The ISO 80369 series 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.
The ISO 80369 series
Click/tap the application heading for more information on these standards and Enersol's reference connectors and equipment. Click/tap the red buttons below to download guidance documents for Enersol Reference Connectors and Equipment for each of the standards.
General requirements and incompatibility requirements for small-bore connectors, which convey liquids or gases in healthcare applications.
This standard is published as ISO 80369-1:2018 (second edition).
This standard includes all the general information about the ISO 80369 series, the methodology to assess incompatibility (non-interconnectable characteristics) of small-bore
connectors and it also contains assessment procedures for small-bore connectors (e.g. new design).
ISO 80369-2 - Breathing systems and driving gases applications
This is currently at FDIS stage, FDIS/ISO 80369-2 (2018). This will be the first edition.
Guidance to reference connectors and equipment for ISO 80369-2
ISO 80369-3 Enteral / gastric applications.
This is published as ISO 80369-3:2016. First edition.
Guidance to reference connectors and equipment for ISO 80369-3
Urethral / urinary applications.
This standard may be eventually published as part 4 in the series.
IEC 80369-5 Limb cuff inflation applications.
This is published as IEC 80369-5:2016. First edition.
Enersol can supply equipment variants for this standard, on request.
ISO 80369-6 Neuraxial applications.
This is published as ISO 80369-6:2016. First edition.
Guidance to reference connectors and equipment for ISO 80369-6
ISO 80369-7 Intravascular or hypodermic applications.
This is published as ISO 80369-7:2016. First edition. (A second edition is underway as of October 2019.)
Guidance to reference connectors and equipment for ISO 80369-7
The ISO 18250 series
Click/tap the application heading for more information on these standards and Enersol's reference connectors and equipment. Click/tap the red buttons below to download guidance documents for Enersol Reference Connectors and Equipment for each of the standards.
General requirements and incompatibility requirements for reservoir connectors, which convey fluids in healthcare applications.
This standard is published as ISO 18250-1:2018 (first edition).
This standard includes all the general information about the ISO 18250 series, the methodology to assess incompatibility (non-interconnectable characteristics) of reservoir
connectors and it also contains assessment procedures for reservoir connectors (e.g. new design).
ISO 18250-3 Enteral applications
This is published as ISO 18250-3:2018. First edition.
This standard includes its own requirements separate to the small-bore ISO 80369-3 standard.
Guidance to reference connectors and equipment for ISO 18250-3
ISO 18250-6 Neuraxial applications
This is published as ISO 18250-6:2018. First edition.
This standard relies on all of the requirements in ISO 80369-6:2016.
ISO 18250-7 Intravascular or hypodermic applications
This is published as ISO 18250-7:2018. First edition.
This standard relies on all of the requirements in ISO 80369-7:2016.
ISO 18250-8 Citrate-based anticoagulant solution for apheresis applications
This standard is published as ISO 18250-8:2018. First edition.
This standard includes its own requirements and is published as ISO 18250-8:2018. First edition.
Guidance to reference connectors and equipment for ISO 18250-8
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.