Absorbable Bone-connecting Plates Four-point Bending Tester
Category：Medical Device Tester
Introduction
The Absorbable Bone-connecting Plates Four-point Bending Tester is a specialized testing machine designed to evaluate the mechanical performance of absorbable bone plates under bending loads. It uses a four-point bending setup to measure parameters such as bending strength, stiffness, and deformation, simulating physiological forces experienced in orthopedic applications. This device is essential for assessing the durability and structural integrity of biodegradable bone fixation implants before clinical use.
Standard
(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).
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 |
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.
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).
Maintenance Information
(1)Regularly clean the bending fixture and loading components to remove debris and prevent corrosion.
(2)Inspect mechanical parts, sensors, and load cells for wear or damage before each test session.
(3)Calibrate the load cell and displacement measurement system periodically according to manufacturer guidelines.
(4)Lubricate moving parts and ensure the hydraulic or electromechanical drive system operates smoothly.
FAQ
1.What is the purpose of this tester?
It evaluates the bending strength, stiffness, and deformation behavior of absorbable bone plates under four-point bending conditions.
2.What types of samples can be tested?
It is designed for absorbable bone-connecting plates and similar orthopedic implants within the specified size range.
3.How is the test performed?
The sample is mounted on a four-point bending fixture, and a controlled load is applied while recording force and displacement until failure or the target deformation.
4.How often should the machine be calibrated?
Load cells and displacement sensors should be calibrated regularly according to the manufacturer’s instructions to ensure test accuracy.
5.What maintenance is required?
Clean the fixture, inspect moving parts and sensors, lubricate mechanical components, and check hydraulic or electromechanical systems for proper operation.
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