dnaSRPS EN ISO 80369-1:2024

Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO/FDIS 80369-1:2025)

Scope

This document 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.
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;
—     other use cases utilizing an ISO 80369-7 small-bore connector.
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 can be developed under future parts of the ISO and IEC 80369 series.
NOTE            Clause A.2 contains guidance or rationale for this Clause.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.