ISO 80369 is an international standard that specifies the testing requirements for small-bore connectors used in medical devices. Its primary goal is to prevent misconnections and ensure patient safety. The standard specifies mechanical tests that verify the safety and reliability of the connector under clinical conditions.

These tests include:

Axial pull-out force

Leakage resistance

Stress cracking

Dimensional verification

For manufacturers and contract test labs, understanding these protocols is essential for compliance and product integrity across connector types, including

Enteral

Respiratory

Limb cuff inflation

Neural

Intravascular or hypodermic