CEI UNI EN ISO 80369-1

This document specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids or gases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES or ACCESSORIES intended for use with a PATIENT.

This document also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are intended to be used.

These healthcare fields include, but are not limited to:

— BREATHING SYSTEMS and driving gases;

— enteral;

— limb cuff inflation;

— neuraxial;

— intravascular or hypodermic.

This document provides the methodology to assess NON-INTERCONNECTABLE characteristics of SMALL-BORE CONNECTORS based on their inherent design and dimensions in order to reduce the RISK of misconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.

This document does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these SMALL-BORE CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.

NOTE 1 Clause 7 allows for additional designs of SMALL-BORE CONNECTORS for new APPLICATIONS for inclusion in the ISO 80369 series.

NOTE 2 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in the ISO 80369 series into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICES standards. It is expected that when the relevant particular MEDICAL DEVICES standards are revised, the risks associated with changing to the new SMALL-BORE CONNECTORS as specified in the ISO 80369 series of standards will be considered.

NOTE 3 The CONNECTORS specified in the ISO 80369 series are intended for use only in their specified APPLICATION. Use of these CONNECTORS for other APPLICATIONS increases RISK that a hazardous misconnection could occur.

NOTE 4 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-BORE CONNECTORS specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.