IEC62304模板.docx
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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
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