Medical Needle Ductility Tester
The Medical Needle Ductility Tester is a specialized device designed to evaluate the structural integrity of medical needles and tubing under mechanical stress. It ensures compliance with ISO 7864, GB 15811, and other international standards for medical device safety.
Applicable Standards
- Regulatory Compliance: Aligns with ISO 7864 (sterile hypodermic needles) and GB 15811 (medical needle standards), addressing needle strength, flexibility, and durability.
- Safety Focus: Validates needle performance to prevent breakage or deformation during clinical use, reducing patient injury risks.
Main Parameters
| Parameter | Specification |
|---|---|
| Test Modes | Three-point/four-point bending, puncture simulation |
| Loading Speed | Adjustable (e.g., 100mm/min for puncture tests) |
| Sensor Precision | 0.01N resolution for force measurement |
| Safety Features | Emergency stop, protective shield, auto-calibration |
| Data Output | Real-time force-displacement curves; statistical reports |
Working Principle
The tester employs pneumatic actuators to apply controlled bending or puncture forces to needle samples. High-resolution sensors measure force distribution and displacement during tests. For bending tests, needles are clamped at one end and loaded until a preset angle or failure occurs. Puncture tests simulate needle insertion into simulated tissue, measuring peak force and penetration depth.
Test Principle
- Sample Preparation: Needles are secured in a fixture, ensuring consistent clamping pressure.
- Mechanical Loading: Forces are applied cyclically (e.g., repeated bending to ±90°) or as a single puncture event.
- Failure Analysis: Tests stop at predefined cycles or upon fracture, with data logged to assess ductility and fatigue resistance.
Key Advantages
- Versatility: Supports diverse needle types (hypodermic, IV, suture) and materials.
- Automation: PLC-controlled testing with preset protocols for repeatability.
- Compliance: Preloaded with international standards for one-click validation.
This tester empowers manufacturers to develop robust medical needles, ensuring they withstand clinical stresses while adhering to strict safety regulations.