Spinal Internal Fixation System Component Testing Machine
Standard
- YY/T 0119-2014 (China): Specifies mechanical testing protocols for spinal fixation components, including screws, plates, rods, and connectors.
- ASTM F2193-18 (International): Defines methodologies for evaluating the static and fatigue performance of spinal implant constructs.
- ISO 12189-1: Additional compliance for mechanical testing of spinal implant components under physiological loading.
Product Advantages
- Universal Testing Compatibility: Modular design accommodates screws (3.5–7.5 mm), plates (20–100 mm length), and rods (4.5–6.5 mm diameter).
- Multi-Axis Loading: Simultaneous axial/torsional/shear loading replicates complex in vivo stresses.
- High-Frequency Stability: 0.1–15 Hz dynamic control with ±0.05% force accuracy.
- Biorelevant Environment: Temperature-controlled (37±1°C) lubrication bath with protein skimmer.
- AI-Powered Analytics: Machine learning algorithms predict failure modes from initial test cycles.
- Regulatory Compliance: Pre-loaded protocols for FDA/CE submission requirements.
Product Features
- Electromagnetic Servo Actuators: 50 kN axial/25 Nm torsional capacity with programmable load ratios (R=0.1–10).
- 6-DOF Kinematic System: Replicates flexion/extension, lateral bending, and axial rotation (±20° range).
- Dynamic Load Control: 0.1–15 Hz frequency range with programmable waveforms (sine, square, random).
- Thermal-Mechanical Chamber: -20°C to +50°C temperature control with 10–95% RH humidity.
- High-Resolution Imaging: Built-in 5MP camera system for crack propagation analysis.
- Safety Suite: Emergency stop, overload clutches, and laser-based specimen breakage detection.
Technical Parameters
| Parameter | Specification |
|---|---|
| Max. Axial Force | ±50,000 N (50 N resolution) |
| Max. Torsional Moment | ±25 Nm (0.1 Nm resolution) |
| Angular Range | ±20° (0.001° resolution) |
| Frequency Range | 0.1–15 Hz (0.01 Hz increments) |
| Load Ratio (R) | 0.1–10 (adjustable) |
| Temperature Control | -20°C to +50°C (PT1000 sensors) |
| Humidity Control | 10–95% RH (non-condensing) |
| Data Acquisition | 100 kHz sampling rate (16-bit resolution) |
| Power Requirements | 220V/110V ±10%, 50/60Hz, 3,500W |
| Dimensions (W×D×H) | 2,200 × 1,600 × 2,300 mm |
| Weight | 1,400 kg (including environmental chamber) |
| Noise Level | <65 dB (A-weighted) |
Accessories
- Spinal Component Fixture Kit:
- Self-centering screw clamps (3.5–7.5 mm)
- Plate/rod bending jigs with laser alignment
- Universal connectors for hybrid constructs
- Thermal-Mechanical Chamber:
- 25L capacity with rapid cooling/heating (15°C/min)
- 316L stainless steel interior with HEPA filtration
- BioTest Pro Software:
- Automated FEA validation and fatigue limit calculation
- 21 CFR Part 11-compliant audit trail with blockchain timestamping
- Remote monitoring via iOS/Android app
- Operator Kit:
- Calibrated torque wrench set (0.5–50 Nm)
- Specimen alignment gauges (ASTM F2193 compliant)
- Calibration Bundle:
- NIST-traceable force/torque calibration weights
- Angular encoder verification tool
- Safety Kit:
- Laser safety curtains
- Acoustic enclosure with 30 dB noise reduction
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