EVS-EN ISO 80369-1:2026

ISO 80369-1 specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. It 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,
—  other use cases utilising an ISO 80369-7 small-bore connector.

ISO 80369-1 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 standard as well as those that can be developed under future parts of the ISO and IEC 80369 series.

ISO 80369-1:2025 text has been approved in Europe as EN ISO 80369-1:2026 without any changes.