EN ISO 80369-1:2026

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

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.

Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2025)

Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 1: Exigences générales (ISO 80369-1:2025)

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.

Priključki majhnega premera za tekočine in pline v zdravstvenih aplikacijah - 1. del: Splošne zahteve (ISO 80369-1:2025)

Ta dokument določa splošne zahteve za vmesnike za majhne priključke (small-bore connectors), ki so del medicinske naprave ali dodatka, ki prenaša tekočine ali pline do pacienta.
Ta dokument prav tako opredeljuje aplikacije, za katere so ti majhni priključki namenjeni, kar vključuje, vendar ni omejeno na:
- respiratorne;
- enteralne;
- napihovanje manšet okončin;
- nevralne;
- intravaskularne ali hipodermične;
- druge primere uporabe, ki uporabljajo majhen priključek ISO 80369-7.
Ta dokument zagotavlja metodologijo za oceno lastnosti majhnih priključkov, ki preprečujejo medsebojno povezljivost, na podlagi njihovega inherentnega dizajna, z namenom zmanjšanja tveganja napačnih povezav med medicinskimi napravami ali med dodatki za različne aplikacije, kot je določeno v tem dokumentu, kot tudi tistih, ki jih je mogoče razviti v prihodnjih delih serije ISO in IEC 80369.
OPOMBA            Klavzula A.2 vsebuje smernice ali utemeljitev za to klavzulo.

General Information

• Status: Published
• Publication Date: 02-Jun-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Drafting Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 03-Jun-2026
• Completion Date: 03-Jun-2026
• Directive: Harmonized Standard2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 1 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: SIST EN ISO 80369-1:2026 - Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2025)

Relations

• Replaces: EN ISO 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)
• Effective Date: 07-Apr-2021
• Refers: ISO 80369-7:2021 - Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
• Effective Date: 24-Jun-2026
• Refers: ISO 80369-3:2016 - Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications
• Effective Date: 24-Jun-2026
• Refers: ISO 14971:2019 - Medical devices — Application of risk management to medical devices
• Effective Date: 24-Jun-2026
• Refers: ISO 80369-2:2024 - Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications
• Effective Date: 24-Jun-2026
• Refers: IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 24-Jun-2026
• Refers: ISO 80369-6:2025 - Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neural applications
• Effective Date: 24-Jun-2026
• Refers: ISO 20417:2021 - Medical devices — Information to be supplied by the manufacturer
• Effective Date: 24-Jun-2026
• Consolidated By: ISO 80369-1:2025 - Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
• Effective Date: 12-Feb-2026

Overview

EN ISO 80369-1:2026, titled Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements (ISO 80369-1:2025), sets the foundational requirements for small-bore connectors in medical devices and accessories that deliver or remove liquids and gases to or from patients. Published by CEN in alignment with ISO, this international standard aims to reduce the risk of misconnections-a recognized hazard in medical practice-by ensuring that connectors intended for different clinical applications are non-interconnectable.

The standard applies to a wide range of healthcare applications, including but not limited to respiratory support, enteral feeding, limb cuff inflation, neural procedures, and intravascular or hypodermic use. EN ISO 80369-1:2026 also provides methodologies for assessing connector designs and defining interface requirements that help minimize patient safety risks associated with wrong route connections.

Key Topics

• General Requirements for Small-bore Connectors
  Specifies the interface and performance requirements for connectors with an internal diameter less than 8.5 mm used in healthcare devices.

• Application-specific Connectors
  Defines intended application areas-such as respiratory, enteral, limb cuff inflation, neural, and intravascular or hypodermic-and the associated connector standards to be used.

• Risk Reduction Methodologies
  Outlines the process for assessing and demonstrating that connectors are non-interconnectable with those from other application groups, thereby minimizing the potential for dangerous misconnections.

• Safety and Information for Use
  Requires manufacturers to include information for safety in documentation, labeling, and instructions for use (IFU), addressing any residual risk to users.

• Methodology for New Connector Designs
  Provides a framework for assessing alternative or future connector designs for compatibility and safety, promoting innovative but safe medical device development.

