EN医疗器械可用性工程评估报告

1、EN62366:2008Checklist/检查表MedicaldevicesApplicationofusabilityengineeringtomedicaldevices可用性工程于医疗器械的应用ProductName产品名称ReportRefereneeNo编号.Version/版本号：验证人：Dateofissue/发布日期：版本修改记录日期版本说明验证人审批人IEC762366checklistClause条款Requirement要求Remark解释Verdict判定4GENERALREQUIREMENT要求GeneralRequirements/总要求4.1.1USABILIT

2、YENGINEERINGPOCESS可用性工程过程HastheMANUFACTURERestablished,documentedandmaintainedaUSABILITYENGINEERINGPROCESStoprovideSAFETYforthePATIENT,USERandothersrelatedtoUSABILITYfortheproduct希U造商是否津廿、记录并维持了一个可用性工程过程，以确保患者、用户和其它涉及产品适用性的人的安全UserManual:Qualitymanual,proceduredocument;ComplianceDoesthePROCESSaddres

3、sUSERINTERActionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENTincluding,butnotlimitedtotransport,storage,installation,operation,maintenance,repairanddisposalj亥过程是否用于解决用户按随机文件与医疗器械的交互，如运输、存储、安装、操作、维护、维修和废弃UserManualCompliance4.1.2AreRESIDUALRISKSassociatedwithUSABILITYoftheEDICALDEVICEpresum

4、edtobeacceptable,unlessthereiiOBJECTIVEEVIDENCEtothecontraryanddocumented矢系医疗器械可用性的剩余风险是否推定可接受Riskanalysisreport;sCompliance4.1.3IEC762366checklistClause条款Requirement要求Remark解释Verdict判定MANUFACTURERSHALLsubjecttheinformationforsafetyusedasaRISKCONTROLtotheUSABILITYENGINEERINGPROCESS?,warningsorlimita

5、tionofuseintheACCOMPANYINGDOCUMENTS,marking,etc?)?对于做为风险控制措施的安全信息，制造商应把它纳入可用性工程过程的控制Riskanalysisreport;UserManual:ComplianceDisregardingsuchinformationforSAFETYisconsideredbeyondanyfurtherreasonablemeansofRISKCONTROL忽视安全信息的行为应被认为是超出风险控制措施的(即非正常使用)RiskanalysisreportComplianceTheresultsoftheUSABILITYE

6、NGINEERINGPROCESSarerecordedintheUSABILITYENGINEERINGFILE可用性工程过程的结果记录于可用性工程文档。Qualitymanual,proceduredocument;ComplianceTherecordsandotherdocumentsthatmakeuptheUSABILITYENGINEERINGFILEMAYformpartofotherdocumentsandfiles?,aMANUFACTURERSproductdesignfileorRISKMANAGEMENTFILE),(SEEListofdocumentsmakeupt

7、heUEfile)纟目成可用牛T.稈文档的记录和其它文件可以是其它文档(如技术文档和风险管理文档)的一部分Qualitymanual,proceduredocumentComplianceIEC762366checklistClause条款Requirement要求Remark解释Verdict判定ScalingoftheUSABILITYENGINEERINGeffort/可用T生工程白勺调整TheUSABILITYENGINEERINGPROCESSisscaledbasedonthesignificaneeofanymodificationsdependingontheresultsof

8、theRISKANALYSISanddocumented可用性工程调整取决于风险分析确认的设计更改的重要程度RiskanalysisreportCompliance5USABILTYENGINEERINGPROCESS用性工程过程Applicationspec辻ication/应用的规格ApplicationofMEDICALDEVICEintheUSABILITYENGINEERINGFILEisspecifiedbytheMANUFACTURERandincludes可用f生工程文档中的医疗器械的应用由制造商决定，包括：uintendedmedicalindication?、conditi

9、ons(s)ordisease(s)tobescreened,monitored,treated,diagnosed,orprevented预期医学用途，如预期要筛查、监护、治疗、诊断或预防的状态或疾病；UserManual)Compliance?intendedPATIENTpopulation?,age,weight,health,condition);预期患者群，如年龄、体重？健康和社会条件：UserManualComplianceIEC762366checklistClause条款Requirement要求Remark解释Verdict判定-intendedpartofthebodyo

