The Medical Needle Tip Penetration Tester is a critical device designed to evaluate the sharpness and penetration efficiency of medical needle tips under controlled conditions. It ensures compliance with ISO 11608 and GB 15811 standards, guaranteeing needle performance for patient safety and comfort.

Applicable Standards

• Regulatory Compliance: Aligns with ISO 11608 (medical needle injection systems) and GB 15811 (sterile hypodermic needles), addressing needle sharpness, penetration force, and structural integrity.
• Safety Focus: Validates needle tips to prevent excessive force during insertion, reducing patient pain and tissue damage risks.

Main Parameters

Working Principle

The tester uses a pneumatic actuator to drive needles vertically into simulated skin (e.g., polyurethane film) at adjustable speeds. A high-resolution load cell measures peak penetration force, while displacement sensors track needle movement. The system automatically generates reports comparing results to predefined standards.

Test Principle

1. Sample Preparation: Needles are clamped vertically above simulated skin, ensuring perpendicular alignment.
2. Controlled Penetration: The actuator moves the needle at a set speed (e.g., 100mm/min) through the material.
3. Data Analysis: Peak force, penetration depth, and force-displacement curves are evaluated to assess sharpness and structural integrity.

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 patient-centric medical needles, ensuring they meet stringent safety and performance criteria.