IEC62304模板Word格式.docx

IEC62304模板Word格式.docx

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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.）

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

5.15.1.1、5.1.2、5.1.3、5.1.6、5.1.7、5.1.8、5.1.9

5.1.5、5.1.10、5.1.11

5.1.4

5.25.2.1、5.2.2、5.2.4、5.2.4、5.2.6

5.2.3

5.35.3.1、5.3.2、5.3.3、5.3.4、5.3.6

5.3.5

5.45.4.1

5.4.2、5.4.3、5.4.4

5.55.5.1

5.5.2、5.5.3、5.5.5

5.5.4

5.6全部要求

5.7全部要求

5.85.8.4

5.8.1、5.8.2、5.8.3、5.8.5、5.8.6、5.8.7、5.8.8

6.16.1

6.26.2.1、6.2.2、6.2.4、6.2.5

6.2.3

6.3全部要求

7.1全部要求

7.2全部要求

7.3全部要求

7.47.4.1

7.4.2、7.4.3

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

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.

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;

d）theacceptancecriteriaforVERIFICATIONoftheDELIVERABLES.

5.1.7

SoftwareRISKMANAGEMENTplanning

conducttheACTIVITIESandTASKSofthesoftwareRISKMANAGEMENTPROCESS,includingthe

managementofRISKSrelatingtoSOUP.[ClassA,B,C]

5.1.8

Documentationplanning

TheMANUFACTURERshallincludeorreferenceinthesoftwaredevelopmentplaninformation

aboutthedocumentstobeproducedduringthesoftwaredevelopmentlifecycle.Foreach

identifieddocumentortypeofdocumentthefollowinginformationshallbeincludedor

referenced:

a）title,nameornamingconvention;

b）purpose;

c）intendedaudienceofdocument;

d）proceduresandresponsibilitiesfordevelopment,review,approvalandmodification.

5.1.9

Softwareconfigurationmanagementplanning

TheMANUFACTURERshallincludeorreferencesoftwareconfigurationmanagementinformation

inthesoftwaredevelopmentplan.Thesoftwareconfigurationmanagementinformationshall

includeorreference:

a）theclasses,types,categoriesorlistsofitemstobecontrolled;

b）thesoftwareconfigurationmanagementACTIVITIESandTASKS;

c）theorganization（s）responsibleforperformingsoftwareconfigurationmanagementand

ACTIVITIES;

d）theirrelationshipwithotherorganizations,suchassoftwaredevelopmentormaintenance;

e）whentheitemsaretobeplacedunderconfigurationcontrol;

f）whentheproblemresolutionPROCESSistobeused.

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