ASTM F2638-2007 使用气溶胶过滤测量替代微生物物障的疏松包装材料性能的标准试验方法

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【英文标准名称】:StandardTestMethodforUsingAerosolFiltrationforMeasuringthePerformanceofPorousPackagingMaterialsasaSurrogateMicrobialBarrier
【原文标准名称】:使用气溶胶过滤测量替代微生物物障的疏松包装材料性能的标准试验方法
【标准号】:ASTMF2638-2007
【标准状态】:现行
【国别】:
【发布日期】:2007
【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】:F02.15
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:气溶胶;物障;过滤;测量;包装材料;性能;疏松材料;测试
【英文主题词】:filtrationefficiency;medicalpackaging;microbialbarrier;microbialchallenge;particulatebarrier;porouspackaging;sterilebarrier;sterilepackaging
【摘要】:1.1Thistestmethodmeasurestheaerosolfiltrationperformanceofporouspackagingmaterialsbycreatingadefinedaerosolof1.0mparticlesandassessingthefiltrationefficiencyofthematerialusingeithersingleordualparticlecounters.1.2Thistestmethodisapplicabletoporousmaterialsusedtopackageterminallysterilizedmedicaldevices.1.3Theintentofthistestmethodistodeterminetheflowratethroughamaterialatwhichmaximumpenetrationoccurs.Theporousnatureofsomematerialsusedinsterilepackagingapplicationsmightprecludeevaluationbymeansofthistestmethod.Themaximumpenetrationpointofaparticularmaterialcouldoccurataflowratethatexceedstheflowcapacityofthetestapparatus.Assuch,thistestmethodmaynotbeusefulforevaluatingthemaximumpenetrationpointofmaterialswithaBendtsenflowrateabove4000mL/minasmeasuredbyISO5636-3.1.4ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A82
【国际标准分类号】:55_040
【页数】:17P.;A4
【正文语种】: