Orthopedic Spine Fixation Component Fatigue Tester ASTM Certified
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Whats/App: +86 156 1874 6768
Web: standard-groups.com
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) |
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