【英文标准名称】:Anaestheticandrespiratoryequipment-Nebulizingsystemsandcomponents
【原文标准名称】:麻醉和呼吸设备.雾化系统和组件
【标准号】:ISO27427-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-03
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC121
【标准类型】:()
【标准水平】:()
【中文主题词】:气溶胶;生物适应性;呼吸装置;呼吸设备;组件;定义;设计;药品管理;电气安全;电磁兼容性;EMC;环境条件;危害;吸入空气;使用说明书;作标记;医用呼吸器;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;喷雾器;救护服务;呼吸器;安全;安全要求;规范(验收);试验;治疗设备
【英文主题词】:Aerosols;Biocompatibility;Breathingapparatus;Breathingequipment;Components;Definitions;Design;Drugadministration;Electricalsafety;Electromagneticcompatibility;EMC;Environmentalconditions;Hazards;Inhaledair;Instructionsforuse;Marking;Medicalbreathingapparatus;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Nebulizers;Rescueandambulanceservices;Respirators;Safety;Safetyrequirements;Specification(approval);Testing;Therapyequipment
【摘要】:ThisInternationalStandardspecifiesrequirementsforthesafety,performanceandtestingforgeneralpurposenebulizingsystemsintendedforcontinuousorbreath-actuateddeliveryofliquids,inanaerosolform,tohumansthroughtherespiratorysystem.ThisInternationalStandardincludesgas-powerednebulizerswhichcanbepoweredby,forexample,compressors,pipelinesystems,cylinders,etc.,andelectrically-powerednebulizers[e.g.spinningdisc,ultrasonic,vibratingmesh(activeandpassive)andcapillarydevices]ormanually-powerednebulizers.*ThisInternationalStandarddoesnotapplytodevicesintendedfornasaldeposition.ThisInternationalStandarddoesnotapplytodevicesintendedsolelytoprovidehumidificationorhydrationbyprovidingwaterinaerosolform.*ThisInternationalStandarddoesnotapplytodrug-specificnebulizers(e.g.metereddoseinhalers,meteredliquidinhalers,drypowderinhalersandtheircomponents).
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:50P.;A4
【正文语种】:英语