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

ASTM F543 is a critical standard developed by ASTM International, outlining specifications and test methods for 

metallic bone screws used in orthopedic and trauma surgeries. These screws are essential for fracture fixation, spinal 

fusion, and other reconstructive procedures. The standard ensures their mechanical performance, safety, and reliability.

Scope and Importance

ASTM F543 covers:

Material Requirements: Specifies acceptable metals (e.g., stainless steel, titanium alloys).

Dimensional Criteria: Defines screw geometry (diameter, pitch, length).

Mechanical Testing: Evaluates performance under surgical conditions.

Testing instrument:PBSC-RP30 Bone screw performance tester

PBSC-RP30接骨螺钉性能测试仪1

PBSC-RP30接骨螺钉性能测试仪1

Key Test Methods

Axial Pullout Strength (F543-17): Measures screw resistance to extraction from a material simulating bone.

Torsional Yield Strength (F543-21): Assesses the torque required to cause plastic deformation.

Bending Strength (F543-23): Evaluates resistance to bending forces.

Drive Recess Integrity (F543-24): Tests the screw head’s durability during insertion.

Clinical Relevance

Compliance with ASTM F543 ensures screws withstand physiological loads without failure. Surgeons and manufacturers 

rely on this standard to optimize screw design and material selection, improving patient outcomes.

Conclusion

ASTM F543 plays a pivotal role in standardizing bone screw performance, enhancing surgical success, and advancing 

orthopedic innovation. Regular updates reflect evolving medical technology and biomechanical research.

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