Foreword

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This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for products with a health purpose including medical devices, in collaboration with Technical Committee IEC/SC 62D, Particular medical equipment, software, and systems, and with the European Committee for Standardization (CEN) Technical Committee CEN/CLC/JTC 3, Quality management and corresponding general aspects for medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This third edition cancels and replaces the second edition (ISO 80369‑1:2018), which has been technically revised.

The main changes are as follows:

update of normative references;
update of the document according to ISO/IEC Directives, Part 2;
addition of respiratory applications;
addition of interference test part, misconnection and unintended connection definitions;
deletion of Clause 4 for materials requirements, as those requirements are or will be placed in the individual connector parts of the series and normative Annex B describes the analysis and testing processes for determining non-interconnectable characteristics;
revision of Annex B by summarising process description and adding figure, editorial changes and adding the dimensional analysis case “potential misconnection”;
deletion of the original Annex C, replaced with normative reference to parts of ISO 20417;
addition of Annex E summarizing the design assessments of the application parts of this series of documents;
replacement of contents of Annex F by referencing the relevant essential principles and labelling guidance of the International Regulators Forum (IMDRF);
extension of the use of the ISO 80369‑7 connector to medical devices and accessories beyond intravascular and hypodermic applications where the risk is acceptable.

A list of all parts in the ISO and IEC 80369 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

In the 1990s, concern grew regarding the proliferation of medical devices fitted with Luer connectors as specified in the ISO 594 series^[1^] and the reports of patient death or injury arising from unintended connections that resulted in the inappropriate delivery of fluids and gases via incorrect routes. In addition to clinical and workplace protocols and warnings, attention was turned to engineering solutions to reduce the probability of wrong route administration of liquids and gases.

Concerns regarding the use of Luer connectors with enteral feeding tubes and gas sampling and gas delivery systems were raised with CEN Bureau Technique (CEN/BT) and the European Commission. In November 1997, the newly created CEN Healthcare Forum (CHeF) steering group set up a Forum Task Group (FTG) to consider the problem.

The FTG produced CEN Report, CEN/CR 13825,^[9^] in which they concluded that there is a problem arising from the use of a single connector design to several different applications. In a coronary care unit, there could be as many as 40 Luer connectors on the medical devices used with a single patient until the use of connectors defined in the ISO and IEC 80369 documents started to be established. Therefore, it is not surprising that unintended connections were made.

Medical devices have, for many years, followed the established principle of “safety under single fault conditions.” Simply stated, this means that a single fault should not result in an unacceptable risk. This principle is embodied in the requirements of numerous medical device standards.^[6^] Extending this principle to the use of Luer connectors (i.e. that an unintended connection should not result in an unacceptable risk to a patient) the FTG recommended that the Luer connector should be restricted to medical devices intended to be connected to the vascular system or a hypodermic syringe. In addition, the FTG recommended that new designs of small-bore connectors should be developed for other applications, and these should be non-interconnectable with Luer connectors and each other.

International medical device regulators forum (IMDRF), GRRP N47:2024,^[10^] Essential Principle 5.1.3, addresses this type of problem:

It is understood that small-bore connector systems cannot be designed to overcome all chances of unintended connections with the potential for wrong route administration or to eliminate deliberate misuse. With these application-specific connectors now available, the risk of unintended connections and wrong route administration is greatly reduced thereby improving patient safety. Introduction of medical devices and accessories utilizing these small-bore connectors is progressing albeit slowly.

The risks associated with unintended connections and subsequent wrong route administration of liquids and gases cannot be fully assessed until these small-bore connectors are part of a medical device or accessory. Therefore, the intended applications specified are recommendations. It is expected that particular medical device standards will reference the connectors from the relevant parts of the ISO and IEC 80369 series if considered appropriate.

This document contains the general requirements to reduce connections between small-bore connectors used in different applications as well as specifying those applications.

It specifies the general requirements and test methods for assessing the non-interconnectable characteristics of small-bore connectors within the ISO and IEC 80369 series.

The Luer connector as originally defined in the withdrawn ISO 594 series has been widely used on many medical devices and accessories and in a wide range of clinical applications for many years. The clinical applications that present the highest risk to a patient from wrong route administration of liquids and gases have been identified and are those included in the application parts of the ISO and IEC 80369 series. ISO 80369‑7, which replaces the ISO 594 series (i.e. the Luer connector), is intended for use with intravascular or hypodermic applications.

However, there are currently medical devices and accessories which incorporate a Luer connector, but do not fall into any of the applications specified by the ISO and IEC 80369 series. There are also some medical devices and accessories within the applications of the ISO and IEC 80369 series applications that incorporate a Luer connector. Those that present no unacceptable risk to the patient from an unintended connection to a medical device or accessory within intravascular or hypodermic application are suitable for consideration for the use of the Luer connector as specified in ISO 80369‑7.

ISO 80369‑20 specifies the common test methods for assessing the basic performance requirements specified in ISO 80369‑2, ISO 80369‑3, IEC 80369‑5, ISO 80369‑6 and ISO 80369‑7 for small-bore connectors.

ISO 80369‑2, ISO 80369‑3, IEC 80369‑5, ISO 80369‑6 and ISO 80369‑7 specify the material requirements, dimensional requirements for the interfaces of the connectors and the specific performance requirements for assessing the interconnectability of the mating connectors.

The designs and dimensions of small-bore connectors specified in ISO 80369‑2, ISO 80369‑3, IEC 80369‑5, ISO 80369‑6 and ISO 80369‑7 have been successfully assessed according to the requirements of this document (i.e. have been proven to be acceptable with regard to the risk of misconnection with the other connectors of this series).

The risks of changing to these new small-bore connectors should be assessed before these small-bore connectors are incorporated into medical devices as they will when the relevant particular medical device standards are revised.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

In this document the following verbal forms are used.

“Shall” indicates requirements.
“Should” indicates recommendations.
“May” indicates permissions.
"Can" indicates possibility or capability.

This document uses italic type to distinguish defined terms from the rest of the text. It is important for the correct understanding of this document that those defined terms are identifiable throughout the text of this document. A list of the defined terms used in italics in this document is given in Annex G.

Requirements in this document have been broken down so that each requirement is clearly delineated and listed individually. This has been done to support the common practice of automatic tracking of requirements and automatic verification of the requirements of this document.

Annex A contains guidance and rationale on specific subclauses in this document.

1 Scope

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

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.

2 Normative references

3 Terms and definitions

4 Small-bore connector non-interconnectable requirement

5 Small-bore connectors for clinical applications

5.1 Small-bore connectors for new clinical applications

5.2 Small-bore connectors for respiratory applications

5.3 Small-bore connectors for enteral applications

5.4 Small-bore connectors for limb cuff inflation applications

5.5 Small-bore connectors for neural applications

5.6 Small-bore connectors for intravascular and hypodermic applications

5.7 Other use cases utilizing an ISO 80369‑7 small-bore connector

6 Alternative small-bore connectors

Bibliography

ISO 80369-1:2025

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

Current

Published:

10 Oct 2025