10、rtypeoftissueappliedtoorinteractedwith;预期使用的身体部位或组织；UserManualCompliance-intendedconditionsofuse?environmentincludinghygienicrequirements,frequencyofuse,location,mobility);and预期的使用状态，如环境包括卫生要求、使用频度、地点和机动性；UserManualComplianceoperatingprinciple(s)操作原理UserManualComplianceFrequentlyusedfunctions/常用功育gA

11、refrequentlyusedfunctionsthatinvolveUSERinteractionwiththeMEDICALDEVICEaredeterminedandrecordedintheUSABILITYENGINEERINGFILE在可用性工程文档中是否确定并记录了涉及用户与医疗器械交互的常用功能UserManualComplianceIdentificationofHAZARDSandHAZARDOUSSITUATIONSrelatedtoUSABILITY/iR另5.3.1Idntif可用性相尖尖的危害和危害处境只另安全特征IEC762366checklistClause条

12、款Requirement要求Remark解释Verdict判定IdentificationofcharacteristicsrelatedtoSAFETY(partofaRISKANALYSIS)thatfocusesonUSABILITYperformedaccordingtoISO14971:2007,.应按ISO14971:2007的要求识别专注于可用性的安全特征RiskanalysisreportComplianceDuringtheidentificationcharacteristicsrelatedtoSAFETY,thefollowingareconsidered:在识另f安全

13、特征日寸，要考虑下列因素：?applicationspecification,includingUSERPROFILE(S);and应用的规格包括用户特征；Afrequentlyusedfunctions-常用功育EUserManualComplianceResultsofthisidentificationcharacteristicsrelatedtoSAFETYrecordedintheUSABILITYENGINEERINGFILE安全待征识别的结果应记录于可用性工程文档UserManualCompliance5.3.2Identificationofknownorforeseeabl

14、eHAZARDSandHAZARDOUSSITUATIONS/识另已知的或可预见的危害和危害处境IEC762366checklistClause条款Requirement要求Remark解释Verdict判定MANUFACTURERhasidentifiedknownorforeseeableHAZARDS(partofaRISKANALYSIS)relatedtoUSABILITYaccordingtoISO14971:2007,.制造商要按ISO14971:2007的要求识别可用性相尖的已知的或可预见的危害RiskreportanalysisComplianceIdentification

15、ofHAZARDSconsideredHAZARDStoPATIENTS,USERSandotherpersons识别危害时要考虑对患考？操作者和其他人员的危害RiskanalysisreportComplianceReasonablyforeseeablesequencesorcombinationsofevent,involvingtheUSERINTERFACEthatcanresultinaHAZARDOUSSITUATIONassociatedwiththeMEDICALDEVICEwereidentified.TheSEVERITYoftheresultingpossibleHAR

16、Misdetermined.包括可能导致危害处境的医疗器械用户界面的合理可预见的事件的次序和组合已经被识别。导致的可能的危害的严重程度己确定RiskanalysisreportsComplianceIEC762366checklistClauseRequirementRemarkVerdict条款要求解释判定Page10of19DuringtheidentificationofHAZARDSandHAZARDOUSSITUATIONS,thefollowingwasconsidered:在识另lj危害和危害处境时，下列需要考虑：-applicationspecification,includi

17、ngUSERROFILE(S);应用的规格，包括用户待征；-taskrelatedrequirements任务相矢的要求；-contextofuse;使用的背景；-informationonHAZARDSandHAZARDOUSSITUATIONSknownforexistingUSERINTERFACESofMEDICALDEVICESofasimilartype,ifavailable:对于现存的类似的医疗器械用户界面的己知的危害和危害处境信息；?preliminaryUSESCENARIOS;初步的使用t冃尽；-possibleUSEERRORS:可能的使用错误；-ifanincorre

18、ctmentalmodeloftheoperationoftheMEDICALDEVICEcancauseaUSEERRORresultinginaHAZARDOUSSITUATION;and操作医疗器械的错误精神模型是否会引起导致危害处境的使用错误；-resultsofthereviewoftheUSERINTERFACE用户界面的评审结果。RiskanalysisreportUserManualComplianceIEC762366checklistClause条款Requirement要求Remark解释Verdict判定TheresultsofthisidentificationofH

