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】:
【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】:
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