EN62366-2008醫(yī)療器械可用性工程評估報告材料

標(biāo)準(zhǔn)實用EN62366:2008 Checklist/ 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 審批人文案大全標(biāo)準(zhǔn)實用4GENERALREQUIREMENTS/總要求4.1GeneralRequirements/總要求4.1.1USABILITYNGINEERINGPROCESSE/可用性工程過程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?DoesthePROCESSaddressUSERINTERActionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENTincluding,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？AreRRISKSassociatedwithUSABILITYofESIDUALtheMEDICALDEVICEpresumedtobeacceptable,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？MANUFACTURERSHALLsubjecttheinformationforsafetyusedasaRISKCONTROLtotheUSABILITYENGINEERINGPROCESS(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

UserManual; ComplianceQualitymanual,proceduredocument;UserManual ComplianceRiskanalysisreport; ComplianceRiskanalysisreport; ComplianceUserManual;文案大全標(biāo)準(zhǔn)實用DisregardingsuchinformationforSAFETYisconsideredbeyondanyfurtherreasonablemeansofRISKCONTROL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）4.2Theresultsofthe USABILITYENGINEERINGPROCESSarerecordedinthe USABILITYENGINEERINGFILE可用性工程過程的結(jié)果記錄于可用性工程文檔。TherecordsandotherdocumentsthatmakeuptheUSABILITYENGINEERINGFILEMAYformpartofotherdocumentsandfiles(e.g.,aMANUFACTURER’Sproductdesignfileor RISKMANAGEMENTFILE),(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

RiskanalysisreportQualitymanual,proceduredocument;Qualitymanual,proceduredocument

ComplianceComplianceCompliance4.3ScalingoftheUSABILITYENGINEERINGeffort/可用性工程的調(diào)整TheUSABILITYENGINEERINGPROCESSisscaledbasedRiskanalysisreportonthesignificanceofanymodificationsdependingontheresultsoftheRISKANALYSISanddocumented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

Compliance5USABILTYENGINEERINGPROCESS/可用性工程過程5.1Applicationspecification/應(yīng)用的規(guī)格文案大全標(biāo)準(zhǔn)實用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??；–intendedPATIENTpopulation(e.g.,age,weight,health,condition);預(yù)期患者群，如年齡、體重、健康和社會條件；–intendedpartofthebodyortypeoftissueappliedtoorinteractedwith;預(yù)期使用的身體部位或組織；–intendedconditionsofuse(e.g..environmentincludinghygienicrequirements,frequencyofuse,location,mobility); and

