Bone Screw Comprehensive Performance Test Bench is a specialized testing device designed to evaluate multiple mechanical properties of orthopedic implants—bone screws (cortical bone screws, cancellous bone screws, etc.). This equipment integrates multiple testing functions to comprehensively assess the mechanical performance of bone screws, ensuring their reliability and safety in clinical applications.
Torsional Strength Test: Fix the screw head and apply torsional load to the screw shaft; record the torque-torsion angle curve to determine failure torque.
Self-Tapping Performance Test: Insert the screw into pre-drilled simulated bone material at a constant rotational speed; record the torque variation during insertion; the peak self-tapping torque reflects the self-tapping performance.
Insertion and Extraction Torque Test: Insert the screw into simulated bone material to a specified depth (insertion torque), then reverse to extract (extraction torque) to evaluate fixation stability.
The Bone Screw Comprehensive Performance Test Bench typically complies with the following domestic and international standards:
| Standard No. | Standard Name | Test Content |
|---|---|---|
| ASTM F543 | Standard Specification and Test Methods for Metallic Medical Bone Screws | Torsion, self-tapping, insertion/extraction torque test methods for metallic bone screws |
| ISO 6475 | Implants for surgery — Metal bone screws with asymmetrical thread — Mechanical requirements and test methods | Mechanical requirements and test methods for asymmetrical thread metal bone screws |
| YY/T 0662 | Implants for surgery — Metal bone screws with asymmetrical thread — Mechanical requirements and test methods | Chinese industry standard corresponding to ISO 6475 |
| ASTM F1839 | Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments | Specification for rigid polyurethane foam used as simulated bone material for testing |
