Luer Testing (ISO 80369)

Work with us to find the right equipment for your luer fitting testing needs

Download our free Medical Device Sector Review here!

Overview

Luer Lock Fittings

Luer lock fittings are utilized in within intravascular or hypodermic applications of medical devices/instrumentation (such as needles, syringes, catheters, and infusion sets) to facilitate a leak-free administration of various fluids to a patient through a central line, eliminating the need for multiple needle insertions within a given patient. Luer fittings consist of both luer slip and luer lock connectors. A luer slip fitting consists of a tapered cone that slips onto its mating tapered cavity, while a luer lock fitting consists of similar components, however with integrated locking threads. Luer slip fittings are simpler and most often utilized in low-pressure applications while threaded luer lock fittings offer more robust and secure connections between medical components. As with most devices in the medical industry, luer fittings must adhere to strict manufacturing and testing protocols. With a more convenient means of delivering fluids to patients came an increase in misconnections and errors during substance administration.

New Standard for Small Bore Connectors & Luer Locks

In response to increasing reports of accidental misconnections of small bore connectors such as luer locks, International Standards Organization created a comprehensive set of standards for manufacturers to adhere by in the design and testing of small bore connectors, ISO 80369-7. ISO 80369-7 replaces ISO 594-1 and ISO 594-2, which had both previously been created to define design and testing requirements of luer fittings. This standard defines general requirements for small-bore connectors relating to their design and dimensions in efforts to reduce the risk of cross connections between applications through connector differentiation.

ISO 80369-20 specifies the general test methods to evaluate the performance requirements of these small-bore connectors, which are categorized into annexes, eight of which are applicable for mechanical testing equipment.

Testing Equipment

ADMET’s engineers have developed an eXpert 8601 Axial-Torsion Testing System package designed specifically for testing per ISO 80369. The package includes a bi-axial testing machine configured to apply the mechanical forces called out in the specification within their respective tolerances. Our bi-axial MTESTQuattro controller includes pre-programmed test procedures to enable users to perform the tests defined within each annex easily and automatically, while also allowing operators to modify and create their own test procedures. The package also includes the appropriate accessories, some of which are uniquely designed for your luer locks, to perform all mechanical tests within the specification.

Read more about the new luer lock testing methods here: