1、EN62366:2021Checklist/檢查表MedicaldevicesApplicationofusabilityengineeringtomedicaldevices可用性工程于醫(yī)療器械的應(yīng)用ProductName/產(chǎn)品名稱ReportReferenceNo/編號.Version/版本號:驗證人:Dateofissue/發(fā)布日期：版本修改記錄:日期版本說明驗證人審批人4GENERALREQUIREMENT求4.1GeneralRequirements/總要求4.1.1USABILITYENGINEERINGROCESSniT生工程過程HastheMANUFACTURERtablish

2、ed,documentedandmaintainedausabilityengineeringprocessprovideSAFETYforthepatientuSERandothersrelatedtousabilityfortheproduct?制造商是否建立、記錄并維持了一個可用性工程過程,以保證患者、用戶和其它涉及產(chǎn)品適用性的人的平安？UserManual;Qualitymanual,proceduredocument;ComplianceDoesthePROCESSiddressuseriNTERAtionswiththemedicalDEViCBccordingtotheaccom

3、panyingDOCUMENTcluding,butnotlimitedtotransport,storage,installation,operation,maintenance,repairanddisposal?該過程是否用于解決用戶按隨機文件與醫(yī)療器械的交互,如運輸、存儲、安裝、操作、維護(hù)、維修和廢棄？UserManualCompliance4.1.2AreResidualRisksassociatedwithUsabilityofthemedicaldevicepresumedtobeacceptable,unlessthereisobjectiveevidencethecontra

4、ryanddocumented?關(guān)系醫(yī)療器械可用性的剩余風(fēng)險是否推定可接受？Riskanalysisreport;Compliance4.1.3manufacturerSHAubjecttheinformationforsafetyusedasariskcontroLotheusabilityengineeringPROCESg.,warningsorlimitationofuseintheaccompanyingDOCUMjENTrking,etc.對于做為風(fēng)險限制舉措的平安信息,制造商應(yīng)把它納入可用性工程過程的限制Riskanalysisreport;UserManual;Complian

5、ceDisregardingsuchinformationforSAFETYisconsideredbeyondanyfurtherreasonablemeansofRISKCONTROL無視平安信息的行為應(yīng)被認(rèn)為是超出風(fēng)險限制舉措的即非正常使用RiskanalysisreportCompliance4.2TheresultsoftheusabilityENGiNEERiNGROCEsarerecordedintheusabilityengineeringfile可用性工程過程的結(jié)果記錄于可用性工程文檔.Qualitymanual,proceduredocument;ComplianceThe

6、recordsandotherdocumentsthatmakeuptheUSABILITYENGINEERINGFILEMArmpartofotherdocumentsandfiles(e.g.,amanufactuRerproductdesignfileorriskMANAGEMENTF)1E(SEEListofdocumentsmakeuptheUEfile)組成可用性工程文檔的記錄和其它文件可以是其它文檔(如技術(shù)文檔和風(fēng)險治理文檔)的一局部Qualitymanual,proceduredocumentCompliance4.3ScalingoftheUSABILITYENGiNEERi

7、NGffort/可用性工程的調(diào)整TheusabilityengineeringPROCESScaledbasedonthesignificanceofanymodificationsdependingontheresultsoftheriskANALYSiSanddocumented可用性工程調(diào)整取決于風(fēng)險分析確認(rèn)的設(shè)計更改的重要程度RiskanalysisreportCompliance5USABILTYENGINEERINGPROCESS性工程過程5.1Applicationspecification/應(yīng)用的規(guī)格ApplicationofMedicaldeviceintheusabilit

8、yengineeringFILEspecifiedbytheMANUFACTURERandincludes可用性工程文檔中的醫(yī)療器械的應(yīng)用由制造商決定,包括：-intendedmedicalindication(e.g.,conditions(s)ordisease(s)tobescreened,monitored,treated,diagnosed,orprevented);預(yù)期醫(yī)學(xué)用途,如預(yù)期要篩查、監(jiān)護(hù)、治療、診斷或預(yù)防的狀態(tài)或疾病；UserManualComplianceintendedPATiENTpopulation(e.g.,age,weight,health,condition

9、);預(yù)期患者群,如年齡、體重、健康和社會條件；UserManualComplianceintendedpartofthebodyortypeoftissueappliedtoorinteractedwith;預(yù)期使用的身體部位或組織；UserManualComplianceintendedconditionsofuse(e.g.environmentincludinghygienicrequirements,frequencyofuse,location,mobility);and預(yù)期的使用狀態(tài),如環(huán)境包括衛(wèi)生要求、使用頻度、地點和機動性；UserManualComplianceoperati

10、ngprinciple(s)操作原理UserManualCompliance5.2Frequentlyusedfunctions/常用功能ArefrequentlyusedfunctionsthatinvolveUSERinteractionwiththeMedicalDEVICEaredeterminedandrecordedintheusabilityENGINEERINGFILE在可用性工程文檔中是否確定并記錄了涉及用戶與醫(yī)療器械交互的常用功能？UserManualCompliance5.3IdentificationofHAZARDSndHAZARDOUSTUATIONSelatedt

11、oUSABILITY識另ij可用性相關(guān)的危害和危害處境5.3.1Identificationofcharacteristicstosafety識別平安特征IdentificationofcharacteristicsrelatedtoSAFETXpartofariskANALYSiSthatfocusesonUSABiLiTYperformedaccordingtoISO14971:2007,4.2.應(yīng)按ISO14971:2007,4.2的要求識別專注十可用性的平安特征RiskanalysisreportComplianceDuringtheidentificationcharacterist

12、icsrelatedtoSAFETYthefollowingareconsidered:在識別平安特征時,要考慮以下因素：applicationspecification,includinguserPROFILES);and應(yīng)用的規(guī)格,包括用戶特征；frequentlyusedfunctions.常用功能.UserManualComplianceResultsofthisidentificationcharacteristicsrelatedtoSAFETYecordedintheusabilityENGINEERINGFILE平安特征識別的結(jié)果應(yīng)記錄于可用性工程文檔UserManualCom

13、pliance5.3.2IdentificationofknownorforeseeableHAZARDSndHAZARDOUSTUATION/S識另ij的或可預(yù)見的危害和危害處境manufacturersidentifiedknownorforeseeableHAZARD(partofaRISKANALYSiSrelatedtoUSABILITYaccordingtoISO14971:2007,4.3.制造尚要按ISO14971:2007,4.3的要求識別可用性相關(guān)的的或可預(yù)見的危害RiskanalysisreportComplianceIdentificationofHAZARDSonsi

14、deredHAZARDS)patientsuSERSandotherpersons識別危害時要考慮對患者、操作者和其他人員的危害RiskanalysisreportComplianceReasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheUSERiNTERFACEthatcanresultinahazardoussituationassociatedwiththemedicalDEVICEwereidentified.TheSEVERITYoftheresultingpossibleHARMisdetermined.包括

15、可能導(dǎo)致危害處境的醫(yī)療器械用戶界面的合理可預(yù)見的事件的次序和組合已經(jīng)被識別.導(dǎo)致的可能的危害的嚴(yán)重程度已確定.RiskanalysisreportComplianceDuringtheidentificationofHAZARDSindhazardousSiTUATiQiNSefollowingwasconsidered:在識別危害和危害處境時,以下需要考慮：applicationspecification,includinguserrofilES；應(yīng)用的規(guī)格,包括用戶特征；taskrelatedrequirements;任務(wù)相關(guān)的要求；contextofuse;使用的背景；informati

16、ononHAZARDSindhazardoussituationknownforexistinguseriNTERFACEofmedicalDEViCESofasimilartype,ifavailable;對于現(xiàn)存的類似的醫(yī)療器械用戶界面的的危害和危害處境信息；preliminaryusescenarios初步的使用情景；possibleuseerrors；可能的使用錯誤；ifanincorrectmentalmodeloftheoperationofthemedicalDEViCEancauseauseERROResultinginahazardousSiTUATiQNid操作醫(yī)療器械的錯

17、誤精神模型是否會引起導(dǎo)致危害處境的使用錯誤；resultsofthereviewoftheuserinterface用戶界面的評審結(jié)果.RiskanalysisreportUserManualSComplianceTheresultsofthisidentificationofhazardshazardousSiTUATiONSidSEVERiTYarerecordedintheusabilityengineeringfile識別危害、危害處境和嚴(yán)重程度的結(jié)果要記錄在可用性工程文檔里.RiskanalysisreportCompliance5.4primaryoperatingfunction

