Standard name: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7: 2016)

Applicable medical devices:

This standard specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.  

Testing capabilities to ISO 80369-7 include:

  • Dimensional requirements for Luer connectors
  • Fluid Leakage by pressure decay
  • Falling drop positive pressure liquid leakage
  • Subatmospheric-pressure air leakage
  • Stress cracking - with reference fitting
  • Resistance to separation from axial load/Separation force of fitting assembly
  • Resistance to separation from unscrewing
  • Resistance to overriding

Custom Testing

In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team is able to develop a custom testing program to meet your specific testing requirements and resolve and design or functionality issues you might have.

Please note: This Standard revises the withdrawn ISO 954-1:1986 and ISO 594-2:1998. Along side with other parts of ISO 80369 family, this part clearly defines, describes and sets the dimensional requirements for the various types of luer connectors, including not only their fittings (intended connection surfaces) thus reducing the risk of misconnection.

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