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F543-02 Standard Specification and Test Methods for Metallic Medical Bone Screws
F543-02 Standard Specification and Test Methods for Metallic Medical Bone Screws
Developed by Subcommittee: F04.21
DOD Adopted;
Book of Standards Volume: 13.01
1. Scope
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.
1.2.4 Annex A4—Specifications for Type HA and Type HB Metallic Bone Screws.
1.2.5 Annex A5—Specifications for Type HC and Type HD Metallic Bone Screws.
1.2.6 Annex A6—Specifications for Metallic Bone Screw Drive Connections.
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.
1.4 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given for information only.
1.5 This standard may involve the use of hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents
E4 Practices for Force Verification of Testing Machines
E6 Terminology Relating to Methods of Mechanical Testing
E8 Test Methods for Tension Testing of Metallic Materials
E122 Practice for Calculating Sample Size to Estimate, With a Specified Tolerable Error, the Average for a Characteristic of a Lot or Process
F67 Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, R50400, R50550, R50700)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F116 Specification for Medical Screwdriver Bits
F136 Specification for Wrought Titanium - 6Aluminum - 4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F620 Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants
F799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
F983 Practice for Permanent Marking of Orthopedic Implant Components
F1295 Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications [UNS R56700]
F1314 Specification for Wrought Nitrogen Strengthened-22Chromium-12.5Nickel-5Manganese-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants
F1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
F1586 Specification for Wrought Nitrogen Strengthened-21Chromium-10Nickel-3Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants
F1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications
F1813 Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant Applications (UNS R58120)
F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
5835 Implants for Surgery-Metal Bone Screws with Hexagonal Driver Connection, Spherical Under Surface of Head, Asymmetrical Thread-Dimensions
6475 Implants for Surgery-Metal Bone Screws with Asymmetrical Thread and Spherical Under-Surface-Mechanical Requirements and Test Methods
9268 Implants for Surgery-Metal Bone Screws with Conical Under-Surface of Head-Dimensions
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