【英文标准名称】:Inhalationalanaesthesiasystems-Part4:Anaestheticvapourdeliverydevices(ISO8835-4:2004)
【原文标准名称】:吸入麻醉系统.第4部分:麻醉蒸气输送装置(ISO8835-4-2004)
【标准号】:BSENISO8835-4-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-06-30
【实施或试行日期】:2009-06-30
【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】:麻醉的;麻醉学;麻醉设备;生物适应性;连接件;连接;定义;电气设备;电气安全性;蒸发器;防火;气体分配;医院;识别方法;吸入;标记;使用说明书;接头;医疗器械;医疗设备;医用气体;医学科学;医疗技术学;病患者保护;保护(装置);安全性要求;规范(验收);监督(认可)
【英文主题词】:Anaestethic;Anaesthesiology;Anaestheticequipment;Biocompatibility;Connectingpieces;Connections;Definitions;Electricalequipment;Electricalsafety;Evaporators;Fireprevention;Gasdistribution;Hospitals;Identificationmethods;Inhalation;Inscription;Instructionsforuse;Joints;Medicaldevices;Medicalequipment;Medicalgases;Medicalsciences;Medicaltechnology;Patientprotection;Protection;Safetyrequirements;Specification(approval);Surveillance(approval)
【摘要】:IEC60601-1:1988,Clause1appliesexceptasfollows.Addition:ThispartofISO8835specifiesparticularrequirementsfortheessentialperformanceofanaestheticvapourdeliverydevices(AVDDs),asdefinedin3.1.ThispartofISO8835isapplicabletoAVDDswhichareacomponentofananaestheticsystemandareintendedtobecontinuouslyoperator-attended.ThispartofISO8835givesspecificrequirementsforAVDDswhicharesupplementarytotheapplicablegeneralrequirementsinIEC60601-2-13.ThispartofISO8835isnotapplicabletoAVDDsintendedforusewithflammableanaesthetics,asdeterminedbyAnnexCC,andAVDDsintendedforusewithinanaestheticbreathingsystems(e.g.draw-overvaporizers).TherequirementsofthispartofISO8835whichreplaceormodifytherequirementsofIEC60601-1:1988anditsAmendments1(1991)and2(1995)areintendedtotakeprecedenceoverthecorrespondinggeneralrequirements.
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:34P.;A4
【正文语种】:英语