-UserManualUserManualUserManualUserManual

-ComplianceComplianceComplianceCompliance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；–operatingprinciple(s)UserManualCompliance操作原理5.2Frequentlyusedfunctions/常用功能ArefrequentlyusedfunctionsthatinvolveUSERUserManualComplianceinteractionwiththeMEDICALDEVICEaredeterminedandrecordedintheUSABILITYENGINEERINGFILE?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？5.3IdentificationofHAZARDSandHAZARDOUSSITUATIONSrelatedtoUSABILITY/識別可用性相關(guān)的危害和危害處境5.3.1Identificationofcharacteristicsto/識別安全特征SAFETY文案大全標(biāo)準(zhǔn)實用IdentificationofcharacteristicsrelatedtoSAFETYRiskanalysisreportCompliance(partofaRISKANALYSIS)thatfocusesonUSABILITYperformedaccordingtoISO14971:2007,4.2.應(yīng)按ISO14971:2007,4.2的要求識別專注于可用性的安全特征DuringtheidentificationcharacteristicsrelatedUserManualComplianceto,thefollowingareconsidered:SAFETY在識別安全特征時，要考慮下列因素：–applicationspecification,includingUSERPROFILES);and(應(yīng)用的規(guī)格，包括用戶特征；–frequentlyusedfunctions.常用功能。ResultsofthisidentificationcharacteristicsUserManualCompliancerelatedtoSAFETYrecordedintheUSABILITYENGINEERINGFILE安全特征識別的結(jié)果應(yīng)記錄于可用性工程文檔5.3.2IdentificationofknownorforeseeableHAZARDSandHAZARDOUSSITUATIONS/識別已知的或可預(yù)見的危害和危害處境MANUFACTURERhasidentifiedknownorRiskanalysisreportComplianceforeseeableHAZARDS(partofaRISKANALYSIS)relatedtoUSABILITYaccordingtoISO14971:2007,4.3.制造商要按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IdentificationofHAZARDSconsideredHAZARDStoRiskanalysisreportCompliancePATIENTS,USERSandotherpersons識別危害時要考慮對患者、操作者和其他人員的危害文案大全標(biāo)準(zhǔn)實用Reasonablyforeseeablesequencesorcombinationsofeventsinvolvingthe USERINTERFACEthatcanresultina HAZARDOUSSITUATION associatedwiththe MEDICALDEVICEwereidentified.The SEVERITYoftheresultingpossible HARMisdetermined.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。Duringtheidentificationof HAZARDSandHAZARDOUSSITUATIONS ,thefollowingwasconsidered:在識別危害和危害處境時，下列需要考慮：–applicationspecification,including USERROFILE(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 HAZARDSand HAZARDOUSSITUATIONSknownforexisting USERINTERFACESofMEDICALDEVICESofasimilartype,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；–ifanincorrectmentalmodeloftheoperationofthe MEDICALDEVICE cancauseaUSEERRORresultinginaHAZARDOUSSITUATION;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；–resultsofthereviewofthe USERINTERFACE用戶界面的評審結(jié)果。

Riskanalysisreport ComplianceRiskanalysisreport ComplianceUserManual文案大全標(biāo)準(zhǔn)實用TheresultsofthisidentificationofHAZARDS,RiskanalysisreportComplianceHAZARDOUSSITUATIONS and SEVERITYarerecordedinthe USABILITYENGINEERINGFILE.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。5.4PRIMARYOPERATINGFUNCTIONS/主要操作功能ThemanufacturerhasdeterminedthePRIMARYUserManualComplianceOPERATINGFUNCTIONS andrecordedintheUSABILITYENGINEERINGFILE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。Theinputstothe

PRIMARYOPERATINGFUNCTIONS UserManual ComplianceincludefrequentlyusedfunctionsandfunctionsrelatedtoSoftheMEDICALDEVICEAFETY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。5.5USABILITYS/可用性規(guī)范PECIFICATIONMANUFACTURERdevelopedaUSABILITYSPECIFICATIONQualitymanual,CompliancerecordedintheUSABILITYENGINEERINGFILEaspartproceduredocumentoftheUSABILITYENGINEERINGPROCESS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。TheUSABILITYSPECIFICATIONrecordedinUSABILITYQualitymanual,ComplianceENGINEERINGFILE.TheUSABILITYSPECIFICATIONmayproceduredocumentbeintegratedintootherspecifications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。文案大全標(biāo)準(zhǔn)實用TheUSABILITYSPECIFICATIONincludes:UserManual可用性規(guī)范包括：Riskanalysisreport–applicationspecification;應(yīng)用的規(guī)格；–PRIMARYOPERATINGFUNCTIONS主要操作功能–HAZARDSandHAZARDOUSITUATIONSrelatedtoStheUSABILITY;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。TheUSABILITYSPECIFICATIONdescribesatleast:

Compliance可用性規(guī)范至少要描述：–USESCENARIOSrelatedtothe PRIMARYOPERATINGFUNCTIONS,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；–USERINTERFACErequirementsforthe PRIMARYOPERATINGFUNCTIONS,includingthosetomitigateISK;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；–RequirementsfordeterminingwhetherPRIMARYOPERATINGFUNCTIONS areeasilyrecognizablebytheU SER.用于決定主要操作功能是否易于被用戶認(rèn)知的要求5.6 USABILITYVALIDATIONplan/可用性確認(rèn)計劃

