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White Paper: Medical

ISO 80369-7: Changing the Standard for Luer Connectors


On October 14, 2016, ISO formally published 80369 Part 7, the long-awaited replacement to ISO 594, the standard governing dimensions and performance requirements of Luer connectors. The publication caps a monumental change in the fundamental thinking surrounding devices that transfer liquids and gases in healthcare settings. Despite the Technical Committee’s desire to disrupt as little as possible surrounding the current practices with Luer connectors, ISO 80369-7 still makes many significant changes.

This white paper highlights the changes that most significantly affect how one should construct their design verification plan, which are:

  • stricter requirements on dimensional and mechanical specifications,
  • testing against slip and lock reference connectors,
  • modifications to assembly and test procedures, and
  • addition of guidance for performance of variable tests.

As should be expected with changes of this magnitude, there are many nuances in the new standardthat require some interpretation. At DDL, we have had the opportunity to work with members of the ISO Technical Committee and many industry partners to interpret these changes.

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