天津市醫(yī)療器械質(zhì)量監(jiān)督檢驗(yàn)中心GB9706.1-2020風(fēng)險(xiǎn)管理文檔檢查表版本：1.0填寫說明1、“判定”一欄填寫“適用”或“不適用”。2、“風(fēng)險(xiǎn)管理文檔清單”一欄應(yīng)以清單形式列出GB9706.1-2020標(biāo)準(zhǔn)所涉及的各風(fēng)險(xiǎn)管理文件，該清單應(yīng)包括文件名、文件編號(hào)及版本。3、“風(fēng)險(xiǎn)管理文檔參考”一欄填寫所要求的風(fēng)險(xiǎn)管理內(nèi)容在文檔中的具體位置，應(yīng)填寫文件名、文件編號(hào)、版本號(hào)、章節(jié)、段落、具體風(fēng)險(xiǎn)編號(hào)等信息，以便于工程師核查風(fēng)險(xiǎn)管理文檔中的具體內(nèi)容。舉例如下：示例1：風(fēng)險(xiǎn)管理報(bào)告A.1版第三章危害H3.10示例2：RMFfileDOC-000-0000RevASection5Hazard1-54、其他填寫問題或標(biāo)準(zhǔn)理解問題請(qǐng)咨詢檢測(cè)工程師。GB9706.1-2020風(fēng)險(xiǎn)管理文檔檢查表PAGE2/=NUMPAGES97-196GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause4.2.2風(fēng)險(xiǎn)管理的通用要求4.2.2GeneralrequirementforRISKMANAGEMENT判定Verdict要求概要RequirementSummary應(yīng)執(zhí)行符合YY/T0316的風(fēng)險(xiǎn)管理過程。為了符合本部分,YY/T0316—2016中風(fēng)險(xiǎn)管理過程的所有要素應(yīng)適用,除了:———生產(chǎn)和生產(chǎn)后監(jiān)控的計(jì)劃及執(zhí)行[YY/T0316—2016中3.1的第四列項(xiàng)、3.4f)和第9章];和———定期復(fù)審風(fēng)險(xiǎn)管理過程的適宜性(YY/T0316—2016中3.2的第四列項(xiàng))。在應(yīng)用任何YY/T0316要求時(shí):———術(shù)語“醫(yī)用設(shè)備”應(yīng)假定與ME設(shè)備或ME系統(tǒng)是相同的意思;———YY/T0316中涉及的術(shù)語“故障狀態(tài)”應(yīng)包括,但不僅限于本部分中定義的單一故障狀態(tài)。通過檢查:———制造商確定的風(fēng)險(xiǎn)可接受準(zhǔn)則的方案來檢驗(yàn)是否符合要求。———特定的ME設(shè)備或ME系統(tǒng)中考慮的風(fēng)險(xiǎn)管理計(jì)劃來檢驗(yàn)是否符合要求?！_認(rèn)制造商準(zhǔn)備了含有風(fēng)險(xiǎn)管理記錄和考慮本部分對(duì)特定的ME設(shè)備或ME系統(tǒng)要求的其他文件的風(fēng)險(xiǎn)管理文檔。ARISKMANAGEMENTPROCESScomplyingwithISO14971shallbeperformed.Forcompliancewiththisstandard,allelementsoftheISO14971:2007RISKMANAGEMENTPROCESSshallbeappliedexcept:–theplanningforandexecutionofproductionandpost-productionmonitoring(subclause3.1,fourthdash,subclause3.4,itemf),andClause9ofISO14971:2007),and–periodicreviewsofthesuitabilityoftheRISKMANAGEMENTPROCESS(subclause3.2,fourthdash,ofISO14971:2007).WhenapplyinganyoftherequirementsofISO14971:–theterm“medicaldevice”shallassumethesamemeaningasMEEQUIPMENTorMESYSTEM;and–theterm“faultconditions”referredtoinISO14971shallinclude,butshallnotbelimitedto,SINGLEFAULTCONDITIONSidentifiedinthisstandard.Complianceischeckedby:–inspectionoftheMANUFACTURER'SpolicyfordeterminingcriteriaforRISKacceptability;–inspectionoftheRISKMANAGEMENTplanfortheparticularMEEQUIPMENTorMESYSTEMunderconsideration;and–confirmingtheMANUFACTURERhaspreparedaRISKMANAGEMENTFILEcontainingtheRISKMANAGEMENTRECORDSandotherdocumentationrequiredbythisstandardfortheparticularMEEQUIPMENTorMESYSTEMunderconsideration.指導(dǎo)Guidance符合性通過以下來確認(rèn)：-檢查制造商的方針來確定風(fēng)險(xiǎn)接受準(zhǔn)則；-檢查考慮中的特定的ME設(shè)備或ME系統(tǒng)的風(fēng)險(xiǎn)管理計(jì)劃-確認(rèn)制造商準(zhǔn)備了含有風(fēng)險(xiǎn)管理記錄和本標(biāo)準(zhǔn)對(duì)考慮中的特定ME設(shè)備或ME系統(tǒng)要求的其它文件的風(fēng)險(xiǎn)管理文檔。制造商是否已經(jīng)具有依據(jù)YY/T0316要求的風(fēng)險(xiǎn)管理過程?風(fēng)險(xiǎn)管理過程是否應(yīng)用到待考慮的裝置？如果是，在這個(gè)點(diǎn)上有限的幾個(gè)更細(xì)節(jié)的問題可以被提出：是否所有的風(fēng)險(xiǎn)管理過程（符合YY/T0316-2016的要求，包括接受準(zhǔn)則）被開發(fā)并應(yīng)用到待考慮裝置上（YY/T0316-2016的條款3.3、3.4、3.5、4到8）？是否對(duì)于待考慮裝置有風(fēng)險(xiǎn)管理計(jì)劃（包括資源和承諾）（YY/T0316條款3.4）？制造商是否為保持風(fēng)險(xiǎn)管理文檔建立起要求（YY/T0316-2016條款3.5）待考慮裝置的綜合剩余風(fēng)險(xiǎn)是否可接受（YY/T0316-2016條款7）？