BS EN 60601-2-50-2009 医用电气设备.婴儿光疗设备基本安全性和基本性能的详细要求
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【英文标准名称】:Medicalelectricalequipment-Particularrequirementsforthebasicsafetyandessentialperformanceofinfantphototherapyequipment
【原文标准名称】:医用电气设备.婴儿光疗设备基本安全性和基本性能的详细要求
【标准号】:BSEN60601-2-50-2009
【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;儿童;定义(术语);电气器具;电气工程;医用电气设备;使用说明书;辐照器;医疗设备;医学科学;医疗技术学;光线疗法;安全性;安全性要求;规范(验收);治疗设备
【英文主题词】:Babies;Children;Definitions;Electricappliances;Electricalengineering;Electricalmedicalequipment;Instructionsforuse;Irradiationapparatus;Medicalequipment;Medicalsciences;Medicaltechnology;Phototherapy;Safety;Safetyrequirements;Specification(approval);Therapyequipment
【摘要】:Clause1ofthegeneralstandardapplies,exceptasfollows:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofINFANTPHOTOTHERAPYEQUIPMENT,asdefinedin201.3.203ofthisstandard,alsoreferredtoasMEEQUIPMENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.ThisparticularstandardspecifiessafetyrequirementsforINFANTPHOTOTHERAPYEQUIPMENT,butalternatemethodsofcompliancewithaspecificclausebydemonstratingequivalentsafetywillnotbejudgedasnon-compliantiftheMANUFACTURERhasdemonstratedinhisRISKMANAGEMENTFILEthattheRISKpresentedbytheHAZARDhasbeenfoundtobeofanacceptablelevelwhenweighedagainstthebenefitoftreatmentfromthedevice.Thisparticularstandarddoesnotapplyto:–devicessupplyingheatviaBLANKETS,PADSorMATTRESSESinmedicaluse,forinformationseeIEC80601-2-35;–INFANTINCUBATORS;forinformationseeIEC60601-2-19;–INFANTTRANSPORTINCUBATORS;forinformation,seeIEC60601-2-20;–INFANTRADIANTWARMERS;forinformationseeIEC60601-2-21.
【中国标准分类号】:C47
【国际标准分类号】:11_040_60
【页数】:34P.;A4
【正文语种】:英语
【原文标准名称】:医用电气设备.婴儿光疗设备基本安全性和基本性能的详细要求
【标准号】:BSEN60601-2-50-2009
【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;儿童;定义(术语);电气器具;电气工程;医用电气设备;使用说明书;辐照器;医疗设备;医学科学;医疗技术学;光线疗法;安全性;安全性要求;规范(验收);治疗设备
【英文主题词】:Babies;Children;Definitions;Electricappliances;Electricalengineering;Electricalmedicalequipment;Instructionsforuse;Irradiationapparatus;Medicalequipment;Medicalsciences;Medicaltechnology;Phototherapy;Safety;Safetyrequirements;Specification(approval);Therapyequipment
【摘要】:Clause1ofthegeneralstandardapplies,exceptasfollows:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofINFANTPHOTOTHERAPYEQUIPMENT,asdefinedin201.3.203ofthisstandard,alsoreferredtoasMEEQUIPMENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.ThisparticularstandardspecifiessafetyrequirementsforINFANTPHOTOTHERAPYEQUIPMENT,butalternatemethodsofcompliancewithaspecificclausebydemonstratingequivalentsafetywillnotbejudgedasnon-compliantiftheMANUFACTURERhasdemonstratedinhisRISKMANAGEMENTFILEthattheRISKpresentedbytheHAZARDhasbeenfoundtobeofanacceptablelevelwhenweighedagainstthebenefitoftreatmentfromthedevice.Thisparticularstandarddoesnotapplyto:–devicessupplyingheatviaBLANKETS,PADSorMATTRESSESinmedicaluse,forinformationseeIEC80601-2-35;–INFANTINCUBATORS;forinformationseeIEC60601-2-19;–INFANTTRANSPORTINCUBATORS;forinformation,seeIEC60601-2-20;–INFANTRADIANTWARMERS;forinformationseeIEC60601-2-21.
【中国标准分类号】:C47
【国际标准分类号】:11_040_60
【页数】:34P.;A4
【正文语种】:英语
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