Designation:F543−13´1StandardSpecificationandTestMethodsforMetallicMedicalBoneScrews1ThisstandardisissuedunderthefixeddesignationF543;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginaladoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.ε1NOTE—AnnexA6wascorrectededitoriallyandportionsofthestandardwerereformattedinDecember2013.1.Scope1.1Thisspecificationprovidesrequirementsformaterials,finishandmarking,careandhandling,andtheacceptabledimensionsandtolerancesformetallicbonescrewsthatareimplantedintobone.Thedimensionsandtolerancesinthisspecificationareapplicableonlytometallicbonescrewsdescribedinthisspecification.1.2Thisspecificationprovidesperformanceconsiderationsandstandardtestmethodsformeasuringmechanicalpropertiesintorsionofmetallicbonescrewsthatareimplantedintobone.Thesetestmethodsmayalsobeapplicabletootherscrewsbesidesthosewhosedimensionsandtolerancesarespecifiedhere.Thefollowingannexesareincluded:1.2.1AnnexA1—TestMethodforDeterminingtheTor-sionalPropertiesofMetallicBoneScrews.1.2.2AnnexA2—TestMethodforDrivingTorqueofMedi-calBoneScrews.1.2.3AnnexA3—TestMethodforDeterminingtheAxialPulloutStrengthofMedicalBoneScrews.1.2.4AnnexA4—TestMethodforDeterminingtheSelf-TappingPerformanceofSelf-TappingMedicalBoneScrews.1.2.5AnnexA5—SpecificationsforTypeHAandTypeHBMetallicBoneScrews.1.2.6AnnexA6—SpecificationsforTypeHCandTypeHDMetallicBoneScrews.1.2.7AnnexA7—SpecificationsforMetallicBoneScrewDriveConnections.1.3Thisspecificationisbased,inpart,uponISO5835,ISO6475,andISO9268.1.4ThevaluesstatedinSIunitsaretoberegardedasstandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Multipletestmethodsareincludedinthisstandard.However,itmustbenotedthattheuserisnotobligatedtotestusingallofthedescribedmethods.Instead,theusershouldonlyselecttestmethodsthatareappropriateforaparticulardevicedesign.Inmostinstances,onlyasu...
