Spinal Internal Fixation System Component Testing Machine

Standard

YY/T 0119-2014 (China): Specifies mechanical testing protocols for spinal fixation components, including screws, plates, rods, and connectors.

ASTM F2193-18 (International): Defines methodologies for evaluating the static and fatigue performance of spinal implant constructs.

ISO 12189-1: Additional compliance for mechanical testing of spinal implant components under physiological loading.

Product Advantages

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).

Multi-Axis Loading: Simultaneous axial/torsional/shear loading replicates complex in vivo stresses.

High-Frequency Stability: 0.1–15 Hz dynamic control with ±0.05% force accuracy.

Biorelevant Environment: Temperature-controlled (37±1°C) lubrication bath with protein skimmer.

AI-Powered Analytics: Machine learning algorithms predict failure modes from initial test cycles.

Regulatory Compliance: Pre-loaded protocols for FDA/CE submission requirements.

Product Features

Electromagnetic Servo Actuators: 50 kN axial/25 Nm torsional capacity with programmable load ratios (R=0.1–10).

6-DOF Kinematic System: Replicates flexion/extension, lateral bending, and axial rotation (±20° range).

Dynamic Load Control: 0.1–15 Hz frequency range with programmable waveforms (sine, square, random).

Thermal-Mechanical Chamber: -20°C to +50°C temperature control with 10–95% RH humidity.

High-Resolution Imaging: Built-in 5MP camera system for crack propagation analysis.

Safety Suite: Emergency stop, overload clutches, and laser-based specimen breakage detection.

Accessories

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

Thermal-Mechanical Chamber:

25L capacity with rapid cooling/heating (15°C/min)

316L stainless steel interior with HEPA filtration

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

Operator Kit:

Calibrated torque wrench set (0.5–50 Nm)

Specimen alignment gauges (ASTM F2193 compliant)

Calibration Bundle:

NIST-traceable force/torque calibration weights

Angular encoder verification tool

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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