Spinal Internal Fixation System Component Testing Machine

Standard

• YY/T 0119-2014 (China): Specifies mechanical testing protocols for spinal fixation components, including screws, plates, rods, and connectors.
• ASTM F2193-18 (International): Defines methodologies for evaluating the static and fatigue performance of spinal implant constructs.
• ISO 12189-1: Additional compliance for mechanical testing of spinal implant components under physiological loading.

Product Advantages

1. Universal Testing Compatibility: Modular design accommodates screws (3.5–7.5 mm), plates (20–100 mm length), and rods (4.5–6.5 mm diameter).
2. Multi-Axis Loading: Simultaneous axial/torsional/shear loading replicates complex in vivo stresses.
3. High-Frequency Stability: 0.1–15 Hz dynamic control with ±0.05% force accuracy.
4. Biorelevant Environment: Temperature-controlled (37±1°C) lubrication bath with protein skimmer.
5. AI-Powered Analytics: Machine learning algorithms predict failure modes from initial test cycles.
6. Regulatory Compliance: Pre-loaded protocols for FDA/CE submission requirements.

Product Features

• Electromagnetic Servo Actuators: 50 kN axial/25 Nm torsional capacity with programmable load ratios (R=0.1–10).
• 6-DOF Kinematic System: Replicates flexion/extension, lateral bending, and axial rotation (±20° range).
• Dynamic Load Control: 0.1–15 Hz frequency range with programmable waveforms (sine, square, random).
• Thermal-Mechanical Chamber: -20°C to +50°C temperature control with 10–95% RH humidity.
• High-Resolution Imaging: Built-in 5MP camera system for crack propagation analysis.
• Safety Suite: Emergency stop, overload clutches, and laser-based specimen breakage detection.

Technical Parameters

Parameter	Specification
Max. Axial Force	±50,000 N (50 N resolution)
Max. Torsional Moment	±25 Nm (0.1 Nm resolution)
Angular Range	±20° (0.001° resolution)
Frequency Range	0.1–15 Hz (0.01 Hz increments)
Load Ratio (R)	0.1–10 (adjustable)
Temperature Control	-20°C to +50°C (PT1000 sensors)
Humidity Control	10–95% RH (non-condensing)
Data Acquisition	100 kHz sampling rate (16-bit resolution)
Power Requirements	220V/110V ±10%, 50/60Hz, 3,500W
Dimensions (W×D×H)	2,200 × 1,600 × 2,300 mm
Weight	1,400 kg (including environmental chamber)
Noise Level	<65 dB (A-weighted)

Accessories

1. Spinal Component Fixture Kit:
   • Self-centering screw clamps (3.5–7.5 mm)
   • Plate/rod bending jigs with laser alignment
   • Universal connectors for hybrid constructs
2. Thermal-Mechanical Chamber:
   • 25L capacity with rapid cooling/heating (15°C/min)
   • 316L stainless steel interior with HEPA filtration
3. BioTest Pro Software:
   • Automated FEA validation and fatigue limit calculation
   • 21 CFR Part 11-compliant audit trail with blockchain timestamping
   • Remote monitoring via iOS/Android app
4. Operator Kit:
   • Calibrated torque wrench set (0.5–50 Nm)
   • Specimen alignment gauges (ASTM F2193 compliant)
5. Calibration Bundle:
   • NIST-traceable force/torque calibration weights
   • Angular encoder verification tool
6. Safety Kit:
   • Laser safety curtains
   • Acoustic enclosure with 30 dB noise reduction

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