Bio-absorbable Internal Fixation Plates and Screws Tester

標準

• 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

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

• 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.

技術パラメータ

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