StandardASTM F2193 (Standard Test Methods for Spinal Pedicle Screws and Rods)ISO 12189 (Implant
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ASTM F2193-18: Specifies static/fatigue testing protocols for spinal constructs, including lamina fixation plates.
ISO 12189-1: Defines methodologies for evaluating mechanical performance under physiological loading.
YY/T 0961-2014 (China): Compliance with static/dynamic testing requirements for spinal interconnection systems.
Custom Protocols: Tailored testing regimens for lamina fixation plate bending/compression fatigue per clinical usage models.
Anatomical Simulation: 4-point bending fixture replicates spinal curvature (0°–45° lordosis adjustment).
Dynamic Compression Control: 0.1–15 Hz frequency range with ±0.05% force accuracy.
Multi-Axial Loading: Combines axial compression (±25 kN) with anterior-posterior shear (±5 kN).
Biorelevant Environment: 37±1°C saline bath with protein skimmer for in vivo corrosion simulation.
AI-Powered Analytics: Machine learning identifies creep-fatigue interactions in real-time.
Modular Design: Dual-station configuration enables simultaneous specimen testing.
Electromagnetic Servo Actuator: 25 kN axial/5 kN shear capacity with programmable load ratios (R=0.1–10).
4-Point Bending Fixture: Self-aligning anvils accommodate plate lengths (30–80 mm) and curvatures.
Dynamic Load Control: Sinusoidal/square/random waveforms with 0.01 Hz resolution.
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.
| Parameter | Specification |
|---|---|
| Max. Axial Force | ±25.000 N (25 N resolution) |
| Max. Shear Force | ±5.000 N (5 N resolution) |
| Frequency Range | 0.1–15 Hz (0.01 Hz increments) |
| Load Ratio (R) | 0.1–10 (adjustable) |
| Bending Angle | 0°–45° (0.1° resolution) |
| 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, 3.000W |
| Dimensions (W×D×H) | 2.000 × 1.200 × 2.000 mm |
| Weight | 950 kg (including environmental chamber) |
| Noise Level | <65 dB (A-weighted) |
Lamina Fixation Fixture Kit:
Self-centering plate clamps (30–80 mm length compatibility)
Anatomical curvature adapters (0°–45° lordosis adjustment)
Thermal-Mechanical Chamber:
15L capacity with rapid cooling/heating (15°C/min)
316L stainless steel interior with HEPA filtration
LaminoplastyTest Pro Software:
Automated stiffness 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 F2193 compliant)
Calibration Bundle:
NIST-traceable force calibration weights
Strain gauge verification tool
Safety Kit:
Laser safety curtains
Acoustic enclosure with 30 dB noise reduction
Qinsun Instruments Co., LTD is a professional laboratory testing instrument manufacturer in China,Have been focusing on laboratory instrument R&D more than 30 years and have rich industry experience,Based on international testing standards,We are also the instrument supplier for BV SGS laboratory,We provide one-stop solutions for lab instruments,Free Training and Turn-Key Service,Products exported all over the world,Offer 36 month warranty and are a trustworthy partner.
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13816217984
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