【英文标准名称】:StandardTestMethodforDetectingGrossLeaksinMedicalPackagingbyInternalPressurization(BubbleTest)
【原文标准名称】:通过内部加压(鼓泡试验)检测医用包装总泄漏量的标准试验方法
【标准号】:ASTMF2096-2004
【标准状态】:现行
【国别】:
【发布日期】:2004
【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】:F02.40
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:漏泄试验;鼓泡试验;包装手段;试验
【英文主题词】:bubbletest;internalpressurization;packageintegrity
【摘要】:Theinternalpressurizationtestmethodprovidesapracticalwaytoexaminepackagesforgrossleaks,whichmayrendertheproductnon-sterile.Thistestmethodisextremelyusefulinatestlaboratoryenvironmentwherenocommonpackagematerial/sizeexists.Thistestmethodmayapplytoverylargeorlongpackages,whichdonotfitintoanyotherpackageintegritytestmethodapparatus.Thistestmethodmaybeusedasameanstoevaluatepackageintegrity.Packageintegrityiscrucialtoconsumersafetysinceheatsealedpackagesaredesignedtoprovideacontaminationfreeandsterileenvironmenttotheproduct.1.1Thistestmethodcoversthedetectionofgrossleaksinmedicalpackaging.Methodsensitivityisdownto250956;mwithan81%probability(seeSection11).Thistestmethodmaybeusedfortrayandpouchpackages.1.2Thesensitivityofthistestmethodhasnotbeenevaluatedforusewithporousmaterialsotherthanspunbondedpolyolefinorwithnonporouspackaging.1.3Thistestmethodisdestructiveinthatitrequiresentryintothepackagetosupplyaninternalairpressure1.4ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A80
【国际标准分类号】:19_060;55_040
【页数】:5P.;A4
【正文语种】: