1、EN62366:2008Checklist/檢查表MedicaldevicesApplicationofusabilityengineeringtomedicaldevices可用性工程于醫療器械的應用ProductName/產品名稱ReportReferenceNo/編號.Version/版本號：驗證人:Dateofissue/發布日期：版本修改記錄:日期版本說明驗證人審批人IEC62366checklistClauseRequirementRemarkVerdict條款要求解釋判定4GENERALREQUIREMENTS/總要求4.1GeneralRequirements/總要求4.1.1

2、USABILITYENGINEERINGPROCESS/W|性工程過程Hasthemanufacturerestablished,documentedandmaintainedausabilityengineeringprocesstoprovidesafetyforthepatient,userandothersrelatedtousabilityfortheproduct?制造商是否建立、記錄并維持了一個可用性工程過程，以確保患者、用戶和其它涉及產品適用性的人的安全？UserManual;Qualitymanual,proceduredocument;ComplianceDoesthePR

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

4、ldevicepresumedtobeacceptable,unlessthereisobjectiveevidencetothecontraryanddocumented?關系醫療器械可用性的剩余風險是否推定可接受？Riskanalysisreport;Compliance4.1.3manufacturershallsubjecttheinformationforsafetyusedasaRISKcontroltotheusabilityengineeringPROCESS(e.g.,warningsorlimitationofuseintheaccompanyingdocuments,ma

5、rking,etc.).對于做為風險控制措施的安全信息，制造商應把它納入可用性工程過程的控制Riskanalysisreport;UserManual;ComplianceDisregardingsuchinformationforsafetyisconsideredbeyondanyfurtherreasonablemeansofRISKCONTROL忽視安全信息的行為應被認為是超出風險控制措施的(即非正常使用)RiskanalysisreportCompliance4.2Theresultsoftheusabilityengineeringprocessarerecordedintheus

6、abilityengineeringfile可用性工程過程的結果記錄于可用性工程文檔。Qualitymanual,proceduredocument;ComplianceIEC62366checklistClauseRequirementRemarkVerdict條款要求解釋判定TherecordsandotherdocumentsthatmakeuptheUSABILITYENGINEERINGFILEMAYformpartofotherdocumentsandfiles(e.g.,amanufacturerSproductdesignfileorRISKmanagementfile),(S

7、EEListofdocumentsmakeuptheUEfile)組成可用性工程文檔的記錄和其它文件可以是其它文檔(如技術文檔和風險管理文檔)的一部分Qualitymanual,proceduredocumentCompliance4.3Scalingoftheusabilityengineeringeffort/可用性工程的調整Theusabilityengineeringprocessisscaledbasedonthesignificanceofanymodificationsdependingontheresultsoftheriskanalysisanddocumented可用性工程

8、調整取決于風險分析確認的設計更改的重要程度RiskanalysisreportCompliance5USABILTYENGINEERINGPROCESS/可用性工程過程5.1Applicationspecification/應用的規格ApplicationofMedicaldeviceintheusabilityENGINEERINGFILEisspecifiedbytheMANUFACTURERandincludes可用性工程文檔中的醫療器械的應用由制造商決定，包括：-intendedmedicalindication(e.g.,conditions(s)ordisease(s)tobesc

9、reened,monitored,treated,diagnosed,orprevented);預期醫學用途，如預期要篩查、監護、治療、診斷或預防的狀態或疾病；UserManualComplianceintendedpatientpopulation(e.g.,age,weight,health,condition);預期患者群，如年齡、體重、健康和社會條件；UserManualComplianceintendedpartofthebodyortypeoftissueappliedtoorinteractedwith;預期使用的身體部位或組織；UserManualComplianceinten

10、dedconditionsofuse(e.g.environmentincludinghygienicrequirements,frequencyofuse,location,mobility);and預期的使用狀態，如環境包括衛生要求、使用頻度、地點和機動性；UserManualComplianceIEC62366checklistClauseRequirementRemarkVerdict條款要求解釋判定operatingprinciple(s)操作原理UserManualCompliance5.2Frequentlyusedfunctions/常用功能Arefrequentlyusedf

11、unctionsthatinvolveUSERinteractionwiththeMedicaldevicearedeterminedandrecordedintheusabilityengineeringfile?在可用性工程文檔中是否確定并記錄了涉及用戶與醫療器械交互的常用功能？UserManualCompliance5.3Identificationofhazardsandhazardoussituationsrelatedtousability/識別可用性相關的危害和危害處境5.3.1Identificationofcharacteristicstosafety/識別安全特征Ident

12、ificationofcharacteristicsrelatedtosafety(partofaRISKanalysis)thatfocusesonusabilityperformedaccordingtoISO14971:2007,4.2.應按ISO14971:2007,4.2的要求識別專注十可用性的安全特征RiskanalysisreportComplianceDuringtheidentificationcharacteristicsrelatedtosafety,thefollowingareconsidered:在識別安全特征時，要考慮下列因素：applicationspecifi

