Skip to main content

We use cookies on our website to enhance your experience. Click here to find out more about our usage.

  • Home
  • //
  • Eox Blog
  • //
  • Coming Soon to Eox - ISO 80369-7 compatible fittings to product line with Barbed and Bond-In Luers

Coming Soon to Eox - ISO 80369-7

Published date: 04 Feb 2019

Back to Article Listing iso-7-050320.jpg


Barbed and Bond-In Luers to our ISO 80369-7 compatible fittings - Available to buy soon


The ISO 80369 series of standards aims to minimise misconnections between small bore connectors of different functional categories.  ISO 80369-7 specifically addresses intervascular and hyperdermic applications.


The dimensions and tolerances given in ISO 80369-7 are similar enough to those given in the previous standard for luer connectors (ISO 594) that most 80369-7 connectors will be backwards compatible with legacy connectors.  Manufacturers of medical devices should, however, take a proactive approach to implementing 80369-7 connectors into their new designs, as there have been significant changes to dimensional tolerences as well as functional testing requirements.

According to the FDA website, as of December 31st, 2019, the agency will no longer be accepting 510(k) submissions for intravascular or hyperdermic applications that incorporate luer connectors of the ISO 594 standard. 

Extensive research has been conducted to determine the best manufacturing methods and proper testing protocol to evaluate and meet compliance to the ISO 80369-7 standard.  The range of 80369-7 luers are 3rd party tested by accredited, independent laboratories certified to ISO 17025.  Only qualified laboratories, with the specific equipment and experience necessary, have been contracted for testing to ISO 80369's mechanical and dimensional requirements

For further information contact sales@eoxshop.com 

Comments

There are currently no comments, be the first to comment.

Leave us your comment

You need to login to submit a comment. Please click here to log in or register.