This article introduces a multifunctional tester designed for comprehensive evaluation of luer taper connectors, ensuring compliance with medical device standards. The tester integrates leakage, torque, and dimensional analysis in one system, providing efficient quality control for manufacturers. Key features include ISO-compliant testing protocols, user-friendly interfaces, and automated data reporting.

Applicable Standards

Main Parameters

• Testing Range: Leakage (0-100 mL/min), Torque (0-5 N·m)
• Precision: ±0.5% FS for pressure, ±1% for torque measurement
• Dimensions: Compact design (300×200×400mm), 8kg weight
• Interface: 7-inch touchscreen with real-time data logging

Working Principle

  The tester employs pneumatic control and sensor technology to simulate clinical connection scenarios. A micro-controller unit processes pressure decay, rotational force, and dimensional scanning data through ISO-standardized algorithms. Automated clamping mechanisms ensure repeatable testing under variable conditions.

Test Principles

1. Leakage Test: Measures pressure decay using differential sensors to detect micro-leaks (<0.05 mL/min)
2. Torque Analysis: Quantifies rotational resistance during coupling/decoupling cycles
3. Dimensional Verification: Laser-based profiling checks taper angles and thread geometries
4. Cycle Durability: Simulates 500+ mating cycles to assess mechanical fatigue

This integrated solution enables manufacturers to achieve ISO 13485 compliance efficiently while reducing human error in quality inspection processes.