Injectech (Fort Collins, Colo.) said today that it has started selling male/female luer locks and male/female bond-in luers that meet the ISO 80369-7 standard.
The new products join Injectech’s existing line of male/female luers.
The ISO 80369 series of standards is meant to minimize misconnections between small-bore connectors of different functional categories, according to Injectech. ISO 80369-7 specifically addresses intervascular 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 tolerances as well as functional testing requirements. According to the FDA website, as of December 31st, 2019, the agency will no longer be accepting device designs for intravascular or hypodermic applications that incorporate luer connectors of the ISO 594 standard.”
Injectech will offer the ISO 80369-7 compliant barbed luers and bond-in luers in sizes that the company already offered, and also welcomes additional sizes ad custom components.