中英文-可用性評(píng)價(jià)報(bào)告-評(píng)價(jià)標(biāo)準(zhǔn)

PagePage#of10產(chǎn)品名可用性評(píng)價(jià)報(bào)告文件編號(hào)：編制:采用標(biāo)準(zhǔn)：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6MedicalelectricalequipmentPart1—^:Generalrequirementsforsafety-CollateralStandard:UsabilityEN62366MedicaldevicesApplicationofusabilityengineeringtomedicaldevicesReportRefereneeNo。TOC\o"1-5"\h\zCompiledby(+signature):Approvedby(+signature):Dateofissue:CompanynameAddress:Testspecification:Standard:EN60601-1—6:2010,EN623662008TestitemdescriptionTOC\o"1-5"\h\zTradeMarkManufacturer:Model/TyperefereneeRatingsPossibletestcaseverdicts:-testcasedoesnotapplytothetestobject:N/A-testobjectdoesmeettherequirement:Pass(P)-testobjectdoesnotmeettherequirement:Fail(F)TestResult:Passed

產(chǎn)品名可用性評(píng)價(jià)報(bào)告文件編號(hào)：JKH-編制:采用標(biāo)準(zhǔn)：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdict4Generalrequirements總要求4。1ConditionsforapplicationtoMEEQUIPMENTME設(shè)備應(yīng)用條件TheMEEQUIPMENTshallprovideadequateUSABILITYsuchthattheRISKSresultingfromNORMALUSEandUSEERRORareacceptable^Seealso7.1。1and12.2ofthegeneralstandarc。ME設(shè)備應(yīng)提供充分的可用性^吏得由于正常使用和使用錯(cuò)誤導(dǎo)致的風(fēng)險(xiǎn)是可以接受的?參見(jiàn)通用標(biāo)準(zhǔn)的7。1。1和12.2。4.2USABILITYENGINEERINGPROCESSforMEEQUIPMENTME設(shè)備的可用性工程程序AUSABILITYENGINEERINGPROCESScomplyingwithIEC62366shallbeperformed可用性工程程序按照IEC62366執(zhí)行?！猠stablishedaUSABILITYENGINEERINGPROCESS建立一個(gè)可用性工程程序；—establishedacceptaneecriteriaforUSABILITYand建立可用性驗(yàn)收標(biāo)準(zhǔn)；和demonstratedthattheacceptaneecriteriaforUSABILITYhavebeenmet。證明可用性已達(dá)到驗(yàn)收標(biāo)準(zhǔn)。4。3REPLACEMENTOFREQUIREMENTSGIVENINIEC62366IEC62366中的代替要求InadditiontorequirementsofIEC62366thefollowingreplacementsshallapply:ReplacethefirsttwoparagraphsincludingNOTES1and2ofClause6ofIEC623662007by:適用IEC62366除了以下的要求更換：將IEC62366:2007第6條款的前兩段包括備注1和2用以下內(nèi)容替換。TheinstructionsforuseshallincludeabriefdescriptionoftheMEEQUIPMENT,itsphysicaloperatingprinciplesandsignificantphysicalandperformaneecharacteristicsrelevantoitsUSABILITY.Thesameinformationshallalsobeincludedinthetechnicaldescription,ifthisisprovidedasaseparatedocument.設(shè)備的簡(jiǎn)要描述，運(yùn)行原理、與可用性相關(guān)的重要物理特性和性能應(yīng)包含在使用說(shuō)明書(shū)中。如果技術(shù)說(shuō)明書(shū)單獨(dú)提供，則相冋的信息也應(yīng)包含在技術(shù)說(shuō)明書(shū)中。tTheinstructionsforuseshallcontainasummaryoftheapplicationspecification使用說(shuō)明應(yīng)包含一個(gè)應(yīng)用規(guī)范的總結(jié)。EN62366

