IEC62304模板.docx

IEC62304模板.docx

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IEC62304模板模板Company：

FileNo.File：

软件验证报告RevisedNo.1软件验证报告公司名称：

CompanyName:

公司地址：

CompanyAddress:

软件名称：

SoftwareName:

版本号：

Versionnumber:

软件适用围:

SoftwareApplications：

软件发布时间:

Softwarereleasetime：

标准：

Standard:

EN62304:

2006MedicaldevicesMedicaldevicesoftware-Softwarelifecycleprocesses结论：

Result:

符合EN62304:

2006要求编写Compiledby:

（Name/Title/Dept.）日期Date:

评审Reviewedby（Name/Title/Dept.）日期Date:

批准Approvedby:

（Name/Title/Dept.）日期Date:

EN62304：

2006的应用软件预期目的和用途识别的危害的可能来源与处理医疗器械数据有关的危害判定已知和合理可预见的危害已进行的安全性标准验证已进行的风险控制方法软件安全性级别：

A级B级C级确定软件安全性级别的依据：

IEC62304:

2006软件安全性级别要求章和条A级B级C级第四章全部要求XXX5.15.1.1、5.1.2、5.1.3、5.1.6、5.1.7、5.1.8、5.1.9XXX5.1.5、5.1.10、5.1.11XX5.1.4X5.25.2.1、5.2.2、5.2.4、5.2.4、5.2.6XXX5.2.3XX5.35.3.1、5.3.2、5.3.3、5.3.4、5.3.6XX5.3.5X5.45.4.1XX5.4.2、5.4.3、5.4.4X5.55.5.1XXX5.5.2、5.5.3、5.5.5XX5.5.4X5.6全部要求XX5.7全部要求XX5.85.8.4XXX5.8.1、5.8.2、5.8.3、5.8.5、5.8.6、5.8.7、5.8.8XX6.16.1XXX6.26.2.1、6.2.2、6.2.4、6.2.5XXX6.2.3XX6.3全部要求XXX7.1全部要求XX7.2全部要求XX7.3全部要求XX7.47.4.1XXX7.4.2、7.4.3XX第8章全部要求XXX第9章全部要求XXXEN62304：

2006Possibletestcaseverdicts:

-testcasedoesnotapplytothetestobject:

N/A-testobjectdoesmeettherequirement:

Pass（P）-testobjectdoesnotmeettherequirement:

Fail（F）4Generalrequirements4.1QualitymanagementsystemTheMANUFACTURERofMEDICALDEVICESOFTWAREshalldemonstratetheabilitytoprovideMEDICALDEVICESOFTWAREthatconsistentlymeetscustomerrequirementsandapplicableregulatoryrequirements.4.2RISKMANAGEMENTTheMANUFACTURERshallapplyaRISKMANAGEMENTPROCESScomplyingwithISO14971.4.3Softwaresafetyclassificationa）TheMANUFACTURERshallassigntoeachSOFTWARESYSTEMasoftwaresafetyclass（A,B,orC）accordingtothepossibleeffectsonthepatient,operator,orotherpeopleresultingfromaHAZARDtowhichtheSOFTWARESYSTEMcancontribute.Thesoftwaresafetyclassesshallinitiallybeassignedbasedonseverityasfollows:

ClassA:

NoinjuryordamagetohealthispossibleClassB:

Non-SERIOUSINJURYispossibleClassC:

