EN醫(yī)療器械可用性工程評(píng)估報(bào)告

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ReportRefereneeNo編號(hào).Version/版本號(hào)：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IEC762366checklistClause條款Requirement要求Remark解釋Verdict判定4GENERALREQUIREMENT要求GeneralRequirements/總要求4.1.1USABILIT

2、YENGINEERINGPOCESS可用性工程過程HastheMANUFACTURERestablished,documentedandmaintainedaUSABILITYENGINEERINGPROCESStoprovideSAFETYforthePATIENT,USERandothersrelatedtoUSABILITYfortheproduct希U造商是否津廿、記錄并維持了一個(gè)可用性工程過程，以確保患者、用戶和其它涉及產(chǎn)品適用性的人的安全UserManual:Qualitymanual,proceduredocument;ComplianceDoesthePROCESSaddres

3、sUSERINTERActionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENTincluding,butnotlimitedtotransport,storage,installation,operation,maintenance,repairanddisposalj亥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(chǔ)、安裝、操作、維護(hù)、維修和廢棄UserManualCompliance4.1.2AreRESIDUALRISKSassociatedwithUSABILITYoftheEDICALDEVICEpresum

4、edtobeacceptable,unlessthereiiOBJECTIVEEVIDENCEtothecontraryanddocumented矢系醫(yī)療器械可用性的剩余風(fēng)險(xiǎn)是否推定可接受Riskanalysisreport;sCompliance4.1.3IEC762366checklistClause條款Requirement要求Remark解釋Verdict判定MANUFACTURERSHALLsubjecttheinformationforsafetyusedasaRISKCONTROLtotheUSABILITYENGINEERINGPROCESS?,warningsorlimita

5、tionofuseintheACCOMPANYINGDOCUMENTS,marking,etc?)?對(duì)于做為風(fēng)險(xiǎn)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(xiǎn)控制措施的(即非正常使用)RiskanalysisreportComplianceTheresultsoftheUSABILITYE

6、NGINEERINGPROCESSarerecordedintheUSABILITYENGINEERINGFILE可用性工程過程的結(jié)果記錄于可用性工程文檔。Qualitymanual,proceduredocument;ComplianceTherecordsandotherdocumentsthatmakeuptheUSABILITYENGINEERINGFILEMAYformpartofotherdocumentsandfiles?,aMANUFACTURERSproductdesignfileorRISKMANAGEMENTFILE),(SEEListofdocumentsmakeupt

7、heUEfile)纟目成可用牛T.稈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(xiǎn)管理文檔)的一部分Qualitymanual,proceduredocumentComplianceIEC762366checklistClause條款Requirement要求Remark解釋Verdict判定ScalingoftheUSABILITYENGINEERINGeffort/可用T生工程白勺調(diào)整TheUSABILITYENGINEERINGPROCESSisscaledbasedonthesignificaneeofanymodificationsdependingontheresultsof

8、theRISKANALYSISanddocumented可用性工程調(diào)整取決于風(fēng)險(xiǎn)分析確認(rèn)的設(shè)計(jì)更改的重要程度RiskanalysisreportCompliance5USABILTYENGINEERINGPROCESS用性工程過程Applicationspec辻ication/應(yīng)用的規(guī)格ApplicationofMEDICALDEVICEintheUSABILITYENGINEERINGFILEisspecifiedbytheMANUFACTURERandincludes可用f生工程文檔中的醫(yī)療器械的應(yīng)用由制造商決定，包括：uintendedmedicalindication?、conditi

9、ons(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?。籙serManual)Compliance?intendedPATIENTpopulation?,age,weight,health,condition);預(yù)期患者群，如年齡、體重？健康和社會(huì)條件：UserManualComplianceIEC762366checklistClause條款Requirement要求Remark解釋Verdict判定-intendedpartofthebodyo

10、rtypeoftissueappliedtoorinteractedwith;預(yù)期使用的身體部位或組織；UserManualCompliance-intendedconditionsofuse?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(dòng)性；UserManualComplianceoperatingprinciple(s)操作原理UserManualComplianceFrequentlyusedfunctions/常用功育gA

11、refrequentlyusedfunctionsthatinvolveUSERinteractionwiththeMEDICALDEVICEaredeterminedandrecordedintheUSABILITYENGINEERINGFILE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UserManualComplianceIdentificationofHAZARDSandHAZARDOUSSITUATIONSrelatedtoUSABILITY/iR另5.3.1Idntif可用性相尖尖的危害和危害處境只另安全特征IEC762366checklistClause條

12、款Requirement要求Remark解釋Verdict判定IdentificationofcharacteristicsrelatedtoSAFETY(partofaRISKANALYSIS)thatfocusesonUSABILITYperformedaccordingtoISO14971:2007,.應(yīng)按ISO14971:2007的要求識(shí)別專注于可用性的安全特征RiskanalysisreportComplianceDuringtheidentificationcharacteristicsrelatedtoSAFETY,thefollowingareconsidered:在識(shí)另f安全

13、特征日寸，要考慮下列因素：?applicationspecification,includingUSERPROFILE(S);and應(yīng)用的規(guī)格包括用戶特征；Afrequentlyusedfunctions-常用功育EUserManualComplianceResultsofthisidentificationcharacteristicsrelatedtoSAFETYrecordedintheUSABILITYENGINEERINGFILE安全待征識(shí)別的結(jié)果應(yīng)記錄于可用性工程文檔UserManualCompliance5.3.2Identificationofknownorforeseeabl

14、eHAZARDSandHAZARDOUSSITUATIONS/識(shí)另已知的或可預(yù)見的危害和危害處境IEC762366checklistClause條款Requirement要求Remark解釋Verdict判定MANUFACTURERhasidentifiedknownorforeseeableHAZARDS(partofaRISKANALYSIS)relatedtoUSABILITYaccordingtoISO14971:2007,.制造商要按ISO14971:2007的要求識(shí)別可用性相尖的已知的或可預(yù)見的危害RiskreportanalysisComplianceIdentification

15、ofHAZARDSconsideredHAZARDStoPATIENTS,USERSandotherpersons識(shí)別危害時(shí)要考慮對(duì)患考？操作者和其他人員的危害RiskanalysisreportComplianceReasonablyforeseeablesequencesorcombinationsofevent,involvingtheUSERINTERFACEthatcanresultinaHAZARDOUSSITUATIONassociatedwiththeMEDICALDEVICEwereidentified.TheSEVERITYoftheresultingpossibleHAR

16、Misdetermined.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(shí)別。導(dǎo)致的可能的危害的嚴(yán)重程度己確定RiskanalysisreportsComplianceIEC762366checklistClauseRequirementRemarkVerdict條款要求解釋判定Page10of19DuringtheidentificationofHAZARDSandHAZARDOUSSITUATIONS,thefollowingwasconsidered:在識(shí)另lj危害和危害處境時(shí)，下列需要考慮：-applicationspecification,includi

17、ngUSERROFILE(S);應(yīng)用的規(guī)格，包括用戶待征；-taskrelatedrequirements任務(wù)相矢的要求；-contextofuse;使用的背景；-informationonHAZARDSandHAZARDOUSSITUATIONSknownforexistingUSERINTERFACESofMEDICALDEVICESofasimilartype,ifavailable:對(duì)于現(xiàn)存的類似的醫(yī)療器械用戶界面的己知的危害和危害處境信息；?preliminaryUSESCENARIOS;初步的使用t冃盡；-possibleUSEERRORS:可能的使用錯(cuò)誤；-ifanincorre

