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

Parameter	Specification
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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