Biodegradable Internal Fixation Device Tester

Standard

YY/T 0509-2009 (China): Specifies mechanical testing protocols for orthopedic plates/screws made of hydrolyzable polymers, including axial pull-out, torsion, and 4-point bending tests.

ASTM F2502-17 (International): Defines methodologies for evaluating the structural integrity of bioabsorbable fixation devices under physiological loading.

ISO 13779-4: Additional compliance for in vitro degradation testing of resorbable materials.

Product Advantages

Multi-Modal Testing: Single platform for axial pull-out, torsion, and 4-point bending tests.

Biodegradation Simulation: 37±1°C pH-controlled water bath with real-time conductivity monitoring.

High-Resolution Sensors: 0.001 N force/0.001 Nm torque resolution for fragile polymer testing.

Modular Fixturing: Self-centering clamps accommodate plates (20–100 mm) and screws (2.0–4.5 mm).

AI-Powered Analytics: Machine learning predicts degradation-induced strength loss over time.

Regulatory Compliance: Pre-loaded YY/T 0509/ASTM F2502 protocols with automated reporting.

Product Features

Electromagnetic Servo Actuator: 5 kN axial/1 Nm torsional capacity with programmable load ratios (R=0.1–10).

4-Point Bending Fixture: Anatomical curvature adapters replicate physiological stress patterns.

Dynamic pH Control: 37±1°C water bath with pH 5.5–8.0 adjustment for degradation studies.

High-Resolution Imaging: Built-in 5MP camera system for crack/corrosion analysis.

Safety Suite: Emergency stop, chemical-resistant enclosure, and leak detection.

Touchscreen Interface: Intuitive controls with pre-loaded ASTM/YY test sequences.

Accessories

Bioabsorbable Fixture Kit:

Self-centering plate clamps (20–100 mm compatibility)

Screw torque adapters (2.0–4.5 mm diameter)

pH-Controlled Water Bath:

15L capacity with recirculating pump

Corrosion-resistant titanium interior

BioTest Pro Software:

Automated degradation curve generation and strength retention analysis

21 CFR Part 11-compliant audit trail with blockchain timestamping

Remote monitoring via iOS/Android app

Operator Kit:

Calibrated torque wrench set (0.1–1 Nm)

Implant alignment jigs (ASTM F2502 compliant)

Calibration Bundle:

NIST-traceable force/torque calibration weights

pH electrode calibration solution

Safety Kit:

Chemical-resistant gloves

Acoustic enclosure with 25 dB noise reduction

Technical Parameters

Parameter	Specification
Max. Axial Force	±5.000 N (0.001 N resolution)
Max. Torsional Moment	±1 Nm (0.001 Nm resolution)
Bending Span	40–120 mm (1 mm increments)
pH Control Range	5.5–8.0 (0.1 resolution)
Temperature Control	37±1°C (PT1000 sensor)
Data Sampling Rate	10 kHz (synchronized across 8 channels)
Power Requirements	220V/110V ±10%, 50/60Hz, 1.200W
Dimensions (W×D×H)	500 × 450 × 750 mm
Weight	75 kg (net) / 90 kg (with bath)
Noise Level	<50 dB (A-weighted)

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