18、ctmentalmodeloftheoperationoftheMEDICALDEVICEcancauseaUSEERRORresultinginaHAZARDOUSSITUATION;and操作醫(yī)療器械的錯(cuò)誤精神模型是否會(huì)引起導(dǎo)致危害處境的使用錯(cuò)誤；-resultsofthereviewoftheUSERINTERFACE用戶界面的評(píng)審結(jié)果。RiskanalysisreportUserManualComplianceIEC762366checklistClause條款Requirement要求Remark解釋Verdict判定TheresultsofthisidentificationofH

19、AZARDS,HAZARDOUSSITUATIONSandSEVERITYarerecordedintheUSABILITYENGINEERINGFILE.識(shí)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。RiskanalysisreportCompliancePrimaryoperatingfunctiOjNs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。UserManual

20、ComplianceTheinputstothePRIMARYOPERATINGFUNCTIONSincludefrequentlyusedfunctionsandfunctionsrelatedtoSAFETY)ftheMEDICALDEVICE主要操作功能的輸入包括常用功能和尖系醫(yī)療器械安全的功能。UserManualComplianceUsabilitySpecification可用性規(guī)范MANUFACTURERdevelopedaUSABILITYSPECIFICATIONrecordedintheUSABILITYENGINEERINGFILEaspartoftheUSABILITY

21、ENGINEERINGPROCESS制造商應(yīng)制定可用T生規(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,proceduredocumentComplianceIEC762366checklistClause條款Requirement要求Remark解釋Verdict判定TheUSABILITYSPECIFICATIONrecordedinUSABILITYENGINEERINGFILE.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

22、整合于其它規(guī)范。Qualitymanual,proceduredocumentComplianceTheUSABILITYSPECIFICATIONincludes:可用T生規(guī)范包括：applicationspecification應(yīng)用白勺規(guī)格；-PRIMARYOPERATINGFUNCTIONS主要操作功能-HAZARDSandHAZARDOUSSITUATIONSrelatedtotheUSABILITY:and尖系可用性的危害和危害處境?knownorforeseeableUSEERRORSassociatedwiththeMEDICALDEVICE已知的或可預(yù)見的矢系醫(yī)療器械的使用錯(cuò)誤

23、。UserManualRiskanalysisreportComplianceTheUSABILITYSPECIFICATIONdescribesatleast:口用性規(guī)范至少要描述：IEC762366checklistClause條款Requirement要求Remark解釋Verdict判定-USESCENARIOSrelatedtothePRIMARYOPERATINGFUNCTIONS,including尖于主要操作功能的使用情景，包括：?frequentUseSeenarios,and常見的使用情景?reasonablyforeseeableworstcaseUseScenarios

24、合理可預(yù)見的最壞使用情景；UserManualRiskanalysisreportComplianceuUSERINTERFACErequirementsforthePRIMARYOPERATINGFUNCTIONS,includingthosetomitigateRISK;主要操作功能對(duì)于用戶界面的要求，包括降低風(fēng)險(xiǎn)的那些；RiskanalysisreportCompliance?RequirementsfordetenniningwhetherPRIMARYOPERATINGFUNCTIONSareeasilyrecognizablebytheUSER?用于決定主要操作功能是否易于被用戶認(rèn)

25、知的要求RiskanalysisreportComplianceUsabilityvalidation屮“可用f生確認(rèn)計(jì)戈ijTheMANUFACTURERhasdevelopedandmaintainsaUSABILITYVALIDATIONplanspecifying:制造商需制定并維護(hù)可用性確認(rèn)計(jì)劃，以規(guī)定：UserManualComplianceIEC762366checklistClause條款Requirement要求Remark解釋Verdict判定anymethodusedforVALIDATIONoftheUSABILITYofthePRIMARYOPERATINGFUNCT

26、IONS;對(duì)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(duì)主要操作功能可用性的確認(rèn)標(biāo)準(zhǔn)UserManualCompliance-theinvolvementofrepresentativeintendedUSERS包含的預(yù)期用戶代表UserManualComplianceUSABILITYVALIDAT