DeathorSERIOUSINJURYispossibleIftheHAZARDcouldarisefromafailureoftheSOFTWARESYSTEMtobehaveasspecified,theprobabilityofsuchfailureshallbeassumedtobe100percent.IftheRISKofdeathorSERIOUSINJURYarisingfromasoftwarefailureissubsequentlyreducedtoanacceptablelevel（asdefinedbyISO14971）byahardwareRISKCONTROLmeasure,eitherbyreducingtheconsequencesofthefailureorbyreducingtheprobabilityofdeathorSERIOUSINJURYarisingfromthatfailure,thesoftwaresafetyclassificationmaybereducedfromCtoB;andiftheRISKofnon-SERIOUSINJURYarisingfromasoftwarefailureissimilarlyreducedtoanacceptablelevelbyahardwareRISKCONTROLmeasure,thesoftwaresafetyclassificationmaybereducedfromBtoA.b）TheMANUFACTURERshallassigntoeachSOFTWARESYSTEMthatcontributestotheimplementationofaRISKCONTROLmeasureasoftwaresafetyclassbasedonthepossibleeffectsoftheHAZARDthattheRISKCONTROLmeasureiscontrolling.c）TheMANUFACTURERshalldocumentthesoftwaresafetyclassassignedtoeachSOFTWARESYSTEMintheRISKMANAGEMENTFILE.d）WhenaSOFTWARESYSTEMisdecomposedintoSOFTWAREITEMS,andwhenaSOFTWAREITEMisdecomposedintofurtherSOFTWAREITEMS,suchSOFTWAREITEMSshallinheritthesoftwaresafetyclassificationoftheoriginalSOFTWAREITEM（orSOFTWARESYSTEM）unlesstheMANUFACTURERdocumentsarationaleforclassificationintoadifferentsoftwaresafetyclass.SucharationaleshallexplainhowthenewSOFTWAREITEMSaresegregatedsothattheymaybeclassifiedseparately.e）TheMANUFACTURERshalldocumentthesoftwaresafetyclassofeachSOFTWAREITEMifthatclassisdifferentfromtheclassoftheSOFTWAREITEMfromwhichitwascreatedbydecomposition.f）Forcompliancewiththisstandard,whereveraPROCESSisrequiredforSOFTWAREITEMSofaspecificclassificationandthePROCESSisnecessarilyappliedtoagroupofSOFTWAREITEMS,theMANUFACTURERshallusethePROCESSESandTASKSwhicharerequiredbytheclassificationofthehighest-classifiedSOFTWAREITEMinthegroupunlesstheMANUFACTURERdocumentsintheRISKMANAGEMENTFILEarationaleforusingalowerclassification.g）ForeachSOFTWARESYSTEM,untilasoftwaresafetyclassisassigned,ClassCrequirementsshallapply.5SoftwaredevelopmentPROCESS5.1Softwaredevelopmentplanning5.1.1SoftwaredevelopmentplanTheMANUFACTURERshallestablishasoftwaredevelopmentplan（orplans）forconductingtheACTIVITIESofthesoftwaredevelopmentPROCESSappropriatetothescope,magnitude,andsoftwaresafetyclassificationsoftheSOFTWARESYSTEMtobedeveloped.ThesOFTWAREDEVELOPMENTLIFECYCLEMODELshalleitherbefullydefinedorbereferencedintheplan（orplans）.Theplanshalladdressthefollowing:

a）thePROCESSEStobeusedinthedevelopmentoftheSOFTWARESYSTEM（seeNote4）;b）theDELIVERABLES（includesdocumentation）oftheACTIVITIESandTASKS;c）TRACEABILITYbetweenSYSTEMrequirements,softwarerequirements,SOFTWARESYSTEMtest,andRISKCONTROLmeasuresimplementedinsoftware;d）softwareconfigurationandchangemanagement,includingSOUPCONFIGURATIONITEMSandsoftwareusedtosupportdevelopment;ande）softwareproblemresolutionforhandlingproblemsdetectedintheSOFTWAREPRODUCTS,DELIVERABLESandACTIVITIESateachstageofthelifecycle.ClassA,B,C5.1.2KeepsoftwaredevelopmentplanupdatedTheMANUFACTURERshallupdatetheplanasdevelopmentproceedsasappropriate.ClassA,B,C5.1.3SoftwaredevelopmentplanreferencetoSYSTEMdesignanddevelopmenta）Asinputsforsoftwaredevelopment,SYSTEMrequirementsshallbereferencedinthesoftwaredevelopmentplanbytheMANUFACTURER.b）TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplanproceduresforcoordinatingthesoftwaredevelopmentandthedesignanddevelopmentvalidationnecessarytosatisfy4.1.5.1.4Softwaredevelopmentstandards,methodsandtoolsplanningTheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplan:

