Designation:F1800−12StandardPracticeforCyclicFatigueTestingofMetalTibialTrayComponentsofTotalKneeJointReplacements1ThisstandardisissuedunderthefixeddesignationF1800;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thispracticecoversaprocedureforthefatiguetestingofmetallictibialtraysusedinkneejointreplacements.Thispracticecoverstheproceduresfortheperformanceoffatiguetestsonmetallictibialcomponentsusingacyclic,constant-amplitudeforce.Itappliestotibialtrayswhichcoverboththemedialandlateralplateausofthetibia.Thispracticemayrequiremodificationstoaccommodateothertibialtraydesigns.1.2Thispracticeisintendedtoprovideuseful,consistent,andreproducibleinformationaboutthefatigueperformanceofmetallictibialtrayswithoneunsupportedcondyle.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E4PracticesforForceVerificationofTestingMachinesE467PracticeforVerificationofConstantAmplitudeDy-namicForcesinanAxialFatigueTestingSystemE468PracticeforPresentationofConstantAmplitudeFa-tigueTestResultsforMetallicMaterialsE1150DefinitionsofTermsRelatingtoFatigue(Withdrawn1996)33.Terminology3.1Definitions:3.1.1Rvalue—TheRvalueistheratiooftheminimumloadtothemaximumload.R5minimumloadmaximumload(1)3.2DefinitionsofTermsSpecifictoThisStandard:3.2.1anteroposteriorcenterline—alinethatpassesthroughthecenterofthetibialtray,paralleltothesagittalplaneandperpendiculartothelineofloadapplication.Forasymmetrictibialtraydesigns,theappropriatecenterofthetibialtrayshall...
