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  • 80369 info

Functionally Tested and Passed 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.

Time is Ticking

80369-7 Fittings

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 compliant
without 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.