產(chǎn)品名可用性評(píng)價(jià)報(bào)告文件編號(hào)：JKH-編制:采用標(biāo)準(zhǔn)：EN60601-1-6:2010,EN62366:2008審核：ClauseRequirement+TestResult—RemarkVerdict4GENERALREQUIREMENTS總要求4。1GeneralRequirements總要求4。1.1UsabilityEngineeringProcess可用性工程過(guò)程TheMANUFACTURERshallestablishdocumentandmaintainaUSABILITYENGINEERINGPROCESStoprovideSAFETYforthePATIENT，USERandothersrelatedtoUSABILITY。ThePROCESSshalladdressUSERinteractionswiththeMEDICALDEVICEaccordingtotheACCOMPANYINGDOCUMENT,including,butnotlimitedto:—transport;-storage；—installation；—operation;—maintenanceandrepair;and-disposal.制造商應(yīng)建立、形成文件和保持可用性工程過(guò)程，以便為患者、用戶和其他與可用性有關(guān)的人員提供安全性?該過(guò)程應(yīng)按照隨附文件描述用戶和醫(yī)療器械的交互，隨附文件包括（但不限于）:運(yùn)輸；儲(chǔ)存；安裝；操作；維護(hù)和維修；處置。4。1。2Residualrisk剩余風(fēng)險(xiǎn)IftheusabilityengineeringprocessdetailedinthisInternationalStandardhasbeencompliedwithandtheacceptaneecriteriadocumentedintheusabilityvalqatqnplanhavebeenmet（see5。9）,then,forthepurposesofISO14971，theresidualrisksassociatedwithusabilityofthemedicaldeviceshallbepresumedtobeacceptable，unlessthereisobjectiveevidencetothecontrary.如果遵守了本標(biāo)準(zhǔn)中詳細(xì)規(guī)定的可用性工程過(guò)程和滿足了可用性確認(rèn)計(jì)劃中形成文件的可接受準(zhǔn)則（見(jiàn)5.9）,則對(duì)ISO14971來(lái)說(shuō)，與醫(yī)療器械的可用性有關(guān)的剩余風(fēng)險(xiǎn)應(yīng)認(rèn)為是可接受的，除非有相反的客觀證據(jù)。4。1.3InformationforSAfety安全性信息IfinformationforSAFETYisusedasaRISKCONTROLmeasure，theMANUFACTURERshallsubjectthisinformationtotheUSABILITYENGINEERINGPROCESSo如果安全性信息用作風(fēng)險(xiǎn)控制措施，制造商應(yīng)將此信息納入可用性工程過(guò)程。

產(chǎn)品名可用性評(píng)價(jià)報(bào)告文件編號(hào)：JKH-編制:采用標(biāo)準(zhǔn)：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdict4。2UsabilityEngineeringFile可用性工程文擋Theresultsoftheusabilityengineeringprocessshallberecordedintheusabilityengineeringfile。TherecordsandotherdocumentsthatformtheusabltyengneerngFILEmayformpartofotherdocumentsandfiles.可用性工程過(guò)程的結(jié)果應(yīng)記錄在可用性工程文檔中。構(gòu)成可用性工程文擋的記錄和其他文檔可以是其他文件和文檔的一部分。4。3ScalingoftheUsabilityEngineeringeffort用性工程工作范圍界定Theusabilityengineeringprocessmayvaryinformandextentbasedonthenatureofthemedqaldevice，itsintendedUSERanditsintendedUSE(seeD.3.2)。Inthecaseofthemodificationofamedicaldevicedesign,theusabilityengineeringprocessmaybescaleduporscaled-downbasedonthesignificaneeofthemodificationasdeterminedbytheresultsoftheRIsKanalysis(seeD.3.2.2)?？捎眯怨こ踢^(guò)程的形式和程度可根據(jù)醫(yī)療器械種類、其預(yù)期用戶和預(yù)期用途(見(jiàn)D3。2)的不同。對(duì)醫(yī)療器械的設(shè)計(jì)更改，可用性工程過(guò)程可以根據(jù)風(fēng)險(xiǎn)分析結(jié)果(見(jiàn)D3。2。2)所確定的更改的重要性而擴(kuò)大或縮小工作范圍。5usabiltyengineeringprocess用性工程過(guò)程5.1Applicationspecification應(yīng)用規(guī)范ThemanufacturershallspecifytheapplicationoftheMEDICALDEVICEintheUSABILITYENGINEERINGFILE。制造商應(yīng)在可用性工程文檔中規(guī)定醫(yī)療器械的應(yīng)用。Thisspecificationshallinclude:一*intendedmedicalindication；一intendedPATIENTpopulation；一intendedpartofthebodyortypeoftissueappliedtoorinteractedwith；-*intendedUSERPROFILE；一*intendedconditionsofuse;and一*operatingprinciple。此規(guī)范應(yīng)包括：-*預(yù)期的醫(yī)療適應(yīng)癥；—所應(yīng)用的或與之交互的預(yù)期的身體部分或組織類型；預(yù)期的用戶特征；預(yù)期的使用條件；—*操作原則.