UserManualRiskanalysisreportRiskanalysisreportRiskanalysisreport

ComplianceComplianceCompliance文案大全標(biāo)準(zhǔn)實用TheMANUFACTURERhasdevelopedandmaintainsUserManualComplianceaUSABILITYVALIDATIONplanspecifying:制造商需制定并維護(hù)可用性確認(rèn)計劃，以規(guī)定：–anymethodusedforVALIDATIONoftheUserManualComplianceUSABILITYofthePRIMARYOPERATINGFUNCTIONS;對于主要操作功能的可用性的確認(rèn)方法；–thecriteriafordeterminingsuccessfulUserManualComplianceVALIDATIONoftheUSABILITYofthePRIMARYOPERATINGFUNCTIONSbasedontheUSABILITYSPECIFICATION;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)–theinvolvementofrepresentativeintendedUserManualComplianceUSERS包含的預(yù)期用戶代表USABILITYVALIDATIONperformedinalaboratoryTestreport.Compliancesetting...................................................................................:可用性確認(rèn)實施的實驗室設(shè)置：USABILITYVALIDATIONperformedinasimulatedTestreportComplianceuseenvironment..............................................................:可用性確認(rèn)實施于模擬使用環(huán)境：USABILITYVALIDATIONperformedintheactualuseTestreportComplianceenvironment.......................................................................:可用性確認(rèn)實施于真實使用環(huán)境：TheUSABILITYVALIDATIONplanaddresses:UserManualCompliance可用性確認(rèn)計劃包括：–frequentUseScenarios,and常見的使用情景；–reasonablyforeseeableworstcase USESCENARIOS合理可預(yù)見的最壞使用情景thatareidentifiedinthe USABILITYSPECIFICATION都要在可用性規(guī)范中識別。文案大全標(biāo)準(zhǔn)實用TheUSABILITYVALIDATION planrecordedinthe UserManual ComplianceUSABILITYENGINEERINGFILE可用性確認(rèn)計劃應(yīng)記錄與可用性工程文檔。5.7 USERINTERFACEdesignandimplementation/ 用戶界面設(shè)計和實施MANUFACTURERdesignedandimplementedthe Productsdonothave non-USERINTERFACEasdescribedinthe USABILITY thisrequirement complianceSPECIFICATIONutilizing,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)范描述的用戶界面。5.8USABILITYVERIFICATION/可用性驗證MANUFACTURERverifiedtheimplementationofProductsdonothavenon-theMEDICALDEVICEUSERINTERFACEdesignthisrequirementcomplianceaccordingtotheUSABILITYSPECIFICATION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。TheresultsoftheverificationarerecordedinProductsdonothavenon-USABILITYENGINEERINGFILEthisrequirementcompliance驗證的結(jié)果應(yīng)記錄于可用性工程文檔。5.9USABILITYVALIDATION/可用性確認(rèn)TheMANUFACTURERhasvalidatedtheUSABILITYofProductsdonothavenon-theMEDICALDEVICEaccordingtotheUSABILITYthisrequirementcomplianceVALIDATIONplan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。Theresultsarerecordedinthe USABILITYENGINEERINGFILE

Productsdonothave non-thisrequirement compliance確認(rèn)的結(jié)果應(yīng)記錄于可用性工程文檔。文案大全標(biāo)準(zhǔn)實用FortheacceptancecriteriadocumentedintheUSABILITYVALIDATION planthatarenotmet:對于沒有可用性確認(rèn)計劃中制定的未被滿足的接收準(zhǔn)則：-furtherU SERINTERFACEdesignandimplementationactivitiesareperformed;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，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。6ACCOMPANYINGDOCUMENTS/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)。AconcisedescriptionoftheMEDICALDEVICE,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。

Productsdonothavenon-thisrequirementcomplianceUserManual ComplianceUserManual Compliance文案大全標(biāo)準(zhǔn)實用TheACCOMPANYINGDOCUMENTiswrittenatalevelUserManualComplianceconsistentwiththe