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 compression 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.
High-Frequency Stability: Advanced electromagnetic actuator maintains 0.1–15 Hz frequency range with ±0.05% force accuracy.
Ultra-Precision Loading: 50 kN axial force capacity with 1 N resolution for submicron displacement control.
Dynamic Load Control: Programmable R=0.1–10 load ratios with real-time stiffness compensation.
Biorelevant Environment: Temperature-controlled (37±1°C) lubrication bath with 20±2 g/L protein concentration.
Extended Durability: Capable of 10+ million cycle testing with <0.2% drift in calibration.
Modular Design: Six-station configuration allows parallel testing of multiple specimens.
Electromagnetic Servo Motor: 50 kN axial force capacity with programmable load ratios (R=0.1–10).
Triaxial Strain Gauge: Measures axial/radial strains simultaneously (0.1 με resolution).
Dynamic Load Control: 0.1–15 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-Resolution Imaging: Optional integration with micro-CT systems for in-situ crack analysis.
Safety System: Emergency stop, overload clutches, and laser-based specimen breakage detection.
Paramètres | Spécification |
---|---|
Max. Axial Force | ±50.000 N (50 N resolution) |
Frequency Range | 0.1–15 Hz (0.01 Hz increments) |
Load Ratio (R) | 0.1–10 (adjustable) |
Axial Displacement | ±15 mm (0.1 μm resolution) |
Contrôle de la température | -20°C to +50°C (PT1000 sensors) |
Humidity Control | 10–95% RH (non-condensing) |
Taux d'échantillonnage des données | 100 kHz (synchronized across 16 channels) |
Power Requirements | 220V/110V ±10%, 50/60Hz, 3.500W |
Dimensions (W×D×H) | 2.200 × 1.600 × 2.300 mm |
Weight | 1.350 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:
25L capacity with rapid cooling/heating (15°C/min)
316L stainless steel interior with HEPA filtration
CompressionMaster Pro Software:
Automated stiffness degradation tracking 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 force calibration weights
Strain gauge verification tool
Safety Kit:
Laser safety curtains
Acoustic enclosure with 30 dB noise reduction
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