Luer Taper and Lock Test Equipment per ISO 80369 and ISO 594
Luer taper and lock test equipment are specially configured to meet ISO 80369 and ISO 594. Luers are convenient connector devices used in the medical industry, which simplify the administration of liquid and gaseous medical fluids. One of the many advantages Luer fittings provide is the ability to be switch IV bags without extracting and reinserting a needle into the patient. They also allow multiple compatible fluids to be administered through the same central line, reducing the number of entry ports required in the patient's body. The ease with which Luer fittings can be connected, and the compatibility of the connectors between different products, increases the risk of connections between incompatible systems or the administration of substances through the wrong delivery system. The issue of misconnection is known and documented throughout the medical field and a joint working group, including members of the the United States Food and Drug Administration (FDA), the International Electrotechnical Commission (IEC), the Association for the Advancement of Medical Instrumentation, and ISO, has assembled to create a unified set of standards for the design and testing of Luer connections.
The collaboration of these organizations has produced a unified standard for Luer connections in ISO 80369-1, which specifies the general requirements of Luer locks and tapers , requiring the incompatibility of connections between certain systems, employing Luer fittings. To ensure incompatibility between systems that do not perform interchangeable functions, forced connections made between these incompatible systems are required to easily fall apart, preventing the perception of a secure connection. By ISO 80369-1, this is defined as the connection separating at or below an applied force of 0.02 N or 2 grams. Testing Luer fittings to ISO standards requires the use of a low force, low torque, axial torsion test machine equipped with special vacuum pressure grips or test fixtures. The machine enables the assembly of threaded Luer lock connectors without exceeding 0.12 Nm and is capable of the force resolution to measure separation forces below the 0.02 N maximum defined by the standard.