13、cation,includinguserPROFILE(S);and應用的規格，包括用戶特征；frequentlyusedfunctions.常用功能。UserManualComplianceResultsofthisidentificationcharacteristicsrelatedtosafetyrecordedintheusabilityengineeringfile安全特征識別的結果應記錄于可用性工程文檔UserManualCompliance5.3.2Identificationofknownorforeseeablehazardsandhazardoussituations/識

14、另iJ已知的或可預見的危害和危害處境manufacturerhasidentifiedknownorforeseeableHAZARDS(partofaRISKANALYSIS)relatedtoUSABILITYaccordingtoISO14971:2007,4.3.制造尚要按ISO14971:2007,4.3的要求識別可用性相關的已知的或可預見的危害RiskanalysisreportComplianceIdentificationofhazardsconsideredhazardstopatients,usersandotherpersons識別危害時要考慮對患者、操作者和其他人員的危

15、害RiskanalysisreportComplianceIEC62366checklistClauseRequirementRemarkVerdict條款要求解釋判定Reasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheuserinterfacethatcanresultinahazardoussituationassociatedwiththemedicaldevicewereidentified.Theseverityoftheresultingpossibleharmisdetermined.包括可能導致危害處境

16、的醫療器械用戶界面的合理可預見的事件的次序和組合已經被識別。導致的可能的危害的嚴重程度已確定。RiskanalysisreportComplianceDuringtheidentificationofhazardsandhazardoussituations,thefollowingwasconsidered:在識別危害和危害處境時，下列需要考慮：applicationspecification,includinguserrofile(S);應用的規格，包括用戶特征；taskrelatedrequirements;任務相關的要求；contextofuse;使用的背景；informationon

17、hazardsandhazardoussituationsknownforexistinguserinterfacesofMEDICALDEVICESofasimilartype,ifavailable;對于現存的類似的醫療器械用戶界面的已知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；ifanincorrectmentalmodeloftheoperationofthemedicaldevicecancauseauseerrorresultinginahazardoussituation；and操作醫

18、療器械的錯誤精神模型是否會引起導致危害處境的使用錯誤；resultsofthereviewoftheuserinterface用戶界面的評審結果。RiskanalysisreportUserManualComplianceTheresultsofthisidentificationofhazards,hazardoussituationsandseverityarerecordedintheusabilityengineeringfile.識別危害、危害處境和嚴重程度的結果要記錄在可用性工程文檔里。RiskanalysisreportCompliance5.4PRIMARYOPERATINGF

19、UNCTIONS/主要操作功能ThemanufacturerhasdeterminedtheprimaryoperatingfunctionsandrecordedintheusabilityENGINEERINGFILE制造商已經確定了主要操作功能并記錄在可用性工程文檔里。UserManualComplianceIEC62366checklistClauseRequirementRemarkVerdict條款要求解釋判定Theinputstotheprimaryoperatingfunctionsincludefrequentlyusedfunctionsandfunctionsrelate

20、dtoSafetyoftheMedicaldevice主要操作功能的輸入包括常用功能和關系醫療器械安全的功能。UserManualCompliance5.5Usabilityspecification/可用性規范MANUFACTURERdevelopedaUSABILITYSPECIFICATIONrecordedintheusabilityengineeringfileaspartoftheusabilityengineeringprocess制造商應制定可用性規范，記錄于可用性工程文檔里作為可用性工程過程的一部分。Qualitymanual,proceduredocumentComplia

21、nceTheusabilityspecificationrecordedinusabilityENGINEERINGFILE.TheUSABILITYSPECIFICATIONmaybeintegratedintootherspecifications可用性規范記錄于可用性工程文檔里。可用性規范可以整合于其它規范。Qualitymanual,proceduredocumentComplianceTheusabilityspecificationincludes:可用性規范包括：applicationspecification;應用的規格；PRIMARYOPERATINGFUNCTIONS主要操

22、作功能hazardsandhazardoussituationsrelatedtotheusability；and關系可用性的危害和危害處境knownorforeseeableuseerrorsassociatedwiththeMEDICALDEVICE已知的或可預見的關系醫療器械的使用錯誤。UserManualRiskanalysisreportComplianceTheusabilityspecificationdescribesatleast:可用性規范至少要描述：usescenariosrelatedtotheprimaryoperatingfunctions,including關于主

23、要操作功能的使用情景，包括：frequentUseScenarios,and常見的使用情景reasonablyforeseeableworstcaseUsescenarios；合理可預見的最壞使用情景；UserManualRiskanalysisreportComplianceIEC62366checklistClauseRequirementRemarkVerdict條款要求解釋判定USERINTERFACErequirementsforthePRIMARYOPERATINGFUNCTIONS,includingthosetomitigateRISK;主要操作功能對于用戶界面的要求，包括降低

