BS EN 60601-2-19-2009 医疗电气设备.婴儿保温箱基本安全性和主要性能的详细要求

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【英文标准名称】:Medicalelectricalequipment.Particularrequirementsforthebasicsafetyandessentialperformanceofinfantincubators
【原文标准名称】:医疗电气设备.婴儿保温箱基本安全性和主要性能的详细要求
【标准号】:BSEN60601-2-19-2009
【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】:准确度;警报系统;分类;分类系统;控制装置;定义(术语);名称与符号;测定;电气设备;电气工程;电气设施;医用电气设备;电气保护设备;电气安全性;电气测试;电磁兼容性;电磁装置;电医学;电子设备及元件;电磁兼容性(EMC);环境条件;环境测试;防火;火险;防火安全性;危害;医院设备;识别方法;保温箱;恒温箱;保育箱(婴儿);批注;使用说明书;作标记;机械安全性;机械测试;医疗器械;医疗设备;医疗技术学;性能测试;防护电气设备;防电击;保护措施;辐射防护;减震系统(防护);安全性;安全装置;安全工程;安全措施;安全性要求;声强;规范(验收);稳定性;材料强度;监督(认可);温度;温度控制器;温度稳定性;测试;测试条件;温度差异;通风
【英文主题词】:Accuracy;Alarmsystems;Classification;Classificationsystems;Controldevices;Definitions;Designations;Determinations;Electricalappliances;Electricalengineering;Electricalequipment;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electricaltesting;Electromagneticcompatibility;Electromagneticdevices;Electromedicine;Electronicequipmentandcomponents;EMC;Environmentalconditions;Environmentaltesting;Fireprevention;Firerisks;Firesafety;Hazards;Hospitalequipment;Identificationmethods;Incubator;Incubators;Incubators(infant);Inscription;Instructionsforuse;Marking;Mechanicalsafety;Mechanicaltesting;Medicaldevices;Medicalequipment;Medicaltechnology;Performancetesting;Protectedelectricalequipment;Protectionagainstelectricshocks;Protectivemeasures;Radiationprotection;Restraintsystems(protective);Safety;Safetydevices;Safetyengineering;Safetymeasures;Safetyrequirements;Soundintensity;Specification(approval);Stability;Strengthofmaterials;Surveillance(approval);Temperature;Temperaturecontrollers;Temperaturestability;Testing;Testingconditions;Uniformityoftemperature;Ventilations
【摘要】:Clause1ofthegeneralstandardapplies,exceptasfollows:Replacement:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofINFANTINCUBATORS,asdefinedin201.3.209ofthisstandard,alsoreferredtoasMEEQUIPMENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin7.2.13and8.4.1ofthegeneralstandard.ThisparticularstandardspecifiessafetyrequirementsforINFANTINCUBATORSbutalternatemethodsofcompliancewithaspecificclausebydemonstratingequivalentsafetywillnotbejudgedasnon-compliantiftheMANUFACTURERhasdemonstratedinhisRISKMANAGEMENTFILEthattheRISKpresentedbytheHAZARDhasbeenfoundtobeofanacceptablelevelwhenweighedagainstthebenefitoftreatmentfromthedevice.Thisparticularstandarddoesnotapplyto:–devicessupplyingheatviaBLANKETS,PADSorMATTRESSESinmedicaluse;forinformationseeIEC80601-2-35;–INFANTRADIANTWARMERS;forinformation,seeIEC60601-2-21;–INFANTTRANSPORTINCUBATORS,forinformation,seeIEC60601-2-20;–INFANTPHOTOTHERAPYEQUIPMENT,forinformationseeIEC60601-2-50
【中国标准分类号】:C47
【国际标准分类号】:11_040_10
【页数】:46P.;A4
【正文语种】:英语