制造商是否為用于記錄風(fēng)險(xiǎn)管理活動(dòng)的風(fēng)險(xiǎn)管理報(bào)告建立起要求（YY/T0316-2016條款8）Complianceischeckedby:-inspectionoftheMANUFACTURER'SpolicyfordeterminingcriteriaforRISKacceptability;-inspectionoftheRISKMANAGEMENTplanfortheparticularMEEQUIPMENTorMESYSTEMunderconsideration;and-confirmingtheMANUFACTURERhaspreparedaRISKMANAGEMENTFILEcontainingtheRISKMANAGEMENTRECORDSandotherdocumentationrequiredbythisstandardfortheparticularMEEQUIPMENTorMESYSTEMunderconsideration.DoesthemanufacturerhaveariskmanagementprocessaccordingtoISO14971:2007inplace?Wasthisprocessusedforthedevicebeingconsidered?Ifso,alimitednumberofmoredetailedquestionscanbeaddressedatthispoint:?Areallriskmanagementprocedures(thatmeettherequirementsofISO14971:2007,includingacceptabilitycriteria)developedandappliedforthedeviceconsidered(clauses3.3,3.4,3.5,4to8ofISO14971:2007)??Isthereariskmanagementplan(includingresourcesandcommitment)forthedeviceconsidered(clause3.4ofISO14971:2007)??HasthemanufacturerestablishedrequirementsformaintainingaRiskmanagementfile(clause3.5ofISO14971:2007)??Istheoverallresidualriskforthedeviceconsideredacceptable(clause7ofISO14971:2007)??HasthemanufacturerestablishedrequirementsforcreatingaRiskmanagementreporttodocumentthereviewofRiskmanagementactivities(clause8ofISO14971:2007)?風(fēng)險(xiǎn)管理文檔清單RMFlist.…

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause4.3基本性能4.3ESSENTIALPERFORMANCE判定Verdict要求概要RequirementSummary在風(fēng)險(xiǎn)分析中,除了與基本安全相關(guān)的性能外,制造商還應(yīng)識(shí)別ME設(shè)備或ME系統(tǒng)臨床功能的性能,這對(duì)于實(shí)現(xiàn)預(yù)期用途是必需的,或者能夠影響ME設(shè)備或ME系統(tǒng)的安全性。在正常狀態(tài)和單一故障狀態(tài)下,從完整的功能到喪失全部確定的性能,制造商應(yīng)規(guī)定性能限值。當(dāng)確定的性能喪失或低于制造商規(guī)定限值后,制造商應(yīng)評(píng)估由此產(chǎn)生的風(fēng)險(xiǎn)。如果導(dǎo)致的風(fēng)險(xiǎn)是不可接受的,那么此性能即可確定為ME設(shè)備或ME系統(tǒng)的基本性能。制造商應(yīng)實(shí)施風(fēng)險(xiǎn)控制措施以減少已識(shí)別性能的喪失或降低而導(dǎo)致的風(fēng)險(xiǎn),使其達(dá)到可接受水平。通過檢查風(fēng)險(xiǎn)管理文檔來檢驗(yàn)是否符合要求。當(dāng)本部分要求在特定試驗(yàn)后保持基本性能時(shí),需通過檢查來檢驗(yàn)是否符合要求,必要時(shí),通過功能試驗(yàn)來證明保持在制造商規(guī)定的限值之內(nèi)或ME設(shè)備或ME系統(tǒng)轉(zhuǎn)換到制造商定義的安全狀態(tài)。DuringRISKANALYSIS,theMANUFACTURERshallidentifytheperformanceoftheclinicalfunction(s)oftheMEEQUIPMENTorMESYSTEM,otherthanthatrelatedtoBASICSAFETY,thatisnecessarytoachieveitsINTENDEDUSEorthatcouldaffectthesafetyoftheMEEQUIPMENTorMESYSTEM.TheMANUFACTURERshallthenspecifyperformancelimitsbetweenfullyfunctionalandtotallossoftheidentifiedperformanceinbothNORMALCONDITIONandSINGLEFAULTCONDITION.TheMANUFACTURERshallthenevaluatetheRISKfromthelossordegradationoftheidentifiedperformancebeyondthelimitsspecifiedbytheMANUFACTURER.IftheresultingRISKisunacceptable,thentheidentifiedperformanceconstitutesanESSENTIALPERFORMANCEoftheMEEQUIPMENTorMESYSTEM.TheMANUFACTURERshallimplementRISKCONTROLmeasurestoreducetheRISKfromthelossordegradationoftheidentifiedperformancetoanacceptablelevel.ComplianceischeckedbyinspectionoftheRISKMANAGEMENTFILE.WherethisstandardrequiresthatESSENTIALPERFORMANCEistobemaintainedfollowingaparticulartest,complianceischeckedbyinspectionand,ifnecessary,byfunctionaltest(s)thatdemonstratetheMANUFACTURER'SspecifiedlimitsaremaintainedortheMEEQUIPMENTorMESYSTEMtransitionstoasafestateasdefinedbytheMANUFACTURER.指導(dǎo)Guidance通過檢查風(fēng)險(xiǎn)管理文檔來確認(rèn)符合性。除了專用安全標(biāo)準(zhǔn)里已識(shí)別的基本性能，由器械性能缺失而導(dǎo)致的不可接受剩余風(fēng)險(xiǎn)的危害處境是否被識(shí)別出來？如果是，該性能是否在風(fēng)險(xiǎn)評(píng)定中被識(shí)別為器械的基本性能？如果是，是否有被識(shí)別的風(fēng)險(xiǎn)控制措施或者特定測(cè)試來確認(rèn)該性能是否被保持？如果是，是否通過檢查或功能測(cè)試來確認(rèn)？Complianceischeckedbyinspectionoftheriskmanagementfile.Have,apartfromtheessentialperformanceidentifiedintheparticularstandards,hazardoussituationsbeenidentifiedwherebytheresidualriskisunacceptableduetotheabsenceofperformanceofthedevice?Ifso,hasthisperformancebeenidentifiedasessentialperformanceforthedeviceduringtheriskassessmentprocess?Ifso,haveriskcontrolmeasuresorparticulartestsbeenidentifiedtocheckwhetherthisperformanceismaintained?Ifso,hasthisbeencheckedbyinspectionorbyfunctionaltest?