Intramedullary Nails/Bone Screw Static Torque Testing Machine
Category：Medical Device Tester
Introduction
The Intramedullary Nails/Bone Screw Static Torque Testing Machine is a specialized mechanical testing device designed to measure the static torque and rotational resistance of intramedullary nails and bone screws. It evaluates the maximum torque they can withstand before failure, ensuring the mechanical reliability, safety, and compliance of orthopedic implants used in surgical applications. This tester is widely used in research, quality control, and regulatory testing for medical device manufacturers.
Standard
(1)YY/T 0591-2011: Chinese standard specifying torsion testing methods for intramedullary nails, including torque application, angular displacement measurement, and failure criteria.
(2)ASTM F1264: International standard covering mechanical testing of intramedullary fixation devices, with protocols for static and quasi-static torsion tests.
Technical Parameters
| Parameter | Specification |
|---|---|
| Torque Range | 0.1–500 Nm (torsional) |
| Angular Resolution | 0.001° |
| Rotational Speed | 0.01°–360°/min |
| Power Supply | 220V/110V, 50/60Hz |
| Dimensions (W×D×H) | 600×500×1.600 mm |
| Weight | 250 kg |
| Compliance | CE, ISO 13485. YY/T 0591. ASTM F1264 |
Features
(1)Torque Capacity: 0.1–500 Nm (torsional).
(2)Torque Resolution: 0.001 Nm.
Angular Accuracy: ±0.01°.
(3)Testing Modes:
Torsional rigidity (ASTM F1264).
Yield torque and failure angle (YY/T 0591).
Load-deflection curve analysis.
(4)Software Suite:
Customizable test profiles with automated pass/fail criteria.
21 CFR Part 11 compliance for audit trails and electronic signatures.
Calibration: NIST-traceable certification included, with annual recalibration available.
Maintenance Information
(1)Regularly clean the fixtures, grips, and testing area to prevent debris accumulation.
(2)Lubricate moving parts and the torque sensor according to the manufacturer’s guidelines.
(3)Calibrate the torque sensor periodically to ensure accurate measurements.
(4)Inspect electrical connections and control software for updates or malfunctions.
FAQ
1.What is the purpose of this machine?
It measures the static torque resistance of intramedullary nails and bone screws to assess their mechanical stability and safety.
2.What types of samples can be tested?
The machine can test metallic and bio-absorbable intramedullary nails, orthopedic bone screws, and similar internal fixation devices.
3.How is a test performed?
Samples are fixed in the testing fixture, torque is applied gradually, and maximum torque and failure points are recorded.
4.Why is torque testing important?
It ensures implants can withstand clinical rotational forces without loosening or failing, supporting implant design and quality control.
5.What safety precautions should be taken?
Ensure samples are securely clamped, avoid exceeding torque limits, and keep hands and tools clear of moving parts during testing.
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