Designation:F2902−12StandardGuideforAssessmentofAbsorbablePolymericImplants1ThisstandardisissuedunderthefixeddesignationF2902;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisguidedescribesgeneralguidelinesforthechemical,physical,mechanical,biocompatibility,andpreclini-calassessmentsofimplantablesyntheticpolymericabsorbabledevices.Thisguidealsodescribesevaluationmethodsthatarepotentiallyusefulandshouldbeconsideredwhenassessingabsorbableimplantsorimplantcomponents.1.2Thedescribedevaluationsmayassistamanufacturerinestablishingthesafetyandeffectivenessofanabsorbableimplantdevice.Thislistingofassessmentmethodsmayalsobeutilizedtoassistinestablishingsubstantialequivalencetoanexistingcommerciallymarketeddevice.However,thesepoly-mericmaterial-orientedguidelinesdonotnecessarilyreflectthetotalneedsforanyparticularimplantapplication(forexample,orthopedic,cardiovascular),whichmayrequiread-ditionalandpotentiallyessentialapplication-specificevalua-tions.1.3Thisguideisintendedtocoverallformsofabsorbablepolymericcomponentsanddevices,includingsolid(forexample,injection-molded)andporous(forexample,fibrous)forms.Thisguideisalsointendedtocoverdevicesfabricatedfromamorphousand/orsemi-crystallineabsorbablepolymersystems.1.4Thisguidehasbeengeneratedwithprincipalemphasisontheevaluationofdevicesformedfromsyntheticpolymersthatdegradeinvivoprimarilythroughhydrolysis(forexample,α-hydroxy-polyesters).Evaluationmethodssuggestedhereinmayormaynotbeapplicabletoimplantsformedfrommaterialsthat,uponimplantation,aresubstantiallydegradedthroughothermechanisms(forexample,enzymaticaction).1.5Thisguidereferencesandgenerallydescribesvariousmeanstoassessabsorbablematerials,components,andde-vices.Theuserneedstorefertospecifictestmethodsforadditionaldetails.Additionally,someoftherecommen...
