Designation:F1327–05StandardTerminologyRelatingtoBarrierMaterialsforMedicalPackaging1ThisstandardisissuedunderthefixeddesignationF1327;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisterminologycontainsrelateddefinitionsandde-scriptionsoftermsusedorlikelytobeusedinmedicalpackagingstandardsthatinvolvebarriermaterials.Thepur-poseofterminologyistopromoteclearunderstandingandinterpretationofthestandardsinwhichtheyareused.2.ReferencedDocument2.1ASTMStandards:2F17TerminologyRelatingtoFlexibleBarrierMaterialsF1980GuideforAcceleratedAgingofSterileMedicalDevicePackages3.TerminologyDefinitionsacceleratedaging—atechniquetosimulatetheeffectsoftimeonapackagebysubjectingtheproduct/packagesystemtoelevatedtemperaturesinacontrolledenvironmentrepresen-tativeofcontrolledenvironmentstorageconditions.TheequivalenttimeisgenerallyestimatedbyassumingthedegradationofpackagingmaterialsfollowsthekineticsdescribedbytheArrheniusreactionratefunction,morediscussionofwhichisavailableinGuideF1980.adhesivetransfer—aconditionoccurringwhenanadhesive-coatedmaterialispeeledawayfromanopposingmaterialtowhichithasbeensealedandshowsvisibleevidenceoftheadhesivebeingleftontheopposingmaterial.Thisevidenceisintheformofanadhesivelayerthatremainswiththeopposingmaterial,theadhesivehavingseparatedeitheradhesivelyfromthecoatedweborcohesivelywithintheadhesiveitself.asepticpackaging—SeeTerminologyF17.barrier—SeeTerminologyF17.barriermaterials—specializedporousornonporouspackag-ingmaterialsthatprovideenvironmentalprotectiontothepackagecontentsaswellasprotectiontotheenvironmentfromthepackagecontents:(1)gas,vapor,humidity,liquid,microbial,orlightresistantmaterialsthatcontrolorelimi-natetheamountofthoseenvironmentalconstituentsthatpassintooroutofapackage;(2)aporousmaterialpreventingthepassageofm...
