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《en62366_2008 医疗器械可用性工程评估方案报告》由会员上传分享，免费在线阅读，更多相关内容在工程资料-天天文库。
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WORD格式可编辑版...4GENERALREQUIREMENTS/总要求4.1GeneralRequirements/总
2、要求4.1.1UsabilityEngineeringProcess/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
3、;Qualitymanual,proceduredocument;ComplianceDoestheProcessaddressuserinteractionswiththemedicaldeviceaccordingtotheaccompanyingdocumentincluding,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，
4、如运输、存储、安装、操作、维护、维修和废弃？UserManualCompliance4.1.2AreResidualRisksassociatedwithUsabilityofthemedicalDevicepresumedtobeacceptable,unlessthereisobjectiveevidencetothecontraryanddocumented?关系医疗器械可用性的剩余风险是否推定可接受？Riskanalysisreport;Compliance4.1.3manufacturersha
5、llsubjecttheinformationforsafetyusedasariskcontroltotheusabilityengineeringprocess(e.g.,warningsorlimitationofuseintheaccompanyingdocuments,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;ComplianceDisregardingsuchinformation
6、forsafetyisconsideredbeyondanyfurtherreasonablemeansofriskcontrol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）RiskanalysisreportCompliance4.2Theresultsoftheusabilityengineeringprocessarerecordedintheusabilityengineeringfile可用性工程过程的结果记录于可用性工程文档。Qualitymanual,proceduredo
7、cument;ComplianceWORD格式可编辑版...Therecordsandotherdocumentsthatmakeuptheusabilityengineeringfilemayformpartofotherdocumentsandfiles(e.g.,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
8、风险管理文档）的一部分Qualitymanual,proceduredocumentCompliance4.3ScalingoftheUsabilityEngineeringeffort/可用性工程的调整Theusabilityengineeringprocessisscaledbasedonthesignificanceofanymodificationsdependingontheresultsoftheriskanaly
