The West Group adds ISO 80369-7 compatible fittings to product portfolio
Announcing the addition of ISO 80369-7 compatible male and female barbed luers and bond-in luers to our range
The ISO 80369 series of standards aims to minimise misconnections between small bore connectors of different categories. This is specifically addressing intravascular and hypodermic applications. ISO 80369-7 dimensions and tolerances are similar enough to those given in the previous standard for luer connectors (ISO 594). The result is 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. This is due to the significant changes to dimensional tolerances as well as functional testing requirements.
From December 31st 2019, the FDA website states the agency will no longer be accepting 510(k) submissions for intravascular or hypodermic applications. This is specifically in relation to those that incorporate luer connectors of the ISO 594 standard. Extensive research has been conducted to determine best manufacturing methods and proper testing protocol. This is to evaluate and meet compliance to the ISO 80369-7 standard. The range of luers are 3rd party tested and accredited, independent laboratories certified to ISO 17025. Qualified laboratories, with specific equipment and necessary experience have been contracted for testing to ISO 80369's mechanical and dimensional requirements.
Compliant barbed and bond-in luers are available in a range of sizes. We are happy to discuss the availability of additional sizes and custom-made components for your requirements.
For full details, contact our Sales Team on +44 (0)23 9226 6031 or e-mail your enquiry.