BS EN 60601-2-31-2008 医用电气设备.第2-31部分:利用内部电源的外部心脏起搏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-Part2-31:Particularrequirementsforthebasicsafetyandessentialperformanceofexternalcardiacpacemakerswithinternalpowersource
【原文标准名称】:医用电气设备.第2-31部分:利用内部电源的外部心脏起搏器基本安全性和必要性能的详细要求
【标准号】:BSEN60601-2-31-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【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】:调整设备;组装;蓄电池组;运河;电路;清洁处理;燃料;元部件;团料;连接;连接器的连接件;恒电流;缺陷;定义(术语);测定;放电;消毒;电力系统;电击;电气设备;电气工程;医用电气设备;电气安全性;电磁兼容性;电医学;电子电源;电磁兼容性(EMC);环境条件;环境测试;外部;特点;频率;高温防护;点火;输入电流;使用说明书;内部;中断;液体;作标记;测量;测量不确定度;医疗设备;医疗技术学;潮气;示波器;引出端;溢水口;起搏器;纸;患者辅助电流;功率消耗;精密度;脉冲发生器;辐射;辐射防护;安全性;安全性要求;规范(验收);灭菌;指示器;温度;测试;工作数据
【英文主题词】:Adjustingequipment;Assembling;Batteries;Canals;Circuits;Cleaning;Combustible;Components;Conglomerates;Connections;Connectoredjoints;Continuouscurrent;Defects;Definitions;Determinations;Discharge;Disinfections;Electricpowersystems;Electricshock;Electricalappliances;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electromagneticcompatibility;Electromedicine;Electronicpowersupplies;EMC;Environmentalconditions;Environmentaltesting;External;Features;Frequencies;Heatprotection;Ignition;Inputcurrent;Instructionsforuse;Internal;Interruptions;Liquids;Marking;Measurement;Measuringincertainity;Medicalequipment;Medicaltechnology;Moisture;Oscilloscopes;Outlets;Overflows;Pacemakers;Paper;Patientauxiliarycurrent;Powerconsumption;Precision;Pulsegenerators;Radiation;Radiationprotection;Safety;Safetyrequirements;Specification(approval);Sterilization(hygiene);Telltales;Temperature;Testing;Workingdata
【摘要】:Clause1ofthegeneralstandardapplies,exceptasfollows:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofEXTERNALPACEMAKERSpoweredbyanINTERNALELECTRICALPOWERSOURCE,hereafterreferredtoasMEEQUIPMENT.ThisstandardappliestoPATIENTCABLESasdefinedin201.3.109.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTwithinthescopeofhisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.ThisstandarddoesnotapplytotheimplantablepartsofactiveimplantablemedicaldevicescoveredbyISO14708-1ThisstandarddoesnotapplytoEXTERNALPACEMAKERSwhichcanbeconnecteddirectlyorindirectlytoaSUPPLYMAINS.ThisstandarddoesnotapplytotransthoracicandoesophagealpacingMEEQUIPMENTandantitachycardiaMEEQUIPMENT.
【中国标准分类号】:C45
【国际标准分类号】:11_040_01;11_040_40
【页数】:40P.;A4
【正文语种】:英语
【原文标准名称】:医用电气设备.第2-31部分:利用内部电源的外部心脏起搏器基本安全性和必要性能的详细要求
【标准号】:BSEN60601-2-31-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【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】:调整设备;组装;蓄电池组;运河;电路;清洁处理;燃料;元部件;团料;连接;连接器的连接件;恒电流;缺陷;定义(术语);测定;放电;消毒;电力系统;电击;电气设备;电气工程;医用电气设备;电气安全性;电磁兼容性;电医学;电子电源;电磁兼容性(EMC);环境条件;环境测试;外部;特点;频率;高温防护;点火;输入电流;使用说明书;内部;中断;液体;作标记;测量;测量不确定度;医疗设备;医疗技术学;潮气;示波器;引出端;溢水口;起搏器;纸;患者辅助电流;功率消耗;精密度;脉冲发生器;辐射;辐射防护;安全性;安全性要求;规范(验收);灭菌;指示器;温度;测试;工作数据
【英文主题词】:Adjustingequipment;Assembling;Batteries;Canals;Circuits;Cleaning;Combustible;Components;Conglomerates;Connections;Connectoredjoints;Continuouscurrent;Defects;Definitions;Determinations;Discharge;Disinfections;Electricpowersystems;Electricshock;Electricalappliances;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electromagneticcompatibility;Electromedicine;Electronicpowersupplies;EMC;Environmentalconditions;Environmentaltesting;External;Features;Frequencies;Heatprotection;Ignition;Inputcurrent;Instructionsforuse;Internal;Interruptions;Liquids;Marking;Measurement;Measuringincertainity;Medicalequipment;Medicaltechnology;Moisture;Oscilloscopes;Outlets;Overflows;Pacemakers;Paper;Patientauxiliarycurrent;Powerconsumption;Precision;Pulsegenerators;Radiation;Radiationprotection;Safety;Safetyrequirements;Specification(approval);Sterilization(hygiene);Telltales;Temperature;Testing;Workingdata
【摘要】:Clause1ofthegeneralstandardapplies,exceptasfollows:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofEXTERNALPACEMAKERSpoweredbyanINTERNALELECTRICALPOWERSOURCE,hereafterreferredtoasMEEQUIPMENT.ThisstandardappliestoPATIENTCABLESasdefinedin201.3.109.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTwithinthescopeofhisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.ThisstandarddoesnotapplytotheimplantablepartsofactiveimplantablemedicaldevicescoveredbyISO14708-1ThisstandarddoesnotapplytoEXTERNALPACEMAKERSwhichcanbeconnecteddirectlyorindirectlytoaSUPPLYMAINS.ThisstandarddoesnotapplytotransthoracicandoesophagealpacingMEEQUIPMENTandantitachycardiaMEEQUIPMENT.
【中国标准分类号】:C45
【国际标准分类号】:11_040_01;11_040_40
【页数】:40P.;A4
【正文语种】:英语
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