IEC 60601-2-4-2010 医用电气设备.第2-4部分:心脏除颤器基本安全性和必要性能的详细要求
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【英文标准名称】:Medicalelectricalequipment-Part2-4:Particularrequirementsforbasicsafetyandessentialperformanceofcardiacdefibrillators
【原文标准名称】:医用电气设备.第2-4部分:心脏除颤器基本安全性和必要性能的详细要求
【标准号】:IEC60601-2-4-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-12
【实施或试行日期】:2010-12
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/SC62D
【标准类型】:()
【标准水平】:()
【中文主题词】:去纤颤器;定义(术语);电气器具;电气工程;医用电气设备;电医学;设备安全性;医疗设备;医学科学;监控器;安全性;安全性工程;安全性要求;测试条件
【英文主题词】:Defibrillators;Definitions;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electromedicine;Equipmentsafety;Medicalequipment;Medicalsciences;Monitors;Safety;Safetyengineering;Safetyrequirements;Testingconditions
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofCARDIACDEFIBRILLATORS,hereafterreferredtoasMEEQUIPMENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.NOTESeealso4.2ofthegeneralstandard.Thisparticularstandarddoesnotapplytoimplantabledefibrillators,remotecontrolDEFIBRILLATORS,externaltranscutaneouspacemakers,orseparatestand-alonecardiacmonitors(whicharestandardizedbyIEC60601-2-27[2]2).CardiacmonitorswhichuseseparateECGmonitoringelectrodesarenotwithinthescopeofthisstandardunlesstheyareusedasthesolebasisforAEDrhythmrecognitiondetectionorbeatdetectionforsynchronizedcardioversion.Defibrillationwaveformtechnologyisevolvingrapidly.Publishedstudiesindicatethattheeffectivenessofwaveformsvaries.Thechoiceofaparticularwaveformincludingwaveshape,deliveredenergy,efficacy,andsafetyhasbeenspecificallyexcludedfromthescopeofthisstandard.However,duetothecriticalimportanceofthetherapeuticwaveform,commentshavebeenaddedtotherationalewhichaddressesconsiderationsinwaveformselection.
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:160P.;A4
【正文语种】:
【原文标准名称】:医用电气设备.第2-4部分:心脏除颤器基本安全性和必要性能的详细要求
【标准号】:IEC60601-2-4-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-12
【实施或试行日期】:2010-12
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/SC62D
【标准类型】:()
【标准水平】:()
【中文主题词】:去纤颤器;定义(术语);电气器具;电气工程;医用电气设备;电医学;设备安全性;医疗设备;医学科学;监控器;安全性;安全性工程;安全性要求;测试条件
【英文主题词】:Defibrillators;Definitions;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electromedicine;Equipmentsafety;Medicalequipment;Medicalsciences;Monitors;Safety;Safetyengineering;Safetyrequirements;Testingconditions
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofCARDIACDEFIBRILLATORS,hereafterreferredtoasMEEQUIPMENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.NOTESeealso4.2ofthegeneralstandard.Thisparticularstandarddoesnotapplytoimplantabledefibrillators,remotecontrolDEFIBRILLATORS,externaltranscutaneouspacemakers,orseparatestand-alonecardiacmonitors(whicharestandardizedbyIEC60601-2-27[2]2).CardiacmonitorswhichuseseparateECGmonitoringelectrodesarenotwithinthescopeofthisstandardunlesstheyareusedasthesolebasisforAEDrhythmrecognitiondetectionorbeatdetectionforsynchronizedcardioversion.Defibrillationwaveformtechnologyisevolvingrapidly.Publishedstudiesindicatethattheeffectivenessofwaveformsvaries.Thechoiceofaparticularwaveformincludingwaveshape,deliveredenergy,efficacy,andsafetyhasbeenspecificallyexcludedfromthescopeofthisstandard.However,duetothecriticalimportanceofthetherapeuticwaveform,commentshavebeenaddedtotherationalewhichaddressesconsiderationsinwaveformselection.
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:160P.;A4
【正文语种】:
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