19、AZARDS,HAZARDOUSSITUATIONSandSEVERITYarerecordedintheUSABILITYENGINEERINGFILE.识别危害、危害处境和严重程度的结果要记录在可用性工程文档里。RiskanalysisreportCompliancePrimaryoperatingfunctiOjNs要操作功能ThemanufacturerhasdeterminedthePRIMARYOPERATINGFUNCTIONSandrecordedintheUSABILITYENGINEERINGFILE制造商已经确定了主要操作功能并记录在可用性工程文档里。UserManual

20、ComplianceTheinputstothePRIMARYOPERATINGFUNCTIONSincludefrequentlyusedfunctionsandfunctionsrelatedtoSAFETY)ftheMEDICALDEVICE主要操作功能的输入包括常用功能和尖系医疗器械安全的功能。UserManualComplianceUsabilitySpecification可用性规范MANUFACTURERdevelopedaUSABILITYSPECIFICATIONrecordedintheUSABILITYENGINEERINGFILEaspartoftheUSABILITY

21、ENGINEERINGPROCESS制造商应制定可用T生规范，记录于可用性工程文档里作为可用性工程过程的一部分。Qualitymanual,proceduredocumentComplianceIEC762366checklistClause条款Requirement要求Remark解释Verdict判定TheUSABILITYSPECIFICATIONrecordedinUSABILITYENGINEERINGFILE.TheUSABILITYSPECIFICATIONmaybeintegratedintootherspecifications可用性规范记录于可用性工程文档里。可用性规范可以

22、整合于其它规范。Qualitymanual,proceduredocumentComplianceTheUSABILITYSPECIFICATIONincludes:可用T生规范包括：applicationspecification应用白勺规格；-PRIMARYOPERATINGFUNCTIONS主要操作功能-HAZARDSandHAZARDOUSSITUATIONSrelatedtotheUSABILITY:and尖系可用性的危害和危害处境?knownorforeseeableUSEERRORSassociatedwiththeMEDICALDEVICE已知的或可预见的矢系医疗器械的使用错误

23、。UserManualRiskanalysisreportComplianceTheUSABILITYSPECIFICATIONdescribesatleast:口用性规范至少要描述：IEC762366checklistClause条款Requirement要求Remark解释Verdict判定-USESCENARIOSrelatedtothePRIMARYOPERATINGFUNCTIONS,including尖于主要操作功能的使用情景，包括：?frequentUseSeenarios,and常见的使用情景?reasonablyforeseeableworstcaseUseScenarios

24、合理可预见的最坏使用情景；UserManualRiskanalysisreportComplianceuUSERINTERFACErequirementsforthePRIMARYOPERATINGFUNCTIONS,includingthosetomitigateRISK;主要操作功能对于用户界面的要求，包括降低风险的那些；RiskanalysisreportCompliance?RequirementsfordetenniningwhetherPRIMARYOPERATINGFUNCTIONSareeasilyrecognizablebytheUSER?用于决定主要操作功能是否易于被用户认

25、知的要求RiskanalysisreportComplianceUsabilityvalidation屮“可用f生确认计戈ijTheMANUFACTURERhasdevelopedandmaintainsaUSABILITYVALIDATIONplanspecifying:制造商需制定并维护可用性确认计划，以规定：UserManualComplianceIEC762366checklistClause条款Requirement要求Remark解释Verdict判定anymethodusedforVALIDATIONoftheUSABILITYofthePRIMARYOPERATINGFUNCT

26、IONS;对于主要操作功能的可用性的确认方法；UserManualCompliancethecriteriafordeterminingsuccessfulVALIDATIONoftheUSABILITYofthePRIMARYOPERATINGFUNCTIONSbasedontheUSABILITYSPECIFICATION;and基于可用性规范，对主要操作功能可用性的确认标准UserManualCompliance-theinvolvementofrepresentativeintendedUSERS包含的预期用户代表UserManualComplianceUSABILITYVALIDAT

