Spinal Internal Fixation System Component 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. Multi-Axial Testing Precision
   • Simultaneous axial, bending, and torsional loading replicates physiological spinal stresses with ±0.3% force accuracy.
2. High-Speed Fatigue Testing
   • 20 Hz operation accelerates testing cycles, reducing R&D timelines for next-gen spinal implants.
3. AI-Powered Analytics
   • Machine learning algorithms predict component failure modes and generate ISO/ASTM-compliant reports automatically.
4. User-Centric Operation
   • 15.6-inch touchscreen with multilingual interface (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 (1–20 Hz) to simulate 10+ years of in-vivo use.
  • Wear Testing: Abrasion resistance evaluation for screw-rod interfaces.
• Simulazione ambientale:
  • Temperature-controlled chamber (-10°C to +50°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 pedicle screws, rods, connectors, and interbody cages.

Parametri tecnici

Accessories Included

1. Specimen Fixtures: Adjustable clamps for pedicle screws (Ø4.5–8.5mm), rods (Ø4–6mm), and interbody cages.
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 (pedicle screws, rods, cages)
• Medical device testing laboratories
• Regulatory certification bodies (FDA, CE, TÜV)
• Biomechanical research institutions