Applications

EN ISO 80369-1:2026 is practical and essential for manufacturers, healthcare providers, and regulatory bodies concerned with the design and use of medical devices involving the transfer of liquids and gases. The typical sectors and scenarios of application include:

• Respiratory Care
  Devices delivering gases such as oxygen or anesthesia benefit from compliant connectors to prevent unwanted cross-connections.

• Enteral Feeding Systems
  Ensures that enteral nutrition connectors cannot be mistakenly connected to devices meant for intravenous administration or other unrelated systems.

• Limb Cuff Inflation Devices
  Blood pressure cuffs and other inflation devices are fitted with dedicated connectors to avoid errors with unrelated tubing or accessories.

• Neural Applications
  Devices used in neurological procedures are risk-managed by specific connector requirements.

• Intravascular and Hypodermic Applications
  Focuses on prevention of misconnections through the use of standardized, application-specific connectors (such as Luer connectors as per ISO 80369-7).

By providing clear guidelines, EN ISO 80369-1:2026 assists manufacturers in designing compliant devices and systems, while supporting regulatory and procurement teams in specifying safe products for clinical use. Implementation reduces the risk of patient harm due to accidental misconnections, thus improving overall healthcare safety.

Related Standards

For comprehensive risk management and global harmonization, EN ISO 80369-1:2026 references and aligns with several related standards, including:

• ISO 14971:2019 – Application of risk management to medical devices
• ISO 20417:2021 – Information to be supplied by the manufacturer
• ISO 80369-2 – Connectors for respiratory applications
• ISO 80369-3 – Connectors for enteral applications
• IEC 80369-5 – Connectors for limb cuff inflation applications
• ISO 80369-6 – Connectors for neural applications
• ISO 80369-7 – Connectors for intravascular or hypodermic applications
• IEC 62366-1 – Application of usability engineering to medical devices

These interlinked standards form a comprehensive framework for medical device connector safety, supporting the consistent application of small-bore connectors across various healthcare sectors.

---

With clear guidance, EN ISO 80369-1:2026 enhances safety, regulatory compliance, and interoperability throughout the healthcare industry, significantly reducing the risk of wrong route administration and support for harmonized international markets. For device designers, implementers, and healthcare procurement professionals, understanding and applying this standard is a critical aspect of medical device safety and performance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2026
Nadomešča:
SIST EN ISO 80369-1:2019
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 1. del:
Splošne zahteve (ISO 80369-1:2025)
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements (ISO 80369-1:2025)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2025)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
1: Exigences générales (ISO 80369-1:2025)
Ta slovenski standard je istoveten z: EN ISO 80369-1:2026
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN ISO 80369-1

NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2026
ICS 11.040.10; 11.040.20
Supersedes EN ISO 80369-1:2018
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 1: General requirements (ISO 80369-
1:2025)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 1: Exigences Flüssigkeiten und Gase in medizinischen
générales (ISO 80369-1:2025) Anwendungen - Teil 1: Allgemeine Anforderungen (ISO
80369-1:2025)
This European Standard was approved by CEN on 16 September 2025.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2026 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 80369-1:2026 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4

