BS EN 60601-2-20-2009 医用电气设备.安全性专门要求.移动保育箱规范
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【英文标准名称】:Medicalelectricalequipment-Particularrequirementsforthebasicsafetyandessentialperformanceofinfanttransportincubators
【原文标准名称】:医用电气设备.安全性专门要求.移动保育箱规范
【标准号】:BSEN60601-2-20-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2010-01-31
【实施或试行日期】:2010-01-31
【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】:分类系统;定义;名称与符号;电器具;电气工程;医用电气设备;电气保护设备;电气安全;电医学;电磁兼容性;环境条件;防火;恒温箱;保育箱(婴儿);初始的;使用说明书;处理;机械安全;医疗设备;医学科学;医疗技术学;防电击;保护措施;辐射防护;警告;安全工程;安全性要求;规范(验收);监督(认可);温度稳定性;测试;运输型婴儿保育箱;温度均匀度;通风
【英文主题词】:Classificationsystems;Definitions;Designations;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electromedicine;EMC;Environmentalconditions;Fireprevention;Incubators;Incubators(infant);Inscription;Instructionsforuse;Marking;Mechanicalsafety;Medicalequipment;Medicalsciences;Medicaltechnology;Protectionagainstelectricshocks;Protectivemeasures;Radiationprotection;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Surveillance(approval);Temperaturestability;Testing;Transportincubators;Uniformityoftemperature;Ventilations
【摘要】:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofINFANTTRANSPORTINCUBATORequipment,asdefinedin201.3.211ofthisstandard,alsoreferredtoasMEEQUIPMENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.NOTESeealso4.2ofthegeneralstandard.ThisparticularstandardspecifiessafetyrequirementsforINFANTTRANSPORTINCUBATORSbutalternatemethodsofcompliancewithaspecificclausebydemonstratingequivalentsafetywillnotbejudgedasnoncompliantiftheMANUFACTURERhasdemonstratedinhisRISKMANAGEMENTFILEthattheRISKpresentedbytheHAZARDhasbeenfoundtobeofanacceptablelevelwhenweighedagainstthebenefitoftreatmentfromthedevice.Thisparticularstandarddoesnotapplyto:–devicessupplyingheatviaBLANKETS,PADSorMATTRESSESinmedicaluse;forinformationseeIEC80601-2-35;–INFANTINCUBATORSwhicharenotINFANTTRANSPORTINCUBATOR;forinformationseeIEC60601-2-19;–INFANTRADIANTWARMERS;forinformation,seeIEC60601-2-21;–INFANTPHOTOTHERAPY;forinformation,seeIEC60601-2-50.
【中国标准分类号】:C47
【国际标准分类号】:11_040_10
【页数】:46P.;A4
【正文语种】:英语
【原文标准名称】:医用电气设备.安全性专门要求.移动保育箱规范
【标准号】:BSEN60601-2-20-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2010-01-31
【实施或试行日期】:2010-01-31
【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】:分类系统;定义;名称与符号;电器具;电气工程;医用电气设备;电气保护设备;电气安全;电医学;电磁兼容性;环境条件;防火;恒温箱;保育箱(婴儿);初始的;使用说明书;处理;机械安全;医疗设备;医学科学;医疗技术学;防电击;保护措施;辐射防护;警告;安全工程;安全性要求;规范(验收);监督(认可);温度稳定性;测试;运输型婴儿保育箱;温度均匀度;通风
【英文主题词】:Classificationsystems;Definitions;Designations;Electricappliances;Electricalengineering;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electromedicine;EMC;Environmentalconditions;Fireprevention;Incubators;Incubators(infant);Inscription;Instructionsforuse;Marking;Mechanicalsafety;Medicalequipment;Medicalsciences;Medicaltechnology;Protectionagainstelectricshocks;Protectivemeasures;Radiationprotection;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Surveillance(approval);Temperaturestability;Testing;Transportincubators;Uniformityoftemperature;Ventilations
【摘要】:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofINFANTTRANSPORTINCUBATORequipment,asdefinedin201.3.211ofthisstandard,alsoreferredtoasMEEQUIPMENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.NOTESeealso4.2ofthegeneralstandard.ThisparticularstandardspecifiessafetyrequirementsforINFANTTRANSPORTINCUBATORSbutalternatemethodsofcompliancewithaspecificclausebydemonstratingequivalentsafetywillnotbejudgedasnoncompliantiftheMANUFACTURERhasdemonstratedinhisRISKMANAGEMENTFILEthattheRISKpresentedbytheHAZARDhasbeenfoundtobeofanacceptablelevelwhenweighedagainstthebenefitoftreatmentfromthedevice.Thisparticularstandarddoesnotapplyto:–devicessupplyingheatviaBLANKETS,PADSorMATTRESSESinmedicaluse;forinformationseeIEC80601-2-35;–INFANTINCUBATORSwhicharenotINFANTTRANSPORTINCUBATOR;forinformationseeIEC60601-2-19;–INFANTRADIANTWARMERS;forinformation,seeIEC60601-2-21;–INFANTPHOTOTHERAPY;forinformation,seeIEC60601-2-50.
【中国标准分类号】:C47
【国际标准分类号】:11_040_10
【页数】:46P.;A4
【正文语种】:英语
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