ASTM_F_543_-_13e1.pdf

Designation:F543131Standard Specification and Test Methods forMetallic Medical Bone Screws1This standard is issued under the fixed designation F543;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1NOTEAnnex A6 was corrected editorially and portions of the standard were reformatted in December 2013.1.Scope1.1 This specification provides requirements for materials,finish and marking,care and handling,and the acceptabledimensions and tolerances for metallic bone screws that areimplanted into bone.The dimensions and tolerances in thisspecification are applicable only to metallic bone screwsdescribed in this specification.1.2 This specification provides performance considerationsand standard test methods for measuring mechanical propertiesin torsion of metallic bone screws that are implanted into bone.These test methods may also be applicable to other screwsbesides those whose dimensions and tolerances are specifiedhere.The following annexes are included:1.2.1 Annex A1Test Method for Determining the Tor-sional Properties of Metallic Bone Screws.1.2.2 Annex A2Test Method for Driving Torque of Medi-cal Bone Screws.1.2.3 Annex A3Test Method for Determining the AxialPullout Strength of Medical Bone Screws.1.2.4 Annex A4Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.1.2.5 Annex A5Specifications for Type HA and Type HBMetallic Bone Screws.1.2.6 Annex A6Specifications for Type HC and Type HDMetallic Bone Screws.1.2.7 Annex A7Specifications for Metallic Bone ScrewDrive Connections.1.3 This specification is based,in part,upon ISO 5835,ISO6475,and ISO 9268.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 Multiple test methods are included in this standard.However,it must be noted that the user is not obligated to testusing all of the described methods.Instead,the user shouldonly select test methods that are appropriate for a particulardevice design.In most instances,only a subset of the hereindescribed test methods will be required.1.6 This standard may involve the use of hazardousmaterials,operations,and equipment.This standard does notpurport to address all of the safety concerns,if any,associatedwith its use.It is the responsibility of the user of this standardto establish appropriate safety and health practices anddetermine the applicability of regulatory limitations prior touse.2.Referenced Documents2.1 ASTM Standards:2E4 Practices for Force Verification of Testing MachinesE6 Terminology Relating to Methods of Mechanical TestingE8 Test Methods for Tension Testing of Metallic MaterialsE122 Practice for Calculating Sample Size to Estimate,WithSpecified Precision,the Average for a Characteristic of aLot or ProcessF67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF116 Specification for Medical Screwdriver BitsF136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy for SurgicalImplant Applications(UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF620 Specification for Titanium Alloy Forgings for SurgicalImplants in the Alpha Plus Beta ConditionF799 Specification for Cobalt-28Chromium-6Molybdenum1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved May 1,2013.Published June 2013.Originallyapproved in 1977.Last previous edition approved in 2009 as F543 071.DOI:10.1520/F0543-13E01.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 Alloy Forgings for Surgical Implants(UNS R31537,R31538,R31539)F983 Practice for Permanent Marking of Orthopaedic Im-plant ComponentsF1295 Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications(UNSR56700)F1314 Specification for Wrought Nitrogen Strengthened 22Chromium13 Nickel5 Manganese2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications(UNSR56400)F1537 Specification for Wrought Cobalt-28Chro