ISO 80369-1:2025
(Main)Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
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.
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 1: Exigences générales
Le présent document spécifie les exigences générales d'interface applicables aux raccords de petite taille faisant partie d'un dispositif médical ou d'un accessoire qui délivre des liquides ou des gaz à un patient. Le présent document identifie également les applications dans le cadre desquelles ces raccords de petite taille sont destinés à être utilisés, ce qui inclut, entre autres:
- les applications respiratoires;
- les applications entérales;
- les applications au gonflement de ballonnet;
- les applications neuraxiales;
- les applications intravasculaires ou hypodermiques;
- les autres cas d'utilisation impliquant un raccord de petite taille relevant de l'ISO 80369-7.
Le présent document indique la méthodologie à suivre pour évaluer les caractéristiques de non-raccordabilité des raccords de petite taille en s'appuyant sur leur conception intrinsèque, afin de réduire le risque d'erreurs de raccordement entre des dispositifs médicaux ou entre des accessoires destinés à différentes applications qui sont spécifiées dans le présent document ou qui peuvent être développées dans les futures parties des séries ISO et IEC 80369.
NOTE L'Article A.2 contient des recommandations ou justifications concernant le présent article.
General Information
Relations
Standards Content (Sample)
International
Standard
ISO 80369-1
Third edition
Small-bore connectors for
2025-10
liquids and gases in healthcare
applications —
Part 1:
General requirements
Raccords de petite taille pour liquides et gaz utilisés dans le
domaine de la santé —
Partie 1: Exigences générales
Reference number
© ISO 2025
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Small-bore connector non-interconnectable requirement . 4
5 Small-bore connectors for clinical applications . 5
5.1 Small-bore connectors for new clinical applications .5
5.2 Small-bore connectors for respiratory applications .5
5.3 Small-bore connectors for enteral applications .5
5.4 Small-bore connectors for limb cuff inflation applications .6
5.5 Small-bore connectors for neural applications .6
5.6 Small-bore connectors for intravascular and hypodermic applications .6
5.7 Other use cases utilizing an ISO 80369-7 small-bore connector .6
6 Alternative small-bore connectors . . 7
Annex A (informative) Rationale . 9
Annex B (normative) Process for demonstrating non-interconnectable characteristics .15
Annex C (normative) Assessment procedures for small-bore connectors .30
Annex D (informative) Applications of small-bore connectors and the relevant standard .33
Annex E (informative) Design assessment summary .35
Annex F (informative) Reference to the IMDRF essential principles .38
Annex G (informative) Alphabetized index of defined terms .39
Bibliography . 41
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
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);
iv
— 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.
v
Introduction
In the 1990s, concern grew regarding the proliferation of medical devices fitted with Luer connectors
[1]
as specified in the ISO 594 series 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.
[9]
The FTG produced CEN Report, CEN/CR 13825, 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
[6]
principle is embodied in the requirements of numerous medical device standards. 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.
[10]
International medical device regulators forum (IMDRF), GRRP N47:2024, Essential Principle 5.1.3,
addresses this type of problem:
Risk control measures adopted by manufacturers for the design and manufacture of the medical device
and IVD medical device should conform to safety principles, taking account of the generally acknowledged
state of the art. When risk reduction is required, manufacturers should control risks so that the residual
risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the
most appropriate solutions, manufacturers should, in the following order of priority:
a) eliminate or appropriately reduce risks through safe design and manufacture;
b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to
risks that cannot be eliminated;
c) provide information for safety (warnings/precautions/contra-indications) and, where appropriate,
training to users.
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.
vi
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, w
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