Designation:F1929−15StandardTestMethodforDetectingSealLeaksinPorousMedicalPackagingbyDyePenetration1ThisstandardisissuedunderthefixeddesignationF1929;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thistestmethoddefinesmaterialsandproceduresthatwilldetectandlocatealeakequaltoorgreaterthanachannelformedbya50µm(0.002in.)wireinpackageedgesealsformedbetweenatransparentmaterialandaporoussheetmaterial.Adyepenetrantsolutionisappliedlocallytothesealedgetobetestedforleaks.Aftercontactwiththedyepenetrantforaspecifiedtime,thepackageisvisuallyinspectedfordyepenetration.1.2Threedyeapplicationmethodsarecoveredinthistestmethod:injection,edgedip,andeyedropper.1.3Thesetestmethodsareintendedforuseonpackageswithedgesealsformedbetweenatransparentmaterialandaporoussheetmaterial.Thetestmethodsarelimitedtoporousmaterialswhichcanretainthedyepenetrantsolutionandpreventitfromdiscoloringthesealareaforaminimumof5seconds.Uncoatedpapersareespeciallysusceptibletoleakageandmustbeevaluatedcarefullyforusewitheachtestmethod.1.4Thesetestmethodsrequirethatthedyepenetrantsolutionhavegoodcontrasttotheopaquepackagingmaterial.1.5ThevaluesarestatedinInternationalSystemofUnits(SIunits)andEnglishunits.Eitheristoberegardedasstandard.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2F17TerminologyRelatingtoFlexibleBarrierPackaging2.2ANSIStandards:3Z1.4SamplingProceduresandTablesforInspectionbyAttributes3.Terminology3.1wicking—themigrationofaliquidintothebodyofafibrousmaterial.ThisisdistinctfromaleakasdefinedinTerminologyF17.3.2dyepenetrant—anaqueoussolutionofadye...