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause4.4預(yù)期使用壽命4.4ExpectedServiceLife判定Verdict要求概要RequirementSummary制造商應(yīng)在風(fēng)險(xiǎn)管理文檔中聲明ME設(shè)備或ME系統(tǒng)的預(yù)期使用壽命。通過檢查風(fēng)險(xiǎn)管理文檔來檢驗(yàn)是否符合要求。TheMANUFACTURERshallstatetheEXPECTEDSERVICELIFEoftheMEEQUIPMENTorMESYSTEMintheRISKMANAGEMENTFILE.ComplianceischeckedbyinspectionoftheRISKMANAGEMENTFILE.風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause4.5ME設(shè)備或ME系統(tǒng)替代的風(fēng)險(xiǎn)控制措施或試驗(yàn)方法4.5AlternativeRISKCONTROLmeasuresortestmethodsforMEEQUIPMENTorMESYSTEMS判定Verdict要求概要RequirementSummary本部分規(guī)定的特定的風(fēng)險(xiǎn)控制措施或試驗(yàn)方法之處,如果制造商可以通過提供科學(xué)數(shù)據(jù)或臨床意見或比較研究來證明應(yīng)用替代的風(fēng)險(xiǎn)控制措施或替代的試驗(yàn)方法所得到的剩余風(fēng)險(xiǎn)仍然是可接受的,且與應(yīng)用本部分的要求所得到的剩余風(fēng)險(xiǎn)可比,則風(fēng)險(xiǎn)控制替代的措施或試驗(yàn)方法是可接受的。文中的比較研究是指研究比較標(biāo)準(zhǔn)規(guī)定的風(fēng)險(xiǎn)控制措施或試驗(yàn)方法,與替代的風(fēng)險(xiǎn)控制措施或替代的試驗(yàn)方法的效果。注:如果提供了附加的補(bǔ)償措施,替代的風(fēng)險(xiǎn)控制措施可以允許超過本部分或其并列或?qū)Ｓ脴?biāo)準(zhǔn)規(guī)定的限值。通過檢查風(fēng)險(xiǎn)管理文檔來檢驗(yàn)是否符合要求WherethisstandardspecifiesaparticularRISKCONTROLmeasureortestmethod,analternativeRISKCONTROLmeasureortestmethodisacceptable,providedthattheMANUFACTURERcandemonstratethroughscientificdataorclinicalopinionorcomparativestudiesthattheRESIDUALRISKthatresultsfromapplyingthealternativeRISKCONTROLmeasureortestmethodremainsacceptableandiscomparabletotheRESIDUALRISKthatresultsfromapplyingtherequirementsofthisstandard.ComparativestudiesinthiscontextmeanstudiescomparingtheeffectofthealternativeRISKCONTROLmeasureortestmethodwiththeRISKCONTROLmeasureortestmethodspecifiedinthisstandard.NOTEAlternativeRISKCONTROLmeasurescanallowforexceedinglimitsspecifiedinthisstandardorinitscollateralorparticularstandardsifadditionalmeasuresforcompensationareprovided.ComplianceischeckedbyinspectionoftheRISKMANAGEMENTFILE.指導(dǎo)Guidance通過檢查風(fēng)險(xiǎn)管理文檔來確認(rèn)符合性。是否存在某些特別的風(fēng)險(xiǎn)，是通過替代措施來控制風(fēng)險(xiǎn)并把風(fēng)險(xiǎn)降到可接受的水平？如果是，是否在風(fēng)險(xiǎn)評(píng)定中已經(jīng)把那些風(fēng)險(xiǎn)識(shí)別出來？如果是，最終的風(fēng)險(xiǎn)等級(jí)是否等于或者小于應(yīng)用本標(biāo)準(zhǔn)的要求導(dǎo)致的剩余風(fēng)險(xiǎn)？Complianceischeckedbyinspectionoftheriskmanagementfile.Arethereparticularrisksforwhichalternativemeansofcontrollingtheserisksareappliedsuchthattheresultingrisklevelisacceptablefortheserisks?Ifso,havetheserisksbeenidentifiedassuchduringtheriskassessmentprocess?Ifso,istheresultingrisklevelequalorlessthantheresidualriskthatresultsfromapplyingtherequirementsofthisstandard?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause4.6與患者接觸的ME設(shè)備或ME系統(tǒng)的部分4.6MEEQUIPMENTorMESYSTEMpartsthatcontactthePATIENT判定Verdict要求概要RequirementSummary對(duì)于那些接觸患者但在應(yīng)用部分定義之外的部分,風(fēng)險(xiǎn)管理過程應(yīng)評(píng)估其是否需要符合應(yīng)用部分的要求。除非評(píng)估確定需要適用BF型應(yīng)用部分或CF型應(yīng)用部分的要求,否則有關(guān)的部分應(yīng)適用B型應(yīng)用部分的要求。若風(fēng)險(xiǎn)管理過程確定那些部分需符合應(yīng)用部分的要求,除7.2.10不適用于那些部分外,本部分以及相關(guān)并列和專用標(biāo)準(zhǔn)的相關(guān)要求和試驗(yàn)應(yīng)適用。通過檢查風(fēng)險(xiǎn)管理文檔來檢驗(yàn)是否符合要求。TheRISKMANAGEMENTPROCESSshallincludeanassessmentofwhetherpartsthatcancomeintocontactwiththePATIENTbutfalloutsideofthedefinitionofAPPLIEDPARTSneedtobesubjecttotherequirementsforAPPLIEDPARTS.Forthepartsconcerned,therequirementsforTYPEBAPPLIEDPARTshallbeappliedunlesstheassessmentidentifiesaneedfortherequirementsforaTYPEBFAPPLIEDPARTorTYPECFAPPLIEDPARTtoapply.IftheRISKMANAGEMENTPROCESSdeterminesthatsuchpartsaresubjecttotherequirementsforAPPLIEDPARTS,thenalltherelevantrequirementsandtestsofthisstandardandofrelevantcollateralandparticularstandardsshallapply,exceptthat7.2.10doesnotapplytosuchparts.ComplianceischeckedbyinspectionoftheRISKMANAGEMENTFILE.