【英文标准名称】:StandardSpecificationforHumidifiersforMedicalUse8212;Part1:GeneralRequirementsforActiveHumidificationSystems
【原文标准名称】:医用加湿器的标准规范.第1部分:自动加湿系统的一般要求
【标准号】:ASTMF1690-1996(2004)
【标准状态】:现行
【国别】:
【发布日期】:1996
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F29.14
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:医疗技术学;呼吸设备;加湿器
【英文主题词】:humidifiers;medicaluse;activehumidificationsystems
【摘要】:1.1TherequirementsgiveninClause1oftheGeneralStandardapplywiththefollowingadditionsandmodifications:1.1.1Replacewiththefollowing:1.1.1.1Thisspecificationincludesrequirementsforthesafetyandperformanceofactivevaporizingandnebulizinghumidificationsystems,asdefinedin3.1.6,suitableforinclusioninbreathingsystems(bothintubatedandnon-intubatedpatients).1.1.1.2Thisspecificationalsoincludesrequirementsforbreathingtubes,includingheatedbreathingtubes(heated-wirebreathingcircuits),anddevicesintendedtocontroltheseheatedbreathingtubes,heatedbreathingtubecontrollers.1.1.1.3Heatandmoistureexchangers(HMEs)areoutsidethescopeofthisspecification.However,itisrecognizedthattheirsafetyandperformancemayaffectthatofhumidificationsystems.NumerousstudieshavebeenpublishedcitingthebenefitsandrisksofHMEsusedinconjunctionwithhumidificationsystems.ItisadvisabletoreviewtheinstructionsforuseprovidedwiththehumidificationsystemsandHMEsandtheavailableliteratureformoredetails.1.1.1.4Devicescommonlyreferredtoas"roomhumidifiers,"humidifiersusedinheating,ventilation,andair-conditioningsystemsandhumidifiersusedtoconditiontheenvironmentwithininfantincubatorsareoutsidethescopeofthisspecification.1.1.1.5Ithasnotbeenfoundpossibletoincludeguidanceonthematterofdropletsizeinthecaseofnebulizinghumidifiers.1.1.1.6Gas-powerednebulizersusedforthedeliveryofdrugstopatientsthroughtheirrespiratorysystemareoutsidethescopeofthisspecification.1.1.1.7Appendicesinthisspecificationarenotmandatoryunlessmadesobyanexplicitstatementinthemaintext.1.2ThevaluesstatedinSIunitsaretoberegardedasthestandard.
【中国标准分类号】:C47
【国际标准分类号】:11_040_10;11_140;91_140_30
【页数】:17P.;A4
【正文语种】: