Designation:F564−10(Reapproved2015)StandardSpecificationandTestMethodsforMetallicBoneStaples1ThisstandardisissuedunderthefixeddesignationF564;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.1.Scope1.1Thisspecificationcoverscharacterizationofthedesignandmechanicalfunctionofmetallicstaplesusedintheinternalfixationofthemuscularskeletalsystem.Itisnottheintentionofthisspecificationtodescribeorspecifyspecificdesignsformetallicbonestaples.1.2Thisspecificationincludesthefollowingfourtestmeth-odsformeasuringmechanicalpropertiesofmetallicbonestaples:1.2.1TestMethodforConstantAmplitudeBendingFatigueTestsofMetallicBoneStaples—AnnexA1.1.2.2TestMethodforPull-OutFixationStrengthofMetal-licBoneStaples—AnnexA2.1.2.3TestMethodforSoftTissueFixationStrengthofMetallicBoneStaples—AnnexA3.1.2.4TestMethodforElasticStaticBendingofMetallicBoneStaples—AnnexA4.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappro-priatesafetyandhealthpracticesanddeterminetheapplica-bilityofregulatorylimitationspriortouse.2.ReferencedDocuments2.1ASTMStandards:2E4PracticesforForceVerificationofTestingMachinesE122PracticeforCalculatingSampleSizetoEstimate,WithSpecifiedPrecision,theAverageforaCharacteristicofaLotorProcessE467PracticeforVerificationofConstantAmplitudeDy-namicForcesinanAxialFatigueTestingSystemF75SpecificationforCobalt-28Chromium-6MolybdenumAlloyCastingsandCastingAlloyforSurgicalImplants(UNSR30075)F86PracticeforSurfacePreparationandMarkingofMetal-licSurgicalImplantsF382SpecificationandTestMethodforMetallicBonePlatesF565PracticeforCareandHandlingofOrthopedicImplantsandInstrumentsF601Practicef...
