Luer Testing in Accordance with ISO 80369 Standards

2019-05-03 22:50:30

Medical Luers are used in a wide variety of medical device and drug delivery applications. Applications include vascular, enteral, respiratory, epidural and intrathecal delivery systems. Traditionally the ISO and the FDA have recognized and approved only one family of designs for these Luer connections with designs based on ISO 594.

Due to the ubiquitous, easy-to-use and compatible nature of Luer connectors, clinicians can inadvertently connect wrong systems together, causing medication or other fluids to be delivered through the wrong route. To prevent these medical mistakes, an ISO committee is in the process of writing a new standard, ISO 80369. ISO 80369 defines 6 different types of Luer connections, with different designs such that incompatible connectors cannot be connected together. The new standard also defines tests for compatibility, as well as new tests to confirm incompatibility with the other Luer designs.

Below is a list of the new Luer design categories and relevant sections in ISO 80369:

ISO 80369-2 - Part 2: Connectors for breathing systems and driving gases applications
ISO 80369-3 - Part 3: Connectors for enteral applications
ISO 80369-4 - Part 4: Connectors for urethral and urinary applications
ISO 80369-5 - Part 5: Connectors for limb-cuff applications
ISO 80369-6 - Part 6: Connectors for Neuroaxial applications
ISO 80369-7 - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications
Part 7, intravascular and hypodermic applications, inherits the historical Luer design from ISO 594-1 and 2.

Part 20 of ISO 80369 describes common test methods. These tests are to be completed for all connectors. The purpose of this test protocol is to verify that the design of the small bore connectors meets the functional requirements and non-interconnectability requirements defined in the new standard. Many of the test methods in this section are identical to or derived from the previous ISO 594-1 and ISO 594-2.