Biodegradable Internal Fixation Device Tester
Standard
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.
ASTM F2502-17 (International): Defines methodologies for evaluating the structural integrity of bioabsorbable fixation devices under physiological loading.
ISO 13779-4: Additional compliance for in vitro degradation testing of resorbable materials.
Product Advantages
Multi-Modal Testing: Single platform for axial pull-out, torsion, and 4-point bending tests.
Biodegradation Simulation: 37±1°C pH-controlled water bath with real-time conductivity monitoring.
High-Resolution Sensors: 0.001 N force/0.001 Nm torque resolution for fragile polymer testing.
Modular Fixturing: Self-centering clamps accommodate plates (20–100 mm) and screws (2.0–4.5 mm).
AI-Powered Analytics: Machine learning predicts degradation-induced strength loss over time.
Regulatory Compliance: Pre-loaded YY/T 0509/ASTM F2502 protocols with automated reporting.
Product Features
Electromagnetic Servo Actuator: 5 kN axial/1 Nm torsional capacity with programmable load ratios (R=0.1–10).
4-Point Bending Fixture: Anatomical curvature adapters replicate physiological stress patterns.
Dynamic pH Control: 37±1°C water bath with pH 5.5–8.0 adjustment for degradation studies.
High-Resolution Imaging: Built-in 5MP camera system for crack/corrosion analysis.
Safety Suite: Emergency stop, chemical-resistant enclosure, and leak detection.
Touchscreen Interface: Intuitive controls with pre-loaded ASTM/YY test sequences.
Accessories
Bioabsorbable Fixture Kit:
Self-centering plate clamps (20–100 mm compatibility)
Screw torque adapters (2.0–4.5 mm diameter)
pH-Controlled Water Bath:
15L capacity with recirculating pump
Corrosion-resistant titanium interior
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
Operator Kit:
Calibrated torque wrench set (0.1–1 Nm)
Implant alignment jigs (ASTM F2502 compliant)
Calibration Bundle:
NIST-traceable force/torque calibration weights
pH electrode calibration solution
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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