Designation:F1608−16StandardTestMethodforMicrobialRankingofPorousPackagingMaterials(ExposureChamberMethod)1ThisstandardisissuedunderthefixeddesignationF1608;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethodisusedtodeterminethepassageofairbornebacteriathroughporousmaterialsintendedforuseinpackagingsterilemedicaldevices.Thistestmethodisdesignedtotestmaterialsunderconditionsthatresultinthedetectablepassageofbacterialsporesthroughthetestmaterial.1.1.1Around-robinstudywasconductedwithelevenlabo-ratoriesparticipating.EachlaboratorytestedduplicatesamplesofsixcommerciallyavailableporousmaterialstodeterminetheLogReductionValue(LRV)(seecalculationinSection12).MaterialstestedunderthestandardconditionsdescribedinthistestmethodreturnedaveragevaluesthatrangefromLRV1.7to4.3.1.1.2Resultsofthisround-robinstudyindicatethatcautionshouldbeusedwhencomparingtestdataandrankingmaterials,especiallywhenasmallnumberofsamplereplicatesareused.Inaddition,furthercollaborativework(suchasdescribedinPracticeE691)shouldbeconductedbeforethistestmethodwouldbeconsideredadequateforpurposesofsettingperformancestandards.1.2Thistestmethodrequiresmanipulationofmicroorgan-ismsandshouldbeperformedonlybytrainedpersonnel.TheU.S.DepartmentofHealthandHumanServicespublicationBiosafetyinMicrobiologicalandBiomedicalLaboratories(CDC/NIH-HHSPublicationNo.84-8395)shouldbecon-sultedforguidance.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E691PracticeforCon...
