ISO 80369-7

The International Organization for Standardization (ISO) is in development of the new ISO 80369 standards to reduce the risk of misconnections between small-bore medical connectors. These connectors are used in respiratory, enteral, urinary, blood pressure, neuraxial and intravenous systems which historically used an identical luer lock design.

This increases the likelihood of a misconnection between the delivery systems used in the medical device industry. We have seen the impact of these new standards which has led to new designs, new parts, new molds, and the replacement of millions of components. The FDA is reviewing the deadline for ISO 80369 enforcement. Injectech is proud to manufacture panel mounts, barbed luers, bond-in luers, filters and check valves that meet the ISO 80369-7 standard.

Functionality and tested for:

• Leakage by pressure decay

• Sub-atmospheric-pressure air leakage

• Stress cracking leakage

• Resistance to separation from axial load

• Resistance to separation from unscrewing

• Resistance to overriding

• Selected materials have a modulus of elasticity of over 700 MPa

Injectech has started with Acrylic, Polycarbonate, and ABS. We will continue with Kynar, Polypropylene, and Nylon. We have performed testing on both barbed and bond-in luers with slip luers, rotating luers and couplers to follow.

Within the coming months, the FDA plans to publish Amendment 1 to the 80369-7 standard and will no longer be accepting device designs for intravascular or hypodermic applications that incorporate luer connectors of the ISO 594 standard after that time. Be proactive and start incorporating these luers into your devices today!

We recommend caution when others designate their parts as 80369-7 compliantwithout offering sufficient evidence to back their claims.It is highly recommended that your suppliers have the appropriate test results to back their claim to the ISO 80369-7 standard to avoid future issues with the FDA.