中英文可用性评价报告评价标准

1、EN60601-1-6MedicalelectricalequipmentPart1-6:Generalrequirementsforsafety-CollateralStandard:UsabilityEN62366MedicaldevicesApplicationofusabilityengineeringtomedicaldevicesReportReferenceNoCompiledby(+signature)Approvedby(+signature)DateofissueCompanynameAddressTestspecification:Standard:EN60601-1-6

2、:2010,EN62366:2008TestitemdescriptionTradeMarkManufacturerModel/TypereferenceRatingsPossibletestcaseverdicts:- testcasedoesnotapplytothetestobject:N/A- testobjectdoesmeettherequirement:Pass(P)- testobjectdoesnotmeettherequirement:Fail(F)TestResult:Passed1/91/9EN60601-1-6ClauseRequirement+TestResult-

3、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12.2o4.2USABILITYE

4、NGINEERINGPROCESSforMEEQUIPMENTME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Ti工程程序；establishedacceptancecriteriaforUSABILITY;and建立可用性收标准；和demonstratedthattheacceptancecriteriaforUSABILITYhavebeenmet.证明

5、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。Theinstructionsforuseshallinclud

6、eabriefdescriptionoftheMEEQUIPMENT,itsphysicaloperatingprinciplesandsignificantphysicalandperformancecharacteristicsrelevanttoitsUSABILITY.Thesameinformationshallalsobeincludedinthetechnicaldescription,ifthisisprovidedasaseparatedocument.设备的简要描述，运行原理、和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

7、在技术说明书中。Theinstructionsforuseshallcontainasummaryoftheapplicationspecification.使用说明应包含一个应用规范的总结。2/92/9EN62366ClauseRequirement+TestResult-RemarkVerdict4GENERALREQUIREMENTS总要求4.1GeneralRequirements总要求4.1.1USABILITYENGINEERINGPROCESSWl性工程过程TheMANUFACTURERshallestablishdocumentandmaintainaUSABILITYENGI

8、NEERINGPROCESStoprovideSAFETYforthePATIENT,USERandothersrelatedtoUSABILITY.ThePROCESSshalladdressUSERinteractionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENT,including,butnotlimitedto:- transport;- storage;- installation;- operation;- maintenanceandrepair;and- disposal.制造商应建立、形成文件和保持可用性工程过

9、程，以便为患者、用户和其他和可用性有关的人员提供安全性。该过程应按照随附文件描述用户和医疗器械的交互，随附文件包括（但不卜M于）:运输；储存；安装；操作；维护和维修；处置。4.1.2RESIDUALRISK乘馀风险IftheusabilityengineeringprocessdetailedinthisInternationalStandardhasbeencompliedwithandtheacceptancecriteriadocumentedintheusabilityvalidationplanhavebeenmet（see5.9）,then,forthepurposesofISO1

10、4971,theRESIDUALRISKSassociatedwithusabilityofthemedicaldeviceshallbepresumedtobeacceptable,unlessthereisobjectiveevidencetothecontrary.如果遵守了本标准中详细规定的可用性工程过程和满足了可用性确认计划中形成文件的可接受准则（见5.9）,则对ISO14971来说，和医疗器械的可用性有关的剩余风险应认为是可接受的，除非有相反的客观证据。4.1.3InformationforSafety安全性信息IfinformationforSAFETYisusedasaRISK

11、CONTROLmeasure,theMANUFACTURERshallsubjectthisinformationtotheUSABILITYENGINEERINGPROCESS.如果安全性信息用作风险控制措施，制造商应将此信息纳入可用性工程过程。4.2USABILITYENGINEERINGFILE可用性工程文挡Theresultsoftheusabilityengineeringprocessshallberecordedintheusabilityengineeringfile.TherecordsandotherdocumentsthatformtheusabilityENGINEER

