ISO 80369 Luer Testing Services
Luers, a type of small-bore connection, are used in enteral, respiratory, urinary, neuraxial, and intravenous applications and are used in connecting multiple lines of medicine and nutrients to patients.
ISO 80369 is a series of standards developed by the International Organization for Standardization to improve patient safety by reducing the risk of small-bore misconnections. ISO 80369 common test methods are described within ISO 80369-20:2015.
Medical Murray can conduct the independent testing of your Luer device against the ISO 80369-3:2016 and ISO 80369-7:2021 standards. ISO 80369-3 provides the specifications for enteral feeding connectors and enteral-specific syringes required to connect to the feeding connectors. ISO 80369-7 provides the specifications for connectors used in intravascular or hypodermic applications.
ISO 80369-3
Connectors for Enteral Applications
> Dimensional Analysis
> Leakage by Pressure Decay
> Positive Pressure Liquid Leakage
> Stress Cracking (48-hour hold)
> Resistance to Separation from Axial Load
> Resistance to Separation from Unscrewing
> Resistance to Overriding
> Disconnection by Unscrewing
ISO 80369-7
Connectors for IV or Hypodermic Applications
> Dimensional Analysis
> Leakage by Pressure Decay
> Positive Pressure Liquid Leakage
> Subatmospheric Pressure Air Leakage
> Stress Cracking (48-hour hold)
> Resistance to Separation from Axial Load
> Resistance to Separation from Unscrewing
> Resistance to Overriding