ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws

This standard provides requirements for materials, coating and marking, care and use, and acceptable dimensions and tolerances for bone-implanted metallic bone screws. There is a wide variety of medical bone screws currently in use.

The following types of screws are used:

• HA type - spherical underside of the head, shallow, asymmetrical support thread and deep screw head,
• HB type - spherical underside of the head, deep, asymmetrical buttress thread and shallow screw head,
• HC type - conical lower surface of the head, symmetrical tooth,
• HD type - conical lower surface of the head, symmetrical teeth.

Torsional strength, breaking angle, axial tensile strength, insertion torque, self-tapping force and pull-out torque shall be tested to meet specified requirements.

This standard provides requirements for materials, coating and marking, care and use, and acceptable dimensions and tolerances for bone-implanted metallic bone screws. Dimensions and tolerances in this test apply only to metallic bone screws described in this standard.

This standard provides performance evaluations and standardized test methods for measuring mechanical properties in torsion of bone-implanted metallic bone screws. These test methods, dimensions and tolerances are applicable to other screws besides those specified here.

Multiple test methods are included in this standard. However, the user does not have to test using all of the methods described. Instead, the user should only select test methods that are justified and appropriate for a particular device design. This may be just a subset of the test methods described here.

This standard may include the use of hazardous materials, processes and equipment. This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices prior to use and to determine the applicability of regulatory restrictions.

EUROLAB assists manufacturers with ASTM F543-17 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.