Understanding needle tubing breakage resistance is crucial for maintaining the safety and quality of medical devices, especially syringes and infusion needles. This test ensures that the tubing can endure bending stress during manufacturing and clinical use without failure. For professionals working in quality control, especially in pharmaceutical and medical device industries, mastering this test is not only vital for compliance but also for patient safety.
Needle tubing must be resilient, especially during repeated handling, bending, and insertion into soft or hard tissues. If the tubing fractures, it could cause serious harm to the patient and pose legal and regulatory risks for the manufacturer. That’s why the needle tubing breakage resistance test is essential — it simulates real-world mechanical stress and evaluates whether the tubing maintains its structural integrity after cyclic bending.
Syringetest.com supports this critical need by providing accurate and repeatable testing systems to help medical device manufacturers meet international standards efficiently.
ISO 9626 is the international standard specifying the mechanical properties of stainless-steel needle tubing used in the manufacture of medical devices. Annex C of ISO 9626 outlines a normative method for testing the tubing’s resistance to breakage under repeated bending stress.
According to Annex C, the tubing must be bent cyclically to simulate mechanical fatigue, and then visually inspected for any signs of fracture. The outcome determines whether the tubing meets the minimum performance requirements necessary for safe medical use.
The breakage resistance test involves precise procedures, which ensure repeatability and compliance. Here’s a breakdown of the method, as referenced in ISO 9626 Annex C:
To conduct the test effectively, the following equipment is necessary:
A complete test report must include:
Accurate documentation ensures traceability and facilitates audits or certification processes, which are essential for companies aiming to export or meet stringent regulatory standards.
At Syringetest.com, we specialize in designing high-precision, automated testing systems that comply with ISO standards, including ISO 9626 Annex C. Our equipment is widely used in medical device quality control, ensuring consistent test results with minimal human error. Furthermore, we offer customizable solutions for unique tubing dimensions or wall types and provide automation transformation services to integrate this test into production lines seamlessly.
Whether you’re in the pharmaceutical, medical device, or quality inspection sector, our instruments help you maintain compliance while improving operational efficiency.