24、風險的那些；RiskanalysisreportComplianceRequirementsfordeterminingwhetherPRIMARYoperatingfunctionsareeasilyrecognizablebytheUSER.用于決定主要操作功能是否易于被用戶認知的要求RiskanalysisreportCompliance5.6USABILITYVALIDATIONplan/可用性確認計劃ThemanufacturerhasdevelopedandmaintainsaUSABILITYVALIDATIONplanspecifying:制造商需制定并維護可用性確認計劃，以規

25、定：UserManualComplianceanymethodusedforvalidationoftheusabilityofthePRIMARYOPERATINGFUNCTIONS;對于主要操作功能的可用性的確認方法；UserManualCompliancethecriteriafordeterminingsuccessfulvalidationoftheusabilityofthePRIMARYoperatingfunctionsbasedontheusabilityspecification;and基于可用性規范，對主要操作功能可用性的確認標準UserManualCompliancet

26、heinvolvementofrepresentativeintendedusers包含的預期用戶代表UserManualComplianceusabilityvalidationperformedinalaboratorysetting可用性確認實施的實驗室設置：Testreport.Complianceusabilityvalidationperformedinasimulateduseenvironment可用性確認實施于模擬使用環境：TestreportComplianceusabilityvalidationperformedintheactualuseenvironment可用性確

27、認實施于真實使用環境：TestreportComplianceIEC62366checklistClauseRequirementRemarkVerdict條款要求解釋判定TheUSABILITYvalidationplanaddresses:可用性確認計劃包括：frequentUseScenarios,and常見的使用情景；reasonablyforeseeableworstcaseusescenarios合理可預見的最壞使用情景thatareidentifiedintheusabilityspecification都要在可用性規范中識別。UserManualComplianceTheusa

28、bilityvalidationplanrecordedintheUSABILITYENGINEERINGFILE可用性確認計劃應記錄與可用性工程文檔。UserManualCompliance5.7USERinterfacedesignandimplementation/用戶界面設計和實施manufacturerdesignedandimplementedtheuserinterfaceasdescribedintheusabilityspecificationutilizing,asappropriate,usabilityengineeringmethodsandtechniques制造商

29、應使用可用性工程的方法和技術來開發并實施可用性規范描述的用尸界向。Productsdonothavethisrequirementnoncompliance5.8USABILITYVERIFICATION/可用性驗證manufacturerverifiedtheimplementationoftheMEDICALDEVICEuserinterfacedesignaccordingtotheUSABILITYSPECIFICATION制造商應根據可用性規范來驗證醫療器械用戶界面設計的實施。ProductsdonothavethisrequirementnoncomplianceTheresult

30、softheverificationarerecordedinUSABILITYENGINEERINGFILE驗證的結果應記錄于可用性工程文檔。Productsdonothavethisrequirementnoncompliance5.9USABILITYVALIDATION/可用性確認TheMANUFACTURERhasvalidatedtheUSABILITYoftheMedicalDeviceaccordingtotheusabilityVALIDATIONplan制造商應根據可用性確認計劃來確認醫療器械用戶界面的可用性。Productsdonothavethisrequirement

31、noncomplianceTheresultsarerecordedintheusabilityENGINEERINGFILE確認的結果應記錄于可用性工程文檔。ProductsdonothavethisrequirementnoncomplianceIEC62366checklistClauseRequirementRemarkVerdict條款要求解釋判定FortheacceptancecriteriadocumentedintheUSABILITYVALIDATIONplanthatarenotmet:對于沒后可用性確認計劃中制定的未被滿足的接收準則：-furtherUserinterfa

32、cedesignandimplementationactivitiesareperformed;or需要進行進一步的用戶界面設計和執行；或-iffurtherimprovementisnotpracticable,theMANUFACTURERmaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheINTENDEDUSEoutweightheRISKarisingfromUSABILITYproblems如果進一步的改進不現實，制造商需要收集并評審數據和文獻，以確定預期用途的醫療收益是否超過可用性問題帶來的風

33、險。Toperformthisstep,theMANUFACTURERneedstoestimatetheRISKarisingfromUSABILITYproblems.為此，制造商需評估可用性問題帶來的風險。Productsdonothavethisrequirementnoncompliance6ACCOMPANYINGDOCUMENTS/隨機文件TheACCOMPANYINGdocumentincludesasummaryoftheMedicaldeviceapplicationspecification隨機文件應包括醫療器械應用的規格的總結。UserManualComplianceA

34、concisedescriptionoftheMedicaldevice,itsoperatingprinciples,significantphysicalandperformancecharacteristicsandintendedUserPROFILEareincludedintheAccompanyingDOCUMENT隨機文件包括醫療器械、工作原理、重要的物理和性能特性和預期用戶的特征的簡要描述。UserManualComplianceTheACCOMPANYINGdocumentiswrittenatalevelconsistentwiththeintendedoperatorprofile隨機文件的編寫要與用戶特征的水平相一致。UserManualComplianceTheACCOMPANYINGdocumentforequipmentare,