12、INGFILEmayformpartofotherdocumentsand3/93/9EN62366ClauseRequirement+TestResult-RemarkVerdictfiles.可用性工程过程的结果应记录在可用性工程文档中。构成可用性工程文挡的记录和其他文档可以是其他文件和文档的一部分。4.3Scalingoftheusabilityengineeringeffort可用性工程工作范围界定TheUSABILITYengineeringprocessmayvaryinformandextentbasedonthenatureofthemedicaldevice,itsinten

13、deduseranditsintendeduse(seeD.3.2).Inthecaseofthemodificationofamedicaldevicedesign,theUSABILITYENGINEERINGPROCESSmaybescaleduporscaled-downbasedonthesignificanceofthemodificationasdeterminedbytheresultsoftheRISKANALYSIS(seeD.3.2.2).可用性工程过程的形式和程度可根据医疗器械种类、其预期用户和预期用途(见D3.2)的不同。对医疗器械的设计更改，可用性工程过程可以根据风

14、险分析结果(见D3.2.2)所确定的更改的重要性而扩大或缩小工作范围o5USABILTYENGINEERINGPROCESS可用性工程过程5.1Applicationspecification应用规范ThemanufacturershallspecifytheapplicationoftheMEDICALDEVICEintheUSABILITYENGINEERINGFILE.制造福应在可用性工程文档中规定医疗器械的应用。Thisspecificationshallinclude:* intendedmedicalindication;intendedPATIENTpopulation;inte

15、ndedpartofthebodyortypeoftissueappliedtoorinteractedwith;* intendedUSERPROFILE;* intendedconditionsofuse;and* operatingprinciple.此规范应包括：一*预期的医疗适应症；一所应用的或和之交互的预期的身体部分或组织类型；一*预期的用户特征；*预期的使用条件；一*操作原则。5.2Frequentlyusedfunctions经常使用的功能Themanufacturershalldeterminethefrequentlyusedfunctionsthatinvolveuser

16、interactionwiththemedicaldeviceandrecordthemintheusabilityengineeringfile.制造商应确定涉及医疗器械用户接口的经常使用的功能，并在可用性工程文档中形成记录。5.3IdentificationofHAZARDSandHAZARDOUSSITUATIONSrelatedtoUSABILITY和可用性有关的危害和危害处境的判定5.3.1IdentificationofcharacteristicsrelatedtoSAFETY和安全性有关的特征的判定Anidentificationofcharacteristicsrelated

17、tosafety(partofaRISKANALYSIS)thatfocusesonusabilityshallbe4/94/9EN62366ClauseRequirement+TestResult-RemarkVerdictperformedaccordingtoISO14971:2007,4.2.应按照ISO14971:2007的4.2判定和可用性有关的安全性特征（风险分析的一部分）。Duringtheidentificationcharacteristicsrelatedtosafety,thefollowingshallbeconsidered:applicationspecifica

18、tion,includinguserprofile(S)(see5.1);andfrequentlyusedfunctions(see5.2).Theresultsofthisidentificationcharacteristicsrelatedtosafetyshallberecordedintheusabilityengineeringfile.在判定安全性特征时，应考虑下列方面：一应用规范，包括用户特征(见5.1);一经常使用的功能(见5.2)。安全性特征的判定结果应记录在可用性文档中。5.3.2IdentificationofknownorforeseeableHAZARDSandH

19、AZARDOUSSITUATIONS已知的或可预见的危害和危害处境的判定ThemanufacturershallidentifyknownorforeseeableHAZARDS(partofaRISKANALYSIS)relatedtoUSABILITYaccordingtoISO14971:2007,4.3.Theidentificationofhazardsshallconsiderhazardstopatients,usersandotherpersons(seeAnnexEandAnnexF).制造商应按照ISO14971:2007的4.3判定和可用性有关的己知的或可预见的危害(风险

20、分析的一部分)。危害的判定应考虑对患者、用户和其他人员的危害。(见附录E和附录F)。ReasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheuserinterfacethatcanresultinaHAZARDOUSsituationassociatedwiththemedicaldeviceshallbeidentified.Theseverityoftheresultingpossibleharmshallbedetermined.应判定合理可预见的可导致和医疗器械有关的危害处境的事件序列或组合。应确定由此引起的可能损

