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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

ParameterSpecification
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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