CE可用性工程評價報告EN

1、EN62366:2008Checklist/檢查表MedicaldevicesApplicationofusabilityengineeringtomedicaldevices可用性工程于醫(yī)療器械的應用ProductName/產品名稱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4GENERALREQUIREMENTS/總要求4.1GeneralRequirements/總要求4.1.1USABILITYENGINEERINGPROCESS/可用性工程過程HastheMANUFACTURERe

2、stablished,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?；颊摺⒂脩艉推渌婕爱a品適用性的人的安全？UserManual;Qualitymanual,proceduredocument;ComplianceDoesthePROCESSaddressUSERINTERActionswiththeMEDICALDEVICEaccord

3、ingtotheACCOMPANYINGDOCUMENTincluding,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、維修和廢棄？UserManualCompliance4.1.2AreRESIDUALRISKSassociatedwithUSABILITYoftheMEDICALDEVICEpresumedtobeacceptable,unlessthereisOBJECTIVEEV

4、IDENCEtothecontraryanddocumented?關系醫(yī)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,marking,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Riskanal

5、ysisreport;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)RiskanalysisreportCompliance4.2TheresultsoftheUSABILITYENGINEERINGPROCESSarerecordedintheUSABILITYENGINEERINGFILE可用性工程過程的結果記錄于可用性工程文檔。Qualitymanu

6、al,proceduredocument;ComplianceTherecordsandotherdocumentsthatmakeuptheUSABILITYENGINEERINGFILEMAYformpartofotherdocumentsandfiles(e.g.,aMANUFACTURERSproductdesignfileorRISKMANAGEMENTFILE),(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(如技術文檔和風險管理文檔)的一部分Qualitymanual,proceduredocumentCom

7、pliance4.3ScalingoftheUSABILITYENGINEERINGeffort/可用性工程的調整TheUSABILITYENGINEERINGPROCESSisscaledbasedonthesignificanceofanymodificationsdependingontheresultsoftheRISKANALYSISanddocumented可用性工程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5.1Applicationspecificati

8、on/應用的規(guī)格ApplicationofMEDICALDEVICEintheUSABILITYENGINEERINGFILEisspecifiedbytheMANUFACTURERandincludes可用性工程文檔中的醫(yī)療器械的應用由制造商決定，包括：-intendedmedicalindication(e.g.,conditions(s)ordisease(s)tobescreened,monitored,treated,diagnosed,orprevented);預期醫(yī)學用途，如預期要篩查、監(jiān)護、治療、診斷或預防的狀態(tài)或疾??；UserManualComplianceintendedP

9、ATIENTpopulation(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；UserManualComplianceintendedconditionsofuse(e.g.environmentincludinghygienicrequirements,frequencyofuse,location,mobility);and預期的使用狀態(tài)，

10、如環(huán)境包括衛(wèi)生要求、使用頻度、地點和機動性；UserManualComplianceoperatingprinciple(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.

11、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IdentificationofcharacteristicsrelatedtoSAFETY(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Riska

12、nalysisreportComplianceDuringtheidentificationcharacteristicsrelatedtoSAFETY,thefollowingareconsidered:在識別安全特征時，要考慮下列因素：applicationspecification,includingUSERPROFILE(S);and應用的規(guī)格，包括用戶特征；frequentlyusedfunctions.常用功能。UserManualComplianceResultsofthisidentificationcharacteristicsrelatedtoSAFETYrecordedi

13、ntheUSABILITYENGINEERINGFILE安全特征識別的結果應記錄于可用性工程文檔UserManualCompliance5.3.2IdentificationofknownorforeseeableHAZARDSandHAZARDOUSSITUATIONS/識另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

14、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害RiskanalysisreportComplianceReasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheUSERINTERFACEthatcanresultinaHAZARDOUSSITUATIONassociatedwiththeMED

15、ICALDEVICEwereidentified.TheSEVERITYoftheresultingpossibleHARMisdetermined.包括可能導致危害處境的醫(yī)療器械用戶界面的合理可預見的事件的次序和組合已經(jīng)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,includingUSERRO

16、FILE(S);應用的規(guī)格，包括用戶特征；taskrelatedrequirements;任務相關的要求；contextofuse;使用的背景；informationonHAZARDSandHAZARDOUSSITUATIONSknownforexistingUSERINTERFACESofMEDICALDEVICESofasimilartype,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；ifanincorrectmentalmodelo

17、ftheoperationoftheMEDICALDEVICEcancauseaUSEERRORresultinginaHAZARDOUSSITUATION;and操作醫(yī)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,HAZARDOUSSITUATIONSandSEVERITYarerecordedintheUSABILITYENGINEERI

18、NGFILE.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。RiskanalysisreportCompliance5.4PRIMARYOPERATINGFUNCTIONS/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。UserManualComplianceTheinputstothePRIMARYOPERATINGFUNCTIONSincludefrequentlyu

19、sedfunctionsandfunctionsrelatedtoSAFETYoftheMEDICALDEVICE主要操作功能的輸入包括常用功能和關系醫(yī)療器械安全的功能。UserManualCompliance5.5USABILITYSPECIFICATION/可用性規(guī)范MANUFACTURERdevelopedaUSABILITYSPECIFICATIONrecordedintheUSABILITYENGINEERINGFILEaspartoftheUSABILITYENGINEERINGPROCESS制造商應制定可用性規(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。Qualitym

