CE可用性工程評估報告EN精選

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俅4.1GeneralRequirements/總要求4.1.1UsabilityENgineerinGRoceIsM用性工程過程HastheMANUFACTURERstablis

2、hed,documentedandmaintainedausabilityengineeringprocessprovideSAFETYforthepatientusERandothersrelatedtousabilityfortheproduct?制造商是否建立、記錄并維持了一個可用性工程過程，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;ComplianceDoesthePROCESsaddressuseriNTERActionswiththemedicalDEViCEaccordingtotheac

3、companyingDOCuMncluding,butnotlimitedtotransport,storage,installation,operation,maintenance,repairanddisposal?該過程是否用丁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、維修和廢弁？UserManualCompliance4.1.2AreResidualrisksassociatedwithUsabilityofthemedicalDevicepresumedtobeacceptable,unlessthereisobjectiveevidence。thecont

4、raryanddocumented?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;Compliance4.1.3manufacturerSHAsmbjecttheinformationforsafetyusedasariskcontroLotheUSABILITYENGINEERINGPROCESS.g.,warningsorlimitationofuseintheaccompanyingDOCUMENTSking,etc.）.對丁做為風(fēng)險控制措施的安全信息，制造冏應(yīng)把它納入可用性工程過程的控制Riskanalysisreport;UserManual;Co

5、mplianceDisregardingsuchinformationforsafetyisconsideredbeyondanyfurtherreasonablemeansofriskcontrol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）RiskanalysisreportCompliance4.2TheresultsoftheusabilityengineeringPROCESsrerecordedintheusabilityENGINEERINGFILE可用性工程過程的結(jié)果記錄丁可'用性工程文檔。Qualitymanual,proceduredocument

6、;ComplianceTherecordsandotherdocumentsthatmakeuptheusabilityengineeringfilemayformpartofotherdocumentsandfiles(e.g.,amanufacturersproductdesignfileorriskmanagementfi),e(seeListofdocumentsmakeuptheUEfile)組成可用性工程文檔的記錄和其它文件可以是其匕文檔(如技術(shù)文檔和風(fēng)險菅理文檔)的'部分Qualitymanual,proceduredocumentCompliance4.3Scaling

7、oftheUsabilityENGiNEERiNGffort/可用性工程的調(diào)整TheUSABILITYENGINEERINGPROCEiSSScaledbasedonthesignificanceofanymodificationsdependingontheresultsoftheriskANALYSISanddocumented可用性工程調(diào)整取決丁風(fēng)險分析確認(rèn)的設(shè)計更改的重要程度RiskanalysisreportCompliance5USABILTYENGINEERINGPROCESS/!工程過程5.1Applicationspecification/應(yīng)用的規(guī)格Applicationof

8、MedicalDEViCEintheusabilityengineeringfilEsspecifiedbytheMANUFACTURandincludes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、治療、診斷或預(yù)防的狀態(tài)或疾?。籙serManualCompliance-intendedpatientpopulation(e.g.,a

9、ge,weight,health,condition);預(yù)期患者群，如年齡、體重、健康和社會條件；UserManualCompliance-intendedpartofthebodyortypeoftissueappliedtoorinteractedwith;預(yù)期使用的身體部位或組織；UserManualCompliance-intendedconditionsofuse(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、地點和機動性

10、；UserManualCompliance-operatingprinciple(s)操作原理UserManualCompliance5.2Frequentlyusedfunctions/常用功能ArefrequentlyusedfunctionsthatinvolveUSERinteractionwiththeMEdicalDevicearedeterminedandrecordedintheusabilityengineeringfil?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？UserManualCompliance5.3IdentificationofHAZA

11、RDandHAZARDOUSiTUATiON$elatedtoUSABILITY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(partofariskanalysisthatfocusesonusabilityperformedaccordingtoISO14971:2007,4.2.應(yīng)按ISO14971:2007,4.2的要求識別專注丁可用性的安全特征RiskanalysisreportComplianceDuring

