ISO 80369: Changing the Standards for Luer Connectors

ISO has 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. 

This DDL white paper highlights the changes that most significantly affect how one should construct their design verification plan. The white paper discusses the following points


  • Stricter requirements and dimensional mechanical specifications
  • Testing against slip and lock reference connectors
  • Modications to assembly and test procedures
  • Addition of guidance for performance of variable tests

Fill out the form below to download the white paper.

ISO 80369 Whitepaper Download