20、anual,proceduredocumentComplianceTheUSABILITYSPECIFICATIONrecordedinUSABILITYENGINEERINGFILE.TheUSABILITYSPECIFICATIONmaybeintegratedintootherspecifications可用性規(guī)范記錄于可用性工程文檔里。 可用性規(guī)范可以整合于其它規(guī)范。Qualitymanual,proceduredocumentComplianceTheUSABILITYSPECIFICATIONincludes:可用性規(guī)范包括：applicationspecification;應用的

21、規(guī)格；PRIMARYOPERATINGFUNCTIONS主要操作功能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(yī)療器械的使用錯誤。UserManualRiskanalysisreportComplianceTheUSABILITYSPECIFICATIONdescribesatleast:可用性規(guī)范至少要描述：USESCENARIOSrelatedtothePRIMARY

22、OPERATINGFUNCTIONS,including關于主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；UserManualRiskanalysisreportComplianceUSERINTERFACErequirementsforthePRIMARYOPERATINGFUNCTIONS,includingthosetomitigateRISK;主要操作功能對于用戶界面的要求，包括降低風險的那些；Riskanalysisreport

23、ComplianceRequirementsfordeterminingwhetherPRIMARYOPERATINGFUNCTIONSareeasilyrecognizablebytheUSER.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(guī)定：UserManualCompliancean

24、ymethodusedforVALIDATIONoftheUSABILITYofthePRIMARYOPERATINGFUNCTIONS;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(guī)范，對主要操作功能可用性的確認標準UserManualCompliancetheinvolvementofrepresent

25、ativeintendedUSERS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(huán)境：TestreportComplianceUSABILITYVALIDATIONperformedintheactualuseenvironment可用性確認實施于真實使用環(huán)境：TestreportCom

26、plianceTheUSABILITYVALIDATIONplanaddresses: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(guī)范中識別。UserManualComplianceTheUSABILITYVALIDATIONplanrecordedintheUSABILITYENGINEERINGFILE可用性確認計劃應記錄與可用性工程文檔。Use

27、rManualCompliance5.7USERINTERFACEdesignandimplementation/用戶界面設計和實施MANUFACTURERdesignedandimplementedtheUSERINTERFACEasdescribedintheUSABILITYSPECIFICATIONutilizing,asappropriate,USABILITYENGINEERINGmethodsandtechniques制造商應使用可用性工程的方法和技術來開發(fā)并實施可用性規(guī)范描述的用尸界向。Productsdonothavethisrequirementnoncompliance5

28、.8USABILITYVERIFICATION/可用性驗證MANUFACTURERverifiedtheimplementationoftheMEDICALDEVICEUSERINTERFACEdesignaccordingtotheUSABILITYSPECIFICATION制造商應根據(jù)可用性規(guī)范來驗證醫(yī)療器械用戶界面設計的實施。ProductsdonothavethisrequirementnoncomplianceTheresultsoftheverificationarerecordedinUSABILITYENGINEERINGFILE驗證的結果應記錄于可用性工程文檔。Product

29、sdonothavethisrequirementnoncompliance5.9USABILITYVALIDATION/可用性確認TheMANUFACTURERhasvalidatedtheUSABILITYoftheMEDICALDEVICEaccordingtotheUSABILITYVALIDATIONplan制造商應根據(jù)可用性確認計劃來確認醫(yī)療器械用戶界面的可用性。ProductsdonothavethisrequirementnoncomplianceTheresultsarerecordedintheUSABILITYENGINEERINGFILE確認的結果應記錄于可用性工程文檔

30、。ProductsdonothavethisrequirementnoncomplianceFortheacceptancecriteriadocumentedintheUSABILITYVALIDATIONplanthatarenotmet:對于沒后可用性確認計劃中制定的未被滿足的接收準則：-furtherUSERINTERFACEdesignandimplementationactivitiesareperformed;or需要進行進一步的用戶界面設計和執(zhí)行；或-iffurtherimprovementisnotpracticable,theMANUFACTURERmaygatherand

31、reviewdataandliteraturetodetermineifthemedicalbenefitsoftheINTENDEDUSEoutweightheRISKarisingfromUSABILITYproblems如果進一步的改進不現(xiàn)實，制造商需要收集并評審數(shù)據(jù)和文獻， 以確定預期用途的醫(yī)療收益是否超過可用性問題帶來的風險。Toperformthisstep,theMANUFACTURERneedstoestimatetheRISKarisingfromUSABILITYproblems.為此，制造商需評估可用性問題帶來的風險。Productsdonothavethisrequir

32、ementnoncompliance6ACCOMPANYINGDOCUMENTS/隨機文件TheACCOMPANYINGDOCUMENTincludesasummaryoftheMEDICALDEVICEapplicationspecification隨機文件應包括醫(yī)療器械應用的規(guī)格的總結。UserManualComplianceAconcisedescriptionoftheMEDICALDEVICE,itsoperatingprinciples,significantphysicalandperformancecharacteristicsandintendedUSERPROFILEareincludedintheACCOMPANYINGDOCUMENT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。User