a）standards,b）methods,andc）toolsassociatedwiththedevelopmentofSOFTWAREITEMSofclassC.ClassC5.1.5SoftwareintegrationandintegrationtestingplanningTheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplan,aplantointegratetheSOFTWAREITEMS（includingSOUP）andperformtestingduringintegration.ClassB,C5.1.6SoftwareVERIFICATIONplanningTheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplanthefollowingVERIFICATIONinformation:

a）DELIVERABLESrequiringVERIFICATION;b）therequiredVERIFICATIONTASKSforeachlifecycleACTIVITY;c）milestonesatwhichtheDELIVERABLESareVERIFIED;andd）theacceptancecriteriaforVERIFICATIONoftheDELIVERABLES.ClassA,B,C5.1.7SoftwareRISKMANAGEMENTplanningTheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplan,aplantoconducttheACTIVITIESandTASKSofthesoftwareRISKMANAGEMENTPROCESS,includingthemanagementofRISKSrelatingtoSOUP.ClassA,B,C5.1.8DocumentationplanningTheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplaninformationaboutthedocumentstobeproducedduringthesoftwaredevelopmentlifecycle.Foreachidentifieddocumentortypeofdocumentthefollowinginformationshallbeincludedorreferenced:

a）title,nameornamingconvention;b）purpose;c）intendedaudienceofdocument;andd）proceduresandresponsibilitiesfordevelopment,review,approvalandmodification.ClassA,B,C5.1.9SoftwareconfigurationmanagementplanningTheMANUFACTURERshallincludeorreferencesoftwareconfigurationmanagementinformationinthesoftwaredevelopmentplan.Thesoftwareconfigurationmanagementinformationshallincludeorreference:

a）theclasses,types,categoriesorlistsofitemstobecontrolled;b）thesoftwareconfigurationmanagementACTIVITIESandTASKS;c）theorganization（s）responsibleforperformingsoftwareconfigurationmanagementandACTIVITIES;d）theirrelationshipwithotherorganizations,suchassoftwaredevelopmentormaintenance;e）whentheitemsaretobeplacedunderconfigurationcontrol;andf）whentheproblemresolutionPROCESSistobeused.ClassA,B,C5.1.10SupportingitemstobecontrolledTheitemstobecontrolledshallincludetools,itemsorsettings,usedtodeveloptheMEDICALDEVICESOFTWARE,whichcouldimpacttheMEDICALDEVICESOFTWARE.ClassB,C5.1.11SoftwareCONFIGURATIONITEMcontrolbeforeVERIFICATIONTheMANUFACTURERshallplantoplaceCONFIGURATIONITEMSunderdocumentedconfigurationmanagementcontrolbeforetheyareVERIFIED.ClassB,C5.2Softwarerequirementsanalysis5.2.1DefineanddocumentsoftwarerequirementsfromSYSTEMrequirementsForeachSOFTWARESYSTEMoftheMEDICALDEVICE,theMANUFACTURERshalldefineanddocumentSOFTWARESYSTEMrequirementsfromtheSYSTEMlevelrequirements.ClassA,B,C5.2.2SoftwarerequirementscontentAsappropriatetotheMEDICALDEVICESOFTWARE,theMANUFACTURERshallincludeinthesoftwarerequirements:

a）functionalandcapabilityrequirements;b）SOFTWARESYSTEMinputsandoutputs;c）interfacesbetweentheSOFTWARESYSTEMandotherSYSTEMS;d）software-drivenalarms,warnings,andoperatormessages;e）SECURITYrequirements;f）usabilityengineeringrequirementsthataresensitivetohumanerrorsandtraining;g）datadefinitionanddatabaserequirements;h）installationandacceptancerequirementsofthedeliveredMEDICALDEVICESOFTWAREattheoperationandmaintenancesiteorsites;i）requirementsrelatedtomethodsofoperationandmaintenance;j）userdocumentationtobedeveloped;k）usermaintenancerequirements;andl）regulatoryrequirements.ClassA,B,C5.2.3IncludeRISKCONTROLmeasuresinsoftwarerequirementsTheMANUFACTURERshallincludeRISKCONTROLmeasuresimplementedinsoftwareforhardwarefailuresandpotential