ISO 5361:2023/Amd 1:2026
(Amendment)Anaesthetic and respiratory equipment — Tracheal tubes and connectors — Amendment 1: Reinstatement of third edition S1 dimensions
General Information
- Abstract
- Status
- Published
- Publication Date
- 01-Jul-2026
- Technical Committee
- ISO/TC 121/SC 2 - Airways and related equipment
- Drafting Committee
- ISO/TC 121/SC 2 - Airways and related equipment
- Current Stage
- 6060 - International Standard published
- Start Date
- 02-Jul-2026
- Due Date
- 03-Jun-2028
- Completion Date
- 02-Jul-2026
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ISO 5361:2023/Amd 1:2026 - Anaesthetic and respiratory equipment — Tracheal tubes and connectors — Amendment 1: Reinstatement of third edition S1 dimensions
ISO 5361:2023/Amd 1:2026 - Matériel d'anesthésie et de réanimation respiratoire — Sondes trachéales et raccords — Amendement 1: Rétablissement des dimensions S1 de la troisième édition
Overview
ISO 5361:2023/Amd 1:2026 is a critical amendment to the international standard for anaesthetic and respiratory equipment, specifically focusing on tracheal tubes and connectors. Published by the International Organization for Standardization (ISO), this amendment reinstates the S1 dimensions from the third edition of the standard. By updating dimensional requirements, this document strengthens safety, compatibility, and performance expectations for tracheal tubes used in various clinical settings worldwide.
Key Topics
- Tracheal Tube Dimensions: The core of this amendment is the reinstatement of clinically validated S1 dimensional specifications for tracheal tubes, addressing neonatal, paediatric, and general patient populations.
- Enhanced Compatibility and Safety: By reverting to prior S1 dimensions, the amendment harmonizes the design of tracheal tubes for improved fit and function, reducing risks such as improper placement and endobronchial intubation.
- Update to Table 1: The amendment replaces the dimensions table for tracheal tubes, specifying precise measurements in millimetres for various tube sizes and patient applications.
- Clinical Guidance: Notes within the amendment reference clinical literature supporting the adoption of shorter tube dimensions for paediatric patients to minimize complications.
Applications
ISO 5361:2023/Amd 1:2026 has broad application across healthcare settings, supporting manufacturers, regulators, and clinicians in the following ways:
- Medical Device Manufacturing: Ensures that tracheal tubes and connectors produced or supplied worldwide meet updated ISO requirements, supporting global harmonization and market access.
- Clinical Practice: Provides hospitals, surgical centers, and emergency departments with standardized expectations for tube sizing and connector interoperability, promoting patient safety during anaesthesia and respiratory care.
- Procurement and Quality Assurance: Helps healthcare providers assess equipment compliance, supporting purchasing decisions that prioritize patient outcomes and regulatory conformity.
- Training and Education: Serves as a reference in the training of clinical staff regarding proper selection and use of airway management devices in surgical, critical, and emergency care environments.
Related Standards
To support consistent safety and performance in anaesthetic and respiratory care, ISO 5361:2023/Amd 1:2026 should be considered alongside related international and regional standards:
- ISO 5361: The parent standard detailing requirements and test methods for tracheal tubes and connectors.
- Other ISO Airway Device Standards: Including those governing oropharyngeal, nasopharyngeal, and other airway adjuncts.
- ISO/IEC Directives: Procedures supporting the drafting and maintenance of international standards.
- CEN/TC 215 European Standards: Documents from the European Committee for Standardization addressing similar respiratory and anaesthetic equipment.
Practical Value
Implementing ISO 5361:2023/Amd 1:2026 offers tangible benefits:
- Patient Safety: Standardized dimensions support safer airway management, particularly in paediatric settings, where improper tube size can lead to serious complications.
- Global Consistency: Facilitates international trade and interoperability of medical devices through harmonized dimensional requirements.
- Regulatory Compliance: Assists organizations in meeting legal and industry obligations for high-quality medical equipment.
By consulting and applying this amendment, stakeholders in the medical device and clinical sectors uphold best practices in anaesthetic and respiratory care, ensuring consistent, safe, and effective patient outcomes.
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 08-Mar-2025
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ISO 5361:2023/Amd 1:2026 - Anaesthetic and respiratory equipment — Tracheal tubes and connectors — Amendment 1: Reinstatement of third edition S1 dimensions
ISO 5361:2023/Amd 1:2026 - Matériel d'anesthésie et de réanimation respiratoire — Sondes trachéales et raccords — Amendement 1: Rétablissement des dimensions S1 de la troisième édition
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Frequently Asked Questions
ISO 5361:2023/Amd 1:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Anaesthetic and respiratory equipment — Tracheal tubes and connectors — Amendment 1: Reinstatement of third edition S1 dimensions". This standard covers: Anaesthetic and respiratory equipment — Tracheal tubes and connectors — Amendment 1: Reinstatement of third edition S1 dimensions
Anaesthetic and respiratory equipment — Tracheal tubes and connectors — Amendment 1: Reinstatement of third edition S1 dimensions
ISO 5361:2023/Amd 1:2026 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 5361:2023/Amd 1:2026 has the following relationships with other standards: It is inter standard links to EN ISO 5361:2023/A1:2026, ISO 5361:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 5361:2023/Amd 1:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
International
Standard
ISO 5361
Fourth edition
Anaesthetic and respiratory
2023-01
equipment — Tracheal tubes and
connectors
AMENDMENT 1
2026-07
AMENDMENT 1: Reinstatement of
third edition S1 dimensions
Matériel d'anesthésie et de réanimation respiratoire — Sondes
trachéales et raccords
AMENDEMENT 1: Rétablissement des dimensions S1 de la
troisième édition
Reference number
ISO 5361:2023/Amd.1:2026(en) © ISO 2026
ISO 5361:2023/Amd.1:2026(en)
© ISO 2026
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 5361:2023/Amd.1:2026(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
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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 document 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)
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rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
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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 pate
...
Norme
internationale
ISO 5361
Quatrième édition
Matériel d'anesthésie et de
2023-01
réanimation respiratoire — Sondes
trachéales et raccords
AMENDEMENT 1
2026-07
AMENDEMENT 1: Rétablissement des
dimensions S1 de la troisième édition
Anaesthetic and respiratory equipment — Tracheal tubes and
connectors
AMENDMENT 1: Reinstatement of third edition S1 dimensions
Numéro de référence
ISO 5361:2023/Amd.1:2026(fr) © ISO 2026
ISO 5361:2023/Amd.1:2026(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2026
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii
ISO 5361:2023/Amd.1:2026(fr)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). L'élaboration des Normes internationales est en général
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Le présent document a été élaboré par le comité technique ISO/TC 12
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