Absorbable Bone - connecting Plates Four - point Bending Tester
Производитель: Шанхайская компания Qianshi Precision Electromechanical Technology Co., Ltd
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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
- 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.
- 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.
- 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.
- 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).
- 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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