European foreword
This document (EN ISO 80369-1:2026) has been 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 CEN-CENELEC/ JTC 3 “Quality management and
corresponding general aspects for medical devices” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2026, and conflicting national standards
shall be withdrawn at the latest by December 2026.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 80369-1:2018.
This document has been prepared under a standardization request addressed to CEN and CENELEC by
the European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80369-1:2025 has been approved by CEN-CENELEC as EN ISO 80369-1:2026 without
any modification.
Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex ZA. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117] and to system or process requirements including those relating to quality
management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up
General Safety and
Performance Clause(s) /
Requirements of subclause(s) of Remarks / Notes
Regulation this EN
(EU) 2017/745
14.1 4, 5 This requirement is partially covered in that
intended connections can only be connected to
intended medical devices or accessories or medical
devices or accessories, where the unintended
connection is an acceptable risk, are able to be
connected. Such unintended connections are
required to be marked with a safety sign and
appropriate information for safety placed in the
instructions for use. Misconnections between small-
bore connectors of this series of standards, which
can result in an unacceptable risk, are made
impossible by design. But coverage is only provided
where the material has a modulus of elasticity
greater than 700 MPa.
The presumption of conformity is only conferred to
small-bore connectors specified in this series of
standards – proprietary small-bore connectors are
not covered.
14.5 4, 5 This requirement is partially covered as it does not
cover manufacture and in that by ensuring that the
intended connections do not leak and can only be
connected to intended medical devices or
accessories. But coverage is only provided where
the material has a modulus of elasticity greater than
700 MPa.
The presumption of conformity is only conferred to
small-bore connectors specified in this series of
standards – proprietary small-bore connectors are
not covered.
20.4 4, 5 This requirement is partially covered in that
intended connections can only be connected to
intended medical devices or accessories or medical
devices or accessories, where the unintended
connection is an acceptable risk, are able to be
connected. Misconnections between small-bore
connectors of this series of standards, which can
result in an unacceptable risk, are made impossible
by design. But coverage is only provided where the
material has a modulus of elasticity greater than
700 MPa.
The presumption of conformity is only conferred to
General Safety and
Performance Clause(s) /
Requirements of subclause(s) of Remarks / Notes
Regulation this EN
(EU) 2017/745
small-bore connectors specified in this series of
standards – proprietary small-bore connectors are
not covered.
20.5 4, 5 This requirement is partially covered in that
misconnections between small-bore connectors of
this series of standards, which can result in an
unacceptable risk, are made impossible by design or
medical devices or accessories, where the
unintended connection is an acceptable risk, are
able to be connected. Such unintended connections
are required to be marked with a safety sign and
appropriate information for safety placed in the
instructions for use. But coverage is only provided
where the material has a modulus of elasticity
greater than 700 MPa.
The presumption of conformity is only conferred to
small-bore connectors specified in this series of
standards – proprietary small-bore connectors are
not covered.
21.1 4, 5 This requirement is partially covered in that by
ensuring that the intended connections do not leak
and can only be connected to intended medical
devices or accessories. Such connections permit a
medical device to be capable of controlling the
flowrate. But coverage is only provided where the
material has a modulus of elasticity greater than
700 MPa.
The presumption of conformity is only conferred to
small-bore connectors specified in this series of
standards – proprietary small-bore connectors are
not covered.
Table ZA.2 — Normative references from Clause 2 of this document and their corresponding
European publications
Reference in International Title Corresponding
Clause 2 Standard Edition European Standard
Edition
ISO 14971:2019 ISO 14971:2019 Medical devices — Application of EN ISO 14971:2019
risk management to medical +A11:2021
devices
ISO 20417:2021 ISO 20417:2021 Medical devices — Information to EN ISO 20417:2021
be supplied by the manufacturer
ISO 80369-2:2024 ISO 80369-2:2024 Small-bore connectors for liquids EN ISO 80369-2:2024
and gases in healthcare
applications — Part 2: Connectors
for respiratory applications
ISO 80369-3:2016 ISO 80369-3:2016 Small-bore connectors for liquids EN ISO 80369-3:2016
+AMD1:2019 +AMD1:2019 and gases in healthcare +A1:2022
applications — Part 3: Connectors
for enteral applications
IEC 80369-5:2016 IEC 80369-5:2016 Small-bore connectors for liquids EN IEC 80369-5:2016
and gases in healthcare +AC:2017-02
applications — Part 5: Connectors +AC:2021-06
for limb cuff inflation applications
ISO 80369-6:2016 ISO 80369-6:2016 Small-bore connectors for liquids EN ISO 80369-6:2016
and gases in healthcare
applications — Part 6: Connectors
for neural applications
ISO 80369-7:2021 ISO 80369-7:2021 Small-bore connectors for liquids EN ISO 80369-7:2021
and gases in healthcare
applications — Part 7: Connectors
for intravascular or hypodermic
applications
IEC 62366-1:2015 IEC 62366-1:2015 Medical devices — Part 1: EN IEC 62366-1:2015
+AMD1:2020 +AMD1:2020 Application of usability +A1:2020 +AC:2015
engineering to medical devices +AC:2016-09
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
WARNING 1 Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
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 80369-1:2025(en) © ISO 2025