產(chǎn)品名可用性評(píng)價(jià)報(bào)告文件編號(hào)：JKH-編制:采用標(biāo)準(zhǔn)：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdict5。2Frequentlyusedfunctions經(jīng)常使用的功能Themanufacturershalldeterminethefrequentlyusedfunctionsthatinvolveuserinteractionwiththemedicaldeviceandrecordthemintheusabilityengineeringfile。制造商應(yīng)確定涉及醫(yī)療器械用戶接口的經(jīng)常使用的功能，并在可用性工程文檔中形成記錄。5.3IdentificationofHAZARDSandHAZARDOUSSITUATIONSrelatedtoUSABILITY與可用性有關(guān)的危害和危害處境的判定5.3o1IdentificationofcharacteristicsrelatedtoSAFETY與安全性有關(guān)的特征的判定Anidentificationofcharacteristicsrelatedtosafety(partofariskanalysis)thatfocusesonusabilityshallbeperformedaccordingtoISO14971:2007,4。2o應(yīng)按照ISO14971:2007的4.2判定與可用性有關(guān)的安全性特征(風(fēng)險(xiǎn)分析的一部分)。Duringtheidentificationcharacteristicsrelatedtosafety,thefollowingshallbeconsidered:一applicationspecification,includinguserproFile(s)(see5o1);and一frequentlyusedfunctions(see5.2)。TheresultsofthisidentificationcharacteristicsrelatedtosafetyshallberecordedintheusabilityengineeringFILEo在判定安全性特征時(shí)，應(yīng)考慮下列方面：一應(yīng)用規(guī)范,包括用戶特征(見(jiàn)5.1);—經(jīng)常使用的功能(見(jiàn)5。2)o安全性特征的判定結(jié)果應(yīng)記錄在可用性文檔中。5。3.2IdentificationofknownorforeseeableHAZARDSandHAZARDOUSSITUATIONS已知的或可預(yù)見(jiàn)的危害和危害處境的判定Themanufacturershallidentifyknownorforeseeablehazards(partofariskanalysis)relatedtousabilityaccordingtoISO14971:2007,4。3。TheidentificationofhazardsshallconsiderhazardstoPATIENTS，usersandotherpersons(seeAnnexEandAnnexF).制造商應(yīng)按照ISO14971:2007的4。3判定和可用性有關(guān)的己知的或可預(yù)見(jiàn)的危害(風(fēng)險(xiǎn)分析的一部分)。危害的判定應(yīng)考慮對(duì)患者、用戶和其他人員的危害。(見(jiàn)附錄E和附錄F).Reasonablyforeseeablesequencesorcombinationsofeventsinvolvingtheuserinterfacethatcanresultinahazardoussituationassociatedwiththemedicaldeviceshallbeidentified.Theseverityoftheresulting

產(chǎn)品名可用性評(píng)價(jià)報(bào)告文件編號(hào)：JKH-編制:采用標(biāo)準(zhǔn)：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdictpossibleharmshallbedetermined.應(yīng)判定合理可預(yù)見(jiàn)的可導(dǎo)致和醫(yī)療器械有關(guān)的危害處境的事件序列或組合。應(yīng)確定由此引起的可能損害的嚴(yán)重度。Duringtheidentificationofhazardsandhazardoussituations，thefollowingshallbeconsidered:一applicationspecification,includinguserprofile（S）（see5。1）;一卡taskrelatedrequirements;一*contextofuse；一informationonhazardsandhazardoussituationsknownforexistinguserinterfacesofmedicaldevicesofasimilartype,ifavailable；-preliminaryusescenarios；一possibleuseerrors（seeC.2forsomeexamplesofpotentialuseerrors）；一*ifanincorrectmentalmodeloftheoperationofthemedicaldevicecancauseauseerrorresultinginaHAZARDOUSSITUATION；and一*resultsofthereviewoftheusernterface（seeCo4andD。2.2）.在判定危害和危害處境期間，應(yīng)考慮下列各項(xiàng)：—應(yīng)用規(guī)范，包括用戶特征（見(jiàn)5。1）—*與工作有關(guān)的要求-*使用環(huán)境—相似類型醫(yī)療器械的現(xiàn)有用戶接口的己知危害或危險(xiǎn)處境的信息（如果有）—初步使用情景—可能的使用錯(cuò)誤（潛在使用錯(cuò)誤治一些示例見(jiàn)C.2）—*醫(yī)療器械操作的二個(gè)錯(cuò)誤的構(gòu)思模型是否會(huì)引起一個(gè)導(dǎo)致危害處境的使用錯(cuò)誤：—*用戶接口的評(píng)審結(jié)果（見(jiàn)C。4和D.2.2）。Theresultsofthisidentificationofhazards，hazardoussituationsandseverityshallberecordedintheusabilityengineeringfile-危害、危害處境和嚴(yán)重度的判定結(jié)果應(yīng)記錄在可用性工程文檔中。5.4Primaryoperatingfunctions基本操作功能TheMANUFACTURERshalldeterminethePRIMARYoperatingfunctionsandrecordthemintheusabilityENGINEERINGFILE-制造商應(yīng)確定基本操作功能并記錄在可用性工程文襠中。Theinputstotheprimaryoperatingfunctionsshallincludethefollowing：一frequentlyusedfunctions（see5。2）；and一functionsrelatedtosafetyofthemedicaldevice-基本操作功能的輸入應(yīng)包括：—經(jīng)常使用的功能（見(jiàn)5.2）；