18、s操作功能ThemanufacturerhasdeterminedtheprimaryoperatingFUNCTiONdrecordedintheusabilityENGINEERINGFILE制造商已經(jīng)確定了主要操作功能并記錄在可用性工程文檔里.UserManualComplianceTheinputstotheprimaryoperatingfunctionsincludefrequentlyusedfunctionsandfunctionsrelatedtoSAFETYoftheMEDICALDEVICE主要操作功能的輸入包括常用功能和關(guān)系醫(yī)療器械安全的功能.UserManualCom

19、pliance5.5UsabilitySpecification可用性標(biāo)準(zhǔn)MANUFACTURdevelopedausabilityspecificationrecordedintheusabilityengineeringfilespartoftheusabilityengineeringprocess制造商應(yīng)制定可用性標(biāo)準(zhǔn),記錄于可用性工程文檔里作為可用性工程過程的一局部.Qualitymanual,proceduredocumentComplianceTheusabilitySPECiFiCATiONecordedinusabilityENGINEERINGFILETheUSABILIT

20、YSPECIFICATIOmaybeintegratedintootherspecifications可用性標(biāo)準(zhǔn)記錄于可用性工程文檔里.可用性標(biāo)準(zhǔn)可以整合于其它標(biāo)準(zhǔn).Qualitymanual,proceduredocumentComplianceTheusabilitySPECiFiCATioNicludes:可用性標(biāo)準(zhǔn)包括：applicationspecification;應(yīng)用的規(guī)格；PRIMARYOPERATINGFUNCTIONS主要操作功能HAZARDSindHAZARDOUSlTUATIONSelatedtotheUsability;and關(guān)系可用性的危害和危害處境knownorf

21、oreseeableuseERROHSsociatedwiththeMedicalDevice的或可預(yù)見的關(guān)系醫(yī)療器械的使用錯誤.UserManualRiskanalysisreportComplianceTheusabilitySPECiFiCATiONescribesatleast:可用性標(biāo)準(zhǔn)至少要描述：usescENARiorelatedtotheprimaryoperatingFUNCTiONSincluding關(guān)于主要操作功能的使用情景,包括：frequentUseScenarios,and常見的使用情景reasonablyforeseeableworstcaseUsescenari

22、os合理可預(yù)見的最壞使用情景；UserManualRiskanalysisreportComplianceUSERINTERFACfequirementsfortheprimaryoperatingFUNCTioincludingthosetomitigateRISK;主要操作功能對于用戶界面的要求,包括降低風(fēng)險的那些；RiskanalysisreportComplianceRequirementsfordeterminingwhetherprimaryoperatingFUNCTIONSeasilyrecognizablebytheUSER用于決定主要操作功能是否易于被用戶認(rèn)知的要求Risk

23、analysisreportCompliance5.6USABILITYVALIDATIONplan/性確認(rèn)計戈UThemanufacturersdevelopedandmaintainsaUSABILITYVALIDATIONplanspecifying:制造商需制定并維護(hù)可用性確認(rèn)方案,以規(guī)定：UserManualComplianceanymethodusedforvalidationstheusabilityofthePRIMARYOPERATINGFUNCTIONS對于主要操作功能的可用性確實認(rèn)方法；UserManualCompliancethecriteriafordetermini

24、ngsuccessfulVALIDATIONoftheUSABILITYofthePRIMARYOPERATINGFUNCTiONSasedontheusabilitySPECiFiCATiONand基于可用性標(biāo)準(zhǔn),對主要操作功能可用性確實認(rèn)標(biāo)準(zhǔn)UserManualCompliancetheinvolvementofrepresentativeintendedUSERS包含的預(yù)期用戶代表UserManualComplianceusabilityVALiDATiorperformedinalaboratorysetting可用性確認(rèn)實施的實驗室設(shè)置：Testreport.Complianceus

