Designation:D7161−05(Reapproved2010)StandardPracticeforDeterminationofRealTimeExpirationDatingofMatureMedicalGlovesStoredUnderTypicalWarehouseConditions1ThisstandardisissuedunderthefixeddesignationD7161;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticecoversallsurgeon’sandexaminationgloves,madefromeithersyntheticornaturalrubberlatex,marketedatthetimethispracticeispublished,forwhichthereisnopreviousrealtimeagingdataavailable,andforwhichthereareatleast12monthsofstorageasfinishedgoodsundertypicalwarehouseconditions.Thispracticedescribeshowtodeveloprealtimeagingdataforglovesthatarepartoffinishedgoodsinventory(includingglovesthatmaynolongerbemanufactured)inordertoverifytheestimatedexpirationdate(seeNote1).ManufacturersmayusethisdataasastartingpointforrealtimeagingstudiesasdescribedinPracticeD7160.NOTE1—Acceleratedagingforthree-yearshelflifeisdescribedinPracticeD7160.1.2Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D412TestMethodsforVulcanizedRubberandThermoplas-ticElastomers—TensionD3078TestMethodforDeterminationofLeaksinFlexiblePackagingbyBubbleEmissionD3577SpecificationforRubberSurgicalGlovesD3578SpecificationforRubberExaminationGlovesD5151TestMethodforDetectionofHolesinMedicalGlovesD5250SpecificationforPoly(vinylchloride)GlovesforMedicalApplicationD6319SpecificationforNitrileExaminationGlovesforMedicalApplicationD7160PracticeforDeterminationofExpirationDatingforMedicalGlovesF88TestMethodforSealStrengthofFlexibleBarrierMaterialsF1929TestMethodforDetectingSealLeaksinPorousMedicalPackagingbyDyePenetration2.2ISO...
