中英文可用性评价报告评价标准

EN60601-1-6MedicalelectricalequipmentPart1-6:Generalrequirementsforsafety-CollateralStandard:UsabilityEN62366MedicaldevicesApplicationofusabilityengineeringtomedicaldevicesReportRefereneeNoCompiledby(+signature)Approvedby(+signature)DateofissueCompanynameAddressTestspecification:Standard:EN60601-1-6:2010,EN62366:2008TestitemdescriptionTradeMarkManufacturerModel/TyperefereneeRatingsPossibletestcaseverdicts:-testcasedoesnotapplytothetestobject:N/A-testobjectdoesmeettherequirement:Pass(P)-testobjectdoesnotmeettherequirement:Fail(F)TestResult:PassedEN60601-1-6ClauseRequirement+TestResult-RemarkVerdict4Generalrequirements总要求4.1ConditionsforapplicationtoMEEQUIPMENTME 设备应用条件TheMEEQUIPMENTshallprovideadequateUSABILITYsuchthattheRISKSresultingfromNORMALUSEandUSEERRORareacceptable.Seealso7.1.1and12.2ofthegeneralstandard.ME 设备应提供充分的可用性，使得由于正常使用和使用错误导致的风险是可以接受的。参见通用标准的 7.1.1 和 12.2。4.2USABILITYENGINEERINGPROCESSforMEEQUIPMENTME 设备的可用性工程程序AUSABILITYENGINEERINGPROCESScomplyingwithIEC62366shallbeperformed.可用性工程程序按照 IEC62366 执行。—establishedaUSABILITYENGINEERINGPROCESS;建立一个可用性工程程序—establishedacceptaneecriteriaforUSABILITY;and 建立可用性验收标准和demonstratedthattheacceptaneecriteriaforUSABILITYhavebeenmet.证明可用性已达到验收标准。4.3REPLACEMENTOFREQUIREMENTSGIVENINIEC62366IEC62366 中的代替要求InadditiontorequirementsofIEC62366thefollowingreplacementsshallapply:ReplacethefirsttwoparagraphsincludingNOTES1and2ofClause6ofIEC62366:2007by:适用 IEC62366 除了以下的要求更换将 IEC62366:2007 第 6 条款的前两段包括备注 1 和 2 用以下内容替换。TheinstructionsforuseshallincludeabriefdescriptionoftheMEEQUIPMENT,itsphysicaloperatingprinciplesandsignificantphysicalandperformaneecharacteristicsrelevanttoitsUSABILITY.Thesameinformationshallalsobeincludedinthetechnicaldescription,ifthisisprovidedasaseparatedocument.设备的简要描述，运行原理、与可用性相关的重要物理特性和性能应包含在使用说明书中...