25、abilityVALiDATiorperformedinasimulateduseenvironment可用性確認(rèn)實施于模擬使用環(huán)境：TestreportComplianceusabilityVALiDATiorperformedintheactualuseenvironment可用性確認(rèn)實施于真實使用環(huán)境：TestreportComplianceTheUSABILITYvalidatio陽anaddresses:可用性確認(rèn)方案包括：frequentUseScenarios,and常見的使用情景；reasonablyforeseeableworstcaseuseSCENARIOS合理可預(yù)見的最

26、壞使用情景thatareidentifiedintheusabilityspecification都要在可用性標(biāo)準(zhǔn)中識別.UserManualComplianceTheUSABILITYVALiDATiOfplanrecordedintheUSABILITYENGINEERINGFILE可用性確認(rèn)方案應(yīng)記錄與可用性工程文檔.UserManualCompliance5.7USERiNTERFACEesignandimplementation/用戶界面設(shè)計和實施MANUFACTURERsignedandimplementedtheUSERinterfacesdescribedintheusabil

27、itySPECiFiCATiONjtilizing,asappropriate,usabilityENGiNEERiNmethodsandtechniques制造商應(yīng)使用可用性工程的方法和技術(shù)來開發(fā)并實施可用性標(biāo)準(zhǔn)描述的用尸界向.Productsdonothavethisrequirementnoncompliance5.8USABILITYVERIFICATION/可用性驗證MANUFACTURVRrifiedtheimplementationoftheMEdicalDEviceUserINTERFACEesignaccordingtotheUSABILITYSPECIFICATION制造商

28、應(yīng)根據(jù)可用性標(biāo)準(zhǔn)來驗證醫(yī)療器械用戶界面設(shè)計的實施.ProductsdonothavethisrequirementnoncomplianceTheresultsoftheverificationarerecordedinUSABILITYENGINEERINGFILE驗證的結(jié)果應(yīng)記錄于可用性工程文檔.Productsdonothavethisrequirementnoncompliance5.9USABILITYVALIDATION可用性確認(rèn)ThemanufacturersvalidatedtheUsabilityofthemedicaldeviceaccordingtotheusabilit

29、yvalidationplan制造商應(yīng)根據(jù)可用性確認(rèn)方案來確認(rèn)醫(yī)療器械用戶界面的可用性.ProductsdonothavethisrequirementnoncomplianceTheresultsarerecordedintheusabilityENGINEERINGFILE確認(rèn)的結(jié)果應(yīng)記錄于可用性工程文檔.ProductsdonothavethisrequirementnoncomplianceFortheacceptancecriteriadocumentedintheusabilityVALiDATiorplanthatarenotmet:對于沒后可用性確認(rèn)方案中制定的未被滿足的接收準(zhǔn)

30、那么：-furtherUSERINTERFACdesignandimplementationactivitiesareperformed;or需要進(jìn)行進(jìn)一步的用戶界面設(shè)計和執(zhí)行；或-iffurtherimprovementisnotpracticable,theMANUFACTURERmaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheINTENDEDUSEoutweightheRISKarisingfromUSABILITYproblems如果進(jìn)一步的改良不現(xiàn)實,制造商需要收集并評審數(shù)據(jù)和文獻(xiàn),以確定預(yù)

31、期用途的醫(yī)療收益是否超過可用性問題帶來的風(fēng)險.Toperformthisstep,theMANUFACTURERneedstoestimatetheRISKarisingfromUSABILITYproblems.為此,制造商需評估可用性問題帶來的風(fēng)險.Productsdonothavethisrequirementnoncompliance6ACCOMPANYINGDOCUMENT機文件TheACCOMPANYINGDOCUMENudesasummaryoftheMedicalDeviceapplicationspecification隨機文件應(yīng)包括醫(yī)療器械應(yīng)用的規(guī)格的總結(jié).UserManu

32、alComplianceAconcisedescriptionoftheMedicalDeviceitsoperatingprinciples,significantphysicalandperformancecharacteristicsandintendedUserPROFiLEareincludedintheAccompanyingdocume卜隨機文件包括醫(yī)療器械、工作原理、重要的物理和性能特性和預(yù)期用戶的特征的簡要描述.UserManualTComplianceTheAccompanyingDOCUMEWTttenatalevelconsistentwiththeintendedoperatorprofile隨機文件的編寫要與用戶特征的水平相一致.UserManualComplianceTheACCOMPANYINGDOCUMENTquipment