指導(dǎo)Guidance通過檢查風(fēng)險(xiǎn)管理文檔來確認(rèn)符合性。風(fēng)險(xiǎn)管理過程中是否識(shí)別出某些部件可能會(huì)和患者接觸，但其又不在應(yīng)用部件定義中？如果是，本標(biāo)準(zhǔn)中所有相關(guān)的條款和測(cè)試是否適用？如果是，剩余風(fēng)險(xiǎn)是否是不可接受？如果是，是否有風(fēng)險(xiǎn)控制措施實(shí)施來確保剩余風(fēng)險(xiǎn)是可以被接受的？Complianceischeckedbyinspectionoftheriskmanagementfile.Havepartsbeenidentifiedduringtheriskmanagementprocesswhichcancomeintocontactwiththepatientbutfalloutsidethedefinitionofappliedparts?Ifso,arealltherelevantrequirementsandtestsofthisstandardapplied?Ifso,arethereresidualriskswhicharenotacceptable?Ifso,areriskcontrolsmeasuresimplementedthatmaketheresidualriskacceptable?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause4.7ME設(shè)備的單一故障狀態(tài)4.7SINGLEFAULTCONDITIONforMEEQUIPMENT判定Verdict要求概要RequirementSummaryME設(shè)備應(yīng)被設(shè)計(jì)和制造成保持單一故障安全,或通過4.2的應(yīng)用,確定風(fēng)險(xiǎn)仍然可接受。ME設(shè)備被認(rèn)為是單一故障安全的,若:a)采用一個(gè)故障可以忽略不計(jì)的單一措施來降低風(fēng)險(xiǎn)(例如:加強(qiáng)絕緣,采用8倍拉伸安全系數(shù)且沒有機(jī)械保護(hù)裝置的懸掛件,高完善性元器件);或b)一個(gè)單一故障發(fā)生,但:———最初的故障在ME設(shè)備預(yù)期使用壽命內(nèi)和降低風(fēng)險(xiǎn)的第二重措施失效前將被發(fā)現(xiàn)(例如:有機(jī)械保護(hù)裝置的懸掛件);———ME設(shè)備預(yù)期使用壽命內(nèi)降低風(fēng)險(xiǎn)的第二重措施不可能失效。當(dāng)一個(gè)單一故障狀態(tài)引發(fā)另外一個(gè)單一故障狀態(tài),那么兩個(gè)故障被認(rèn)為是一個(gè)單一故障狀態(tài)。在單一故障狀態(tài)下的任何試驗(yàn)期間,每次應(yīng)只能施加一個(gè)故障。應(yīng)使用風(fēng)險(xiǎn)分析的結(jié)果來確定哪些故障應(yīng)予以試驗(yàn)。每次任意一個(gè)元器件的可能導(dǎo)致危險(xiǎn)情況的故障,包括13.1提到的故障,應(yīng)被實(shí)際或理論上模擬。評(píng)價(jià)元器件的模擬故障應(yīng)以該元器件在ME設(shè)備的預(yù)期使用壽命內(nèi)的故障相關(guān)的風(fēng)險(xiǎn)為準(zhǔn)。該評(píng)價(jià)應(yīng)通過應(yīng)用風(fēng)險(xiǎn)管理的原則。該評(píng)價(jià)應(yīng)考慮到的問題諸如可靠性、拉伸安全系數(shù)和元器件的等級(jí)。另外,在模擬單一故障狀態(tài)期間,極有可能的或不易察覺的元器件故障應(yīng)被模擬。這些要求和相關(guān)試驗(yàn)應(yīng)不適用雙重絕緣或加強(qiáng)絕緣的失效或高完善性元器件的失效。通過應(yīng)用13.2確定的與單一故障狀態(tài)相關(guān)的規(guī)范要求和試驗(yàn),和從評(píng)價(jià)風(fēng)險(xiǎn)分析結(jié)果確定的故障的試驗(yàn)來確定是否符合。如果每次引入13.2所述任意單一故障狀態(tài)中的一個(gè)而不會(huì)直接導(dǎo)致13.1所述的危險(xiǎn)情況,或任何其他不可接受風(fēng)險(xiǎn)的結(jié)果,則認(rèn)為是符合要求的。MEEQUIPMENTshallbesodesignedandmanufacturedthatitremainsSINGLEFAULTSAFE,ortheRISKremainsacceptableasdeterminedthroughapplicationof4.2.MEEQUIPMENTisconsideredSINGLEFAULTSAFEif:a)itemploysasinglemeansforreducingaRISKthathasanegligibleprobabilityoffailure(e.g.,REINFORCEDINSULATION,suspendedmasseswithoutMECHANICALPROTECTIVEDEVICESemployingaTENSILESAFETYFACTORof8X,COMPONENTWITHHIGH-INTEGRITYCHARACTERISTICS),orb)aSINGLEFAULTCONDITIONoccurs,but:-TheinitialfaultwillbedetectedduringtheEXPECTEDSERVICELIFEoftheMEEQUIPMENTandbeforeasecondmeansforreducingaRISKfails(e.g.,suspendedmasseswithMECHANICALPROTECTIVEDEVICES);or-TheprobabilitythatthesecondmeansofreducingtheRISKwillfailduringtheEXPECTEDSERVICELIFEoftheMEEQUIPMENTisnegligible.WhereaSINGLEFAULTCONDITIONcausesanotherSINGLEFAULTCONDITION,thetwofailuresareconsideredasoneSINGLEFAULTCONDITION.DuringanytestunderSINGLEFAULTCONDITION,onlyonefaultatatimeshallbeapplied.TheresultsoftheRISKANALYSISshallbeusedtodeterminewhichfailuresshallbetested.ThefailureofanyonecomponentatatimethatcouldresultinaHAZARDOUSSITUATION,includingthosementionedin3.1,shallbesimulated,physicallyortheoretically.TheevaluationofwhetheracomponentissubjecttofailuresimulationshalltakeintoaccounttheRISKassociatedwiththefailureofthecomponentduringtheEXPECTEDSERVICELIFEoftheMEEQUIPMENT.ThisevaluationshallbeaccomplishedbyapplyingtheprinciplesofRISKMANAGEMENT.Theevaluationshalltakeintoaccountissuessuchasreliability,TENSILESAFETYFACTORS,andratingofcomponents.Additionally,duringthesimulationofSINGLEFAULTCONDITIONS,componentfailuresthatarehighlyprobableorundetectableshallbesimulated.ComplianceisdeterminedbyapplyingthespecificrequirementsandtestsassociatedwiththeSINGLEFAULTCONDITIONSidentifiedin13.2,andtestsforthefailuresidentifiedfromevaluationoftheresultsoftheRISKANALYSIS.ComplianceisconfirmediftheintroductionofanyoftheSINGLEFAULTCONDITIONSdescribedin13.2,oneatatime,doesnotleaddirectlytotheHAZARDOUSSITUATIONSdescribedin13.1,oranyotheroutcomethatresultsinanunacceptableRISK.指導(dǎo)Guidance符合性通過應(yīng)用條款13.2定義的單一故障狀態(tài)所涉及的特定要求和測(cè)試，并測(cè)試風(fēng)險(xiǎn)分析結(jié)論評(píng)估中識(shí)別的故障來確定。如果發(fā)生條款13.2描述的任一單一故障狀態(tài)，每次發(fā)生一個(gè)，不會(huì)直接導(dǎo)致條款13.1描述的危害處境或者其它導(dǎo)致不可以接受風(fēng)險(xiǎn)的結(jié)果，則可以確定其符合要求。是否有單一故障狀態(tài)可以直接導(dǎo)致條款13.1描述的危害處境或者導(dǎo)致不可接受的風(fēng)險(xiǎn)？Complianceisdeterminedbyapplyingthespecificrequirementsandtestsassociatedwiththesinglefaultconditionsidentifiedin13.2,andtestsforthefailuresidentifiedfromevaluationoftheresultsoftheriskanalysis.Complianceisdeterminediftheintroductionofanyofthesinglefaultconditionsdescribedin13.2,oneatthetime,doesnotleaddirectlytothehazardoussituationsdescribedin13.1,oranyotheroutcomethatresultsinanunacceptablerisk.Aretheresinglefaultconditionswhichleaddirectlytohazardoussituationsdescribedin13.1ortorisksthatareunacceptable?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause4.8ME設(shè)備的元器件4.8ComponentsofMEEQUIPMENT判定Verdict要求概要RequirementSummary除本部分中特殊規(guī)定的或通過風(fēng)險(xiǎn)管理過程控制的特例外,其故障可能導(dǎo)致危險(xiǎn)情況的所有元器件,包括電線,應(yīng)根據(jù)它們規(guī)定的額定值使用。作為防護(hù)措施使用的元器件的可靠性應(yīng)對(duì)其在ME設(shè)備中使用的條件進(jìn)行評(píng)估。這些元器件應(yīng)符合以下兩者之一(參見4.5):a)有相關(guān)的國家標(biāo)準(zhǔn)或行業(yè)標(biāo)準(zhǔn)適用的安全要求;b)沒有相關(guān)的國家標(biāo)準(zhǔn)或行業(yè)標(biāo)準(zhǔn)適用的安全要求,本部分的要求應(yīng)適用。見圖5所示a)和b)的流程圖。通過檢查和必要的試驗(yàn)來檢驗(yàn)是否符合要求。本部分對(duì)電動(dòng)機(jī)(見13.2.8和)和變壓器(見15.5.3)的試驗(yàn)被認(rèn)為是全面的,并依據(jù)表22對(duì)電動(dòng)機(jī)或變壓器的絕緣系統(tǒng)一起進(jìn)行評(píng)價(jià)。提供與非ME設(shè)備隔離的ME系統(tǒng)的元器件由第16章評(píng)價(jià)。Allcomponents,includingwiring,thefailureofwhichcouldresultinaHAZARDOUSSITUATIONshallbeusedinaccordancewiththeirspecifiedratingsunlessaspecificexceptionismadeinthisstandardorthroughtheRISKMANAGEMENTPROCESS.ThereliabilityofcomponentsthatareusedasMEANSOFPROTECTIONshallbeassessedfortheconditionsofuseintheMEEQUIPMENT.Theyshallcomplywithoneofthefollowing(seealso4.5):a)theapplicablesafetyrequirementsofarelevantIECorISOstandard;b)wherethereisnorelevantIEC/ISOstandard,therelevantANSIstandardshallbeapplied;SeeFigure5foraschematicflowchartfor(a)and(b).Complianceischeckedbyinspectionand,wherenecessary,bytest.Thetestsofthisstandardformotors(see13.2.8and)andtransformers(see15.5.3)areconsideredtobecomprehensiveandtogetherwiththeevaluationofthemotorortransformerinsulationsystemaccordingtoTable22representalltestingrequiredbythisstandard.MESYSTEMcomponentsthatprovideisolationfromnon-MEEQUIPMENTareevaluatedtoclause16.指導(dǎo)Guidance符合性通過檢查以及必要時(shí)通過測(cè)試來確認(rèn)。本標(biāo)準(zhǔn)有關(guān)馬達(dá)（見條款13.2.8和）和變壓器（見條款15.5.5）的測(cè)試被認(rèn)為是全面的，且依據(jù)表格22對(duì)于馬達(dá)和變壓器絕緣系統(tǒng)的評(píng)估則可以認(rèn)為其滿足本標(biāo)準(zhǔn)對(duì)馬達(dá)和變壓器的測(cè)試要求。ME系統(tǒng)元器件與非ME設(shè)備的隔離，需要按照16章評(píng)估。是否存在特別例外允許待評(píng)估器械的元器件不按額定參數(shù)使用？如有，例外是否經(jīng)由風(fēng)險(xiǎn)管理流程結(jié)論論證過的？如有，檢查或者檢測(cè)要求是否經(jīng)過論證來確定危害處境是可接受的？Complianceischeckedbyinspectionand,wherenecessary,bytest.Thetestsofthisstandardformotors(see13.2.8and)andtransformers(see15.5.3)areconsideredtobecomprehensiveandtogetherwiththeevaluationofthemotorortransformerinsulationsystemaccordingtoTable22representalltestingrequiredbythisstandard.MEsystemcomponentsthatprovideisolationfromnon-MEequipmentareevaluatedtoclause16.Arespecificexceptionsmadeforanycomponentofthedeviceunderinvestigationtoallowittobeusednotinaccordancewithitsspecifiedrating?Ifso,aretheseexceptionsformulatedastheresultoftheriskmanagementprocess?Ifso,haveinspectionortestrequirementsbeenformulatedtomakethehazardoussituationsacceptable?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause4.9ME設(shè)備中高完善性元器件的使用4.9UseofCOMPONENTSWITHHIGH-INTEGRITYCHARACTERISTICSinMEEQUIPMENT判定Verdict要求概要RequirementSummary當(dāng)某一特定元器件的一個(gè)故障可產(chǎn)生不可接受的風(fēng)險(xiǎn)時(shí),應(yīng)使用高完善性元器件。高完善性元器件選擇和評(píng)價(jià)應(yīng)符合其在ME設(shè)備預(yù)期使用壽命內(nèi)的使用條件和可預(yù)見的合理的誤用.通過檢查風(fēng)險(xiǎn)管理文檔和高完善性元器件的選擇標(biāo)準(zhǔn)來檢驗(yàn)是否符合要求。ACOMPONENTWITHHIGH-INTEGRITYCHARACTERISTICSshallbeusedwhenafaultinaparticularcomponentcangenerateanunacceptableRISK.COMPONENTSWITHHIGH-INTEGRITYCHARACTERISTICSshallbeselectedandevaluatedconsistentwiththeirconditionsofuseandreasonablyforeseeablemisuseduringtheEXPECTEDSERVICELIFEoftheMEEQUIPMENT.ComplianceischeckedbyinspectionoftheRISKMANAGEMENTFILEandtheselectioncriteriafortheCOMPONENTSWITHHIGH-INTEGRITYCHARACTERISTICS.指導(dǎo)Guidance通過檢查風(fēng)險(xiǎn)管理文檔和高完善性元器件的選擇準(zhǔn)則來確認(rèn)其符合性。是否有使用高完善性元器件？如有，在風(fēng)險(xiǎn)評(píng)定過程中其使用相關(guān)聯(lián)的風(fēng)險(xiǎn)是否被識(shí)別？或者換句話說，在ME設(shè)備預(yù)期使用壽命中，其選擇和評(píng)估是否符合其使用條件和可預(yù)見的誤使用？Complianceischeckedbyinspectionoftheriskmanagementfileandtheselectioncriteriaforthecomponentswithhighintegritycharacteristics.Arecomponentswithhigh-integritycharacteristicsapplied?Ifso,havetherisksassociatedwithitsusebeenidentifiedassuchduringtheriskassessmentprocess,orinotherwordsaretheyselectedandevaluatedconsistentwiththeirconditionsofuseandreasonablyforeseeablemisuseduringtheexpectedservicelifeoftheMEequipment?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause5.1型式試驗(yàn)5.1TYPETESTS判定Verdict要求概要RequirementSummary本部分中描述的試驗(yàn)都是型式試驗(yàn)。考慮第4章,尤其是4.2的要求確定要執(zhí)行的試驗(yàn)。如果經(jīng)分析表明試驗(yàn)條件在其他試驗(yàn)或方法中已得到充分評(píng)價(jià),則不需要進(jìn)行該試驗(yàn)。同時(shí)發(fā)生的獨(dú)立故障組合可能導(dǎo)致危險(xiǎn)情況的應(yīng)記錄在風(fēng)險(xiǎn)管理文檔中(見4.7)。獨(dú)立故障同時(shí)發(fā)生時(shí)仍能保持基本安全和基本性能需通過試驗(yàn)進(jìn)行證明,應(yīng)在最惡劣情況下進(jìn)行相關(guān)試驗(yàn)。ThetestsdescribedinthisstandardareTYPETESTS.Theteststobeperformedaredeterminedtakingintoconsiderationtherequirementsofclause4,inparticular4.2.Atestneednotbeperformedifanalysisshowsthattheconditionbeingtestedhasbeenadequatelyevaluatedbyothertestsormethods.ThecombinationofsimultaneousindependentfaultsthatcouldresultinaHAZARDOUSSITUATIONshallbedocumentedintheRISKMANAGEMENTFILE(seealso4.7).WhentestingisnecessarytodemonstratethatBASICSAFETYandESSENTIALPERFORMANCEaremaintainedundersuchsimultaneousindependentfaults,therelatedtestingmaybelimitedtoworstcasesituations.指導(dǎo)Guidance在確定測(cè)試項(xiàng)目時(shí)需考慮條款4的要求，尤其是條款4.2。在選擇測(cè)試項(xiàng)目時(shí)，是否應(yīng)用了由YY/T0316-2016定義的風(fēng)險(xiǎn)管理流程？如果是，則滿足要求。風(fēng)險(xiǎn)分析的結(jié)果用來定義哪些同時(shí)發(fā)生的故障組合需要被測(cè)試。