Designation:F622–79(Reapproved2002)StandardSpecificationforPreformedCranioplastyPlatesThatCanBeAltered1ThisstandardisissuedunderthefixeddesignationF622;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(e)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverspreformedcranioplastyplatesthatallowalterationforcoveringskulldefects.2.ReferencedDocuments2.1ASTMStandards:F67SpecificationforUnalloyedTitanium(UNSR50250,UNSR50400,UNSR50550,R50700)forSurgicalImplantApplications2F86PracticeforSurfacePreparationandMarkingofMe-tallicSurgicalImplants2F90SpecificationforWroughtCobalt-20Chromium-15Tungsten-10NickelAlloyforSurgicalImplantApplica-tions(UNSR30605)2F136SpecificationforWroughtTitanium-6Aluminum-4–VanadiumELI(ExtraLowInterstitial)Alloy(UNSR56401)forSurgicalImplantApplications22.2ASQCStandard:C1-1968SpecificationsofGeneralRequirementsforaQualityProgram33.Terminology3.1Definition:3.1.1cranioplastyplate—animplantedprostheticdeviceusedtorepairorcoveraskulldefectorhole.4.Materials4.1CranioplastyplatesconformingtothisspecificationshallbefabricatedfromoneofthematerialscoveredbythefollowingASTMspecificationsorothersuchmaterialsfoundacceptableforneurosurgicalproceduresonly:F67,F90,andF136.5.DimensionsandTolerances5.1Cranioplastyplatesconformingtothisspecificationshallbefabricatedinavarietyofdimensionstoaccommodatevarioussizedskulldefects.Theseplatesmaybealteredintheoperatingroombytheneurosurgeoninordertofitaparticularskulldefect.5.2Theshapeoftheplateshallbecontouredsoastoreestablishthenormalconfigurationandsymmetryoftheskullatvariousanticipatedsitesofdefect,suchastheparietalbosses,theinion,thebrow,thelineatemporalis,andsoforth.5.3Platesshallcontainmultipleperforations.5.4Thicknessandindividualshapesshallvarywithneed.Thicknesstolerancesshallbeasfollows:SpecifiedThickness,in.(mm)Tolerances,in.(mm)0...
