- Performance evaluation: Test indicators such as the fatigue strength, stiffness and deformation of
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YY/T 0959-2014 (China): Specifies shear fatigue testing protocols for intervertebral fusion devices, including load ratios, frequency, and failure criteria.
ASTM F2077-17 (International): Defines methodologies for evaluating the fatigue strength of intervertebral body fusion devices under shear loading.
ISO 12189-1: Additional compliance for mechanical testing of spinal implant components.
Multi-Angle Shear Control: Dual-axis actuator system provides 0°–45° adjustable shear plane orientation.
Dynamic Load Precision: Electromagnetic servo motor maintains R=0.1 load ratio with ±0.05% accuracy.
5 Million Cycle Endurance: Proven capability to complete YY/T 0959’s 5×10⁶-cycle fatigue test without calibration drift.
Real-Time Deformation Monitoring: 3D digital image correlation (DIC) tracks micro-strains during testing.
Biorelevant Environment: Temperature-controlled (37±1°C) lubrication bath with 20±2 g/L protein concentration.
Modular Test Chambers: Quick-swap pods for simulated physiological (-20°C to +50°C) and corrosive environments.
Electromagnetic Servo Motor: 10 kN axial/shear force capacity with programmable load ratios (R=0.1–10).
Adjustable Shear Plane: Motorized 0°–45° tilt mechanism with laser alignment system.
Dynamic Load Control: 0.1–10 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: Built-in 5MP camera system for crack propagation analysis.
Safety System: Emergency stop, overload clutches, and laser-based specimen breakage detection.
| Parameter | Specification |
|---|---|
| Max. Shear Force | ±10.000 N (100 N resolution) |
| Shear Plane Adjustment | 0°–45° (0.1° resolution) |
| Frequency Range | 0.1–10 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, 2.500W |
| Dimensions (W×D×H) | 1.800 × 1.200 × 2.100 mm |
| Weight | 1.050 kg (including environmental chamber) |
| Noise Level | <65 dB (A-weighted) |
Spinal Implant Fixture Kit:
Self-centering collet system (8–20 mm implant diameter compatibility)
Adjustable shear blades with diamond-like carbon (DLC) coating
Thermal-Mechanical Chamber:
20L capacity with rapid cooling/heating (15°C/min)
316L stainless steel interior with HEPA filtration
ShearMaster Pro Software:
Automated S-N curve generation 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 (1–50 Nm)
Specimen alignment gauges (ASTM F2077 compliant)
Calibration Bundle:
NIST-traceable force calibration weights
Angular encoder verification tool
Safety Kit:
Laser safety curtains
Acoustic enclosure with 30 dB noise reduction
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