A few months ago on October 14, ISO formally published 80369 Part 7, the long-awaited replacement to everyone’s familiar friend, 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.
As should be expected with changes of this magnitude, there are many nuances in the new standard that 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.
In a new white paper, DDL’s Product and Materials Engineer Levi Loesch highlights the changes that most significantly affect how one should construct their design verification plan. Levi discusses the following points in the white paper:
- 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.
Update: On December 23rd, 2016, the FDA added ISO 80369-7 to its list of recognized consensus standards. The FDA website states that the Agency will continue to accept declaration of conformity to ISO 594 in support of pre-market submissions until December 31st, 2019. DDL will continue to offer testing to both ISO 594 and 80369 to meet the needs of our customers.
It should also be noted this white paper is intended to give a high-level overview of the differences between ISO 594 and 80369-7 and is not intended to be a substitute for a comprehensive understanding of the contents of the standards. We at DDL always welcome an opportunity to discuss the nuances of the standards in greater detail, so please don’t hesitate to contact us if you have any lingering questions or would like to discuss an upcoming project.
Please click here to download a copy of the new white paper.
Please contact us today for more information on ISO 80369 ISO testing.