White Paper: The New ISO 80369-2 Standard For Respiratory Applications

The goal of ISO 80369 is to standardize connector use for common procedures. Essentially, moving away from the luer connector as a standard interface for different devices. This will avoid misconnections that could result in injuries or death. Luer connectors are now specifically used for intravascular and hypodermic applications as detailed in the ISO 80369-7 standard.

In July of 2024, the new ISO 80369-2 standard was released. The corrected version was released in September of 2024 where commas were added to the dimensional values. This standard applies to connectors for respiratory applications.

The connectors in the ISO 80369-2 are specific to materials with a nominal modulus of elasticity either in flexure or in tension that is greater than 700 MPa. There is new nomenclature for the configurations as well. The male connector is now referred to as the “cone”. The female connector is now referred to as the “socket”.

The standard details four connectors in all. The first cone and socket are for use with low pressure applications which is designated as R1. The other cone and socket connectors are for use with higher pressure applications which is designated as R2.

R1: These connectors (cone and socket) are intended for use on respiratory devices subjected to pressures up to 15 kPa. Examples are breathing systems (low-flow equipment such as sample ports on anesthetic and ventilator breathing systems). The geometry is straight with a small, angled sealing surface towards the middle of the connection.

R2: These connectors (cone and socket) are intended for use on respiratory devices subjected to higher pressures between 15 kPa and 600 kPa. Examples are oxygen therapy tubing, driving gases, flowmeters, nebulizer therapy face masks and nasal cannulae. The geometry is a 6% taper (visually similar to luer connectors) that seals along the opposing taper.

All new medical devices and accessories with connections to the ancillary port connection of a breathing system or to be used with a respirable gas should implement the new connectors to avoid unnecessary changes once the standard is enforced. At this time, there is no readily available information as to when the FDA will require existing devices and accessories to change. Examples of medical devices can be found in Table D.1 of the standard.

Injectech offers our line of patent pending ISO 80369-7 connectors. To aid with the transition, our respiratory adapters are available in the following R1 configurations:

•        Female luer lock to ISO 80369-2 cone
•        Male rotating luer to ISO 80369-2 socket

We are expanding our product line which will include cone/socket connectors to bond-in ports and barbs for assembly to tubing. This product line will offer multiple sizes and materials as well as customization services to meet your specific device requirements.

For more information on how this change may affect you, please contact Dave Splett at (970) 482-0273 or Dave@injectech.us.

Dave Splett is the Vice President of Business Development for Injectech, LLC.  Injectech, LLC is a leading worldwide supplier of medical components.