Luer Fitting Testing
Luer fittings (6% taper) are used in many medical devices, including hypodermic needles and syringes, catheters, and infusion devices. Where two medical devices that carry small volumes of liquids must be joined, the Luer fitting is the most common means of achieving a leak-free junction.
There are two types of Luer fitting, which were named for the 19th century German medical instrument maker, Hermann Wulfing Luer. The simpler one, a slip fitting, consists of a tapered cone and a mating tapered cavity. A more secure fitting is achieved by adding locking threads to the two halves of a Luer slip fitting, forming a Luer lock fitting; this is the more popular of the two. CITECH has tested Luer fittings alone and as part of testing the devices on which they were used.
The primary standard for dimensional and performance requirements of Luer fittings is ISO 594, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. It consists of two separate standards, ISO 594-1 (Part 1: General requirements) and ISO 594-2, (Part 2: Lock fittings); these were first issued in 1986 and 1991, respectively. The first edition of ISO 594-2 allowed two different configurations of the female fitting thread--either full threads or two short lugs. However, other thread variants were being developed and introduced. In 1996, the European Community issued EN 1707 (1996), a European standard with the same title as ISO 594-2, but with two additional thread alternatives for the female fitting. Test requirements were the same as those in ISO 594-2. In 1998, the second edition of ISO 594-2 was issued; it contained the additional thread designs of EN 1707.
Tests of Luer fittings include dimensional checks, as well as tests for leakage under pressure and vacuum, and security of the assembled fitting. Most of the tests require that the sample be assembled onto a particular precision steel fitting, representing either minimum or maximum allowable dimensions, whichever is the worst case. CITECH has the necessary fittings.
CITECH has tested Luer fittings for many companies seeking to market their products in the United States, Europe, and elsewhere. In some cases, our testing helped qualify new molds. Where the Luer fitting is used on a hypodermic needle or syringe, CITECH can combine several of the Luer fitting tests of ISO 594 with those of the needle or syringe standard (ISO 7864 and ISO 7886-1, respectively), cutting the client’s cost.
If your device includes a Luer fitting and you need independent testing to support a 510(k) or for any other reason, call CITECH for a prompt quotation.
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