BS EN 60601-2-27-2006 医疗电气设备.第2-27部分:心电图监测设备的安全(包括基本性能)特殊要求
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【英文标准名称】:Medicalelectricalequipment—Part2-27:Particularrequirementsforthesafety,includingessentialperformance,ofelectrocardiographicmonitoringequipment
【原文标准名称】:医疗电气设备.第2-27部分:心电图监测设备的安全(包括基本性能)特殊要求
【标准号】:BSEN60601-2-27-2006
【标准状态】:现行
【国别】:英国
【发布日期】:2006-05-31
【实施或试行日期】:2006-05-31
【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】:随附表格;报警系统;心脏病学;控制仪器;去纤维性颤动;去纤颤器;定义;测定;诊断设备;电器;电气工程;医用电气设备;电气安全;心电图;心电图仪;电医学;环境条件;设备安全;特点;危害;指示范围;使用说明书;医疗设备;医疗器械;医学科学;医疗技术学;监视装置;监控器;防电击;保护装置;保护措施;安全;安全要求;测试;用户信息
【英文主题词】:Accompanyingforms;Alarmsystems;Cardiography;Cardiology;Controlinstruments;Defibrillationprotections;Defibrillators;Definition;Definitions;Determinations;Diagnosticequipment;Electricappliances;Electricalappliances;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electrocardiograms;Electrocardiographs;Electromedicine;Environmentalconditions;Equipmentsafety;Features;Hazards;Indicationranges;Instructionsforuse;Medicalequipment;Medicalinstruments;Medicalsciences;Medicaltechnology;Monitoringdevice;Monitors;Protectionagainstelectricshocks;Protectivedevices;Protectivemeasures;Safety;Safetyrequirements;Testing;Userinformation
【摘要】:Addition:ThisParticularStandardspecifiestheparticularsafetyrequirements,includingessentialperformance,forELECTROCARDIOGRAPHIC(ECG)MONITORINGEQUIPMENTasdefinedin2.101andhereinafteralsoreferredtoasEQUIPMENT.ThisstandardisapplicabletoEQUIPMENTusedinahospitalenvironment.IftheEQUIPMENTisusedoutsidethehospitalenvironment,suchasinambulancesandairtransport,theEQUIPMENTshallcomplywiththisstandard.NOTEAdditionalstandardsapplytotheEQUIPMENTcoveringspecificallyuseoutsidethehospitalenvironment.Thisstandardisnotapplicabletoelectrocardiographicmonitorsforhomeuse.However,manufacturersshouldconsiderusingrelevantclausesofthisstandardasappropriatefortheirintendeduse.ECGtelemetrysystems,ambulatory("Holter")monitorsandotherECGrecordingdevicesareoutsidethescopeofthisParticularStandard.
【中国标准分类号】:C39
【国际标准分类号】:11_040_55
【页数】:74P.;A4
【正文语种】:英语
【原文标准名称】:医疗电气设备.第2-27部分:心电图监测设备的安全(包括基本性能)特殊要求
【标准号】:BSEN60601-2-27-2006
【标准状态】:现行
【国别】:英国
【发布日期】:2006-05-31
【实施或试行日期】:2006-05-31
【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】:随附表格;报警系统;心脏病学;控制仪器;去纤维性颤动;去纤颤器;定义;测定;诊断设备;电器;电气工程;医用电气设备;电气安全;心电图;心电图仪;电医学;环境条件;设备安全;特点;危害;指示范围;使用说明书;医疗设备;医疗器械;医学科学;医疗技术学;监视装置;监控器;防电击;保护装置;保护措施;安全;安全要求;测试;用户信息
【英文主题词】:Accompanyingforms;Alarmsystems;Cardiography;Cardiology;Controlinstruments;Defibrillationprotections;Defibrillators;Definition;Definitions;Determinations;Diagnosticequipment;Electricappliances;Electricalappliances;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electrocardiograms;Electrocardiographs;Electromedicine;Environmentalconditions;Equipmentsafety;Features;Hazards;Indicationranges;Instructionsforuse;Medicalequipment;Medicalinstruments;Medicalsciences;Medicaltechnology;Monitoringdevice;Monitors;Protectionagainstelectricshocks;Protectivedevices;Protectivemeasures;Safety;Safetyrequirements;Testing;Userinformation
【摘要】:Addition:ThisParticularStandardspecifiestheparticularsafetyrequirements,includingessentialperformance,forELECTROCARDIOGRAPHIC(ECG)MONITORINGEQUIPMENTasdefinedin2.101andhereinafteralsoreferredtoasEQUIPMENT.ThisstandardisapplicabletoEQUIPMENTusedinahospitalenvironment.IftheEQUIPMENTisusedoutsidethehospitalenvironment,suchasinambulancesandairtransport,theEQUIPMENTshallcomplywiththisstandard.NOTEAdditionalstandardsapplytotheEQUIPMENTcoveringspecificallyuseoutsidethehospitalenvironment.Thisstandardisnotapplicabletoelectrocardiographicmonitorsforhomeuse.However,manufacturersshouldconsiderusingrelevantclausesofthisstandardasappropriatefortheirintendeduse.ECGtelemetrysystems,ambulatory("Holter")monitorsandotherECGrecordingdevicesareoutsidethescopeofthisParticularStandard.
【中国标准分类号】:C39
【国际标准分类号】:11_040_55
【页数】:74P.;A4
【正文语种】:英语
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