scope:

NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.

This document specifies general requirements for small-bore connectorsthat form part of a medical device or accessory that conveys liquids or gases to a patient.

This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:

- respiratory;

- enteral;

- limb cuff inflation;

- neural;

- intravascular or hypodermic.

This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design 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 might be developed under future parts of the ISO and IEC 80369 series.

This document specifies the small-bore connector-related interface requirements for the medical devices and accessories that use these small-bore connectors.

These interface requirements reduce the risk of wrong route administration of liquids or gases between the medical device or accessory by incorporating these small-bore connectors in different applications.

NOTE 2 6.1 allows for additional designs of small-bore connectors for inclusion in the ISO and IEC 80369 series.

NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO and IEC 80369 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO and IEC 80369 series of documents will be considered.

NOTE 4 Manufacturers and other entities including those accountable for the use of a medical device and the clinical incident monitoring are encouraged to report their experience with the small-bore connectors specified in the ISO and IEC 80369 series to the Committee Manager of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO and IEC 80369 series.