System of Spinal Pedicle Screw-Rod System Torsional Fatigue Tester
StandardASTM F2193 (Standard Test Methods for Spinal Pedicle Screws and Rods)ISO 12189 (Implants for
Email: info@standard-groups.com
Content
Standard
- YY/T 0857-2011 (China): Specifies torsional fatigue testing protocols for spinal pedicle screw-rod systems, including load ratios, frequency, and failure criteria.
- YY/T 1560-2017 (China): Defines methodologies for evaluating the fatigue strength of spinal implant assemblies under complex loading.
- ASTM F1717-18 (International): Standard test methods for spinal implant constructs in vertebrectomy models.
- ASTM F2706-19: Specifies static and fatigue testing requirements for occipito-cervical and occipito-cervico-thoracic spinal implants.
Product Advantages
- Multi-Axis Torsion Control: Advanced electromagnetic actuators maintain R=-1 load ratio (fully reversed torsion) with ±0.05% accuracy.
- 5 Million Cycle Endurance: Proven capability to complete YY/T 0857’s 5×10⁶-cycle fatigue test without calibration drift.
- Dynamic Angle Control: 0.001° resolution ensures precise replication of physiological spinal motion.
- Real-Time Fracture Detection: AI-powered acoustic emission monitoring identifies micro-cracks at sub-millisecond intervals.
- Intuitive Workflow: 21.5” capacitive touchscreen with gesture control and pre-loaded SOPs for 10+ implant geometries.
- Modular Environmental Chambers: Quick-swap pods for simulated physiological (-20°C to +50°C) and corrosive environment testing.
Product Features
- Electromagnetic Servo Motors: Dual-axis torsional actuators (±180° rotation, 50 Nm peak torque).
- 6-DOF Kinematic Simulation: Replicates natural spinal motion (flexion/extension ±20°, lateral bending ±15°, axial rotation ±10°).
- Dynamic Load Control: 0.1–5 Hz frequency range with programmable waveforms (sine, square, random, custom).
- Thermal-Mechanical Chamber: ±0.3°C temperature stability with integrated humidity control (10–95% RH).
- High-Speed Imaging Ready: Syncs with external cameras for full-field strain mapping (DIC optional upgrade).
- Safety System: Triple-redundant emergency stop, overload clutches, and laser-based specimen breakage detection.
Technical Parameters
| Parameter | Specification |
|---|
| Max. Torsional Moment | ±50 Nm (1 Nm resolution) |
| Angular Range | ±180° (0.001° resolution) |
| Frequency Range | 0.1–5 Hz (0.01 Hz increments) |
| Load Ratio (R) | -1 to 0.1 (adjustable) |
| Temperature Control | -20°C to +50°C (PT1000 sensors) |
| Humidity Control | 10–95% RH (non-condensing) |
| Data Sampling Rate | 100 kHz (synchronized across 16 channels) |
| Power Requirements | 220V/110V ±10%, 50/60Hz, 2,500W |
| Dimensions (W×D×H) | 1,800 × 1,200 × 2,100 mm |
| Weight | 1,100 kg (including environmental chamber) |
| Noise Level | <65 dB (A-weighted) |
Accessories
- Spinal Implant Fixture Kit:
- Self-centering pedicle screw clamps (4.5–7.5 mm diameter compatibility)
- Rod-bending jigs with laser-aligned loading anvils
- Thermal-Mechanical Chamber:
- 20L capacity with rapid cooling/heating (15°C/min)
- 316L stainless steel interior with HEPA filtration
- TorsionMaster Pro Software:
- Automated S-N curve generation and fatigue limit calculation
- 21 CFR Part 11-compliant audit trail with blockchain timestamping
- Remote monitoring via dedicated iOS/Android app
- Operator Kit:
- Calibrated torque wrench set (0.5–50 Nm)
- Specimen alignment gauges (ASTM F1717 compliant)
- Calibration Bundle:
- NIST-traceable torque calibration weights
- Angular encoder verification tool
- Safety Kit:
- Laser safety curtains
- Acoustic enclosure with 30 dB noise reduction
Disclaimer: The above content is for reference and communication only among industry insiders, and does not guarantee its accuracy or completeness. According to relevant laws and regulations and the regulations of this website, units or individuals who purchase related items should obtain valid qualifications and qualification conditions.