21、害的严重度。Duringtheidentificationofhazardsandhazardoussituations,thefollowingshallbeconsidered:applicationspecification,includinguserprofile(S)(see5.1);* taskrelatedrequirements;* contextofuse;informationonhazardsandhazardoussituationsknownforexistinguserinterfacesofmedicaldevicesofasimilartype,ifavaila

22、ble;preliminaryusescenarios;possibleuseerrors(seeC.2forsomeexamplesofpotentialuseerrors);* ifanincorrectmentalmodeloftheoperationofthemedicaldevicecancauseauseerrorresultinginaHAZARDOUSSITUATION;and* resultsofthereviewoftheuserinterface(seeC.4andD.2.2).在判定危害和危害处境期间，应考虑下列各项：一应用规范，包括用户特征(见5.1)一*和工作有关的

23、要求*使用环境5/95/9EN62366ClauseRequirement+TestResult-RemarkVerdict一相似类型医疗器械的现有用户接口的己知危害或危险处境的信息（如果有）初步使用情景一可能的使用错误（潜在使用错误治一些示例见C.2）*医疗器械操作的二个错误的构思模型是否会引起一个导致危害处境的使用错误：一*用户接口的评审结果（见C.4和D.2.2）oTheresultsofthisidentificationofhazards,hazardoussituationsandSEVERITYshallberecordedintheUSABILITYENGINEERINGFIL

24、E.危害、危害处境和严重度的判定结果应记录在可用性工程文档中。5.4PRIMARYOPERATINGFUNCTIONS基本操作功能TheMANUFACTURERshalldeterminethePRIMARYoperatingfunctionsandrecordthemintheusabilityENGINEERINGFILE.制造商应确定基本操作功能并记录在可用性工程文裆中。Theinputstotheprimaryoperatingfunctionsshallincludethefollowing:frequentlyusedfunctions(see5.2);andfunctionsre

25、latedtosafetyofthemedicaldevice.基本操作功能的输入应包括：一经常使用的功能(见5.2);一和医疗器械安全性有关的功能。5.5UsabilitySpecification可用性规范ThemanufacturershalldeveloptheusabilitySPECIFICATION.TheUSABILITYSPECIFICATIONshallprovide:testablerequirementsforusabilityverification;andtestablerequirementsforusabilityoftheprimaryoperatingfun

26、ctionsincludingcriteriafordeterminingtheadequacyofRISKcontrolachievedbytheusabilityENGINEERINGPROCESS.制造商应编制可用性规范。可用性规范应提供：一用于可用性验证的可测试的要求：一对基本操作功能可用性的可测试的要求，包括通过可用性工程过程达到的风险控制充分性的判定准则。可用性规范应记录在可用性，程文挡中。可用性规范可整合到其他规范中。Theinputstotheusabilityspecificationshallincludethefollowing:applicationspecificat

27、ion(see5.1);PRIMARYOPERATINGFUNCTIONS(see5.4);hazardsandhazardoussituationsrelatedtoUSABILITY(see5.3);andknownorforeseeableuseerrorsassociatedwiththeMEDICALDEVICE.可用性规范的输入应包括：一应用规范(见5.1);一基本操作功能(见5.4)一和可用性有关的危害和危害处境(见5.3);6/96/9EN62366ClauseRequirement+TestResult-RemarkVerdict一和医疗器械有关的己知的或可预见的使用错误。T

28、heUSABILITYspecificationshalldescribeatleast:usescenariosrelatedtotheprimaryoperatingfunctions,including;*frequentusescenarios；andreasonablyforeseeableworstcaseusescenarios；USERINTERFACErequirementsforthePRIMARYOPERATINGFUNCTIONS,includingthosetomitigateRISK；requirementsfordeterminingwhetherprimaryo

