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(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?、用戶和其它涉及產(chǎn)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(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？UserManualCompliance4.1.2AreRESIDUALRISKSassociatedwithUSABILITYoftheMEDICALDEVICEpresumedtobeacceptable,unlessthereisOBJECTIVEEV

4、IDENCEtothecontraryanddocumented?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,marking,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Riskanal

5、ysisreport;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)RiskanalysisreportCompliance4.2TheresultsoftheUSABILITYENGINEERINGPROCESSarerecordedintheUSABILITYENGINEERINGFILE可用性工程過程的結(jié)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(shù)文檔和風(fēng)險管理文檔)的一部分Qualitymanual,proceduredocumentCom

7、pliance4.3ScalingoftheUSABILITYENGINEERINGeffort/可用性工程的調(diào)整TheUSABILITYENGINEERINGPROCESSisscaledbasedonthesignificanceofanymodificationsdependingontheresultsoftheRISKANALYSISanddocumented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/可用性工程過程5.1Applicationspecificati

8、on/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)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??；UserManualComplianceintendedP

9、ATIENTpopulation(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；UserManualComplianceintendedconditionsofuse(e.g.environmentincludinghygienicrequirements,frequencyofuse,location,mobility);and預(yù)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(jī)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(guān)的危害和危害處境5.3.1IdentificationofcharacteristicstoSAFETY/識別安全特征IdentificationofcharacteristicsrelatedtoSAFETY(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Riska

12、nalysisreportComplianceDuringtheidentificationcharacteristicsrelatedtoSAFETY,thefollowingareconsidered:在識別安全特征時，要考慮下列因素：applicationspecification,includingUSERPROFILE(S);and應(yīng)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(jié)果應(yīng)記錄于可用性工程文檔UserManualCompliance5.3.2IdentificationofknownorforeseeableHAZARDSandHAZARDOUSSITUATIONS/識另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

14、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害RiskanalysisreportComplianceReasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheUSERINTERFACEthatcanresultinaHAZARDOUSSITUATIONassociatedwiththeMED

15、ICALDEVICEwereidentified.TheSEVERITYoftheresultingpossibleHARMisdetermined.包括可能導(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。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(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；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(dǎo)致危害處境的使用錯誤；resultsofthereviewoftheUSERINTERFACE用戶界面的評審結(jié)果。RiskanalysisreportUserManualComplianceTheresultsofthisidentificationofHAZARDS,HAZARDOUSSITUATIONSandSEVERITYarerecordedintheUSABILITYENGINEERI

18、NGFILE.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。RiskanalysisreportCompliance5.4PRIMARYOPERATINGFUNCTIONS/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(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。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(yīng)用的

21、規(guī)格；PRIMARYOPERATINGFUNCTIONS主要操作功能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：USESCENARIOSrelatedtothePRIMARY

22、OPERATINGFUNCTIONS,including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reasonablyforeseeableworstcaseUSESCENARIOS;合理可預(yù)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(fēng)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(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)定：UserManualCompliancean

24、ymethodusedforVALIDATIONoftheUSABILITYofthePRIMARYOPERATINGFUNCTIONS;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)UserManualCompliancetheinvolvementofrepresent

25、ativeintendedUSERS包含的預(yù)期用戶代表UserManualComplianceUSABILITYVALIDATIONperformedinalaboratorysetting可用性確認(rèn)實施的實驗室設(shè)置：Testreport.ComplianceUSABILITYVALIDATIONperformedinasimulateduseenvironment可用性確認(rèn)實施于模擬使用環(huán)境：TestreportComplianceUSABILITYVALIDATIONperformedintheactualuseenvironment可用性確認(rèn)實施于真實使用環(huán)境：TestreportCom

26、plianceTheUSABILITYVALIDATIONplanaddresses: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。UserManualComplianceTheUSABILITYVALIDATIONplanrecordedintheUSABILITYENGINEERINGFILE可用性確認(rèn)計劃應(yīng)記錄與可用性工程文檔。Use

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

28、.8USABILITYVERIFICATION/可用性驗證MANUFACTURERverifiedtheimplementationoftheMEDICALDEVICEUSERINTERFACEdesignaccordingtotheUSABILITYSPECIFICATION制造商應(yīng)根據(jù)可用性規(guī)范來驗證醫(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。Product

29、sdonothavethisrequirementnoncompliance5.9USABILITYVALIDATION/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。ProductsdonothavethisrequirementnoncomplianceTheresultsarerecordedintheUSABILITYENGINEERINGFILE確認(rèn)的結(jié)果應(yīng)記錄于可用性工程文檔

30、。ProductsdonothavethisrequirementnoncomplianceFortheacceptancecriteriadocumentedintheUSABILITYVALIDATIONplanthatarenotmet: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：-furtherUSERINTERFACEdesignandimplementationactivitiesareperformed;or需要進(jìn)行進(jìn)一步的用戶界面設(shè)計和執(zhí)行；或-iffurtherimprovementisnotpracticable,theMANUFACTURERmaygatherand

31、reviewdataandliteraturetodetermineifthemedicalbenefitsoftheINTENDEDUSEoutweightheRISKarisingfromUSABILITYproblems如果進(jìn)一步的改進(jìn)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)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。Productsdonothavethisrequir

32、ementnoncompliance6ACCOMPANYINGDOCUMENTS/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)。UserManualComplianceAconcisedescriptionoftheMEDICALDEVICE,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。User