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1、Page2of13ReportNo.Error!Referencesourcenotfound.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Page11of11Report
2、IEC 62366checklistClause条款Requirement要求Remark解释Verdict判定4GENERALREQUIREMENTS/总要求4.1GeneralRequirements/总要求4.1.1UsabilityEngineeringProcess/可用性工程过程Hasthemanufacturerestablished,documentedandmaintainedausabilityengineeringprocesstoprovideSafetyforthepatient
3、,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;ComplianceDoestheProcessaddressuserinteractionswiththemedicaldeviceaccordingtotheaccompanyingdocumentincluding,butnotl
4、imitedtotransport,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?UserManualCompliance4.1.2AreResidualRisksassociatedwithUsabilityofthemedicalDevicepresumedtobeacceptable,unlessthereisobjectiveev
5、idencetothecontraryanddocumented?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.,warningsorlimitationofuseintheaccompanyingdocuments,marking,etc
6、.).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)RiskanalysisreportCompliance4.2Theresultsoftheusability
7、engineeringprocessarerecordedintheusabilityengineeringfile可用性工程过程的结果记录于可用性工程文档。Qualitymanual,proceduredocument;CompliancePage11of11ReportIEC 62366checklistClause条款Requirement要求Remark解释Verdict判定Therecordsandotherdocumentsthatmakeuptheusabilityengineeringfi
8、lemayformpartofotherdocumentsandfiles(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(如技术文档和风险管理文档)的一部分Qualitymanual,proceduredocumentCompliance