IEC62304模板.docx
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IEC62304模板
Company:
.
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:
软件适用范围:
SoftwareApplications:
软件发布时间:
Softwarereleasetime:
标准:
Standard:
EN62304:
2006Medicaldevices
Medicaldevicesoftware-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
X
X
X
5.15.1.1、5.1.2、5.1.3、5.1.6、5.1.7、5.1.8、5.1.9
X
X
X
5.1.5、5.1.10、5.1.11
X
X
5.1.4
X
5.25.2.1、5.2.2、5.2.4、5.2.4、5.2.6
X
X
X
5.2.3
X
X
5.35.3.1、5.3.2、5.3.3、5.3.4、5.3.6
X
X
5.3.5
X
5.45.4.1
X
X
5.4.2、5.4.3、5.4.4
X
5.55.5.1
X
X
X
5.5.2、5.5.3、5.5.5
X
X
5.5.4
X
5.6全部要求
X
X
5.7全部要求
X
X
5.85.8.4
X
X
X
5.8.1、5.8.2、5.8.3、5.8.5、5.8.6、5.8.7、5.8.8
X
X
6.16.1
X
X
X
6.26.2.1、6.2.2、6.2.4、6.2.5
X
X
X
6.2.3
X
X
6.3全部要求
X
X
X
7.1全部要求
X
X
7.2全部要求
X
X
7.3全部要求
X
X
7.47.4.1
X
X
X
7.4.2、7.4.3
X
X
第8章全部要求
X
X
X
第9章全部要求
X
X
X
EN62304:
2006
Possibletestcaseverdicts:
-testcasedoesnotapplytothetestobject:
N/A
-testobjectdoesmeettherequirement:
Pass(P)
-testobjectdoesnotmeettherequirement:
Fail(F)
4
Generalrequirements
4.1
Qualitymanagementsystem
TheMANUFACTURERofMEDICALDEVICESOFTWAREshalldemonstratetheabilitytoprovide
MEDICALDEVICESOFTWAREthatconsistentlymeetscustomerrequirementsandapplicable
regulatoryrequirements.
4.2
RISKMANAGEMENT
TheMANUFACTURERshallapplyaRISKMANAGEMENTPROCESScomplyingwithISO14971.
4.3
Softwaresafetyclassification
a)TheMANUFACTURERshallassigntoeachSOFTWARESYSTEMasoftwaresafetyclass(A,B,or
C)accordingtothepossibleeffectsonthepatient,operator,orotherpeopleresultingfrom
aHAZARDtowhichtheSOFTWARESYSTEMcancontribute.
Thesoftwaresafetyclassesshallinitiallybeassignedbasedonseverityasfollows:
ClassA:
Noinjuryordamagetohealthispossible
ClassB:
Non-SERIOUSINJURYispossible
ClassC:
DeathorSERIOUSINJURYispossible
IftheHAZARDcouldarisefromafailureoftheSOFTWARESYSTEMtobehaveasspecified,the
probabilityofsuchfailureshallbeassumedtobe100percent.
IftheRISKofdeathorSERIOUSINJURYarisingfromasoftwarefailureissubsequently
reducedtoanacceptablelevel(asdefinedbyISO14971)byahardwareRISKCONTROL
measure,eitherbyreducingtheconsequencesofthefailureorbyreducingtheprobability
ofdeathorSERIOUSINJURYarisingfromthatfailure,thesoftwaresafetyclassificationmay
bereducedfromCtoB;andiftheRISKofnon-SERIOUSINJURYarisingfromasoftware
failureissimilarlyreducedtoanacceptablelevelbyahardwareRISKCONTROLmeasure,the
softwaresafetyclassificationmaybereducedfromBtoA.
b)TheMANUFACTURERshallassigntoeachSOFTWARESYSTEMthatcontributestothe
implementationofaRISKCONTROLmeasureasoftwaresafetyclassbasedonthepossible
effectsoftheHAZARDthattheRISKCONTROLmeasureiscontrolling.
c)TheMANUFACTURERshalldocumentthesoftwaresafetyclassassignedtoeachSOFTWARE
SYSTEMintheRISKMANAGEMENTFILE.
d)WhenaSOFTWARESYSTEMisdecomposedintoSOFTWAREITEMS,andwhenaSOFTWARE
ITEMisdecomposedintofurtherSOFTWAREITEMS,suchSOFTWAREITEMSshallinheritthe
softwaresafetyclassificationoftheoriginalSOFTWAREITEM(orSOFTWARESYSTEM)unless
theMANUFACTURERdocumentsarationaleforclassificationintoadifferentsoftwaresafety
class.SucharationaleshallexplainhowthenewSOFTWAREITEMSaresegregatedsothat
theymaybeclassifiedseparately.
e)TheMANUFACTURERshalldocumentthesoftwaresafetyclassofeachSOFTWAREITEMifthat
classisdifferentfromtheclassoftheSOFTWAREITEMfromwhichitwascreatedby
decomposition.
f)Forcompliancewiththisstandard,whereveraPROCESSisrequiredforSOFTWAREITEMSofa
specificclassificationandthePROCESSisnecessarilyappliedtoagroupofSOFTWARE
ITEMS,theMANUFACTURERshallusethePROCESSESandTASKSwhicharerequiredbythe
classificationofthehighest-classifiedSOFTWAREITEMinthegroupunlessthe
MANUFACTURERdocumentsintheRISKMANAGEMENTFILEarationaleforusingalower
classification.
g)ForeachSOFTWARESYSTEM,untilasoftwaresafetyclassisassigned,ClassC
requirementsshallapply.
