Designation:F2638−12StandardTestMethodforUsingAerosolFiltrationforMeasuringthePerformanceofPorousPackagingMaterialsasaSurrogateMicrobialBarrier1ThisstandardisissuedunderthefixeddesignationF2638;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodmeasurestheaerosolfiltrationperfor-manceofporouspackagingmaterialsbycreatingadefinedaerosolof1.0µmparticlesandassessingthefiltrationeffi-ciencyofthematerialusingeithersingleordualparticlecounters.1.2Thistestmethodisapplicabletoporousmaterialsusedtopackageterminallysterilizedmedicaldevices.1.3Theintentofthistestmethodistodeterminetheflowratethroughamaterialatwhichmaximumpenetrationoccurs.Theporousnatureofsomematerialsusedinsterilepackagingapplicationsmightprecludeevaluationbymeansofthistestmethod.Themaximumpenetrationpointofaparticularmate-rialcouldoccurataflowratethatexceedstheflowcapacityofthetestapparatus.Assuch,thistestmethodmaynotbeusefulforevaluatingthemaximumpenetrationpointofmaterialswithaBendtsenflowrateabove4000mL/minasmeasuredbyISO5636–3.1.4ThevaluesstatedinSIunitsaretoberegardedasthestandard.Thevaluesgiveninparenthesesareforinformationonly.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E177PracticeforUseoftheTermsPrecisionandBiasinASTMTestMethodsE691PracticeforConductinganInterlaboratoryStudytoDeterminethePrecisionofaTestMethod2.2ISOStandard:3ISO5636–3PaperandBoard—DeterminationofAirPer-meance(MediumRange)—Part3:BendtsenMethod3.Terminology3.1Definitions:3.1.1challengeaerosol—asufficientquantityofaerosolized1.0µmparticlesthatenableeffectiveparticleco...
