ISO 80369 Series of standards under revision
Luer connectors and conical fittings are key components for the manufacture of medical devices used to deliver liquid and gases safely to patients.
In the 1990’s the majority of these devices utilized the Luer connector designed using ISO 594 series (part 1 & 2) for Conical fittings with a 6% (luer) taper. However, there were misconnection issues reported in the field as medical devices of different applications could inadvertently be connected via the luer connectors, there by resulting in patient risk and incorrect delivery of fluids and gases. In May 2000 a CEN Report, CR 13825 was published by a Task Group set up to review issues with luer connectors. A key recommendation from this report was that new small-bore connector designs should be developed for each application.
This work was undertaken by ISO/TC210 – Quality management & corresponding aspects for products with a health purpose including medical devices, and specifically JWG4 – small bore connectors. This working group identified several different application areas and experts began working on replacing the ISO 594 series with ISO 80369 – Small bore connectors for liquids and gases in health care applications. ISO 80369-1 is the first in the series and was first published in 2010. Subsequent parts were produced for different applications for example enteral feeding, limb cuff inflation, neural axial & intravascular.
Planned revisions for ISO 80369 Series of standards
ISO/TC 210/JWG4 are working of revisions of some of the series as well as developing new application parts. During the revision work the JWG is taking the opportunity to harmonize the series wording to make it easier to understand and apply each standard. The following document outlines the current work programme for ISO/TC 210 JWG4 and changes in the ISO 80369 Series
The updates provided in table 1 are based on a report from an NSAI expert’s, who is actively involved in the work of ISO/TC 210 JWG4 and attended a recent meeting in Berlin in early March 2023. This working group is very active at present and participation is beneficial as it allows participants contribute to drafting and gain valuable knowledge on the development history.
Access to information through NSAI standards committees
National stakeholders interested in finding out more about these changes are encouraged to join NSAI Standards committees NSAI/TC 5 Healthcare Standards Committees. Members of this committee have access to draft standards and can provide feedback on the development of the ISO 80369 series, through the national ballot system. All national inputs are provided to ISO TC 210/JWG 4 and will inform changes for the next draft.
Participation in NSAI Standard committees allows manufacturers to get insights into the changes that are planned for these standards which can assist in the process of transitioning from the older ISO 594 designed Luer connector to these newly developed small-bore connectors standards as set out in the ISO 80369 Series. This article was prepared by Patrick Dunne (BSCI) who is a member of ISO/TC 210/JWG4 & NSAI/TC 5
For more information on getting involved in NSAI committees see the NSAI website Healthcare Standards | NSAI