Designation:F624−09(Reapproved2015)´1StandardGuideforEvaluationofThermoplasticPolyurethaneSolidsandSolutionsforBiomedicalApplications1ThisstandardisissuedunderthefixeddesignationF624;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.ε1NOTE—Section1.2waseditoriallycorrectedinMay2015.1.Scope1.1Thisguidecoverstheevaluationofthermoplasticpoly-urethanesinbothsolidandsolutionformforbiomedicalapplications.Thepolymershavebeenreactedtocompletionandrequirenofurtherchemicalprocessing.1.2Thetestsandmethodslistedinthisguidemaybereferencedinspecificationscontainingminimumrequiredvaluesandtolerancesforspecificend-useproducts.1.3Standardtestsforbiocompatibilityareincludedtoaidintheassessmentofsafeutilizationinbiomedicalapplications.Compliancewiththesecriteriashallnotbeconstruedasanendorsementofimplantability.Sincemanycompositions,formulations,andformsofthermoplasticpolyurethanesinsolidandsolutionformsarewithinthismaterialclass,theformulatororfabricatormustevaluatethebiocompatibilityofthespecificcompositionorformintheintendeduseandaftercompletionofallmanufacturingprocessesincludingsteriliza-tion.1.4Purchasespecificationsmaybepreparedbyagreementbetweenthebuyerandsellerbyselectionofappropriatetestsandmethodsfromthoselistedapplicabletothespecificbiomedicalenduse.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D149TestMethodforDielectricBreakdownVoltageandDielectricStrengthofSolidElectricalInsulatingMaterialsatCommercialPowerFrequenciesD150TestMethodsforACLossCharacteristicsandPermit-tivity(DielectricConstant)ofSolidElectricalInsulationD257TestMeth...
