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1、WORD资料整理EN62366:2008Checklist/检查表MedicaldevicesApplicationofusabilityengineeringtomedicaldevices可用性工程于医疗器械的应用ProductName/产品名称ReportReferenceNo/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完美格式可编辑WORD资料整理4GENERALREQUIREMENTS/总要求4.1GeneralRequirements/总要求4.1.1UsabilityE
2、ngineeringProcess/可用性工程过程Hasthemanufacturerestablished,documentedandmaintainedausabilityengineeringprocesstoprovideSafetyforthepatient,userandothersrelatedtousabilityfortheproduct?制造商是否建立、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;Complian
3、ceDoestheProcessaddressuserinteractionswiththemedicaldeviceaccordingtotheaccompanyingdocumentincluding,butnotlimitedtotransport,storage,installation,operation,maintenance,repairanddisposal?该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？UserManualCompliance4.1.2AreResidualRisksas
4、sociatedwithUsabilityofthemedicalDevicepresumedtobeacceptable,unlessthereisobjectiveevidencetothecontraryanddocumented?关系医疗器械可用性的剩余风险是否推定可接受？Riskanalysisreport;Compliance4.1.3manufacturershallsubjecttheinformationforsafetyusedasariskcontroltotheusabilityengineeringprocess(e.g.,w
5、arningsorlimitationofuseintheaccompanyingdocuments,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）Riskanalysisrepor
6、tCompliance4.2Theresultsoftheusabilityengineeringprocessarerecordedintheusabilityengineeringfile可用性工程过程的结果记录于可用性工程文档。Qualitymanual,proceduredocument;Compliance完美格式可编辑WORD资料整理Therecordsandotherdocumentsthatmakeuptheusabilityengineeringfilemayformpartofotherdocumentsandfiles(e.g.,
7、amanufacturer’sproductdesignfileorriskmanagementfile),(seeListofdocumentsmakeuptheUEfile)组成可用性工程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,proceduredocumentCompliance4.3ScalingoftheUsabilityEngineeringeffort/可用性工程的调整Theusabilityengineeringprocessisscaledbasedonthesignifica
8、nceofanymodificationsdependingontheresultsofthe
