Bio-absorbable Internal Fixation Plates and Screws Tester
Whats/App: +86 156 1874 6768
Web: standard-groups.com
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.
Product Advantages
(1)Multi-Modal Testing: Single platform for axial pull-out, torsion, and 4-point bending tests.
(2)Biodegradation Simulation: 37±1°C pH-controlled water bath with real-time conductivity monitoring.
(3)High-Resolution Sensors: 0.001 N force/0.001 Nm torque resolution for fragile polymer testing.
(4)Modular Fixturing: Self-centering clamps accommodate plates (20–100 mm) and screws (2.0–4.5 mm).
(5)AI-Powered Analytics: Machine learning predicts degradation-induced strength loss over time.
(6)Regulatory Compliance: Pre-loaded YY/T 0509/ASTM F2502 protocols with automated reporting.
Product 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.
Accessories
(1)Bioabsorbable Fixture Kit:
Self-centering plate clamps (20–100 mm compatibility)
Screw torque adapters (2.0–4.5 mm diameter)
(2)pH-Controlled Water Bath:
15L capacity with recirculating pump
Corrosion-resistant titanium interior
(3)BioTest Pro Software:
Automated degradation curve generation and strength retention analysis
21 CFR Part 11-compliant audit trail with blockchain timestamping
Remote monitoring via iOS/Android app
(4)Operator Kit:
Calibrated torque wrench set (0.1–1 Nm)
Implant alignment jigs (ASTM F2502 compliant)
(5)Calibration Bundle:
NIST-traceable force/torque calibration weights
pH electrode calibration solution
(6)Safety Kit:
Chemical-resistant gloves
Acoustic enclosure with 25 dB noise reduction
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) |
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