Femoral Stem Fatigue Performance Testing Machine

Standard

• ASTM F2003 (Standard Test Method for Fatigue Testing of Orthopedic Implants)
• ISO 14879-1 (Total Hip Joint Prostheses - Fatigue Testing of Femoral Stems)
• FDA 21 CFR Part 820 (Quality System Regulation for Medical Devices)
  

Product Advantages

1. Biomechanically Accurate Testing
   • Multi-axis load application (axial, bending, torsion) replicates physiological gait cycles with ±1% force accuracy.
2. High-Frequency Performance
   • 50 Hz operation accelerates testing cycles, reducing time-to-market for new implant designs.
3. Advanced Data Analytics
   • AI-powered software predicts fatigue life (S-N curves) and identifies crack initiation points 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.

Product Features

• Multi-Modal Testing:
  • Axial Compression: 0–10 kN (±0.01 kN accuracy).
  • Bending Moment: 0–50 Nm (±0.05 Nm accuracy).
  • Torsional Load: ±180° rotation (0.01° resolution).
  • Combined Loading: Programmable waveforms for simultaneous axial/bending/torsional stress.
• Environmental Control:
  • Temperature-regulated bath (-20°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.

Technical Parameters

Accessories Included

1. Specimen Clamps: Adjustable fixtures for femoral stems (Ø8–25mm).
2. Calibration Kit: Load cell, torque sensor, 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:

• Orthopedic implant manufacturers (hip/knee prostheses)
• Medical device testing laboratories
• Regulatory certification bodies (FDA, CE, TÜV)
• Biomechanical research institutions