產(chǎn)品名可用性評(píng)價(jià)報(bào)告文件編號(hào)：JKH-編制:采用標(biāo)準(zhǔn)：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdict—與醫(yī)療器械安全性有關(guān)的功能.5。5UsabilitySpecification可用性規(guī)范ThemanufacturershalldeveloptheusabilitySPECIFICATION-TheUSABILITYSPECIFICATIONshallprovide：一testablerequirementsforusabilityverification；and一testablerequirementsforusabilityoftheprimaryoperatingfunctionsincludingcriteriafordeterminingtheadequacyofriskcontrolachievedbytheusabilityENGINEERINGPROCESS-制造商應(yīng)編制可用性規(guī)范?？捎眯砸?guī)范應(yīng)提供：-用于可用性驗(yàn)證的可測(cè)試的要求：—對(duì)基本操作功能可用性的可測(cè)試的要求，包括通過(guò)可用性工程過(guò)程達(dá)到的風(fēng)險(xiǎn)控制充分性的判定準(zhǔn)則.可用性規(guī)范應(yīng)記錄在可用性工程文擋中.可用性規(guī)范可整合到其他規(guī)范中。Theinputstotheusabilityspecificationshallincludethefollowing：一applicationspecification（see5。1）;一PRIMARYOPERATINGFUNCTIONS（see5。4）；一hazardsandhazardoussituationsrelatedtousability（see5。3）；and一knownorforeseeableuseerrorsassociatedwiththeMEDICALDEVICE-可用性規(guī)范的輸入應(yīng)包括：一應(yīng)用規(guī)范（見(jiàn)5。1）；-基本操作功能（見(jiàn)5.4）—與可用性有關(guān)的危害和危害處境（見(jiàn)5.3）;-與醫(yī)療器械有關(guān)的己知的或可預(yù)見(jiàn)的使用錯(cuò)誤-Theusabilityspecificationshalldescribeatleast：一usescenariosrelatedtotheprimaryoperatingfunctions,including；-*frequentusescenarios；and一reasonablyforeseeableworstcaseusescenarqs；一userinterfacerequirementsfortheprimaryoperatingfunctions,includingthosetomitigaterisk；一requirementsfordeterminingwhetherprimaryoperatingfunctionsareeasilyrecognizablebytheUSER-可用性規(guī)范至少應(yīng)描述：—與基本操作功能有關(guān)的使用情景，包括：一*經(jīng)常的使用情景；-合理可預(yù)見(jiàn)的最壞的使用情景/方案；-基本操作功能的用戶接口要求，包括降低風(fēng)險(xiǎn)的要求等；

