Spinal Pedicle Screw-Rod System Torsional Fatigue Testing Machine

Standard

• ASTM F2193 (Standard Test Methods for Spinal Pedicle Screws and Rods)
• ISO 12189 (Implants for Surgery - Spinal Pedicle Screw Systems - Mechanical Testing)
• FDA 21 CFR Part 820 (Quality System Regulation for Medical Devices)
  

Vantaggi del prodotto

1. Biomechanically Accurate Testing
   • Multi-axis load application (torsion, bending, axial) replicates physiological spinal motion with ±0.5% torque accuracy.
2. High-Frequency Performance
   • 30 Hz operation accelerates testing cycles, reducing time-to-market for new spinal implant designs.
3. Advanced Data Analytics
   • AI-powered software predicts fatigue life (S-N curves) and identifies screw-rod interface wear using real-time strain mapping.
4. User-Centric Design
   • 15.6-inch touchscreen interface with multilingual support (English, German, Chinese, Japanese) and one-touch test protocol selection.
5. Regulatory Compliance
   • Built-in audit trails, electronic signatures, and 21 CFR Part 11 compliance for seamless FDA/CE submissions.

Caratteristiche del prodotto

• Multi-Modal Testing:
  • Torsional Load: ±180° rotation (0.01° resolution).
  • Bending Moment: 0–30 Nm (±0.03 Nm accuracy).
  • Axial Load: 0–5 kN (±0.005 kN accuracy).
  • Combined Loading: Programmable waveforms for simultaneous torsion/bending/axial stress.
• Controllo ambientale:
  • Temperature-regulated bath (5°C to +50°C) for simulating in-vivo conditions (e.g., cryogenic fatigue).
• Safety First:
  • Overload protection, emergency stop, and laser-guided specimen alignment prevent sample damage and operator injury.
• Modular Expandability:
  • Optional upgrades for high-temperature testing, corrosion simulation, and third-party software integration.

Parametri tecnici

Accessories Included

1. Specimen Clamps: Adjustable fixtures for pedicle screws (Ø4.5–8.5mm) and rods (Ø4–6mm).
2. Calibration Kit: Torque sensor, load cell, and certification for annual validation.
3. Safety Gear: Heat-resistant gloves, face shield, and emergency eyewash station.
4. User Manual & Software: Digital guide (multilingual) + AI analytics platform for fatigue life prediction.
5. Environmental Chamber: Temperature-controlled bath with antifreeze additive.

Ideal For:

• Spinal implant manufacturers (pedicle screws, rods, connectors)
• Medical device testing laboratories
• Regulatory certification bodies (FDA, CE, TÜV)