Spinal Internal Fixation Components System Tester

• 

Standard

• YY/T 0961-2014 (China): Specifies static/fatigue testing protocols for spinal fixation systems, including connection integrity and anti-loosening performance.
• ASTM F1798-17 (International): Defines methodologies for evaluating the mechanical performance of spinal implant interconnections under cyclic loading.
• ISO 12189-1: Additional compliance for connection durability testing in spinal implant assemblies.

Product Advantages

1. Universal Interconnection Testing: Modular fixturing accommodates screw-rod, plate-screw, and hook-rod connections.
2. Multi-Axis Load Application: Simultaneous axial/torsional/shear loading replicates complex physiological stresses.
3. Anti-Loosening Detection: High-precision torque sensors monitor connection degradation in real-time.
4. Biorelevant Environment: Temperature-controlled (37±1°C) lubrication bath with protein skimmer.
5. AI-Powered Analytics: Machine learning algorithms predict connection failure thresholds.
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 micro-movement analysis.
• Safety Suite: Emergency stop, overload clutches, and laser-based specimen breakage detection.

Technical Parameters

Accessories

1. Spinal Interconnection Fixture Kit:
   • Self-centering screw-rod clamps (3.5–7.5 mm)
   • Plate-screw locking jigs with torque calibration
   • Hook-rod alignment tools
2. Thermal-Mechanical Chamber:
   • 25L capacity with rapid cooling/heating (15°C/min)
   • 316L stainless steel interior with HEPA filtration
3. ConnectionMaster Pro Software:
   • Automated torque degradation tracking 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 F1798 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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