29、peratingfunctionsareeasilyrecognizablebytheUSER.可用性规范至少应描述：一和基本操作功能有关的使用情景，包括：一*经常的使用情景；合理可预见的最坏的使用，情景/方案；一基本操作功能的用户接口要求，包括降低风险的要求等；一决定基本操作功能是否易于被用户认知的要求。5.6USABILITYVALIDATIONplan可可用性确认计划ThemanufacturershallprepareandmaintainaUSABILITYVALIDATIONplan.TheUSABILITYvalidationplanshallspecify:anymethodu

30、sedforvalidationoftheusabilityofthePRIMARYOPERATINGFUNCTIONS；thecriteriafordeterminingsuccessfulvalidationoftheusabilityoftheprimaryoperatingfunctionsbasedontheusabilityspecification；andtheinvolvementofrepresentativeintendedusers.制造福应制定和保持可用性确认计划。可用性确认计划应规定：一用于基本操作功能可用性确认的方法；一决定基十可用性规范的基本操作功能可用性成功确认

31、的判定准则；一有代表性的预期用户的参和。USABILITYvalidationmethodsmaybequantitativeorqualitative.Usabilityvalidationmaybeperformedinalaboratorysetting,inasimulateduseenvironmentorintheactualuseenvironment.可用性确认方法可以是定量的或定性的。可用性确认可以在实验室、模拟的使用环境或实际的使用环境中实施。Theusabilityvalidationplanshalladdress:frequentUSESCENARIOS,andrea

32、sonablyforeseeableworstcaseusescenarios,thatareidentifiedintheusabilityspecification.TheusabilityvalidationplanshallberecordedintheUSABILITYENGINEERINGFILE.可用性确认计划应阐述：一经常的使用情景一合理可预见的最坏的使用情景上述内容的识别见可用性规范。7/97/9EN62366ClauseRequirement+TestResult-RemarkVerdict可用性确认计划应记录在可用性工程文档中。5.7USERINTERFACEdesign

33、andimplementation用户接口的设计和实施ThemanufacturershalldesignandimplementtheuserinterfaceasdescribedintheusabilitySPECIFICATIONutilizing,asappropriate,usabilityengineeringmethodsandtechniques.制造商应设计和实施可用性规范中描述的用户接口，适当时，利用可用性工程的方法和技术。5.8USABILITYVERIFICATION可用性验证AspartofthemedicaldevicedesignverificationPROC

34、ESS,theMANUFACTURERshallVERIFYtheimplementationofthemedicaldeviceuserinterfacedesignagainsttherequirementsoftheusabilityspecification.Theresultsoftheverificationshallberecordedinusabilityengineeringfile.作为医疗器械设计验证过程的一部分，制造商应按照可用性规范要求验证医疗器械用户接口设计的实施。验证结果应记录在可用性工程文档中。5.9USABILITYVALIDATION可用性确认TheMANU

35、FACTURERshallVALIDATEUSABILITYofthemedicaldeviceaccordingtotheUSABILITYvalidationplan.TheresultsshallberecordedintheusabilityENGINEERINGFILE.制造商应按照可用性确认计划对医疗器械的可用性进行确认。其结果应记录在可用性工程文档中。Iftheacceptancecriteriadocumentedintheusabilityvalidationplanarenotmet:furtheruserinterfacedesignandimplementationac

36、tivitiesshallbeperformed(see5.6);oriffurtherimprovementisnotpracticable,themanufacturermaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheINTENDEDuseoutweightheRISKarisingfromusabilityproblems.IfthisevidencedoesnotsupporttheconclusionthatthemedicalbenefitsoutweightheRISK,thentheRISKisunacceptable.如果不满足在可用性确认计划中形成文件的验收准则：应进行步的用户接口设计和实施活动(见5.6);或如果小T的改进是不可行的，制造商可收集资料和文献并进行评审以确定是否预期用途的医疗受益超过了可用性问题引起的风险。如果此证据不支持医疗受益超过风险的结论，则风险是不可接受的。6Accompanying