This article presents a specialized tester designed to evaluate the mechanical durability of catheters under repetitive bending cycles, critical for ensuring device integrity during clinical use. The system simulates physiological bending motions to assess material fatigue, kink resistance, and structural stability, complying with international medical device standards.

Applicable Standards

Main Parameters

• Bending Angle Range: 0-180° (±0.1° precision)
• Cycle Frequency: 10-60 cycles/min (adjustable)
• Test Duration: 1-10,000 cycles (programmable)
• Data Output: Force-displacement curves with failure mode analysis

Working Principle

  The tester uses a servo-controlled actuator to apply cyclic bending forces to catheter samples mounted in adjustable fixtures. Strain gauges and displacement sensors monitor real-time mechanical stress while thermal chambers simulate body temperature conditions. Software algorithms detect structural deformations and predict fatigue limits.

Test Principles

1. Dynamic Bending Testing: Simulates in-vivo motion patterns
2. Static Kink Analysis: Measures permanent deformation under load
3. Cyclic Fatigue Assessment: Evaluates material degradation over time

This integrated solution enables manufacturers to optimize catheter designs for improved flexibility and longevity, meeting FDA 21 CFR Part 820 quality requirements while ensuring patient safety through rigorous mechanical characterization.