ASTM F543-01e1

ASTM F543-01e1 - 10.4.2002

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

9268	Implants for Surgery--Metal Bone Screws with Conical Under-Surface of Head--Dimensions
F1314-18	Standard Specification for Wrought Nitrogen Strengthened 22 Chromium-13 Nickel-5 Manganese-2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
F138-19	Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
F799-19	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)
F983-86(2018)	Standard Practice for Permanent Marking of Orthopaedic Implant Components
F1295-23	Standard Specification for Wrought Titanium-6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700)
F116-12(2021)	Standard Specification for Medical Screwdriver Bits
F136-13(2021)e1	Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) (Includes all amendments and changes 8/19/2021).
E4-21	Standard Practices for Force Calibration and Verification of Testing Machines
E6-23a	Standard Terminology Relating to Methods of Mechanical Testing (Includes all amendments and changes 3/29/2023).
E8-04	Standard Test Methods for Tension Testing of Metallic Materials
E122-17(2022)	Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
F86-21	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
10664	Hexalobular Internal Driving Feature for Bolts and Screws
F620-20	Standard Specification for Titanium Alloy Forgings for Surgical Implants in the Alpha Plus Beta Condition
F565-21	Standard Practice for Care and Handling of Orthopedic Implants and Instruments
F67-13(2017)	Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
F1472-23	Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
F1713-08(2021)e1	Standard Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications (UNS R58130) (Includes all amendments and changes 12/8/2021).
F1813-21	Standard Specification for Wrought Titanium-12Molybdenum-6Zirconium-2Iron Alloy for Surgical Implant (UNS R58120)
F1839-08(2021)	Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
F2066-23	Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)
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
8319-1	Orthopaedic Instruments--Drive connections--Part 1: Keys for use with hexagon socket heads
8319-2	Orthopaedic Instruments--Drive connections--Part 2: Screwdrivers for single slot head screws, screws with cruciate and cross-ecessed head screws
F1537-20	Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
F1586-21	Standard Specification for Wrought Nitrogen Strengthened 21Chromium—10Nickel—3Manganese—2.5Molybdenum Stainless Steel Alloy Bar for Surgical Implants (UNS S31675)