ASTM F543 Standard Test for Metallic Bone Screws

ASTM F543 is a testing standard used by the medical device industry to conduct quality control assessments in the manufacturing and use processes of metallic bone screws.

The specification describes four inserts, each designed to test a specific set of mechanical properties. This is a general guide aimed at helping you understand the basic test procedure and the equipment needed to correctly complete each test.

Test procedure

• Fix the sample with five threads or 20% of the sample exposed. Make sure that the clamping mechanism prevents the sample from rotating.
• Drive the sample at the specified speed.
• Record the axial load required to hold the screwdriver bit in the screw head.

Test Analysis

• Torsional Offset Yield Strength is determined at an offset of 2 degrees using the torque-rotation angle curve.
• Maximum Torque is determined by the largest value on the torque-to-rotation angle curve.
• The Angle of Fracture is the point where the torque portion of the curve shows the fastest descent to full failure.

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 and to determine the applicability of regulatory restrictions prior to use.

EUROLAB assists manufacturers with ASTM F543 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.