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ISO 80369-1:2025

Current

Current

The latest, up-to-date edition.

Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

10-10-2025

€174.00
Excluding VAT

This document specifies general interface requirements forsmall-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:

other use cases utilizing an ISO80369-7 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 IEC80369 series.

NOTE Clause A.2 contains guidance or rationale for this Clause.

DocumentType
Standard
Pages
41
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Standards Relationship
AS ISO 80369.1:2026 Identical
BS EN ISO 80369-1:2026 Identical

Frequently Asked Questions

ISO 80369-1 specifies design and performance requirements intended to prevent misconnections between small-bore medical connectors. It is an international standard published by International Organization for Standardization (ISO).

ISO 80369-1 is used by medical device manufacturers and laboratories designing or testing fluid and gas connectors. It is an international standard published by International Organization for Standardization (ISO).

ISO 80369-1 is International Organization for Standardization (ISO)'s standard for small-bore connectors for healthcare, while IEC 60601-1-11 covers medical electrical equipment safety (International). ISO 80369-1 specifies design and performance requirements intended to prevent misconnections between small-bore medical connectors. IEC 60601-1-11 sets general requirements for basic safety and essential performance of medical electrical equipment and systems. It supports consistent specification, verification and documented acceptance across the relevant lifecycle.

ISO 80369-1 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO 80369-1 specifies design and performance requirements intended to prevent misconnections between small-bore medical connectors. In practice it is applied by medical device manufacturers and laboratories designing or testing fluid and gas connectors.
€174.00
Excluding VAT