The ISO 80369 and ISO 18250 series for small-bore connectors and reservoir delivery systems

What are the ISO 80369 and ISO 18250 series?

The ISO 80369 and ISO 18250 series of standards were introduced to prevent accidental mis-connections between different medical connectors. The prevention of mis-connection is achieved through the specification of the different types of small-bore connectors and reservoir connectors so that they are purposely dimensionally incompatible. This must be proven through CAD-analysis and/or physical testing.

There are currently eight standards in the ISO 80369 series, of which six are currently published and one is underway. The eighth standard has been in development for urethral and urinary applications for some time, although development of this standard has stalled.

While developing the ISO 80369 series it became apparent that mis-connections on the patient side were not the only ones possible. The ISO 18250 series was therefore developed to cover reservoir connectors and assist in reducing risk of mis-connection between small-bore connectors and reservoir connectors. This series contains five standards, and all are published.

What do the ISO 80369 standards and ISO 18250 standards contain and how are they used?

The ISO 80369-1 standard contains general information about the small-bore connector series including the requirements for connector incompatibility. Similarly, ISO 18250-1 contains the general information about the reservoir connector series including the requirements for connector incompatibility.

The ISO 80369-20 standard contains the performance requirement test methods along with the testing equipment requirements. The FDIS/ISO 80369-2, ISO 80369-3, ISO 80369-6 and ISO 80369-7 standards for small-bore connectors, along with the ISO 18250-3 and ISO 18250-8 standards for reservoir connectors, use ISO 80369-20 for testing the connectors. The IEC 80369-5 standard uses modified methods that are detailed within its part standard. The other ISO 18250 standards, ISO 18250-6 and ISO 18250-7, refer to the partner ISO 80369-6 and ISO 80369-7 for the performance requirements.

The FDIS/ISO 80369-2, ISO 80369-3, IEC 80369-5, ISO-80369-6, ISO 80369-7, ISO 18250-3 and ISO 18250-8 standards contain dimensional and material specifications of the small-bore connectors and reservoir themselves, the performance requirements of the small-bore connectors and reservoir connectors, as well as details and dimensions of the reference connectors that are used for testing the connectors.

Enersol reference connectors and testing equipment for the ISO 80369 and ISO 18250 series of standards

Enersol's range of reference connectors, testing equipment and accessories are made specifically to meet requirements of the ISO 80369 series and ISO 18250 series. Enersol also conducts testing in its ISO 17025 accredited laboratory in Sydney, Australia.

Enersol's 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.

Enersol's small-bore connector and reservoir connector testing equipment, devices and accessories are designed specifically to meet requirements of ISO 80369-20:2015 and the individual part standards. Enersol also has a range of equipment for ISO 594 series, ISO 7886 series, ISO 8537 and other similar standards.

Some of Enersol's ISO 80369-20 equipment is backwards compatible with ISO 594-1:1986 and ISO 594-2:1998, thus allowing a laboratory to continue to test syringes and other medical devices requiring ISO 594 tests. Some of the items in this range also include equipment that can also be used for ISO 7886, ISO 8537 and similar standards.

Enersol's reference connectors have a hex grip area (for use in Enersol test equipment). The hex grip has an internal M5 thread. On request, reference connectors can be made to order with different threads (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.

The reference connectors are supplied in individual containers, with silica gel packs and care instructions. A long-form calibration certificate by an ISO 17025 accredited calibration laboratory is also supplied (at no extra cost or lead).

ENERSOL can also provide the ISO 594-1 gauges (figures 3a/3b/3c) on request).

To find out more about the reference connectors, or testing equipment, please contact Enersol by emailing or submitting a request for catalogue.

Contact Enersol for information by Email Online request for catalogue

Enersol's testing facility for medical devices, including small-bore connectors (ISO 80369 series) and reservoir connectors (ISO 18250 series)

Enersol runs an ISO 17025 accredited and ISO 9001 certified testing laboratory which includes the testing of ISO 80369-20 and similar standards.

The laboratory uses Enersol's own equipment, researched, designed and made in-house. It's accreditation includes the methods in ISO 80369-20, as well as ISO 594, ISO 7886 and similar standards

Enersol has highly trained technical staff profiecient in the tests in these standards who will be happy to assist with any enquiries for testing.

Enersol's laboratory can (and has) been used during the development stages for device manufacturers, as well as Government organisations performing pre or post market testing.

Last updated: 1 June 2021

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