Laminoplasty Plate System 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 (bending, shear, torsion) replicates physiological spinal stresses with ±0.4% force accuracy.
2. High-Frequency Performance
   • 18 Hz operation accelerates testing cycles, reducing R&D timelines for innovative laminoplasty plate designs.
3. AI-Powered Analytics
   • Machine learning algorithms predict fatigue life (S-N curves) and identify plate-screw interface wear using real-time strain mapping.
4. User-Centric Design
   • 15.6-inch touchscreen interface with multilingual support (English, German, Chinese, Spanish) and one-touch protocol selection.
5. Regulatory Compliance
   • Built-in audit trails, electronic signatures, and 21 CFR Part 11 compliance streamline FDA/CE approvals.

Caratteristiche del prodotto

• Comprehensive Testing Modes:
  • Static Testing: Ultimate tensile strength, yield point, and stiffness measurement.
  • Dynamic Fatigue: Cyclic loading (1–18 Hz) to simulate 10+ years of in-vivo use.
  • Wear Testing: Abrasion resistance evaluation for plate-screw interfaces.
• Simulazione ambientale:
  • Temperature-controlled chamber (-5°C to +45°C) and saline bath for corrosion testing.
• Advanced Safety:
  • Overload protection, emergency stop, and laser-guided alignment minimize operational risks.
• Modular Design:
  • Interchangeable fixtures for laminoplasty plates (20–50mm width) and fixation screws.

Parametri tecnici

Accessories Included

1. Specimen Fixtures: Adjustable clamps for laminoplasty plates (20–50mm width) and fixation screws (Ø3.5–5.5mm).
2. Calibration Kit: Load cell, torque sensor, and NIST-traceable certification.
3. Safety Gear: Heat-resistant gloves, face shield, and emergency eyewash station.
4. Software Suite: AI analytics platform with S-N curve generator and FDA submission templates.
5. Environmental Chamber: Temperature/saline bath with corrosion-resistant lining.

Ideal For:

• Spinal implant manufacturers (laminoplasty plates, fixation screws)
• Medical device testing laboratories
• Regulatory certification bodies (FDA, CE, TÜV)
• Biomechanical research institutions