在定義哪些同時(shí)發(fā)生的故障組合需要被測(cè)試時(shí)，風(fēng)險(xiǎn)評(píng)定是否被運(yùn)用？Theteststobeperformedaredeterminedtakingintoconsiderationtherequirementsofclause4,inparticular4.2.Fortheselectionoftheteststobeperformed,isariskmanagementprocessaccordingtoISO14971:2000applied?Ifso,thisrequirementisfulfilled.Theresultsoftheriskanalysisareusedtodeterminewhichcombination(s)ofsimultaneousfaultsaretobetested.Forthedeterminationofwhichcombination(s)ofsimultaneousfaultshavetobetested,isariskassessmentapplied?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause7.2.2標(biāo)識(shí)7.2.2Identification判定Verdict要求概要RequirementSummaryME設(shè)備應(yīng)標(biāo)記:———制造商的名稱或商標(biāo)以及聯(lián)系信息;———型號(hào)或類型參考號(hào);———序列號(hào)或批號(hào)或批次標(biāo)識(shí);和———制造日期或失效日期,若適用。注:見YY/T0466.1中制造商、序列號(hào)、批號(hào)或批次、制造日期和失效日期的符號(hào)。序列號(hào)、批號(hào)或批次標(biāo)識(shí),以及制造日期可以用人可讀的代碼或通過例如條形碼或射頻識(shí)別(RFID)的自動(dòng)識(shí)別技術(shù)來提供。除非誤識(shí)別不會(huì)導(dǎo)致不可接受的風(fēng)險(xiǎn),否則,ME設(shè)備可拆卸的元器件應(yīng)標(biāo)記:———制造商的名稱或商標(biāo);和———型號(hào)或類型參考號(hào)MEEQUIPMENTshallbemarkedwith:–thenameortrademarkandcontactinformationoftheMANUFACTURER;–aMODELORTYPEREFERENCE;–aserialnumberorlotorbatchidentifier;and–thedateofmanufactureorusebydate,ifapplicable.NOTESeeISO15223-1forsymbolsforMANUFACTURER,serialnumber,lotorbatch,yearofmanufactureandusebydate.Theserialnumber,lotorbatchidentifier,andthedateofmanufacturemaybeprovidedinahumanreadablecodeorthroughautomaticidentificationtechnologysuchasbarcodesorRFID.DetachablecomponentsoftheMEEQUIPMENTshallbemarkedwith:–thenameortrademarkoftheMANUFACTURER;and–aMODELORTYPEREFERENCE;unlessmisidentificationdoesnotresultinanunacceptableRISK.指導(dǎo)GuidanceME設(shè)備及其可拆卸元器件沒有標(biāo)識(shí)制造商的名稱或商標(biāo)和型號(hào)或型式標(biāo)記不會(huì)產(chǎn)生不可接受的風(fēng)險(xiǎn)？MEEquipmentanditsdetachablepartsnotmarkedwiththenameortrademarkofthemanufacturerandwithaModelorTypereferencedoesnotpresentanunacceptablerisk?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause7.2.13生理效應(yīng)(安全標(biāo)志和警告說明)7.2.13Physiologicaleffects(safetysignsandwarningstatements)判定Verdict要求概要RequirementSummaryME設(shè)備產(chǎn)生的生理效應(yīng)對(duì)操作者是不明顯的,且能夠?qū)颊呋虿僮髡咴斐蓚Φ?應(yīng)具有適合的安全標(biāo)志(見7.5)。安全標(biāo)志應(yīng)出現(xiàn)在顯著位置,使其在ME設(shè)備正確安裝后的正常使用時(shí)清晰易認(rèn)。使用說明書應(yīng)描述出危險(xiǎn)(源)的性質(zhì)以及避免或是降低相關(guān)風(fēng)險(xiǎn)的預(yù)防措施。MEEQUIPMENTproducingphysiologicaleffectsthatarenotobvioustotheOPERATORandcancauseHARMtothePATIENTorOPERATORshallbearasuitablesafetysign(see7.5).ThesafetysignshallappearinaprominentlocationsothatitwillbeCLEARLYLEGIBLEinNORMALUSEaftertheMEEQUIPMENThasbeenPROPERLYINSTALLED.TheinstructionsforuseshalldescribethenatureoftheHAZARDandtheprecautionsforavoidingitorminimizingtheassociatedRISK.指導(dǎo)Guidance說明書是否描述出危害的性質(zhì)以及避免或是降低相關(guān)風(fēng)險(xiǎn)的預(yù)防措施？DotheinstructionsforusedescribethenatureoftheHAZARDandtheprecautionsforavoidingitorminimizingtheassociatedRISK?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause7.2.17保護(hù)性包裝7.2.17Protectivepackaging判定Verdict要求概要RequirementSummary若在運(yùn)輸或貯存中要采取特別措施,在包裝上應(yīng)作出相應(yīng)的標(biāo)記(見GB/T191)。運(yùn)輸和貯存容許的環(huán)境條件應(yīng)標(biāo)記在外包裝上(見和YY/T0466.1)。如果過早地拆開ME設(shè)備或其部件的包裝會(huì)導(dǎo)致不可接受的風(fēng)險(xiǎn),則在包裝上應(yīng)標(biāo)記適合的安全標(biāo)志(見7.5)。ME設(shè)備或附件的無菌包裝應(yīng)標(biāo)記無菌并指出滅菌的方法(見YY/T0466.1)。