ISO 80369 Luer Testing

Compliance of Luer Fittings to ISO 80369 standards is critical to maintain compatibility between devices and protect the safety of patients.

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