【英文标准名称】:Medicalelectricalequipment-Part2-31:Particularrequirementsforbasicsafetyandessentialperformanceofexternalcardiacpacemakerswithinternalpowersource
【原文标准名称】:医用电气设备.第2-31部分:带内部能源的体外心脏起搏器基本安全和基本性能的特殊要求
【标准号】:IEC60601-2-31-2008
【标准状态】:现行
【国别】:国际
【发布日期】:2008-03
【实施或试行日期】:
【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】:蓄电池组;定义;测定;电力系统;电气设备;电气工程;医用电气设备;电气安全;电磁兼容性;电医学;电子电源;EMC;环境条件;外部;特点;高温防护;内部;医疗设备;医疗技术学;起搏器;脉冲发生器;辐射防护;安全;安全要求;规范(验收);测试
【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】:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofEXTERNALPACEMAKERSpoweredbyanINTERNALELECTRICALPOWERSOURCE,hereafterreferredtoasMEEQUIPMENT.ThisstandardappliestoPATIENTCABLESasdefinedin201.3.109.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.NOTESeealso4.2ofthegeneralstandard.ThisstandarddoesnotapplytotheimplantablepartsofactiveimplantablemedicaldevicescoveredbyISO14708-1ThisstandarddoesnotapplytoEXTERNALPACEMAKERSwhichcanbeconnecteddirectlyorindirectlytoaSUPPLYMAINS.ThisstandarddoesnotapplytotransthoracicandoesophagealpacingMEEQUIPMENTandantitachycardiaMEEQUIPMENT.
【中国标准分类号】:C45
【国际标准分类号】:11_040_01;11_040_60
【页数】:71P;A4
【正文语种】:英语