Designation:D4196−05(Reapproved2019)StandardTestMethodforConfirmingtheSterilityofMembraneFilters1ThisstandardisissuedunderthefixeddesignationD4196;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethoddescribesatesttoconfirmthesterilityofeithermanufacturerpresterilizedoruser-sterilizedanalyticalmembranefilters.1.2ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafety,health,andenvironmentalpracticesanddeter-minetheapplicabilityofregulatorylimitationspriortouse.1.4Thisinternationalstandardwasdevelopedinaccor-dancewithinternationallyrecognizedprinciplesonstandard-izationestablishedintheDecisiononPrinciplesfortheDevelopmentofInternationalStandards,GuidesandRecom-mendationsissuedbytheWorldTradeOrganizationTechnicalBarrierstoTrade(TBT)Committee.2.ReferencedDocuments2.1ASTMStandards:2D1129TerminologyRelatingtoWaterD1193SpecificationforReagentWater2.2OtherStandard:TheUnitedStatesPharmacopeiaCurrentEdition3(SectionsonSterilizationandSterilityTesting)3.Terminology3.1Definitions:3.1.1Fordefinitionsoftermsusedinthisstandard,refertoTerminologyD1129.4.SummaryofTestMethod4.1Themembranefiltersareimmersedinsterileculturemediaandincubatedattemperaturesthataresuitableforgrowthofviablebacteria,fungi,andyeasts.Growthoforganismsisevidencethatthefilterhasfailedthetest.5.SignificanceandUse5.1Thistestmethodmaybeemployedtocheckthesterilityofcommerciallyprocuredsterilemembranefilters.Thetestalsoconfirmsthatsterilizedfiltershavenotbeencontaminated.Additionally,thistestmaybeusedtomonitortheefficacyofin-housesterilizationprocedures.Filterpackagesthathaveobviouspac...