Ifspecialhandlingmeasureshavetobetakenduringtransportorstorage,thepackagingshallbemarkedaccordingly(seeISO780).Thepermissibleenvironmentalconditionsfortransportandstorageshallbemarkedontheoutsideofthepackaging(seeandISO15223-1).WhereprematureunpackingofMEEQUIPMENToritspartscouldresultinanunacceptableRISK,thepackagingshallbemarkedwithasuitablesafetysign(see7.5).ThepackagingofMEEQUIPMENTorACCESSORIESsuppliedsterileshallbemarkedassterileandindicatethemethodofsterilization(seeISO15223-1).指導(dǎo)Guidance過早地拆開ME設(shè)備或其部件的包裝是否會(huì)導(dǎo)致不可接受的風(fēng)險(xiǎn)？包裝是否標(biāo)記適當(dāng)?shù)陌踩珮?biāo)志？CanprematureunpackingofMEEquipmentoritspartsresultinanunacceptableRISK?Isthepackagingmarkedwithasuitablesafetysign?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause7.3.3電池7.3.3Batteries判定Verdict要求概要RequirementSummary應(yīng)標(biāo)記電池的型號(hào)及其裝入方法(若適用)(見)。預(yù)期僅由維護(hù)人員使用工具才能更換的電池,使用隨附文件資料說明中提到的識(shí)別標(biāo)記即可。當(dāng)鋰電池或燃料電池被裝入,并當(dāng)不正確替換會(huì)導(dǎo)致不可接受的風(fēng)險(xiǎn),除了在隨附文件資料中給出識(shí)別標(biāo)記外,還應(yīng)警示未經(jīng)充分培訓(xùn)的人員替換電池會(huì)導(dǎo)致危險(xiǎn)(源)(諸如超溫、著火或爆炸)。Thetypeofbatteryandthemodeofinsertion(ifapplicable)shallbemarked(see).ForbatteriesintendedtobechangedonlybySERVICEPERSONNELwiththeuseofaTOOL,anidentifyingmarkingreferringtoinformationstatedintheACCOMPANYINGDOCUMENTSissufficient.WherelithiumbatteriesorfuelcellsareincorporatedandwhereincorrectreplacementwouldresultinanunacceptableRISK,awarningindicatingthatreplacementbyinadequatelytrainedpersonnelcouldresultinaHAZARD(suchasexcessivetemperatures,fire,orexplosion)shallbegiveninadditiontotheidentifyingmarkingreferringtoinformationstatedintheACCOMPANYINGDOCUMENTS.指導(dǎo)Guidance使用鋰電池和燃料電池時(shí)，不正確的替換是否會(huì)導(dǎo)致不可接受的風(fēng)險(xiǎn)？如果是，是否有警告說明未經(jīng)充分培訓(xùn)的人員替換電池會(huì)導(dǎo)致危害？AretherelithiumbatteriesorfuelcellswhichareincorporatedwhereincorrectreplacementcouldresultinanunacceptableRISK?Ifso,isthereawarningindicatingthatreplacementbyinadequatelytrainedpersonnelcouldresultinaHAZARD?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/section)

GB9706.1-2020條款I(lǐng)EC60601-1：2012Clause7.3.7供電端子7.3.7Supplyterminals判定Verdict要求概要RequirementSummary除非可以證明互換連接不會(huì)導(dǎo)致不可接受的風(fēng)險(xiǎn),供電導(dǎo)線的端子應(yīng)在端子的相鄰處做標(biāo)記。若ME設(shè)備太小,無法在端子處貼標(biāo)記,則應(yīng)在隨附文件中說明。在永久性安裝的ME設(shè)備中,專門用來連接電源中性線的端子,應(yīng)標(biāo)記GB/T4026中相應(yīng)的代碼(參見表D.3的代碼1)。若連接到三相電源的標(biāo)記是必要的,應(yīng)符合GB/T4026的要求。在電氣連接點(diǎn)上或相鄰處的標(biāo)記不應(yīng)貼在連接時(shí)需要拆除的部件上,在連接后應(yīng)仍然可見。TerminalsforsupplyconductorsshallbemarkedadjacenttotheterminalsunlessitcanbedemonstratedthatnounacceptableRISKcanresultifconnectionsareinterchanged.IfMEEQUIPMENTissosmallthattheterminalmarkingcannotbeaffixed,theyshallbeincludedintheACCOMPANYINGDOCUMENTS.TerminalsthatareprovidedexclusivelyfortheconnectionoftheneutralsupplyconductorinPERMANENTLYINSTALLEDMEEQUIPMENTshallbemarkedwiththeappropriatecodefromIEC60445(seeTableD.3,Code1).Ifmarkingforconnectiontoathree-phasesupplyisnecessary,itshallbeaccordingtoIEC60445.Markingsthatareonoradjacenttoelectricalconnectionpointsshallnotbeaffixedtopartsthathavetoberemovedtomaketheconnection.Theyshallremainvisibleaftertheconnectionhasbeenmade.指導(dǎo)Guidance連接導(dǎo)線的接線板/排在其附近有無標(biāo)記？如果沒有，互換連接時(shí)是否能識(shí)別已知的或者可預(yù)見的危害（風(fēng)險(xiǎn)管理文檔）不會(huì)導(dǎo)致危害處境發(fā)生？AreTerminalsforsupplyconductorsmarkedadjacenttotheterminals?Ifnot,doestheidentificationofknownorforeseeablehazards(riskmanagementfile)demonstratethatnoHAZARDOUSSITUATIONcanresultifconnectionsareinterchanged?風(fēng)險(xiǎn)管理文檔參考（文件名/編號(hào)、版本號(hào)、章節(jié)）RMFReference(s)(DocumentName/NO.,RevisionNumber,Paragraph/sect