ISO 80369-1:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 80369-1:2025(en)
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
ISO 80369-1:2025(en)
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
ISO 80369-1:2025(en)
— 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
ISO 80369-1:2025(en)
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
ISO 80369-1:2025(en)
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.

vii
International Standard ISO 80369-1:2025(en)
Small-bore connectors for liquids and gases in healthcare
applications —
Part 1:
General requirements
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
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 20417:2021, Medical devices — Information to be supplied by the manufacturer
ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for
respiratory applications
ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for
enteral applications
IEC 80369-5, Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for
limb cuff inflation applications
ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for
neuraxial applications
ISO 80369-1:2025(en)
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for
intravascular or hypodermic applications
IEC 62366-1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14971, IEC 62366-1 and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE For convenience, the sources of all defined terms that appear in italics in this document are given in
Annex G.
3.1
accessory
additional part(s) for use with a medical device in order to:
— achieve the intended use;
— adapt it to some special use;
— facilitate its use;
— enhance its performance; or
— enable its functions to be integrated with those of other medical devices
[SOURCE: IEC 60601-1:2005+AMD1:2012+AMD2:2020, 3.3, modified — Replaced “equipment” with “a
medical device”.]
3.2
application
specific healthcare use
Note 1 to entry: Annex D lists examples of uses of the applications of small-bore (3.17) connectors (3.5).
3.3
cone
connector (3.5) with external sealing surface
Note 1 to entry: The sealing surface need not be conical.
Note 2 to entry: This type of connector (3.5) was previously referred to as male.
3.4
connection
union or joining of two connectors (3.5)
3.5
connector
part of a medical device, consisting of one of two mating halves and designed to join a conduit to convey
liquids or gases
ISO 80369-1:2025(en)
3.6
contactable surface
any surface on a connector (3.5) that has an interaction potential in which physical contact occurs with any
other surface on an opposing connector
Note 1 to entry: Contactable surfaces may include, but are not limited to, sealing surfaces as intended by design, crest
geometry of external or internal threads, faces, shrouds, grips. These are surfaces on a connector that can possibly
interact with another connector.
3.7
information for safety
information provided to the user or responsible organization as a risk control measure
EXAMPLE 1 Warnings, precautions or contraindications.
EXAMPLE 2 Instructions for the use of a medical device or accessory (3.1) to prevent use error or avoid a hazardous
situation.
EXAMPLE 3 Explanation of a safety feature of a medical device.
Note 1 to entry: Information for safety can be found in any or all types of information supplied by the manufacturer.
Note 2 to entry: Information for safety can be located on the display of a medical device.
[SOURCE: ISO 20417:2021, 3.9]
3.8
instructions for use
portion of the accompanying information that is essential for the safe and effective use of a medical device or
accessory (3.1) directed to the user of the medical device
Note 1 to entry: For the purposes of this document, a user can be either a lay user or professional user with relevant
specialized training.
[SOURCE: ISO 20417:2021, 3.11, modified — Deleted admitted term “package insert”; deleted Notes 2 to 5
to entry.]
3.9
interference test part
component that physically represents a small-bore (3.17) connector (3.5) or connector feature
Note 1 to entry: An interference test part is used to evaluate whether or not a contactable surface (3.6) can misconnect.
3.10
least material condition
LMC
condition in which a feature contains the least amount of material within the stated tolerance
EXAMPLE Maximum hole diameter, minimum shaft diameter.
3.11
Luer connector
small-bore (3.17) connector (3.5) that contains a conical mating surface with a 6 % (Luer) taper intended for
use in intravascular or hypodermic applications (3.2) of medical devices and related accessories (3.1)
Note 1 to entry: A Luer connector can be either a Luer slip connector or a Luer lock connector.
[SOURCE: ISO 80369-7:2021, 3.2, modified — Deleted Note 2 to entry.]

