICATIONtaskXX55SoftwareCodingActivity5.5.1ImplementeachSOFTWAREUNITtaskXX5.5.2EstablishSOFTWAREUNITVERIFICATIONPROCESStaskXX5.5.3VerifysoftwarecodetaskXX5.5.4AdditionalsoftwarecodeVERIFICATIONtaskXX5.5.5DocumenttheresultsofsoftwarecodeVERIFICATIONtaskXX56IntegrationandTestingActivity5.6.1Integr

9、ateSOFTWAREUNITStaskXX5.6.2VerifysoftwareintegrationtaskXX5.6.3DocumenttheresultsofsoftwareintegrationtaskXX5.5.4AdditionalsoftwarecodeVERIFICATIONtaskXX5.6.5IntegrationtestingcontenttaskXX5.6.6Includeintegrationtestingfornon-normalcasesXtask5.6.7ConductregressionteststaskXX5.6.8Documentresultsofsof

10、twareintegrationteststaskXX5.6.9IntegrationtestdocumentationcontentstaskXX5.6.10UseformalsoftwareproblemresolutionPROCESStaskXX57SystemTestingActivity5.7.1EstablishtestsforeachsoftwarerequirementtaskXX5.7.2UseformalsoftwareproblemresolutionPROCESStaskXX5.7.3RepeattestsandconductregressionteststaskXX

11、5.7.4VerifySOFTWARESYSTEMtestingtaskXX5.7.5RecorddataforeachtesttaskXX5.8ReleaseActivity5.8.1EnsuresoftwareVERIFICATIONiscompleteXX5.8.2EnsuredocumentationiscompleteXX5.8.3DocumentknownresidualanomaliesXX5.8.4EvaluateknownresidualanomaliesXX5.8.5DocumentreleasedVERSIONSXX5.8.6Documenthowreleasedsoft

12、warewascreatedXX5.8.7ArchivemastercopiesXX588UseestablishedproceduresforsoftwarereleaseXX6SOFTWAREMAINTENANCEProcess61EstablishsoftwaremaintenanceplanActivity6.1.1EstablishsoftwaremaintenanceplantaskXXX6.2ProblemandModificationAnalysisActivity6.2.1RecordandevaluatefeedbacktaskXXX6.2.2Usesoftwareprob

13、lemresolutionPROCESStaskXXX6.2.3AnalysemodificationrequeststaskXXX6.2.4ConductanalysisofchangesimpliedbymodificationrequesttaskXXX6.2.5Documentnew,modifiedanddeleteditemtaskXXX6.2.6ReviewandapprovemodificationtaskXXX6.2.7DocumentmodificationtaskXX6.3ModificationImplementationActivity6.3.1Useestablis

14、hedPROCESStoimplementmodificationtaskXXX6.3.2DefinecriteriafortestingmodificationstaskXX6.3.3VerifymodificationstaskXX6.3.4ConductregressiontestingtaskXX6.3.5DemonstratesoftwareRISKCONTROLmeasuresremaineffectivetaskXX6.3.6DocumentthetestresultstaskXXsee53ArchitecturalDesignActivitysee5.4DetailedDesi

15、gnActivitysee55SoftwareCodingActivitysee56IntegrationandTestingActivitysee57SystemTestingActivitysee5.8ReleaseActivitySUPPORTINGPROCESSES7SOFTWARERISKMANAGEMENTProcess(referencedISO14971)71AnalysisofsoftwarecontributingtoHAZARDSActivity7.1.1IdentifySOFTWAREITEMSthatcouldcontributetoaHAZARDtaskXX7.1.

16、2IdentifypotentialcausesofcontributiontoaHAZARDtaskXX7.1.3ConsiderspecificpotentialcausestaskXX7.1.4ReviewpublishedSOUPanomalyliststaskXX7.1.5DocumentpotentialcausestaskXX7.1.6DocumentsequencesofeventstaskXX72RISKCONTROLmeasuresActivity7.2.1DefineRISKCONTROLmeasurestaskXX7.2.2RISKCONTROLmeasuresimpl

17、ementedinsoftwaretaskXX73VERIFICATIONofRISKCONTROLmeasuresActivity7.3.1VerifyRISKCONTROLmeasurestaskXX7.3.2DocumentanynewsequencesofeventstaskXX7.3.3DocumentTRACEABILITYtaskXX7.4RISKMANAGEMENTofsoftwarechangesActivity7.4.1AnalysechangesTOMEDICALDEVICESOFTWAREwithrespecttosafetytaskXXX7.4.2Analyseimp

18、actsoftwarechangesonexistingRISKCONTROLmeasurestaskXX7.4.3PerformRISKMANAGEMENTACTIVITIESbasedonanalysestaskXX8SOFTWARECONFIGURATIONMANAGEMENTProcess81ConfigurationidentificationActivity8.1.1EstablishmeanstoidentifyCONFIGURATIONITEMStaskXXX8.1.2IdentifySOUPtaskXXX8.1.3DocumentSOUPdesignatortaskxXX8.1.4IdentifySYSTEMconfigurationdocumentationtaskxXX82ConfigurationcontrolActivity8.2.1Identif