Development and validation of a specialized system for self-tapping medical bone screw testing

Area of Science:

• Biomedical Engineering
• Materials Science

Background:

• Standardized testing of medical bone screws is crucial for ensuring patient safety and device efficacy.
• Existing methods may lack precision in evaluating self-tapping performance, particularly concerning insertion forces and alignment.

Purpose of the Study:

• To develop and validate a specialized system for accurate self-tapping medical bone screw testing.
• To meet and exceed ASTM F543-A4 (YY/T 1505-2016) standards for screw performance evaluation.

Main Methods:

• Automated identification of self-tap onset via torque curve slope analysis.
• Precise load control for accurate self-tapping force determination.
• Integrated mechanical platform for automatic axial alignment of screws with pilot holes.

Main Results:

• Consistent torque and axial force curves achieved through automated identification and alignment.
• Self-tapping time points from torque data correlate well with axial displacement turning points.
• Low mean values and standard deviations in determined self-tapping forces indicate high accuracy and repeatability.

Conclusions:

• The developed system effectively and accurately assesses the self-tapping performance of medical bone screws.
• This advancement contributes to refining standard test methods for bone screw characterization.
• The system's precision enhances the reliability of medical device testing and quality control.