Intervertebral Fusion Cages Shear Fatigue Tester
Category：Medical Device Tester
Introduction
The Intervertebral Fusion Cages Shear Fatigue Tester is a specialized biomechanical testing device used to evaluate the shear fatigue performance of intervertebral fusion cages, which are implants designed to stabilize spinal segments. It simulates repetitive shear loads that the implant would experience in the human spine over time, helping to assess durability, structural integrity, and long-term safety before clinical use.
Standard
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.
Application
The Intervertebral Fusion Cages Shear Fatigue Tester is used to evaluate the mechanical durability and fatigue resistance of spinal fusion cages under repeated shear loading. It helps manufacturers and researchers assess implant performance, predict long-term reliability, and ensure compliance with biomechanical testing standards before clinical use.
Technical Parameters
| 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) |
Features
(1)Electromagnetic Servo Motor: 10 kN axial/shear force capacity with programmable load ratios (R=0.1–10).
(2)Adjustable Shear Plane: Motorized 0°–45° tilt mechanism with laser alignment system.
(3)Dynamic Load Control: 0.1–10 Hz frequency range with programmable waveforms (sine, square, random, custom).
(4)Thermal-Mechanical Chamber: ±0.3°C temperature stability with integrated humidity control (10–95% RH).
(5)High-Resolution Imaging: Built-in 5MP camera system for crack propagation analysis.
Safety System: Emergency stop, overload clutches, and laser-based specimen breakage detection.
Accessories
(1)Spinal Implant Fixture Kit:
Self-centering collet system (8–20 mm implant diameter compatibility)
Adjustable shear blades with diamond-like carbon (DLC) coating
(2)Thermal-Mechanical Chamber:
20L capacity with rapid cooling/heating (15°C/min)
316L stainless steel interior with HEPA filtration
(3)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
(4)Operator Kit:
Calibrated torque wrench set (1–50 Nm)
Specimen alignment gauges (ASTM F2077 compliant)
(5)Calibration Bundle:
NIST-traceable force calibration weights
Angular encoder verification tool
(6)Safety Kit:
Laser safety curtains
Acoustic enclosure with 30 dB noise reduction
FAQ
1. What is the main purpose of this tester?
It evaluates the shear fatigue performance of intervertebral fusion cages, simulating repetitive spinal loads to assess durability and structural integrity.
2. Which types of implants can be tested?
The tester is designed for intervertebral fusion cages of various materials, sizes, and designs used in spinal stabilization procedures.
3. How does the tester simulate real-life conditions?
It applies cyclic shear loads that mimic the mechanical stresses experienced by spinal implants during daily activities over extended periods.
4. What standards does the device comply with?
It supports testing protocols in accordance with international biomechanical standards, such as ASTM and ISO guidelines for spinal implants.
5. Who typically uses this equipment?
Biomechanical laboratories, medical device manufacturers, and research institutions use it for preclinical evaluation and quality assurance of spinal fusion implants.
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