Bio-absorbable Internal Fixation Plates and Screws Tester
Category：Medical Device Tester
Introduction
The Bio-absorbable Internal Fixation Plates and Screws Tester is a specialized mechanical testing device designed to evaluate the performance of bio-absorbable orthopedic implants. It measures properties such as bending strength, torsional stability, and pull-out resistance of plates and screws used in internal fixation. This tester simulates physiological loading conditions to ensure that implants can withstand mechanical stresses during healing, providing critical data for product development, quality control, and regulatory compliance in orthopedic applications.
Standard
(1)YY/T 0509-2009 (China): Specifies mechanical testing protocols for orthopedic plates/screws made of hydrolyzable polymers, including axial pull-out, torsion, and 4-point bending tests.
(2)ASTM F2502-17 (International): Defines methodologies for evaluating the structural integrity of bioabsorbable fixation devices under physiological loading.
(3)ISO 13779-4: Additional compliance for in vitro degradation testing of resorbable materials.
Technical Parameters
| Parameter | Specification |
|---|---|
| Max. Axial Force | ±5.000 N (0.001 N resolution) |
| Max. Torsional Moment | ±1 Nm (0.001 Nm resolution) |
| Bending Span | 40–120 mm (1 mm increments) |
| pH Control Range | 5.5–8.0 (0.1 resolution) |
| Temperature Control | 37±1°C (PT1000 sensor) |
| Data Sampling Rate | 10 kHz (synchronized across 8 channels) |
| Power Requirements | 220V/110V ±10%, 50/60Hz, 1.200W |
| Dimensions (W×D×H) | 500 × 450 × 750 mm |
| Weight | 75 kg (net) / 90 kg (with bath) |
| Noise Level | <50 dB (A-weighted) |
Features
(1)Electromagnetic Servo Actuator: 5 kN axial/1 Nm torsional capacity with programmable load ratios (R=0.1–10).
(2)4-Point Bending Fixture: Anatomical curvature adapters replicate physiological stress patterns.
(3)Dynamic pH Control: 37±1°C water bath with pH 5.5–8.0 adjustment for degradation studies.
(4)High-Resolution Imaging: Built-in 5MP camera system for crack/corrosion analysis.
(5)Safety Suite: Emergency stop, chemical-resistant enclosure, and leak detection.
(6)Touchscreen Interface: Intuitive controls with pre-loaded ASTM/YY test sequences.
Maintenance Information
(1)Keep the testing machine clean and free from dust or debris after each use.
(2)Regularly check and calibrate load cells, torque sensors, and displacement transducers.
(3)Lubricate moving parts and ensure fixtures are in good condition to prevent wear.
(4)Inspect electrical connections, software settings, and safety components periodically to maintain accurate and safe operation.
FAQ
1.What is the purpose of this tester?
It evaluates the mechanical performance of bio-absorbable plates and screws, including bending strength, torsion resistance, and pull-out strength, ensuring safety and compliance with medical standards.
2.What types of tests can be performed?
The tester supports four-point bending, torsion, and pull-out tests to measure maximum load, stiffness, deformation, and overall mechanical stability.
3.How are samples prepared for testing?
Plates and screws are mounted on the machine using the proper fixtures according to their size and geometry, ensuring alignment with load application points.
.4What safety precautions are needed?
Ensure the machine is calibrated, use proper personal protective equipment, and avoid contact with moving parts during operation.
5.How often should maintenance be performed?
Regular maintenance is recommended after each test session, including cleaning, lubrication, calibration, and inspection of sensors and fixtures to maintain accuracy and longevity.
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