ISO 80369 evaluates the functionality of small-bore connectors for liquids and gases in healthcare applications. These connectors, also known as luer connectors, are universally used in medical applications to ensure that medical products such as syringes and catheters will reliably connect with one another, no matter where in the world they are produced.

Luer connectors are used exclusively within the healthcare industry and can be found in a wide range of medical products. They are critical for ensuring that patients receive appropriate treatments, such as the delivery of medication or the withdrawal of bodily fluids. Any failure in the device connector could cause dangerous complications: this can include the contamination of medication or the inability to make a secure connection between devices.

Types of Luer Connectors

Luer connectors can be either male or female and come in two distinct types: Luer slips are caps which are held in place by the frictional forces introduced by the 6-degree tapered fitting, while Luer locks utilize a threaded connection for a more secure attachment.

 

Challenges of Testing to ISO 80369

ISO 80369 tests are performed as a quality control measure to determine any possibly defects in connectors before the devices leave the manufacturing facility. The test method includes different subsection, each addressing different healthcare applications ranging from intravascular to neuraxial. The test methods outlined by the standard serve to evaluate the closure quality through applied forces, torques, and internal pressures to simulate typical and extraordinary use cases. 

The main difficulty associated with testing to ISO 80369 is the numerous test setups needed to fully evaluate the connections. Many labs still use manual methods to determine the closure quality of the connectors, resulting in low throughput and lab efficiency as they move from one test setup to another. Incorporating the pressure sensor into the universal testing machine has been a major improvement on the test workflow, as it minimizes the time needed in between setups and reduces required lab space. 

To read the full standard, purchase ISO 80369. To learn more about testing drug delivery devices and containers, click here.

Materials Testing System

For labs testing to ISO 80369, we recommend using an Instron 68SC1 testing system with Torsion Add-On 3.0, which provides the testing system with torsional capabilities.