27、IONperformedinalaboratorysettingTestreport?Compliance03Rd丁d丄1-A/-THA、口？USABILITYVALIDATIONperformedinasimulateduseenvironmentTestreportCompliance=TE上丄T%上I/十丄H4、/士匚口丁才丄七？USABILITYVALIDATIONperformedintheactualuseenvironmentTestreportCompliance=r匚匸rgrzsi宀十？十7*口qt-廠丄比IEC762366checklistClause條款Requireme

28、nt要求Remark解釋Verdict判定UserManualComplianceTheUSABILITYVALIDATIONplanaddresses:可用性確認(rèn)計(jì)劃包括：?fiequentUseSeenarios,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(shí)別。TheUSABILITYVALIDATIONplanrecordedintheUSABILITYENGINEERINGFILE可用性確認(rèn)計(jì)

29、劃應(yīng)記錄與可用性工程文檔。UserManualComplianceUSERINTERFACEdesignandimplementation/用戶界面設(shè)j十禾口頭施MANUFACTURERdesignedandimplementedtheUSERINTERFACEasdescribedintheUSABILITYSPECIFICATIONutilizing,asappropriate,USABILITYENGINEERINGmethodsandtechniques希0造商應(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)范描述的用戶界面。Productsdonothavethisrequireme

30、ntnoncomplianceUsabilityverification/可用性驗(yàn)證IEC762366checklistClause條款Requirement要求Remark解釋Verdict判定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(jì)的實(shí)施。ProductsdonothavethisrequirementnoncomplianceTheresultsoftheveri

31、ficationarerecordedinUSABILITYENGINEERINGFILE驗(yàn)證的結(jié)果應(yīng)記錄于可用性工程文檔。ProductsdonothavethisrequirementnoncomplianceUsabilityValidation可用性確認(rèn)TheMANUFACTURERhasvalidatedtheUSABILITYoftheMEDICALDEVICEaccordingtotheUSABILITYVALIDATIONplan制造商應(yīng)根據(jù)可用性確認(rèn)計(jì)劃來確認(rèn)醫(yī)療器械用戶界面的可用性。ProductsdonothavethisrequirementnoncomplianceT

32、heresultsarerecordedintheUSABILITYENGINEERINGFILE確認(rèn)的結(jié)果應(yīng)記錄于可用性工程文檔。ProductsdonothavethisrequirementnoncomplianceIEC762366checklistClause條款Requirement要求Remark解釋Verdict判定FortheacceptaneecriteriadocumentedintheUSABILITYVALIDATIONplanthatarenotmet:對(duì)于沒有可用f生確認(rèn)計(jì)劃中制定的未被滿足的接收準(zhǔn)則：-furtherUSERINTERFACEdesignandi

33、mplementationactivitiesareperformed;or需要進(jìn)仃進(jìn)一步的用戶界面設(shè)計(jì)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(píng)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(xiǎn)。Toperformt

34、hisstep,theMANUFACTURERneedstoestimatetheRISKarisingfromUSABILITYproblems?為此，制造商需評(píng)估可用性問題帶來的風(fēng)險(xiǎn)oProductsdonothavethisrequirementnoncompliance6ACCOMPANYINGDO（取JIMS/隨機(jī)文件IEC762366checklistClause條款Requirement要求Remark解釋Verdict判定TheACCOMPANYINGDOCUMENTineludesasummaryoftheMEDICALDEVICEapplicationspecificati

35、on隨彳兀文件應(yīng)包括醫(yī)療器械應(yīng)用的規(guī)格的總結(jié)。UserManualComplianceAconcisedescriptionoftheMEDICALDEVICE,itsoperatingprinciples,significantphysicalandperformaneecharacteristicsandintendedUSERPROFILEareincludedintheACCOMPANYINGDOCUMENT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(jiǎn)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,optionally,prov