EN ISO 5361:2023/A1:2026
(Amendment)Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1: Reinstatement of third edition S1 dimensions (ISO 5361:2023/Amd 1:2026)
Anästhesie- und Beatmungsgeräte - Trachealtuben und Verbindungsstücke - Änderung 1: Wiedereinführung der Abmessungen der dritten Auflage von S1 (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 (ISO 5361:2023/Amd 1:2026)
Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki - Dopolnilo A1: Ponovna uvedba dimenzij S1 iz tretje izdaje (ISO 5361:2023/DAM 1:2025)
General Information
- Status
- Not Published
- Publication Date
- 07-Jul-2026
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 4 - Tracheal tubes and other equipment
- Current Stage
- 6055 - CEN Ratification completed (DOR) - Publishing
- Start Date
- 29-Nov-2025
- Completion Date
- 29-Nov-2025
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 11-Jun-2025
Overview
EN ISO 5361:2023/A1:2026 is an important amendment to the international standard governing anaesthetic and respiratory equipment, specifically tracheal tubes and connectors. Issued by CEN in harmonization with ISO, this amendment (Amendment 1) reintroduces the S1 dimension specifications from the third edition of the standard (ISO 5361:2023/Amd 1:2026). The core objective is to reinstate critical dimensional requirements for tracheal tubes, thereby supporting compatibility, safety, and performance in airway management.
This amendment is particularly relevant to manufacturers and users of anaesthetic and respiratory medical devices, ensuring that tracheal tubes and their connectors meet proven dimensional parameters for a wide range of patient populations, from neonates to adults.
Key Topics
- Tracheal Tubes S1 Dimensions: Reinstates the third edition S1 dimensions, providing standardized measurements including minimum tube lengths, distances from patient ends to inflatable cuff sections, and other critical geometric parameters.
- Standardization in Patient Safety: Re-emphasizes the role of dimensional accuracy in reducing adverse events, such as incorrect intubation depth and associated airway complications.
- Scope Across Patient Groups: Addresses general, neonatal, and paediatric requirements, ensuring inclusivity in clinical application.
- Product Interoperability: Supports consistent manufacturing criteria, facilitating compatibility of tracheal tubes and connectors across equipment from different suppliers.
Applications
EN ISO 5361:2023/A1:2026 applies widely in the design, manufacturing, and clinical use of anaesthetic and respiratory equipment, with practical value in:
- Medical Device Manufacturing: Ensuring products meet international dimensional requirements, simplifying regulatory approvals, and promoting market access in the EU and globally.
- Clinical Practice: Enhancing patient safety and outcomes by standardizing tracheal tube dimensions for effective airway management in anaesthesia, surgery, intensive care, and emergency medicine.
- Procurement and Quality Assurance: Hospitals, clinics, and procurement agencies use this standard to verify tracheal tube and connector conformity, assuring consistency in vital respiratory equipment.
- Regulatory Compliance: Facilitates alignment with medical device regulations and supports references in national and regional healthcare legislation.
Related Standards
Professionals working with anaesthetic and respiratory equipment should be aware of the following related standards:
- EN ISO 5361:2023: The consolidated parent standard detailing general requirements for tracheal tubes and connectors.
- ISO 80369 Series: Standards on small-bore connectors for liquids and gases in healthcare applications, supporting compatibility and patient safety.
- ISO 11712: Requirements and test methods for connectors for anaesthetic and respiratory equipment, ensuring leak-free and secure connections.
- ISO 5360: Standard for anaesthetic vaporizers - another critical component in anaesthetic breathing systems.
Practical Value
The amendment EN ISO 5361:2023/A1:2026 ensures a harmonized approach to tracheal tube dimensions, building upon established clinical experience and supporting global interoperability. Its implementation benefits device manufacturers, healthcare providers, and patients by:
- Reducing variability in production and use
- Enhancing safety in airway management
- Supporting seamless market access and compliance
- Reinforcing trust and quality in respiratory and anaesthetic equipment
Keywords: EN ISO 5361:2023/A1:2026, tracheal tubes, S1 dimensions, anaesthetic equipment, respiratory connectors, medical device standard, patient safety, airway management, dimensional requirements.
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Frequently Asked Questions
EN ISO 5361:2023/A1:2026 is a draft published by the European Committee for Standardization (CEN). Its full title is "Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1: Reinstatement of third edition S1 dimensions (ISO 5361:2023/Amd 1:2026)". This standard covers: Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1: Reinstatement of third edition S1 dimensions (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)
EN ISO 5361:2023/A1:2026 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.
EN ISO 5361:2023/A1:2026 has the following relationships with other standards: It is inter standard links to ISO 5361:2023/Amd 1, EN ISO 5361:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 5361:2023/A1:2026 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)
SLOVENSKI STANDARD
01-oktober-2025
Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki -
Dopolnilo A1: Ponovna uvedba dimenzij S1 iz tretje izdaje (ISO 5361:2023/DAM
1:2025)
Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1:
Reinstatement of third edition S1 dimensions (ISO 5361:2023/DAM 1:2025)
Anästhesie- und Beatmungsgeräte - Trachealtuben und Verbindungsstücke - Änderung
1: Wiedereinführung der Abmessungen der dritten Auflage von S1 (ISO 5361:2023/DAM
1:2025)
Matériel d'anesthésie et de réanimation respiratoire - Sondes trachéales et raccords -
Amendement 1: Rétablissement des dimensions S1 de la troisième édition (ISO
5361:2023/DAM 1:2025)
Ta slovenski standard je istoveten z: EN ISO 5361:2023/prA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
Amendment
ISO 5361:2023/
DAM 1
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Tracheal tubes and
connectors
Voting begins on:
2025-08-05
AMENDMENT 1: Reinstatement of
Voting terminates on:
third edition S1 dimensions 2025-10-28
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO 5361:2023/DAM 1:2025(en)
DRAFT
ISO 5361:2023/DAM 1:2025(en)
Amendment
ISO 5361:2023/
DAM 1
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Tracheal tubes and
connectors
Voting begins on:
AMENDMENT 1: Reinstatement of
Voting terminates on:
third edition S1 dimensions
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 5361:2023/DAM 1:2025(en)
ii
ISO 5361:2023/DAM 1:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national s
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