中英文 可用性评价报告 评价标准

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1、产品名称:可用性评价报告文件编号：编制：采用标准：EN 606011-6:2010,EN62366:2008审核：EN60601-1-6MedicalelectricalequipmentPart1-6:Generalrequirementsforsafety-CollateralStandard:UsabilityEN62366MedicaldevicesApplicationofusabilityengineeringtomedicaldevicesReportReferenceNo.:Compiledby(+signa

2、ture):Approvedby(+signature):Dateofissue:Companyname:Address:Testspecification:Standard:EN 606011-6:2010,EN62366:2008Testitemdescription:TradeMark:Manufacturer:Model/Typereference:Ratings:Possibletestcaseverdicts:-testcasedoesnotapplytothetestobject:N/A-testobjectd

3、oesmeettherequirement:Pass(P)-testobjectdoesnotmeettherequirement:Fail(F)TestResult:PassedPage10of10产品名称:可用性评价报告文件编号：JKH-编制：采用标准：EN 606011-6:2010,EN62366:2008审核：EN 60601-1-6ClauseRequirement+TestResult-RemarkVerdict4Generalrequirements总要求4.1Conditionsforapplication

4、toMEEQUIPMENTME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。4.2USABILITYENGINEERINGPROCESSforMEEQUIPME

5、NTME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;—establishedacceptancecriteriaforUSABILITY;and建立可用性验收标准;和demonstratedthattheacceptancecriteriaforUSABILITYhavebee

6、nmet.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

7、2用以下内容替换。TheinstructionsforuseshallincludeabriefdescriptionoftheMEEQUIPMENT,itsphysicaloperatingprinciplesandsignificantphysicalandperformancecharacteristicsrelevanttoitsUSABILITY.Thesameinformationshallalsobeincludedinthetechnicaldescription,ifthisisprovidedasasepa

8、ratedocument.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。如果技术说明书单独提供，则相同的信息也应包含在技术说明书中。Theinstructionsforuseshallcontainasummaryoftheapplicati