Bio-absorbable Internal Fixation Plates and Screws Tester

供应商: 标准集团

供应产品

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.

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.

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.

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)

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

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