Absorbable Implant Plate Mechanical Strength Tester ASTM/ISO
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Whats/App: +86 156 1874 6768
Web: standard-groups.com
Standards
(1)ASTM F2119: Standard test method for constant load testing of bioabsorbable screws and washers, applicable to bending performance evaluation.
(2)ISO 10993-1: Biological evaluation of medical devices, ensuring compatibility with biodegradable material testing.
(3)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
(1)Load Capacity: 5 kN (axial) / 250 Nm (torsional).
(2)Force Resolution: 0.001 N (axial) / 0.0001 Nm (torsional).
(3)Displacement Accuracy: ±0.1 μm.
(4)Testing Modes:
Bending stiffness (ASTM F2119).
Bending strength (YY/T 0342 adaptation).
Creep testing (constant load over time).
(5)Software Suite:
Customizable test profiles with automated pass/fail criteria.
21 CFR Part 11 compliance for audit trails and electronic signatures.
(6)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 |
Accessoriess
(1)Standard Kit:
Four-point bending clamps (6mm, 9.5mm, 13mm rollers).
Calibration weights and digital torque wrench.
Test control software with preloaded SOPs.
(2)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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