Designation:F2345−03(Reapproved2013)StandardTestMethodsforDeterminationofStaticandCyclicFatigueStrengthofCeramicModularFemoralHeads1ThisstandardisissuedunderthefixeddesignationF2345;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thesetestmethodscovertheevaluationofthestaticandcyclicfatiguestrengthofceramicmodularfemoralheads,mountedonaconeasusedonthefemoralstemofthetotalhiparthroplasty.1.2Thesetestmethodswereprimarilydevelopedforevalu-ationofceramic(SpecificationsF603andF1873)headdesignsonmetalconesbutmayhaveapplicationtoothermaterials.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E4PracticesforForceVerificationofTestingMachinesF603SpecificationforHigh-PurityDenseAluminumOxideforMedicalApplicationF1873SpecificationforHigh-PurityDenseYttriaTetragonalZirconiumOxidePolycrystal(Y-TZP)forSurgicalIm-plantApplications(Withdrawn2007)3F1875PracticeforFrettingCorrosionTestingofModularImplantInterfaces:HipFemoralHead-BoreandConeTaperInterface2.2OtherDocuments:DIN4768DeterminationofSurfaceRoughnessRa,Rz,andRmaxwithElectricStylusInstruments;BasicData4FDAGuidanceDocumentforthePreparationofPremarketNotificationsforCeramicBallHipSystems(draftJan.10,1995)53.Terminology3.1Definitions:3.1.1circularity—deviationsoftapercrosssectionfromaperfectcircle.3.1.2cone—theproximalendofthefemoralcomponentfabricatedasatruncatedrightconeandusedtoengagewithamatingconicalboreofthemodularfemoralhead.3.1.3coneangle—includedangleofcone(Fig.1).3.1.4...
