We are proud to announce the addition of Barbed and Bond-In Luers to our ISO 80369-7 compatible fittings.
The ISO 80369 series of standards aims to minimise misconnections between small bore connectors of different functional categories. ISO 80369-7 specifically addresses intravascular and hypodermic 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 hypodermic 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
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