Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F543 is a testing standard used exclusively in the biomedical industry that defines specifications for metallic medical bone screws. Bone screws are used in surgical procedures for securing implants, osteosynthesis devices, and fracture fixation plates to the skeletal system. In normal clinical use, a surgeon applies combined axial and torsional forces to implant a bone screw into the body. Bone screws are designated Class 2 FDA devices, requiring significant testing and analysis  of mechanical properties prior to approval and release.

ASTM F543-17 includes multiple annexes which address the properties related to the functional use of bone screws and the axial torsion forces associated with their use. The standard also includes geometric specifications for the design of these devices. The annexes include both purely torsional as well as biaxial testing for a complete evaluation of these devices.