ASTM D4196-2005 确定膜过滤器的无菌性的标准试验方法

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【英文标准名称】:StandardTestMethodforConfirmingtheSterilityofMembraneFilters
【原文标准名称】:确定膜过滤器的无菌性的标准试验方法
【标准号】:ASTMD4196-2005
【标准状态】:现行
【国别】:
【发布日期】:2005
【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】:D19.08
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:薄膜材料;无菌;膜过滤器;水;过滤器;试验;灭菌(卫生)
【英文主题词】:filters;membrane;sterility
【摘要】:Thistestmethodmaybeemployedtocheckthesterilityofcommerciallyprocuredsterilemembranefilters.Thetestalsoconfirmsthatsterilizedfiltershavenotbeencontaminated.Additionally,thistestmaybeusedtomonitortheefficacyofin-housesterilizationprocedures.Filterpackagesthathaveobviouspackagingdefectsshouldnotbetestedbecausesterilitymayhavebeencompromised.1.1Thistestmethoddescribesatesttoconfirmthesterilityofeithermanufacturerpresterilizedoruser-sterilizedanalyticalmembranefilters.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyproblems,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:N64
【国际标准分类号】:11_080_99
【页数】:2P.;A4
【正文语种】: