Spinal Internal Fixation Components System Tester - China

Standard

YY/T 0961-2014 (China): Specifies static/fatigue testing protocols for spinal fixation systems, including connection integrity and anti-loosening performance.

ASTM F1798-17 (International): Defines methodologies for evaluating the mechanical performance of spinal implant interconnections under cyclic loading.

ISO 12189-1: Additional compliance for connection durability testing in spinal implant assemblies.

Product Advantages

Universal Interconnection Testing: Modular fixturing accommodates screw-rod, plate-screw, and hook-rod connections.

Multi-Axis Load Application: Simultaneous axial/torsional/shear loading replicates complex physiological stresses.

Anti-Loosening Detection: High-precision torque sensors monitor connection degradation in real-time.

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

AI-Powered Analytics: Machine learning algorithms predict connection failure thresholds.

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 micro-movement analysis.

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

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)

Accessories

Spinal Interconnection Fixture Kit: Self-centering screw-rod clamps (3.5–7.5 mm) Plate-screw locking jigs with torque calibration Hook-rod alignment tools Thermal-Mechanical Chamber: 25L capacity with rapid cooling/heating (15°C/min) 316L stainless steel interior with HEPA filtration ConnectionMaster Pro Software: Automated torque degradation tracking 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 F1798 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

Company Contact:

• Posted By: Standard International Group (HK) Limited

• Phone: 18355172336

• Address: No.2578 Gu Dai road, Min Hang district, Shanghai, shanghai , Shanghaai , China

• Email:

• Website: https://www.standard-groups.com/en/

• Business Description: Standard Groups is an integrated supplier specialized in providing material test instruments and “The Whole Laboratory Program” solutions.
  
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