软件确认报告-模板

FileNo:xxxxxxIEC60601-1第三版对可编程医疗电气系统PEMS的要求14可编程医疗电气系统（以下简称PEMS）14.1概述本条款适用于PEMS，下列情况除外：—PESM提供的功能或性能不属于基本安全或基本性能;；或—符合ISO14971标准,，即PEMS的故障不会导致不可接受的风险。否则，则这章节应适用。注1：本章要求在整个PEMS开发生命周期要遵照一定的过程，并且要建立该过程的记录。14.2文件化第14章要求的文件是ISO14971中规定的记录和文件的补充，应作为风险管理文档的一部分。14.3风险管理计划应引用PEMS确认计划（风险管理中应包含软件风险的评估）……更详细的要求见本文档后面附录：IEC60601-1第三版对可编程医疗电气系统PEMS的要求-------------------------------------------------------------------------------------------------------------------------------------------------提供以下软件文件列表或按“软件确认报告模板”提供相关的文件：（表格用英文填写）Deliverables（表格用英文填写）Title相关文件名称DocumentNo.:文档编号revision#:版本Date发布日期PEMS开发生命周期计划PEMSrequirementsspecificationPEMS需求说明Subsystemsrequirementsspecification子系统需求说明PEMSarchitecturespecificationPEMS架构说明Subsystemsarchitecturespecification子系统架构说明Designspecification设计说明Testspecification测试说明Descriptivedataregardingthedesignenvironment设计开发环境的相关数据Verificationplan验证计划Verificationmethodsandresultsforeachhazard每个危害的验证方法和结果（---软件风险的验证）Validationplan确认计划Validationmethodsandresultsforeachhazard每个危害的确认方法和结果Modification/changeprocedures设计更改控制程序Assessmentreport评估报告

软件确认报告模板（本文档仅供参考，IEC60601-1第三版对可编程医疗电气系统PEMS的要求---见此文档后面的附录）1.软件描述简单概述下软件实现的功能有哪些PurposeandScopeThisdocumentgivesacomprehensiveoverviewoftheXXXXfeaturesthatarecontrolledbysoftware,anddescribetheintendedoperationalenvironment.ProductspecificationandperformanceTheintendeduseofthisdeviceis……Function如：ThesoftwareoftheXXXXincludesthefollowingfunctions:TheLCDdisplayControlTimeclockandNVMemory(nonvolatilememory)managementPressuremeasuringKeyboardscontrol(flowmeterknot)Alarmsystem(suchasbuzzeraudioalarmcontrol)……2.SoftwareDevelopmentEnvironmentDescriptionSoftwaredevelopmentlifecycleplan软件设计生命周期计划软件生命周期计划起始-完成时间负责人或小组成员实际完成时间设计输出文件（文件编号+文件名称+版本）备注系统分析及软件定义软件需求分析软件确认计划软件详细设计、编程软件验证（单元测试、系统集成和系统测试）软件确认（安装与确认）软件发布、维护、终止……3.软件设计需求及架构3.1Third-partyandoff-the-shelf(OTS)software第三方或现用软件（适用时）Theserequirementsshouldincludethefollowing:–titleandmanufacturer,versionlevel,releasedate,patchnumberandupgradedesignation;–thesystemhardwareandsoftwarenecessarytosupportproperoperation(e.g.processortypeandspeed,memorytypeandsize,andsystem,communicationanddisplaysoftwarerequirements);–interfacestothesoftwarecomponent;–safetycriticalandRISKCONTROLmeasurefunctionsdependentonthesoftwarecomponent.3.2Integration系统集成（对于复杂的系统适用时）ThedevelopershouldestablishanintegrationplantointegratethecomponentsofeachPESSandofthePEMS.Theplanshouldincludetheapproach,responsibilitiesandsequence,andincludeallsoftwarecomponents.3.3Requirementsspecification需求说明（依产品实际情况，包含以下适用项目的相关内容）Therequirementsshouldinclude,asappropriatetothePEMSsoftware:functionalandcapabilityrequirements,includingESSENTIALPERFORMANCE,physicalcharacteristics,andenvironmentalconditionsunderwhichthesoftwareistoperform;–interfacesexternaltothesoftware;–safetyrequirementsincludingRISKCONTROLmeasuresforhardwarefailuresandpotentialsoftwaredefectsandspecificationsrelatedtomethodsofoperationandmaintenance,environmentalinfluences,andRISKCONTROL;–softwaredrivenalarmsignals,warningsandOPERATORmessages;–securityrequirements,wherelackofsecuritywouldcompromisesafety;–human-factorsengineeringrequirementsrelatedtotheuseofthePEMS,includingthoserelatedtosupportformanualoperations,human-equipmentinteractions,constraintsonpersonnel,andareasneedingconcentratedhumanattentionthataresensitivetohumanerrorsandtraining;–datadefinitionanddatabaserequirements;–installationandacceptancerequirementsforthePEMSsoftware;–documentationtobedeveloped;–operationandexecutionrequirements;–maintenancerequirements.3.4Configurationmanagement配置管理Aconfigurationmanagementplanshouldbeestablishedthatdescribes:–theitemstobecontrolled;–theconfigurationmanagementactivities;–PROCEDURESandscheduleforperformingtheseactivities;–responsibilitiesforperformingtheseactivities;PROCEDUREStocontrolthereceipt,installation,andacceptanceofeachsoftwarecomponent.如：配置管理描述其控制管理方式或引用的控制文件编号和名称客户反馈管理软件版本控制软件升级控制软件发布控制设计更改控制Modification/changecontrol更改控制Formodification/changecontrol,thefollowingshouldbeperformed:–identificationandrecordingofchangerequests;–analysisandevaluationofthechanges;–approvalordisapprovaloftherequest;–implementation,VERIFICATIONandreleaseofthemodifiedsoftware.软件维护软件文档控制管理3.5Designandimplementation设计与实施DuringapplicationofthePEMSDEVELOPMENTLIFE-CYCLEmodel,designandimplementationwillincludetheselectionof:a)thedesignenvironment,forexample:–softwaredevelopmentmethods;–computeraidedsoftwareengineering(CASE)tools;–programminglanguage;–hardwareandsoftwaredevelopmentplatforms;–simulationtools;–designandcodingstandards;b)electroniccomponents;c)redundanthardware;d)human-PEMSinterface;e)energysources;f)environmentalconditions;g)third-partysoftware;h)networkingoptions.

