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Absorbable Bone - connecting Plates Four - point Bending Tester

Standard

  • ASTM F2119: Standard test method for constant load testing of bioabsorbable screws and washers, applicable to bending performance evaluation.
  • ISO 10993-1: Biological evaluation of medical devices, ensuring compatibility with biodegradable material testing.
  • YY/T 0342: Chinese standard for bending strength and stiffness testing of metallic bone plates (adapted for bioabsorbable materials).

Product Advantages

  1. Biodegradable Material Expertise:
    • Optimized for polymers (PLA, PGA) and composites, with adjustable test parameters to accommodate degradation-induced property changes.
    • Environmental control options (37°C ± 2°C, pH-regulated media) for simulating in-vivo conditions.
  2. Precision Four-Point Bending:
    • Electromagnetic load frame with ±0.1% force accuracy, ensuring compliance with ASTM F2119’s resolution requirements.
    • Adjustable span ratios (10:1 to 20:1) for tailored stress distribution analysis.
  3. Advanced Data Acquisition:
    • Real-time monitoring of force, displacement, and bending modulus with 5000Hz sampling rate.
    • Automatic calculation of key parameters: bending strength (MPa), flexural modulus (GPa), and strain-at-break.
  4. User-Centric Design:
    • Intuitive software with preloaded SOPs for ASTM F2119 and ISO 10993-1 compliance.
    • Multi-language interface (English/Chinese/Spanish) and exportable reports (PDF/Excel/CSV).
  5. Durability & Safety:
    • Corrosion-resistant components and overload protection system for long-term reliability.
    • Low-noise operation (<65 dB) suitable for laboratory environments.

Product Features

  • Load Capacity: 5 kN (axial) / 250 Nm (torsional).
  • Force Resolution: 0.001 N (axial) / 0.0001 Nm (torsional).
  • Displacement Accuracy: ±0.1 μm.
  • Testing Modes:
    • Bending stiffness (ASTM F2119).
    • Bending strength (YY/T 0342 adaptation).
    • Creep testing (constant load over time).
  • Software Suite:
    • Customizable test profiles with automated pass/fail criteria.
    • 21 CFR Part 11 compliance for audit trails and electronic signatures.
  • Calibration: NIST-traceable certification included, with annual recalibration available.

Technical Parameters

ParameterSpecification
Force Range 1 N–5 kN (axial)
Torque Range 0.01–250 Nm (torsional)
Crosshead Speed 0.001–500 mm/min
Temperature Range Ambient (optional: 37°C ± 2°C with chamber)
Power Supply 220V/110V, 50/60Hz
Dimensions (W×D×H) 500×400×1,200 mm
Weight 200 kg
Compliance CE, ISO 13485, ASTM F2119, ISO 10993-1

Accessories

  • Standard Kit:
    • Four-point bending clamps (6mm, 9.5mm, 13mm rollers).
    • Calibration weights and digital torque wrench.
    • Test control software with preloaded SOPs.
  • Optional Upgrades:
    • Environmental chamber (37°C, pH 7.4 simulated body fluid).
    • Custom fixturing for pediatric/specialized bioabsorbable plates.
    • Remote diagnostics and preventive maintenance package.
    • Creep testing module (constant load up to 1,000 hours).

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