1、EN62366:2008Checklist/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(yàn)證人:Dateofissue/發(fā)布日期：版本修改記錄:日期版本說明驗(yàn)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?；颊?、用戶和其它涉及產(chǎn)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(jī)文件與醫(yī)療器械的交互，如運(yùn)輸、存儲、安裝、操作、維護(hù)、維修和廢棄？UserManualCompliance4.1.2AreRESIDUALRISKSassociatedwithUSABILITYofthemedica

4、ldevicepresumedtobeacceptable,unlessthereisobjectiveevidencetothecontraryanddocumented?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;Compliance4.1.3manufacturershallsubjecttheinformationforsafetyusedasaRISKcontroltotheusabilityengineeringPROCESS(e.g.,warningsorlimitationofuseintheaccompanyingdocuments,ma

5、rking,etc.).對于做為風(fēng)險控制措施的安全信息，制造商應(yīng)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(yīng)被認(rèn)為是超出風(fēng)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(jié)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(shù)文檔和風(fēng)險管理文檔)的一部分Qualitymanual,proceduredocumentCompliance4.3Scalingoftheusabilityengineeringeffort/可用性工程的調(diào)整Theusabilityengineeringprocessisscaledbasedonthesignificanceofanymodificationsdependingontheresultsoftheriskanalysisanddocumented可用性工程

8、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/可用性工程過程5.1Applicationspecification/應(yīng)用的規(guī)格ApplicationofMedicaldeviceintheusabilityENGINEERINGFILEisspecifiedbytheMANUFACTURERandincludes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)tobesc

9、reened,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?。籙serManualComplianceintendedpatientpopulation(e.g.,age,weight,health,condition);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；UserManualComplianceinten

10、dedconditionsofuse(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(diǎn)和機(jī)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(yī)療器械交互的常用功能？UserManualCompliance5.3Identificationofhazardsandhazardoussituationsrelatedtousability/識別可用性相關(guān)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(yīng)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(yīng)用的規(guī)格，包括用戶特征；frequentlyusedfunctions.常用功能。UserManualComplianceResultsofthisidentificationcharacteristicsrelatedtosafetyrecordedintheusabilityengineeringfile安全特征識別的結(jié)果應(yīng)記錄于可用性工程文檔UserManualCompliance5.3.2Identificationofknownorforeseeablehazardsandhazardoussituations/識

14、另iJ已知的或可預(yù)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(guān)的已知的或可預(yù)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(dǎo)致危害處境

16、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。RiskanalysisreportComplianceDuringtheidentificationofhazardsandhazardoussituations,thefollowingwasconsidered:在識別危害和危害處境時，下列需要考慮：applicationspecification,includinguserrofile(S);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；informationon

17、hazardsandhazardoussituationsknownforexistinguserinterfacesofMEDICALDEVICESofasimilartype,ifavailable;對于現(xiàn)存的類似的醫(yī)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(yī)

18、療器械的錯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。RiskanalysisreportUserManualComplianceTheresultsofthisidentificationofhazards,hazardoussituationsandseverityarerecordedintheusabilityengineeringfile.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。RiskanalysisreportCompliance5.4PRIMARYOPERATINGF

19、UNCTIONS/主要操作功能ThemanufacturerhasdeterminedtheprimaryoperatingfunctionsandrecordedintheusabilityENGINEERINGFILE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。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(guān)系醫(yī)療器械安全的功能。UserManualCompliance5.5Usabilityspecification/可用性規(guī)范MANUFACTURERdevelopedaUSABILITYSPECIFICATIONrecordedintheusabilityengineeringfileaspartoftheusabilityengineeringprocess制造商應(yīng)制定可用性規(guī)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(guī)范記錄于可用性工程文檔里?？捎眯砸?guī)范可以整合于其它規(guī)范。Qualitymanual,proceduredocumentComplianceTheusabilityspecificationincludes:可用性規(guī)范包括：applicationspecification;應(yīng)用的規(guī)格；PRIMARYOPERATINGFUNCTIONS主要操

22、作功能hazardsandhazardoussituationsrelatedtotheusability；and關(guān)系可用性的危害和危害處境knownorforeseeableuseerrorsassociatedwiththeMEDICALDEVICE已知的或可預(yù)見的關(guān)系醫(yī)療器械的使用錯誤。UserManualRiskanalysisreportComplianceTheusabilityspecificationdescribesatleast:可用性規(guī)范至少要描述：usescenariosrelatedtotheprimaryoperatingfunctions,including關(guān)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(yù)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(fēng)險的那些；RiskanalysisreportComplianceRequirementsfordeterminingwhetherPRIMARYoperatingfunctionsareeasilyrecognizablebytheUSER.用于決定主要操作功能是否易于被用戶認(rèn)知的要求RiskanalysisreportCompliance5.6USABILITYVALIDATIONplan/可用性確認(rèn)計劃ThemanufacturerhasdevelopedandmaintainsaUSABILITYVALIDATIONplanspecifying:制造商需制定并維護(hù)可用性確認(rèn)計劃，以規(guī)