5
SoftwaredevelopmentPROCESS
5.1
Softwaredevelopmentplanning
5.1.1
Softwaredevelopmentplan
TheMANUFACTURERshallestablishasoftwaredevelopmentplan(orplans)forconductingthe
ACTIVITIESofthesoftwaredevelopmentPROCESSappropriatetothescope,magnitude,and
softwaresafetyclassificationsoftheSOFTWARESYSTEMtobedeveloped.ThesOFTWARE
DEVELOPMENTLIFECYCLEMODELshalleitherbefullydefinedorbereferencedintheplan(or
plans).Theplanshalladdressthefollowing:
a)thePROCESSEStobeusedinthedevelopmentoftheSOFTWARESYSTEM(seeNote4);
b)theDELIVERABLES(includesdocumentation)oftheACTIVITIESandTASKS;
c)TRACEABILITYbetweenSYSTEMrequirements,softwarerequirements,SOFTWARESYSTEM
test,andRISKCONTROLmeasuresimplementedinsoftware;
d)softwareconfigurationandchangemanagement,includingSOUPCONFIGURATIONITEMSand
softwareusedtosupportdevelopment;and
e)softwareproblemresolutionforhandlingproblemsdetectedintheSOFTWAREPRODUCTS,
DELIVERABLESandACTIVITIESateachstageofthelifecycle.
[ClassA,B,C]
5.1.2
Keepsoftwaredevelopmentplanupdated
TheMANUFACTURERshallupdatetheplanasdevelopmentproceedsasappropriate.
[ClassA,B,C]
5.1.3
SoftwaredevelopmentplanreferencetoSYSTEMdesignanddevelopment
a)Asinputsforsoftwaredevelopment,SYSTEMrequirementsshallbereferencedinthe
softwaredevelopmentplanbytheMANUFACTURER.
b)TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplanprocedures
forcoordinatingthesoftwaredevelopmentandthedesignanddevelopmentvalidation
necessarytosatisfy4.1.
5.1.4
Softwaredevelopmentstandards,methodsandtoolsplanning
TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplan:
a)standards,
b)methods,and
c)tools
associatedwiththedevelopmentofSOFTWAREITEMSofclassC.[ClassC]
5.1.5
Softwareintegrationandintegrationtestingplanning
TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplan,aplanto
integratetheSOFTWAREITEMS(includingSOUP)andperformtestingduringintegration.[ClassB,
C]
5.1.6
SoftwareVERIFICATIONplanning
TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplanthefollowing
VERIFICATIONinformation:
a)DELIVERABLESrequiringVERIFICATION;
b)therequiredVERIFICATIONTASKSforeachlifecycleACTIVITY;
c)milestonesatwhichtheDELIVERABLESareVERIFIED;and
d)theacceptancecriteriaforVERIFICATIONoftheDELIVERABLES.
[ClassA,B,C]
5.1.7
SoftwareRISKMANAGEMENTplanning
TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplan,aplanto
conducttheACTIVITIESandTASKSofthesoftwareRISKMANAGEMENTPROCESS,includingthe
managementofRISKSrelatingtoSOUP.[ClassA,B,C]
5.1.8
Documentationplanning
TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplaninformation
aboutthedocumentstobeproducedduringthesoftwaredevelopmentlifecycle.Foreach
identifieddocumentortypeofdocumentthefollowinginformationshallbeincludedor
referenced:
a)title,nameornamingconvention;
b)purpose;
c)intendedaudienceofdocument;and
d)proceduresandresponsibilitiesfordevelopment,review,approvalandmodification.
[ClassA,B,C]
5.1.9
Softwareconfigurationmanagementplanning
TheMANUFACTURERshallincludeorreferencesoftwareconfigurationmanagementinformation
inthesoftwaredevelopmentplan.Thesoftwareconfigurationmanagementinformationshall
includeorreference:
a)theclasses,types,categoriesorlistsofitemstobecontrolled;
b)thesoftwareconfigurationmanagementACTIVITIESandTASKS;
c)theorganization(s)responsibleforperformingsoftwareconfigurationmanagementand
ACTIVITIES;
d)theirrelationshipwithotherorganizations,suchassoftwaredevelopmentormaintenance;
e)whentheitemsaretobeplacedunderconfigurationcontrol;and
f)whentheproblemresolutionPROCESSistobeused.
[ClassA,B,C]
5.1.10
Supportingitemstobecontrolled
Theitemstobecontrolledshallincludetools,itemsorsettings,usedtodeveloptheMEDICAL
DEVICESOFTWARE,whichcouldimpacttheMEDICALDEVICESOFTWARE.[ClassB,C]
5.1.11
SoftwareCONFIGURATIONITEMcontrolbeforeVERIFICATION
TheMANUFACTURERshallplantoplaceCONFIGURATIONITEMSunderdocumentedconfiguration
managementcontrolbeforetheyareVERIFIED.[ClassB,C]
5.2
Softwarerequirementsanalysis
5.2.1
DefineanddocumentsoftwarerequirementsfromSYSTEMrequirements
ForeachSOFTWARESYSTEMoftheMEDICALDEVICE,theMANUFACTURERshalldefineand
documentSOFTWARESYSTEMrequirementsfromtheSYSTEMlevelrequirements.[ClassA,B,C]
5.2.2
Softwarerequirementscontent
AsappropriatetotheMEDICALDEVICESOFTWARE,th