ISO 80369 Testing

ISO 80369 Small-bore connectors for liquids and gases in healthcare applications, was developed to reduce the amount of incorrect system connections on patients on or being treated with multiple system, such as intravenous lines and epidural anaesthetics. 

MET’s laboratory service assesses connector compliance according to the following standards:

ISO 80369-3 : Connectors for enteral applications
ISO 80369-5 : Connectors for limb-cuff applications
ISO 80369-6 : Connectors for neuroaxial applications
ISO 80369-7 : Connectors for intravascular or hypodermic applications
ISO 80369-20 : Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods. (This section includes measures for preventing incorrect connections.)

Tests for the verification of connectivity include dimensional analysis and various leakage and stress tests according to each section of the standard

There are other areas under development for this standard:

ISO 80369-2 : Connectors for breathing systems and driving gases applications
ISO 80369-4 : Connectors for urethral and urinary applications

Analyses include:

  • Dimensional requirements for Luer connectors
  • Fluid leakage measurement by pressure decay testing using specific reference fittings
  • Falling drop positive pressure liquid leakage
  • Sub-atmospheric pressure air intrusion analysis
  • Stress cracking with reference fitting
  • Resistance to separation from axial load and unscrewing
  • Resistance to overriding by reference connector

This test programme supports our comprehensive range of validation testing for a wide variety of devices.