25、定：UserManualComplianceanymethodusedforvalidationoftheusabilityofthePRIMARYOPERATINGFUNCTIONS;對于主要操作功能的可用性的確認(rèn)方法；UserManualCompliancethecriteriafordeterminingsuccessfulvalidationoftheusabilityofthePRIMARYoperatingfunctionsbasedontheusabilityspecification;and基于可用性規(guī)范，對主要操作功能可用性的確認(rèn)標(biāo)準(zhǔn)UserManualCompliancet

26、heinvolvementofrepresentativeintendedusers包含的預(yù)期用戶代表UserManualComplianceusabilityvalidationperformedinalaboratorysetting可用性確認(rèn)實(shí)施的實(shí)驗(yàn)室設(shè)置：Testreport.Complianceusabilityvalidationperformedinasimulateduseenvironment可用性確認(rèn)實(shí)施于模擬使用環(huán)境：TestreportComplianceusabilityvalidationperformedintheactualuseenvironment可用性確

27、認(rèn)實(shí)施于真實(shí)使用環(huán)境：TestreportComplianceIEC62366checklistClauseRequirementRemarkVerdict條款要求解釋判定TheUSABILITYvalidationplanaddresses:可用性確認(rèn)計劃包括：frequentUseScenarios,and常見的使用情景；reasonablyforeseeableworstcaseusescenarios合理可預(yù)見的最壞使用情景thatareidentifiedintheusabilityspecification都要在可用性規(guī)范中識別。UserManualComplianceTheusa

28、bilityvalidationplanrecordedintheUSABILITYENGINEERINGFILE可用性確認(rèn)計劃應(yīng)記錄與可用性工程文檔。UserManualCompliance5.7USERinterfacedesignandimplementation/用戶界面設(shè)計和實(shí)施manufacturerdesignedandimplementedtheuserinterfaceasdescribedintheusabilityspecificationutilizing,asappropriate,usabilityengineeringmethodsandtechniques制造商

29、應(yīng)使用可用性工程的方法和技術(shù)來開發(fā)并實(shí)施可用性規(guī)范描述的用尸界向。Productsdonothavethisrequirementnoncompliance5.8USABILITYVERIFICATION/可用性驗(yàn)證manufacturerverifiedtheimplementationoftheMEDICALDEVICEuserinterfacedesignaccordingtotheUSABILITYSPECIFICATION制造商應(yīng)根據(jù)可用性規(guī)范來驗(yàn)證醫(yī)療器械用戶界面設(shè)計的實(shí)施。ProductsdonothavethisrequirementnoncomplianceTheresult

30、softheverificationarerecordedinUSABILITYENGINEERINGFILE驗(yàn)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)TheMANUFACTURERhasvalidatedtheUSABILITYoftheMedicalDeviceaccordingtotheusabilityVALIDATIONplan制造商應(yīng)根據(jù)可用性確認(rèn)計劃來確認(rèn)醫(yī)療器械用戶界面的可用性。Productsdonothavethisrequirement

31、noncomplianceTheresultsarerecordedintheusabilityENGINEERINGFILE確認(rèn)的結(jié)果應(yīng)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(rèn)計劃中制定的未被滿足的接收準(zhǔn)則：-furtherUserinterfa

32、cedesignandimplementationactivitiesareperformed;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)一步的改進(jìn)不現(xiàn)實(shí)，制造商需要收集并評審數(shù)據(jù)和文獻(xiàn)，以確定預(yù)期用途的醫(yī)療收益是否超過可用性問題帶來的風(fēng)

33、險。Toperformthisstep,theMANUFACTURERneedstoestimatetheRISKarisingfromUSABILITYproblems.為此，制造商需評估可用性問題帶來的風(fēng)險。Productsdonothavethisrequirementnoncompliance6ACCOMPANYINGDOCUMENTS/隨機(jī)文件TheACCOMPANYINGdocumentincludesasummaryoftheMedicaldeviceapplicationspecification隨機(jī)文件應(yīng)包括醫(yī)療器械應(yīng)用的規(guī)格的總結(jié)。UserManualComplianceA

34、concisedescriptionoftheMedicaldevice,itsoperatingprinciples,significantphysicalandperformancecharacteristicsandintendedUserPROFILEareincludedintheAccompanyingDOCUMENT隨機(jī)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。UserManualComplianceTheACCOMPANYINGdocumentiswrittenatalevelconsistentwiththeintendedoperatorprofile隨機(jī)文件的編寫要與用戶特征的水平相一致。UserManualComplianceTheACCOMPANYINGdocumentforequipmentare,