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

A specialized system for accurate self-tapping medical bone screw testing is developed, fully meeting the requirements of ASTM F543-A4 (YY/T 1505-2016). The onset of self-tap is identified automatically according to a change in the slope of the torque curve. Precise load control is applied to determine the self-tapping force accurately. A simple mechanical platform is embedded to ensure the automatic axial alignment of a tested screw with the pilot hole in a test block. In addition, comparative experiments are conducted on different self-tapping screws to verify the system's effectiveness. By the automatic identification and alignment method, both torque curves and axial force curves for each screw exhibit significant consistency. The self-tapping time point derived from the torque curve agrees well with the turning point of the axial displacement curve. The determined self-tapping forces' mean values and standard deviations are both small, which are proved to be effective and accurate in the insertion tests. This work contributes to improving the standard test method for accurate determination of the self-tapping performance of medical bone screws.

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Declaration of Competing Interest We declare that we have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.