Spinal Internal Fixation Components Tester
Standard
YY/T 0961-2014 (China): Specifies static/fatigue testing protocols for spinal fixation systems, including connection integrity and anti-loosening performance.
ASTM F1798-17 (International): Defines methodologies for evaluating the mechanical performance of spinal implant interconnections under cyclic loading.
ISO 12189-1: Additional compliance for connection durability testing in spinal implant assemblies.
Product Advantages
Universal Interconnection Testing: Modular fixturing accommodates screw-rod, plate-screw, and hook-rod connections.
Multi-Axis Load Application: Simultaneous axial/torsional/shear loading replicates complex physiological stresses.
Anti-Loosening Detection: High-precision torque sensors monitor connection degradation in real-time.
Biorelevant Environment: Temperature-controlled (37±1°C) lubrication bath with protein skimmer.
AI-Powered Analytics: Machine learning algorithms predict connection failure thresholds.
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 micro-movement 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 Interconnection Fixture Kit:
Self-centering screw-rod clamps (3.5–7.5 mm)
Plate-screw locking jigs with torque calibration
Hook-rod alignment tools
Thermal-Mechanical Chamber:
25L capacity with rapid cooling/heating (15°C/min)
316L stainless steel interior with HEPA filtration
ConnectionMaster Pro Software:
Automated torque degradation tracking 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 F1798 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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