Designation:D4196−05(Reapproved2011)StandardTestMethodforConfirmingtheSterilityofMembraneFilters1ThisstandardisissuedunderthefixeddesignationD4196;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethoddescribesatesttoconfirmthesterilityofeithermanufacturerpresterilizedoruser-sterilizedanalyticalmembranefilters.1.2ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D1129TerminologyRelatingtoWaterD1193SpecificationforReagentWater2.2OtherStandard:TheUnitedStatesPharmacopeia,CurrentEdition3(Sec-tionsonSterilizationandSterilityTesting)3.Terminology3.1Definitions—Fordefinitionsoftermsusedinthistestmethod,refertoTerminologyD1129.4.SummaryofTestMethod4.1Themembranefiltersareimmersedinsterileculturemediaandincubatedattemperaturesthataresuitableforgrowthofviablebacteria,fungi,andyeasts.Growthoforganismsisevidencethatthefilterhasfailedthetest.5.SignificanceandUse5.1Thistestmethodmaybeemployedtocheckthesterilityofcommerciallyprocuredsterilemembranefilters.Thetestalsoconfirmsthatsterilizedfiltershavenotbeencontaminated.Additionally,thistestmaybeusedtomonitortheefficacyofin-housesterilizationprocedures.Filterpackagesthathaveobviouspackagingdefectsshouldnotbetestedbecausesteril-itymayhavebeencompromised.6.ReagentsandMaterials6.1PurityofWater—Unlessotherwiseindicated,referencetowatershallbeunderstoodtomeanTypeIIreagentgradewaterinaccordancewithSpecificationD1193.6.2Media—Usecommerciallyavailabledehydratedmedia.Dissolveandsterili...