產(chǎn)品名可用性評(píng)價(jià)報(bào)告文件編號(hào)：JKH-編制:采用標(biāo)準(zhǔn)：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdict—決定基本操作功能是否易于被用戶認(rèn)知的要求。5。6USABILITYVALIDATIONplan可用性確認(rèn)計(jì)劃ThemanufacturershallprepareandmaintainaUSABILITYVALIDATIONplan。TheUSABILITYvalidationplanshallspecify:一anymethodusedforvalidationoftheusabilityofthePRIMARYOPERATINGFUNCTIONS；一thecriteriafordeterminingsuccessfulvalqatqnoftheusabilityoftheprimaryoperatingfunctionsbasedontheusabilityspecification；and一theinvolvementofrepresentativeintendedusers.制造商應(yīng)制定和保持可用性確認(rèn)計(jì)劃。可用性確認(rèn)計(jì)劃應(yīng)規(guī)定：—用于基本操作功能可用性確認(rèn)的方法；—決定基于可用性規(guī)范的基本操作功能可用性成功確認(rèn)的判定準(zhǔn)則；—有代表性的預(yù)期用戶的參與.Usabilityvalidationmethodsmaybequantitativeorqualitative。Usabilityvalidationmaybeperformedinalaboratorysetting,inasimulateduseenvironmentorintheactualuseenvironment?？捎眯源_認(rèn)方法可以是定量的或定性的?？捎眯源_認(rèn)可以在實(shí)驗(yàn)室、模擬的使用環(huán)境或?qū)嶋H的使用環(huán)境中實(shí)施。Theusabilityvalidationplanshalladdress：-frequentusescenarios,and一reasonablyforeseeableworstcaseusescenarqs，thatareidentifiedintheusabilityspecification。TheusabilityvalidationplanshallberecordedintheUSABILITYENGINEERINGFILE-可用性確認(rèn)計(jì)劃應(yīng)闡述：—經(jīng)常的使用情景-合理可預(yù)見(jiàn)的最壞的使用情景上述內(nèi)容的識(shí)別見(jiàn)可用性規(guī)范?？捎眯源_認(rèn)計(jì)劃應(yīng)記錄在可用性工程文檔中.5。7UserINTERFACEdesignandimplementation用戶接口的設(shè)計(jì)和實(shí)施Themanufacturershalldesignandimplementtheuserinterfaceasdescribedintheusabilityspecificationutilizing,asappropriate,usabilityengineeringmethodsandtechniques.制造商應(yīng)設(shè)計(jì)和實(shí)施可用性規(guī)范中描述的用戶接口，適當(dāng)時(shí)，利用可用性工程的方法和技術(shù).5.8Usabilityverification可用性驗(yàn)證

產(chǎn)品名可用性評(píng)價(jià)報(bào)告文件編號(hào)：JKH-編制:采用標(biāo)準(zhǔn)：EN60601-1-6:2010,EN62366:2008審核：EN60601-1—6ClauseRequirement+TestResult-RemarkVerdictAspartofthemedicaldevicedesignverificationPROCESS，theMANUFACTURERshallVERIFYtheimplementationofthemedicaldeviceuserinterfacedesignagainsttherequirementsoftheusabilityspecification°Theresultsoftheverificationshallberecordedinusabilityengineeringfile-作為醫(yī)療器械設(shè)計(jì)驗(yàn)證過(guò)程的一部分，制造商應(yīng)按照可用性規(guī)范要求驗(yàn)證醫(yī)療器械用戶接口設(shè)計(jì)的實(shí)施?驗(yàn)證結(jié)果應(yīng)記錄在可用性工程文檔中。5.9Usabilityvalidation可用性確認(rèn)TheMANUFACTURERshallVALIDATEUSABILITYofthemedicaldeviceaccordingtotheusabilityvalidationplan.TheresultsshallberecordedintheusabltyENGINEERINGFILE-制造商應(yīng)按照可用性確認(rèn)計(jì)劃對(duì)醫(yī)療器械的可用性進(jìn)行確認(rèn)。其結(jié)果應(yīng)記錄在可用性工程文檔中。Iftheacceptaneecriteriadocumentedintheusabltyvalidationplanarenotmet:一furtheruser[nterfacedesignandimplementationactivitiesshallbeperformed（see5.6）；or一iffurtherimprovementisnotpracticable,themanufacturermaygatherandreviewdataandliteraturetodetermineifthemedicalbenefitsoftheintendeduseoutweightheriskarisingfromusabilityproblems。IfthisevidencedoesnotsupporttheconclusionthattheMEDIcALbenefitsoutweightheRIsK,thentheRIsKisunacceptable□如果不滿足在可用性確認(rèn)計(jì)劃中形成文件的驗(yàn)收準(zhǔn)則：—應(yīng)進(jìn)行進(jìn)步的用戶接口設(shè)計(jì)和實(shí)施活動(dòng)（見(jiàn)5。6）；或—如果進(jìn)步的改進(jìn)疋不可仃的，制造商可收集資料和文獻(xiàn)并進(jìn)行評(píng)審以確定是否預(yù)期用途的醫(yī)療受益超過(guò)了可用性問(wèn)題引起的風(fēng)險(xiǎn)。如果此證據(jù)不支持醫(yī)療受益超過(guò)風(fēng)險(xiǎn)的結(jié)論，則風(fēng)險(xiǎn)是不可接受的