Spinal Pedicle Screw-Rod System Torsional Fatigue Testing Machine
StandardASTM F2193 (Standard Test Methods for Spinal Pedicle Screws and Rods)ISO 12189 (Implants for
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Inhalt
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)
Product Advantages
- Biomechanically Accurate Testing
- Multi-axis load application (torsion, bending, axial) replicates physiological spinal motion with ±0.5% torque accuracy.
- High-Frequency Performance
- 30 Hz operation accelerates testing cycles, reducing time-to-market for new spinal implant designs.
- Advanced Data Analytics
- AI-powered software predicts fatigue life (S-N curves) and identifies screw-rod interface wear using real-time strain mapping.
- User-Centric Design
- 15.6-inch touchscreen interface with multilingual support (English, German, Chinese, Japanese) and one-touch test protocol selection.
- Regulatory Compliance
- Built-in audit trails, electronic signatures, and 21 CFR Part 11 compliance for seamless FDA/CE submissions.
Product Features
- 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.
- Environmental Control:
- 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.
Technical Parameters
| Parameter | Spezifikation |
|---|
| Torsional Range | ±180° (0.01° resolution) |
| Bending Moment Capacity | 0–30 Nm (±0.03 Nm accuracy) |
| Axial Load Capacity | 0–5 kN (±0.005 kN accuracy) |
| Frequency Range | 0.1–30 Hz (adjustable) |
| Temperature Control | 5°C to +50°C (±0.5°C accuracy) |
| Data Acquisition Rate | 50,000 Hz (strain/load channels) |
| Power Supply | 220V/110V AC, 50/60Hz, 2.0kW |
| Dimensions (L×W×H) | 1.0×0.7×1.6 m |
| Weight | 300 kg |
| Operating Environment | 10–35°C, ≤70% RH (non-condensing) |
Accessories Included
- Specimen Clamps: Adjustable fixtures for pedicle screws (Ø4.5–8.5mm) and rods (Ø4–6mm).
- Calibration Kit: Torque sensor, load cell, and certification for annual validation.
- Safety Gear: Heat-resistant gloves, face shield, and emergency eyewash station.
- User Manual & Software: Digital guide (multilingual) + AI analytics platform for fatigue life prediction.
- 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)
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