ISO 80369-7:2016 Connectors with 6% (Luer) taper for intravascular or hypodermic applications

What is the ISO 80369-7 standard? What happened to ISO 594-1 and ISO 594-2?

The ISO 80369-7 standard is for small-bore connectors for use in intravascular applications or hypodermic connections. The ISO 80369-7 standard cancelled and replaced ISO 594-1:1986 and ISO 594-2:1998, and their content, which have been consolidated and technically revised in ISO 80369-7.

It is likely that ISO 594-1 and ISO 594-2 have some life left in them, and will continued to be used for some time as they are also referenced in other standards, such as the ISO 7886 series for syringes. Those standards are also being revised.

Some countries also refer to ISO 594-1 and ISO 594-2 in legislation and similar. In time, the ISO 80369 series will be used universally.

Performance testing of ISO 80369-7 Luer connectors

The ISO 80369-7 standard includes performance tests following the methods of the ISO 80369-20 standard. Enersol has the reference connectors for ISO 80369-6, and the test equipment needed for the performance tests (ISO 80369-20).

Enersol can supply its reference connectors and test equipment, or for early stage testing/small lot testing this can be performed by Enersol in its ISO 17025 accredited laboratory.

Click the BUTTON below to download guidance documents for Enersol Reference Connectors and Equipment needed for the performance tests of ISO 80369-20.

Guidance document for testing Luer Connectors

Enersol reference connectors for ISO 80369-7:2016

Enersol's reference connectors have been designed specifically to meet requirements of ISO 80369-7. These reference connectors are backwards compatible with ISO 594-1:1986 and ISO 594-2:1998.

Enersol currently makes its reference connectors for ISO 80369-7 and dual certifies them for use with for ISO 80369-7, and the ISO 594-1 / ISO 594-2 standards. In time, once ISO 80369-7 is universally adopted the certification will only reference ISO 80369-7.

(Cat. # S07) ISO 80369-7 Figure C.1 Female reference lock connector for testing male luer connector. Also suitable where ISO 594-2 Figure 5 is required.

(Cat. # S08) ISO 80369-7 Figure C.3 Female reference connector for testing male luer lock connector. Also suitable where ISO 594-2 Figure 6 is required.

(Cat. # S09) ISO 80369-7 Figure C.4 Male reference luer lock connector for testing female luer connector. Also suitable where ISO 594-2 Figure 7 is required.

(Cat. # S10) ISO 80369-7 Figure C.6 Male reference connector for testing female luer lock connector. Also suitable where ISO 594-2 Figure 8 is required)

(Cat. # S11) ISO 80369-7 Figure C.2 Male reference luer slip connector for testing female luer connector. Also suitable where ISO 594-1 Figure 5 is required.

(Cat. # S12) ISO 80369-7 Figure C.5 Feale reference luer slip connector for testing male luer connector. Also suitable where ISO 594-1 Figure 4 is required.

The reference connectors are made from stainless steel and are designed to be used with Enersol ISO 80369-20 testing equipment and devices.

Enersol's ISO 80369-7:2016 reference connectors are made from stainless steel and have been designed to be used with Enersol testing equipment and devices. On request, Enersol can supply adapters to fit the reference connectors to machines other than Enersol's.

The reference connectors have a hex grip area with 9mm flats (for use in Enersol test equipment). The hex grip has an internal M5 thread. On request, reference connectors can be made to order with threads other than M5 either internal or external, as requested. Alternatively, adapters can be supplied to convert to a different thread type.

Reference connectors that are used for leakage tests are shipped with push-in fittings for use with 4mm hoses, making them fast and easy to use with Enersol testing equipment.

Provided with the reference connectors are individual wooden display boxes and long-form calibration certificates by an ISO 17025 accredited calibration laboratory (at no extra cost or lead).

Testing equipment for ISO 80369-7:2016 and ISO 80369-20:2015

Enersol has a full range of equipment for the tests in ISO 80369-20 and ISO 80369-7. Please see the ISO 80369-20 page, which you can visit here.

To find out more, please contact Enersol by emailing or submitting a request for catalogue.

Pricing and lead time

For pricing information and lead times, please contact Enersol. Lead times vary and rely on order size and stock on-hand. The price per unit improves with bulk purchases of 3 or more units of the same reference connector.

Contact Enersol for information by Email Online request for catalogue or pricing

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