Designation:F619−14StandardPracticeforExtractionofMedicalPlastics1ThisstandardisissuedunderthefixeddesignationF619;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticecoversmethodsofextractionofmedicalplasticsandmaybeapplicabletoothermaterials.Thispracticeidentifiesamethodforobtaining“extractliquid”foruseindeterminingthebiologicalresponseinpreclinicaltesting.Furthertestingofthe“extractliquid”isspecifiedinotherASTMstandards.Theextractmayundergochemicalanalysisaspartofthepreclinicalevaluationofthebiologicalresponse,andthematerialafterextractionmayalsobeexamined.1.2Thispracticemaybeusedfor,butisnotlimitedtothefollowingareas:partialevaluationofrawmaterials,auditingmaterialswithinthemanufacturingprocess,andtestingfinalproducts.Thispracticemayalsobeusedasarefereemethodforthemeasurementofextractablesinplasticsusedinmedicaldevices.1.3Thispracticewasinitiallydevelopedforextractionofmedicalplasticsnotintendedtoundergodegradationorab-sorptionduringnormalmedicaldeviceusage.Whenappliedtotheextractionofabsorbablematerials,additionalconsider-ationsmaybenecessaryintheselectionofextractionproce-duresandfluids.1.4Thevaluesstatedininch-poundunitsaretoberegardedasstandard.ThevaluesgiveninparenthesesaremathematicalconversionstoSIunitsthatareprovidedforinformationonlyandarenotconsideredstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D543PracticesforEvaluatingtheResistanceofPlasticstoChemicalReagentsD570TestMethodforWaterAbsorptionofPlasticsD1193SpecificationforReagentWaterD1239TestMethodforResistanceofPlasticFilmstoExtr...
