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Standard:
EN62304:
2006Medicaldevices
Medicaldevicesoftware-Softwarelifecycleprocesses
结论:
Result:
符合EN62304:
2006要求
编写piledby:
(Name/Title/Dept.)
日期Date:
评审Reviewedby
批准Approvedby:
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
判定和合理可预见的危害
已进展的安全性标准验证
已进展的风险控制方法
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
5.6全部要求
5.7全部要求
6.16.1
6.3全部要求
7.1全部要求
7.2全部要求
7.3全部要求
第8章全部要求
第9章全部要求
2006
Possibletestcaseverdicts:
-testcasedoesnotapplytothetestobject:
N/A
-testobjectdoesmeettherequirement:
Pass(P)
-testobjectdoesnotmeettherequirement:
Fail(F)
4
Generalrequirements
Qualitymanagementsystem
TheMANUFACTURERofMEDICALDEVICESOFTWAREshalldemonstratetheabilitytoprovide
MEDICALDEVICESOFTWAREthatconsistentlymeetscustomerrequirementsandapplicable
regulatoryrequirements.
RISKMANAGEMENT
TheMANUFACTURERshallapplyaRISKMANAGEMENTPROCESSplyingwithISO14971.
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)WhenaSOFTWARESYSTEMisdeposedintoSOFTWAREITEMS,andwhenaSOFTWARE
ITEMisdeposedintofurtherSOFTWAREITEMS,suchSOFTWAREITEMSshallinheritthe
softwaresafetyclassificationoftheoriginalSOFTWAREITEM(orSOFTWARESYSTEM)unless
theMANUFACTURERdocumentsarationaleforclassificationintoadifferentsoftwaresafety
class.SucharationaleshallexplainhowthenewSOFTWAREITEMSaresegregatedsothat
theymaybeclassifiedseparately.
e)TheMANUFACTURERshalldocumentthesoftwaresafetyclassofeachSOFTWAREITEMifthat
classisdifferentfromtheclassoftheSOFTWAREITEMfromwhichitwascreatedby
deposition.
f)Forpliancewiththisstandard,whereveraPROCESSisrequiredforSOFTWAREITEMSofa
specificclassificationandthePROCESSisnecessarilyappliedtoagroupofSOFTWARE
ITEMS,theMANUFACTURERshallusethePROCESSESandTASKSwhicharerequiredbythe
classificationofthehighest-classifiedSOFTWAREITEMinthegroupunlessthe
MANUFACTURERdocumentsintheRISKMANAGEMENTFILEarationaleforusingalower
classification.
g)ForeachSOFTWARESYSTEM,untilasoftwaresafetyclassisassigned,ClassC
requirementsshallapply.
5
SoftwaredevelopmentPROCESS
Softwaredevelopmentplanning
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]
Keepsoftwaredevelopmentplanupdated
TheMANUFACTURERshallupdatetheplanasdevelopmentproceedsasappropriate.
SoftwaredevelopmentplanreferencetoSYSTEMdesignanddevelopment
a)Asinputsforsoftwaredevelopment,SYSTEMrequirementsshallbereferencedinthe
softwaredevelopmentplanbytheMANUFACTURER.
b)TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplanprocedures
forcoordinatingthesoftwaredevelopmentandthedesignanddevelopmentvalidation
necessarytosatisfy4.1.
Softwaredevelopmentstandards,methodsandtoolsplanning
TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplan:
a)standards,
b)methods,and
c)tools
associatedwiththedevelopmentofSOFTWAREITEMSofclassC.[ClassC]
Softwareintegrationandintegrationtestingplanning
TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplan,aplanto
integratetheSOFTWAREITEMS(includingSOUP)andperformtestingduringintegration.[ClassB,
C]
SoftwareVERIFICATIONplanning
TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplanthefollowing
VERIFICATIONinformation:
a)DELIVERABLESrequiringVERIFICATION;
b)therequiredVERIFICATIONTASKSforeachlifecycleACTIVITY;
c)milestonesatwhichtheDELIVERABLESareVERIFIED;
d)theacceptancecriteriaforVERIFICATIONoftheDELIVERABLES.
SoftwareRISKMANAGEMENTplanning
conducttheACTIVITIESandTASKSofthesoftwareRISKMANAGEMENTPROCESS,includingthe
managementofRISKSrelatingtoSOUP.[ClassA,B,C]
Documentationplanning
TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplaninformation
aboutthedocumentstobeproducedduringthesoftwaredevelopmentlifecycle.Foreach
identifieddocumentortypeofdocumentthefollowinginformationshallbeincludedor
referenced:
a)title,nameornamingconvention;
b)purpose;
c)intendedaudienceofdocument;
d)proceduresandresponsibilitiesfordevelopment,review,approvalandmodification.
Softwareconfigurationmanagementplanning
TheMANUFACTURERshallincludeorreferencesoftwareconfigurationmanagementinformation
inthesoftwaredevelopmentplan.Thesoftwareconfigurationmanagementinformationshall
includeorreference:
a)theclasses,types,categoriesorlistsofitemstobecontrolled;
b)thesoftwareconfigurationmanagementACTIVITIESandTASKS;
c)theorganization(s)responsibleforperformingsoftwareconfigurationmanagementand
ACTIVITIES;
d)theirrelationshipwithotherorganizations,suchassoftwaredevelopmentormaintenance;
e)whentheitemsaretobeplacedunderconfigurationcontrol;
f)whentheproblemresolutionPROCESSistobeused.
Supportingitemstobecontrolled
Theitemstobecontrolledshallincludetools,itemsorsettings,usedtodeveloptheMEDICAL
DEVICESOFTWARE,whichcouldimpacttheMEDICALDEVICESOFTWARE.[ClassB,C]
SoftwareCONFIGURATIONITEMcontrolbeforeVERIFICATION
TheMANUFACTURERshallplantoplaceCONFIGURATIONITEMSunderdocumentedconfiguration
managementcontrolbeforetheyareVERIFIED.[ClassB,C]
Softwarerequirementsanalysis
DefineanddocumentsoftwarerequirementsfromSYSTEMrequirements
ForeachSOFTWARESYSTEMoftheMEDICALDEVICE,theMANUFACTURERshalldefineand
documentSOFTWARESYSTEMrequirementsfromtheSYSTEMlevelrequirements.[ClassA,B,C]
Softwarerequirementscontent
AsappropriatetotheMEDICALDEVICESOFTWARE,theMANUFACTURERshallincludeinthe
softwarerequirements:
a)functionalandcapabilityrequirements;
b)SOFTWARESYSTEMinputsandoutputs;
c)interfacesbetweentheSOFTWARESYSTEMandotherSYSTEMS;
d)software-drivenalarms,warnings,andoperatormessages;
e)SECURITYrequirements;
f)usabilityengineeringrequirementsthataresensitivetohumanerrorsandtraining;
g)datadefinit