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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