BS EN 60601-2-4-2003 医疗电气设备.安全的特殊要求.心脏去纤颤器的特殊安全要求

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【英文标准名称】:Medicalelectricalequipment-Particularrequirementsforsafety-Particularrequirementsforthesafetyofcardiacdefibrillators
【原文标准名称】:医疗电气设备.安全的特殊要求.心脏去纤颤器的特殊安全要求
【标准号】:BSEN60601-2-4-2003
【标准状态】:现行
【国别】:英国
【发布日期】:2003-09-19
【实施或试行日期】:2003-09-19
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:电气器具;去纤颤器;安全工程;医用电气设备;监视器;试验条件;安全;规范(验收);医疗设备;医学科学;设备安全;电医学;电气工程;安全要求;定义
【英文主题词】:Defibrillators;Definition;Definitions;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electromedicine;Equipmentsafety;Medicalequipment;Medicalsciences;Monitors;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Testingconditions
【摘要】:Addition:ThisParticularStandardspecifiesrequirementsforthesafetyofCARDIACDEFIBRILLATORSasdefinedin2.1.101,hereinafterreferredtoasEQUIPMENT.ThisParticularStandarddoesnotapplytoimplantabledefibrillators,remotecontrolDEFIBRIL-LATORS,externaltranscutaneouspacemakers,orseparatestandaloneCARDIACMONITORS(whicharestandardizedbyIEC60601-2-27).CardiacmonitorswhichuseseparateECGmonitoringelectrodesarenotwithinthescopeofthisstandardunlesstheyareusedasthesolebasisforAEDrhythmrecognitiondetectionorbeatdetectionforsynchronizedcardioversion.Defibrillationwaveformtechnologyisevolvingrapidly.Publishedstudiesindicatethattheeffectivenessofwaveformsvaries.Thechoiceofaparticularwaveformincludingwaveshape,deliveredenergy,efficacy,andsafetyhasbeenspecificallyexcludedfromthescopeofthisstandard.However,duetothecriticalimportanceofthetherapeuticwaveform,commentshavebeenaddedtotherationalewhichaddressconsiderationsinwaveformselection.
【中国标准分类号】:C36
【国际标准分类号】:11_040_10
【页数】:60P.;A4
【正文语种】:英语