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Bio-absorbable Internal Fixation Plates and Screws 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

  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.

Technical Parameters

ParameterSpecification
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)

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


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