27、IONperformedinalaboratorysettingTestreport?Compliance03Rd丁d丄1-A/-THA、口？USABILITYVALIDATIONperformedinasimulateduseenvironmentTestreportCompliance=TE上丄T%上I/十丄H4、/士匚口丁才丄七？USABILITYVALIDATIONperformedintheactualuseenvironmentTestreportCompliance=r匚匸rgrzsi宀十？十7*口qt-厂丄比IEC762366checklistClause条款Requireme

28、nt要求Remark解释Verdict判定UserManualComplianceTheUSABILITYVALIDATIONplanaddresses:可用性确认计划包括：?fiequentUseSeenarios,and常见的使用情景；-reasonablyforeseeableworstcaseUSESCENARIOS合理可预见的最坏使用情景thatareidentifiedintheUSABILITYSPECIFICATION都要在可用性规范中识别。TheUSABILITYVALIDATIONplanrecordedintheUSABILITYENGINEERINGFILE可用性确认计

29、划应记录与可用性工程文档。UserManualComplianceUSERINTERFACEdesignandimplementation/用户界面设j十禾口头施MANUFACTURERdesignedandimplementedtheUSERINTERFACEasdescribedintheUSABILITYSPECIFICATIONutilizing,asappropriate,USABILITYENGINEERINGmethodsandtechniques希0造商应使用可用性工程的方法和技术来开发并实施可用性规范描述的用户界面。Productsdonothavethisrequireme

30、ntnoncomplianceUsabilityverification/可用性验证IEC762366checklistClause条款Requirement要求Remark解释Verdict判定MANUFACTURERverifiedtheimplementationoftheMEDICALDEVICEUSERINTERFACEdesignaccordingtotheUSABILITYSPECIFICATION制造商应根据可用性规范来验证医疗器械用户界面设计的实施。ProductsdonothavethisrequirementnoncomplianceTheresultsoftheveri

31、ficationarerecordedinUSABILITYENGINEERINGFILE验证的结果应记录于可用性工程文档。ProductsdonothavethisrequirementnoncomplianceUsabilityValidation可用性确认TheMANUFACTURERhasvalidatedtheUSABILITYoftheMEDICALDEVICEaccordingtotheUSABILITYVALIDATIONplan制造商应根据可用性确认计划来确认医疗器械用户界面的可用性。ProductsdonothavethisrequirementnoncomplianceT

32、heresultsarerecordedintheUSABILITYENGINEERINGFILE确认的结果应记录于可用性工程文档。ProductsdonothavethisrequirementnoncomplianceIEC762366checklistClause条款Requirement要求Remark解释Verdict判定FortheacceptaneecriteriadocumentedintheUSABILITYVALIDATIONplanthatarenotmet:对于没有可用f生确认计划中制定的未被满足的接收准则：-furtherUSERINTERFACEdesignandi

33、mplementationactivitiesareperformed;or需要进仃进一步的用户界面设计和执行；或-iffurtherimprovementisnotpracticable,theMANUFACTURERmaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheINTENDEDUSEoutweightheRISKarisingfromUSABILITYproblems如果进一步的改进不现实，制造商需要收集并评审数据和文献，以确定预期用途的医疗收益是否超过可用性问题带来的风险。Toperformt

34、hisstep,theMANUFACTURERneedstoestimatetheRISKarisingfromUSABILITYproblems?为此，制造商需评估可用性问题带来的风险oProductsdonothavethisrequirementnoncompliance6ACCOMPANYINGDO（取JIMS/随机文件IEC762366checklistClause条款Requirement要求Remark解释Verdict判定TheACCOMPANYINGDOCUMENTineludesasummaryoftheMEDICALDEVICEapplicationspecificati

35、on随彳兀文件应包括医疗器械应用的规格的总结。UserManualComplianceAconcisedescriptionoftheMEDICALDEVICE,itsoperatingprinciples,significantphysicalandperformaneecharacteristicsandintendedUSERPROFILEareincludedintheACCOMPANYINGDOCUMENT随机文件包括医疗器械、工作原理、重要的物理和性能特性和预期用户的特征的简要描述。UserManualComplianceTheACCOMPANYINGDOCUMENTiswrittenatalevelconsistentwiththeintendedOPERATORPROFILE随机文件的编写要与用户特征的水平相一致。UserManualComplianceTheACCOMPANYINGDOCUMENTforequipmentare,optionally,prov