EN62366:2008Checklist/检查表MedicaldevicesApplicationofusabilityengineeringtomedicaldevices可用性工程于医疗器械的应用ReportReferenceNo/编号.............:版本号:验证人:Dateofissue/发布日期:Testitemdescription/项目.............:Model/Typereference/型号..............:Abbreviationsusedinthereport/缩写:-UsabilityEngineering/可用性工程:UE-Riskanalysis/风险分析:RA-Userinterface/用户界面:UI-Riskmana...
ProductName/产品名称2GENERALREQUIREMENTS/GeneralRequirements/USABILITYENGINEERINGPROCESS/可用性工程过程HastheMANUFACTURERestablished,documentedandmaintainedaUSABILITYENGINEERINGPROCESStoprovideSAFETYforthePATIENT,USERandothersrelatedtoUSABILITYfortheproduct?DoesthePROCESSaddressUSERINTERActionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENTincluding,butnotlimitedtotransport,AreRESIDUALRI...
ProductName/产品名称GENERALREQUIREMENTS/GeneralRequirements/USABILITYENGINEERINGPROCESS/可用性工程过程HastheMANUFACTURERestablished,documentedandmaintainedaUSABILITYENGINEERINGPROCESStoprovideSAFETYforthePATIENT,USERandothersrelatedtoUSABILITYfortheproduct?DoesthePROCESSaddressUSERINTERActionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENTincluding,butnotlimitedtotransport,AreRESIDUALRIS...