【英文标准名称】:Medicalelectricalequipment-Part2-21:Particularrequirementsforthebasicsafetyandessentialperformanceofinfantradiantwarmers
【原文标准名称】:医用电气设备.第2-21部分:辐射式婴儿保温器的基本安全性和必要性能的详细要求
【标准号】:BSEN60601-2-21-2009
【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】:婴儿;电气器具;电气工程;医用电气设备;电气保护设备;电气安全性;电医学;热辐射器;热辐射设备;恒温箱;婴儿保温箱;幼儿;检验;机械安全性;医疗设备;医学科学;医疗技术学;保护装置;辐射防护;安全性;安全工程;安全性要求;规范(验收);测试
【英文主题词】:Babies;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electromedicine;Heatradiators;Heat-radiatingequipment;Incubators;Infantradiantwarmers;Infants;Inspection;Mechanicalsafety;Medicalequipment;Medicalsciences;Medicaltechnology;Protectivedevices;Radiationprotection;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Testing
【摘要】:Clause1ofthegeneralstandardapplies,exceptasfollows:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofINFANTRADIANTWARMERSasdefinedin201.3.204,alsoreferredtoasMEEQUIPMENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.ThisparticularstandardspecifiesthesafetyrequirementsforINFANTRADIANTWARMERS,butalternatemethodsofcompliancewithaspecificclause,bydemonstratingequivalentsafety,willnotbejudgedasnon-compliant,iftheMANUFACTURERhasdemonstratedinhisRISKMANAGEMENTFILEthattheRISKpresentedbytheHAZARDhasbeenfoundtobeofanacceptablelevelwhenweighedagainstthebenefitoftreatmentfromthedevice.Thisparticularstandarddoesnotapplyto:–devicessupplyingheatviaBLANKETS,PADSorMATTRESSESinmedicaluse;forinformationseeIEC80601-2-35;–INFANTINCUBATORS;forinformationseeIEC60601-2-19;–INFANTTRANSPORTINCUBATORS,forinformationseeIEC60601-2-20;–INFANTPHOTOTHERAPYEQUIPMENT,forinformationseeIEC60601-2-50.
【中国标准分类号】:C47
【国际标准分类号】:11_040_10
【页数】:42P.;A4
【正文语种】:英语