Spinal Internal Fixation System Component Testing Machine
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The Spinal Internal Fixation System Component Testing Machine is a specialized mechanical testing device designed to evaluate the performance, durability, and safety of spinal implants, including rods, screws, plates, and interbody devices. It simulates physiological loads such as compression, torsion, bending, and cyclic fatigue that spinal implants experience in vivo. The machine provides critical data on mechanical strength, stiffness, deformation, and failure modes, helping manufacturers and researchers ensure that spinal fixation components meet clinical safety standards and perform reliably under long-term physiological conditions.
Standard
(1)YY/T 0119-2014 (China): Specifies mechanical testing protocols for spinal fixation components, including screws, plates, rods, and connectors.
(2)ASTM F2193-18 (International): Defines methodologies for evaluating the static and fatigue performance of spinal implant constructs.
(3)ISO 12189-1: Additional compliance for mechanical testing of spinal implant components under physiological loading.
Product Advantages
(1)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).
(2)Multi-Axis Loading: Simultaneous axial/torsional/shear loading replicates complex in vivo stresses.
(3)High-Frequency Stability: 0.1–15 Hz dynamic control with ±0.05% force accuracy.
(4)Biorelevant Environment: Temperature-controlled (37±1°C) lubrication bath with protein skimmer.
(5)AI-Powered Analytics: Machine learning algorithms predict failure modes from initial test cycles.
(6)Regulatory Compliance: Pre-loaded protocols for FDA/CE submission requirements.
Product Features
(1)Electromagnetic Servo Actuators: 50 kN axial/25 Nm torsional capacity with programmable load ratios (R=0.1–10).
(2)6-DOF Kinematic System: Replicates flexion/extension, lateral bending, and axial rotation (±20° range).
(3)Dynamic Load Control: 0.1–15 Hz frequency range with programmable waveforms (sine, square, random).
(4)Thermal-Mechanical Chamber: -20°C to +50°C temperature control with 10–95% RH humidity.
(5)High-Resolution Imaging: Built-in 5MP camera system for crack propagation analysis.
(6)Safety Suite: Emergency stop, overload clutches, and laser-based specimen breakage detection.
Accessories
(1)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
(2)Thermal-Mechanical Chamber:
25L capacity with rapid cooling/heating (15°C/min)
316L stainless steel interior with HEPA filtration
(3)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
(4)Operator Kit:
Calibrated torque wrench set (0.5–50 Nm)
Specimen alignment gauges (ASTM F2193 compliant)
(5)Calibration Bundle:
NIST-traceable force/torque calibration weights
Angular encoder verification tool
(6)Safety Kit:
Laser safety curtains
Acoustic enclosure with 30 dB noise reduction
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) |