12、theidentificationcharacteristicsrelatedtoSAFETYthefollowingareconsidered:在識別安全特征時，要考慮卜列因素：-applicationspecification,includinguserprofilES);and應(yīng)用的規(guī)格，包括用戶特征；-frequentlyusedfunctions.常用功能。UserManualComplianceResultsofthisidentificationcharacteristicsrelatedtosafetyrecordedintheusabilityengineeringfile安

13、全特征識別的結(jié)果應(yīng)記錄丁可'用性工程文檔UserManualCompliance5.3.2IdentificationofknownorforeseeableHAZARDandhazardousSITUATIONS識別已知的或可預(yù)見的危害和危害處境manufacturersidentifiedknownorforeseeableHAZARDSpartofariskanalysisrelatedtousabilityaccordingtoISO14971:2007,4.3.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Riskanalysisrep

14、ortComplianceIdentificationofHAZARDconsideredHAZARDtopatientsusERandotherpersons識別危害時要考慮對患者、操作者和其他人員的危害RiskanalysisreportComplianceReasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheuserINTERFACEthatcanresultinaHAZARDOUSSITUATIONassociatedwiththeMEDICALDEVICEwereidentified.TheSEVERITYof

15、theresultingpossibleHARMisdetermined.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。RiskanalysisreportComplianceComplianceDuringtheidentificationofHAZARDSRiskanalysisandHAZARDOUSSITUATIONS,thereportfollowingwasconsidered:UserManual在識別危害和危害處境時，下列需要考慮：-applicationspecification,includinguserr

16、ofile(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;對丁現(xiàn)存的類似的醫(yī)療器械用戶界面的已知TheresultsofthisidentificationofHAZARDS,HAZARDOUSSITUATIONSandSEVERITYarerecordedintheUSABIL

17、ITYENGINEERINGFILE.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!?操作功能ThemanufacturerhasdeterminedtheprimaryoperatingFUNCTiondrecordedintheUSABILITYENGINEERINGFILE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。UserManualComplianceTheinputstotheprimaryoperatingFUNCTiONSncludefreq

18、uentlyusedfunctionsandfunctionsrelatedtoSAFETYOftheMEDICALDEVICE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MANUFACTURdevelopedausabilitySPECiFiCATiONrecordedintheusabilityENGINEERINGFILEispartoftheUSABILITYENGINEERINGPROCESS制造冏應(yīng)制正可用性規(guī)氾，記錄M用性工程文檔里作為可用性工程過程的F分。Qualit

19、ymanual,proceduredocumentComplianceTheusabilitysPECiFiCATiONrecordedinUSABILITYENGINEERINGFILETheUSABILITYSPECiFiCATiONmaybeintegratedintootherspecifications可用性規(guī)范記錄于可用性工程文檔里?？捎眯砸?guī)范可以整合丁其它規(guī)范。Qualitymanual,proceduredocumentComplianceTheUSABILITYSPECIFICATIONncludeS：UserManualComplianceRiskanalysisrepor

20、t可用性規(guī)范包括：-applicationspecification;應(yīng)用的規(guī)格；PRIMARYOPERATINGFUNCTIONS主要操作功能-HAZARDSandHAZARDOUSITUATIONSrelatedtotheUsability；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。TheusabilitysPECiFiCATiordescribesatleast:可用性規(guī)范至少要描述：usescENARioselatedtotheprimary

21、OPERATINGFUNCTIONSncluding關(guān)丁主要操作功能的使用寸青景，包括：-frequentUseScenarios,and常見的使用情景-reasonablyforeseeableworstcaseUSEScenarios合理可預(yù)見的最壞使用It景；UserManualRiskanalysisreportCompliance-UserINTERFACEequirementsfortheprimaryoperatingFUNCT,OncludingthosetomitigateRisk；主要操作功能對丁用戶界面的要求，包括降低風(fēng)險的那些；RiskanalysisreportCom

22、pliance-RequirementsfordeterminingwhetherprimaryoperatingfunctionseasilyrecognizablebytheUser用丁決定主要操作功能是否易丁被用戶認(rèn)知的要求RiskanalysisreportCompliance5.6Usabilityvalidationplan/可用性確認(rèn)計劃TheMANUFACTURhasdevelopedandmaintainsausabilityVALiDATiONplanspecifying:制造商需制定并維護可用性確認(rèn)計劃，以規(guī)UserManualCompliance-anymethodus

