ASTM F543 – Standard Specification and Test Methods for Metallic Medical Bone Screws

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:

  • Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.
  • Annex A2—Test Method for Driving Torque of Medical Bone Screws.
  • Annex A3—Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.
  • Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.
  • Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.
  • Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.
  • Annex A7—Specifications for Metallic Bone Screw Drive Connections.

This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.

Test results are shown below for each test method Annex.

ASTM F543 Graph 1

ASTM F543 Graph 2

ASTM F543 Graph 3

ASTM F543 Graph 4

Photos of Test