StandardASTM F2193 (Standard Test Methods for Spinal Pedicle Screws and Rods)ISO 12189 (Implants for
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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.
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.
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.
| Parameter | Specifikation |
|---|---|
| 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) |
| Temperaturkontroll | -20°C to +50°C (PT1000 sensors) |
| Luftfuktighetskontroll | 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 |
| Vikt | 1.100 kg (including environmental chamber) |
| Noise Level | <65 dB (A-weighted) |
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
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