Designation:F881−94(Reapproved2014)StandardSpecificationforSiliconeElastomerFacialImplants1ThisstandardisissuedunderthefixeddesignationF881;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverstherequirementsforsiliconeelastomerimplantsusedinfacialsurgery(thatis,chin,nasal,malar,andearimplants).1.2Limitations—Thisspecificationdoesnotcoverimplantscontainingsiliconegelsorothergelsorliquids.Itdoesnotnecessarilycoveranycustom-fabricatedprosthesismanufac-turedtoanyotherspecification.1.3Thefollowingsafetyhazardscaveatpertainsonlytothemechanicaltestingandtestmethodsportion,Section7,ofthisspecification:Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2D412TestMethodsforVulcanizedRubberandThermoplas-ticElastomers—TensionD624TestMethodforTearStrengthofConventionalVul-canizedRubberandThermoplasticElastomersD2240TestMethodforRubberProperty—DurometerHard-nessF604SpecificationforSiliconeElastomersUsedinMedicalApplications(Withdrawn2001)3F748PracticeforSelectingGenericBiologicalTestMethodsforMaterialsandDevicesF981PracticeforAssessmentofCompatibilityofBiomate-rialsforSurgicalImplantswithRespecttoEffectofMaterialsonMuscleandBoneF1251TerminologyRelatingtoPolymericBiomaterialsinMedicalandSurgicalDevices(Withdrawn2012)32.2OtherDocuments:UnitedStatesPharmacopeia,VolumeXX4FederalRegister,Title21,Part8205DowCorningCorporateTestMethod—CTM0930—Adhesion—OneHundredEightyDegreeShear—ThinElastometricSubstrates63.Terminology3.1Definitions:3.1.1fixationsite—anareaonthesurfaceoftheimplantwhichhasmaterialonitthatallowstissueingro...
