Designation:F755−99(Reapproved2011)StandardSpecificationforSelectionofPorousPolyethyleneforUseinSurgicalImplants1ThisstandardisissuedunderthefixeddesignationF755;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoversthepropertiesandtestmeth-odsforporoushighdensityandultrahighmolecularweightpolyethylenesintendedforuseinsurgicalimplants.Theporouspolyethylenemaybeusedasafreestandingproductorasacoatingonasubstrateinnonloadedapplications.1.2Evaluationoftissueresponsetoaporouspolyethylenemustbecompleted.Guidanceinestablishingbiocompatibilitymaybefoundinthelistofreferences.1.3Clinicalexperienceandanimalstudieshaveshownthattissuewillgrowintotheopenporesofporouspolyethylene.Thetissueingrowthintotheporesmayallowfortheestablish-mentofimplantfixation.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thissectiondoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D638TestMethodforTensilePropertiesofPlasticsD732TestMethodforShearStrengthofPlasticsbyPunchToolD790TestMethodsforFlexuralPropertiesofUnreinforcedandReinforcedPlasticsandElectricalInsulatingMateri-alsD883TerminologyRelatingtoPlasticsD1238TestMethodforMeltFlowRatesofThermoplasticsbyExtrusionPlastometerD1505TestMethodforDensityofPlasticsbytheDensity-GradientTechniqueD1621TestMethodforCompressivePropertiesofRigidCellularPlasticsD1623TestMethodforTensileandTensileAdhesionProp-ertiesofRigidCellularPlasticsD1898PracticeforSamplingofPlastics(Withdrawn1998)3D2238TestMethodsforAbsorbanceofPolyethyleneDuetoMethylGroupsat1378cm−1D28...