23、edforVALiDATiONoftheUSABILITYofthePRIMARYOPERATINGFUNCT；ON對丁主要操作功能的可用性的確認(rèn)方法；UserManualSCompliance-thecriteriafordeterminingsuccessfulVALIDATIONoftheUSABILITYoftheprimaryoperatingFUNCTIbasedontheUSABILITYSPECIFICATIONand基丁可用性規(guī)范，對主要操作功能可用性的確認(rèn)標(biāo)準(zhǔn)UserManualCompliance-theinvolvementofrepresentativeintende

24、dusers包含的預(yù)期用戶代表UserManualComplianceusabilityVALiDATiONperformedinalaboratorysettingTestreport.Compliance可用性確認(rèn)實施的實驗室設(shè)置：usabilityVALiDATiONperformedinasimulateduseenvironmentTestreportCompliance可用性確認(rèn)實施丁模擬使用環(huán)境：usabilityVALiDATiONperformedintheactualuseenvironmentTestreportCompliance可用性確認(rèn)實施丁真實使用環(huán)境：Theus

25、abilityVALiDATiONplanaddresses: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It景thatareidentifiedintheusabilitySPECIFICATION都要在可用性規(guī)范中識別。UserManualComplianceTheusabilityVALiDATiorplanrecordedintheUSABILITYENGINEERINGFILE可用性確認(rèn)計劃應(yīng)記錄與可用性工程文檔。UserManualCo

26、mpliance5.7UseriNTERFACdesignandimplementation/用戶界面設(shè)計和實施MNUFACTURdesignedandimplementedtheusERiNTERFAcasdescribedintheUSABILITYSPECIFICATIONutilizing,asappropriate,usabilityENGINEERINmethodsandtechniques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。Productsdonothavethisrequirementnon-compliance5.8Usabilityver

27、ification/可用性驗證MANUFACTUREverifiedtheimplementationoftheMedicalDeviceuseriNTERFACdesignaccordingtotheusabilityspecification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。Productsdonothavethisrequirementnon-complianceTheresultsoftheverificationarerecordedinusabilityengineeringfile驗證的結(jié)果應(yīng)記錄于可用性工程文檔。Productsdonothavethisr

28、equirementnon-compliance5.9UsabilityValidation可用性確認(rèn)TheMANUFACTURhasvalidatedtheUsabilityoftheMEdicalDeviceaccordingtotheusabilityVALiDATiONplan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。Productsdonothavethisrequirementnon-complianceTheresultsarerecordedintheusabilityengineeringfile確認(rèn)的結(jié)果應(yīng)記錄于可用性工程文檔。Productsdonotha

29、vethisrequirementnon-complianceProductsdonothavethisrequirementnon-complianceFortheacceptancecriteriadocumentedintheusabilityVALiDATiONplanthatarenotmet:對丁沒有可用性確認(rèn)計劃中制定的未被滿足的接收準(zhǔn)則：-furtherUserINTERFACdesignandimplementationactivitiesareperformed;or需要進行進一步的用戶界面設(shè)計和執(zhí)行；或-iffurtherimprovementisnotpracticab

30、le,theMANUFACTURERmaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheINTENDEDUSEoutweightheRISKarisingfromUSABILITYproblems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(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,theMANUFACTURERneedstoestimatetheRISKarising6ACCOMPANYINGDOCUMENTS/件TheAccompanyingD

31、OCuMENludesasummaryoftheMedicalDeviceapplicationspecification隨機文件應(yīng)包括醫(yī)療器械應(yīng)用的規(guī)格的總結(jié)。UserManualComplianceAconcisedescriptionoftheMedicalDeviceitsoperatingprinciples,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(yù)期用戶的特征的簡要描述。UserManualComplianceTheAccompanyingDOCuMEwrittenatalevelconsistentwiththeintendedoperatorprofile隨機文件的編寫要與用戶特征的水平相一致。UserManualComplianceTheAccompa