ISO 80369-1:2025(en)
3.12
marking
information, in text or graphical format, durably affixed, printed, etched (or equivalent) to a medical device
or accessory (3.1)
Note 1 to entry: For the purposes of this document, the term marked is used to designate the corresponding act.
Note 2 to entry: For the purposes of this document, marking is different from ‘direct marking’ as commonly described
in unique device identification (UDI) standards and regulations. A UDI ‘direct marking’ is a type of marking.
[SOURCE: ISO 20417:2021, 3.16, modified — Deleted Note 3 to entry.]
3.13
maximum material condition
MMC
condition in which a feature contains the maximum amount of material within the stated tolerance
EXAMPLE Minimum hole diameter, maximum shaft diameter.
3.14
misconnection
connection (3.4) between two connectors (3.5) of a different type
3.15
non-interconnectable
having characteristics which incorporate geometries or other features that prevent different connectors
(3.5) from making a connection (3.4)
3.16
patient
person undergoing a medical, surgical or dental procedure
[SOURCE: IEC 60601-1:2005+A1:2012, 3.76, modified — Replaced “living being (person or animal)” with
“person”; deleted the note.]
3.17
small-bore
inner-fluid pathway of a connection (3.4) with a diameter less than 8,5 mm
Note 1 to entry: For the purposes of this document, the 8,5 mm cone (3.3) and socket (3.18) specified in ISO 5356-1 is
not considered a small-bore (3.17) connector (3.5).
3.18
socket
connector (3.5) with internal sealing surface
Note 1 to entry: This type of connector (3.5) was previously referred to as female.
3.19
test method
definitive procedure for evaluating connectors (3.5) that produces a test result
3.20
unintended connection
connection (3.4) between two connectors (3.5) of the same type for different use cases
4 Small-bore connector non-interconnectable requirement
NOTE 1 A.2.3 contains guidance and rationale for this Clause.

ISO 80369-1:2025(en)
Small-bore connectors of each application category specified in this document shall be non-interconnectable
with any of the small-bore connectors of every other application category unless otherwise indicated within
the ISO and IEC 80369 series.
Check conformity by confirming that objective evidence demonstrates that the acceptability criteria specified
in Annex B are met.
The use of a connector specified by the ISO and IEC 80369 series is considered as objective evidence that the
acceptability criteria specified in Annex B are met.
NOTE 2 For the purpose of this document, dimensional conformity and modulus of elasticity conformity with the
requirements of the various application parts of the ISO and IEC 80369 series is considered sufficient objective evidence
of non-interconnectable characteristics.
5 Small-bore connectors for clinical applications
NOTE 1 A.2.4 contains guidance and rationale for this Clause.
NOTE 2 Annex D lists examples of the sort of medical devices or accessories for which the small-bore connectors
within each application are intended.
NOTE 3 Annex E summarizes the assessments of the designs of the small-bore connectors of this series of documents.
NOTE 4 This document has been prepared to address the relevant essential principles and labelling guidances of
the International Regulators Forum (IMDRF) as indicated in Annex F.
5.1 Small-bore connectors for new clinical applications
Designs of small-bore connectors for applications other than those specified in 5.2 to 5.6, for inclusion in the
ISO and IEC 80369 series, and used in medical devices or accessories intended for use with a patient, shall
meet the requirements of Annex C.
Check conformity by application of Annex C.
5.2 Small-bore connectors for respiratory applications
Small-bore connectors intended to be used for connections in the respiratory application shall conform to
a) ISO 80369-2, unless the use of these connectors creates an unacceptable risk for a specific medical device
or accessory, or
b) Clause 6.
Check conformity by inspection of the documentation demonstrating that the small-bore connector conforms
to the requirements of ISO 80369-2 or, in case of alternative connectors as per Clause 6, by applying the
performance tests of ISO 80369-2 using appropriate reference connectors for the alternative design.
5.3 Small-bore connectors
...