如：HardwareRequirementsHardwarerequirementsgenerallyinclude:microprocessors：如芯片型号或要求memorydevices：如128x8bytesofDataMemory(RAM);64x8bytesofEEPROMDataMemory;2Kx14wordsofFLASHProgramMemory;sensorsenergysourcessafetyfeaturescommunicationsProgrammingLanguageRequirementsProgramminglanguagerequirementsincludeprogramsizerequirementsorrestrictions,andinformationonmanagementofmemoryleaks.InterfaceRequirementsInterfacerequirementsgenerallyincludebothcommunicationbetweensystemcomponentsandcommunicationwiththeusersuchas:printersmonitorskeyboardmouse.PerformanceandFunctionalRequirementsSoftwareperformanceandfunctionalrequirementsincludealgorithmsorcontrolcharacteristicsfortherapy,diagnosis,monitoring,alarms,analysis,andinterpretationwithfulltextreferencesorsupportingclinicaldata,ifnecessary.Softwareperformanceandfunctionalrequirementsmayalsoinclude:devicelimitationsduetosoftwareinternalsoftwaretestsandcheckserrorandinterrupthandlingfaultdetection,tolerance,andrecoverycharacteristicssafetyrequirementstimingandmemoryrequirementsidentificationofoff-the-shelfsoftware,ifappropriate.ArchitectureDesignChart硬件框图、软件设计框图或架构3.6Documentation设计输出文档需求如应输出哪些文档？4.软件验证/确认计划/风险管理计划应包含软件确认小组成员列表、验证/测试方法及判定标准VERIFICATIONplan验证计划PEMSVALIDATIONplan系统确认计划PEMSRiskmanagementPlan软件风险控制5．SoftwareDesignSpecification(SDS)软件详细设计说明如：参见文件编号####软件详细设计说明或XXX功能模块参见文件编号####XXX功能模块软件详细设计说明6.软件风险管理PEMS风险控制ThesoftwareHazardAnalysisshouldtakeintoaccountallhazardsassociatedwiththesoftware’sintendeduse,includingbothhardwareandsoftwarehazards.hazardouseventseverityofthehazardcause(s)ofthehazardmethodofcontrolcorrectivemeasurestakenverificationthatthemethodofcontrole.g.,alarm,hardwaredesigne.g.testing/validation或者参见风险管理报告##章节7.软件测试和软件确认软件测试记录序号测试项目测试步骤或测试方法判定通过的标准测试数据或结果结论或备注Pass/Fail测试人员、测试日期软件确认-追溯矩阵（可引用文件编号）设计需求潜在风险及风险控制措施设计说明软件测试需求软件验证/确认记录###功能###功能8.软件更改记录（历史版本记录）软件名称软件版本发布日期更改说明更改验证记录参见文件###9.软件中未解决的异常Alistofallunresolvedsoftwareanomalies.Foreachanomaly,pleaseindicatethe:problemimpactondeviceperformanceanyplansortimeframesforcorrectingtheproblem(whereappropriate)10．软件相关的文件清单（列表方式）文件编号文件名称发布日期版本号归档位置11．其他（适用时）如果有涉及到网络和数据耦合NETWORK/DATACOUPLING请参考标准EN60601-2006中附录H中H.6和H.7的要求，补充相关内容H.6NETWORK/DATACOUPLINGH.7DesignconsiderationsforNETWORK/DATACOUPLING-----END-----14PROGRAMMABLEELECTRICALMEDICALSYSTEMS(PEMS)14.1Requirementsofthisclausenotappliedtopesswhenitprovidednobasicsafetyoressentialperformance,or-whenapplicationofriskmanagementshowedthatfailureofpessdoesnotleadtounacceptablerisk :Requirementsof14.13appliedtopemsintendedtobeincorporatedintoanitnetworkSoftwaredevelopmentprocessforSoftwareClassificationappliedinaccordancewithClause4.3ofIEC62304 :SoftwaredevelopmentprocessappliedaccordingtoClause5ofIEC62304 :SoftwaredevelopmentprocessforSoftwareriskmanagementappliedaccordingtoClause7ofIEC62304 :SoftwaredevelopmentprocessConfigurationManagementappliedaccordingtoClause8ofIEC62304 :SoftwaredevelopmentprocessforSoftwareProblemResolutionappliedaccordingtoClause9ofIEC62304 :14.2DocumentsrequiredbyClause14reviewed,approved,issuedandrevisedaccordingtoaformaldocumentcontrolprocess :14.3Riskmanagementplanrequiredby4.2.2includesreferencetopemsvalidationplan14.4Apemsdevelopmentlife-cycleincludingasetofdefinedmilestoneshasbeendocumentedAteachmilestone,activitiestobecompleted,andverificationmethodstobeappliedtoactivitieshavebeendefinedEachactivityincludingitsinputsandoutputsdefined,andeachmilestoneidentifiesriskmanagementactivitiesthatmustbecompletedbeforethatmilestonePemsdevelopmentlife-cycletailoredforaspecificdevelopmentbymakingplansdetailingactivities,milestones,andschedulesPemsdevelopmentlife-cycleincludesdocumentationrequirements14.5Adocumentedsystemforproblemresolutionwithinandbetweenallphasesandactivitiesofpemsdevelopmentlife-cyclehasbeendevelopedandmaintainedwhereappropriateProblemresolutionsystemmeetsprescribedcriteriadependingontypeofproduct:–itisdocumentedasapartofpemsdevelopmentlife-cycle–itallowsreportingofpotentialorexistingproblemsaffectingbasicsafetyoressentialperformance–itincludesanassessmentofeachproblemforassociatedrisks–itidentifiescriteriathatmustbemetfortheissuetobeclosed–itidentifiestheactiontobetakentoresolveeachproblem14.6Riskmanagementprocess14.6.1Manufacturerconsideredhazardsassociatedwithsoftwareandhardwareaspectsofpemsincludingthoseassociatedwiththeincorporatingpemsintoanit-network,componentsofthird-partyorigin,legacysubsystemswhencompilinglistofknownorforeseeablehazards :14.6.2Suitablyvalidatedtoolsandproceduresassuringeachriskcontrolmeasurereducesidentifiedrisk(s)satisfactorilyprovidedinadditiontopemsrequirementsinClause4.2.2 :14.7Adocumentedrequirementspecificationforpemsandeachofitssubsystems(e.g.forapess)whichincludesessentialperformanceandriskcontrolmeasuresimplementedbythatsystemorsubsystem :14.8Anarchitecturesatisfyingtherequirementisspecifiedforpemsandeachofsubsystems :Thearchitecturespecificationmakesuseofconsidersthespecifieditemstoreducerisktoanacceptablelevel,whereappropriate:a)Componentswithhigh-integritycharacteristicsb)fail-safefunctionsc)redundancyd)diversity;e)partitioningoffunctionalityf)defensivedesignpotentiallylimitinghazardouseffectsbyrestrictingavailableoutputpowerorbyintroducingmeanstolimittravelofactuatorsg)allocationofriskcontrolmeasurestosubsystemsandcomponentsofpemsh)failuremodesofcomponentsandtheireffects;i)commoncausefailuresj)systematicfailuresk)testintervaldurationanddiagnosticcoveragel)maintainabilitym)protectionfromreasonablyforeseeablemisusen)it-networkspecification,whenapplicable14.9Designisbrokenupintosubsystems,eachwithadesignandtestspecificationwhereappropriate,anddescriptivedataondesignenvironmentdocumented :14.10Averificationplancontainingthespecifiedinformationusedtoverifyanddocumentfunctionsimplementingbasicsafety,essentialperformance,orriskcontrolmeasures :–milestone(s)whenverificationistobeperformedforeachfunction–selectionanddocumentationofverificationstrategies,activities,techniques,andappropriatelevelofindependenceofthepersonnelperformingtheverification–selectionandutilizationofverificationtools–coveragecriteriaforverification14.11Apemsvalidationplancontainingvalidationofbasicsafety&essentialperformance :MethodsusedforpemsvalidationdocumentedThepersonwithoverallresponsibilityforpemsvalidationisindependentofdesignteam,andnomemberofadesignteamisresponsibleforpemsvalidationoftheirowndesignAllprofessionalrelationshipsofmembersofpemsvalidationteamwithmembersofdesignteamdocumentedinriskmanagementfile14.12Continuedvalidityofpreviousdesigndocumentationassessedunderadocumentedmodification/changeprocedureSoftwareClassificationforSoftwarechangesappliedinaccordancewithClause4.3ofIEC62304 :SoftwareProcessforSoftwarechangesappliedaccordingtoClause5ofIEC62304 :riskmanagementforSoftwarechangesappliedaccordingtoClause7ofIEC62304 :Configurationmanagementofsoftwa