Designation:F452−76(Reapproved2014)StandardSpecificationforPreformedCranioplastyPlates1ThisstandardisissuedunderthefixeddesignationF452;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverspreformedcranioplastyplateswhichdonotrequirefurtheralterationforcoveringskulldefects.Thisspecificationcoverscompositionalandphysicalperformanceandpackagingrequirements,butdoesnotcovertoxicitynorbiocompatibilityofthematerials.2.ReferencedDocuments2.1ASTMStandards:2F56SpecificationforStainlessSteelSheetandStripforSurgicalImplants(Withdrawn1989)3F75SpecificationforCobalt-28Chromium-6MolybdenumAlloyCastingsandCastingAlloyforSurgicalImplants(UNSR30075)F86PracticeforSurfacePreparationandMarkingofMetal-licSurgicalImplantsF139SpecificationforWrought18Chromium-14Nickel-2.5MolybdenumStainlessSteelSheetandStripforSur-gicalImplants(UNSS31673)2.2AmericanSocietyforQuality(ASQ)Standard:ASQC1SpecificationsofGeneralRequirementsforaQual-ityProgram43.Materials3.1CranioplastyplatesconformingtothisspecificationshallbefabricatedfrommaterialsdescribedinthelatestissueofSpecificationsF56,Grade2,F75,orF139,Grade2.Theconditionofthematerial(suchas,annealed,coldfinished,andsoforth)shouldbespecifiedinthepurchaseorder.4.DimensionsandTolerances4.1Cranioplastyplatesconformingtothisspecificationshallbefabricatedinavarietyofdimensionstoaccommodate,withoutfurtheralteration,varioussizedskulldefects.4.2Shapeshallbecontouredsoastore-establishthenormalconfigurationandsymmetryoftheskullatvariousanticipatedsitesofdefectsuchastheparietalbosses,theinion,thebrow,thelineatemporalis,andsoforth.4.3Platesshallcontainmultipleperforations(seeFig.1).4.4Thicknessesandindividualshapesshallvarywithneed.Thicknesstolerancesshallbeasfollows:SpecifiedThickness,in.(mm)ThicknessTolerances,in.(mm)0.005(0....
