SIST EN ISO 5361:2023/oprA1:2025
(Amendment)Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1: Reinstatement of third edition S1 dimensions (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)
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
- Public Enquiry End Date
- 27-Oct-2025
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 4020 - Public enquire (PE) (Adopted Project)
- Start Date
- 14-Aug-2025
- Due Date
- 01-Jan-2026
- Completion Date
- 05-Nov-2025
Relations
- Effective Date
- 11-Jun-2025
Overview
EN ISO 5361:2023/prA1 (Amendment 1) is a CEN-adopted amendment to ISO 5361:2023 titled "Anaesthetic and respiratory equipment - Tracheal tubes and connectors". This amendment reinstates the third‑edition S1 dimensions and replaces Table 1 of the base standard with updated basic dimensions for tracheal (endotracheal) tubes and connectors. The draft circulated by ISO/TC 121/SC 2 (secretariat ANSI) is intended to harmonize tube geometry requirements used by manufacturers, regulators and clinical users.
Key topics and requirements
- Reinstatement of S1 dimensions: Amendment 1 restores the S1 dimension set from the third edition to ensure consistent interchangeability and fit of tracheal tubes and connectors.
- Revised Table 1 - Basic dimensions: The amended table provides dimensions (in millimetres) across designated tube sizes (2.0 to 11.0), covering:
- Minimum tube lengths for neonatal/paediatric and general patient populations
- Distances related to inflating tube separation and inflatable cuff positioning
- Maximum distances from the patient end to the machine end of the cuff’s inflatable length
- Clinical guidance note: The document explicitly notes that clinical literature indicates a shorter Dimension C can reduce the likelihood of endobronchial intubation in paediatric patients (see Annex A/B for rationale).
- Draft status and review: The amendment is issued as a draft for comment and voting (ISO 5361:2023/DAM 1:2025), and the finalized values are subject to approval.
Applications and who uses it
- Medical device manufacturers designing and producing endotracheal tubes and connectors will use these dimensions to ensure compatibility and regulatory compliance.
- Regulatory and standards bodies that reference ISO/CEN standards in device approvals and procurement specifications.
- Clinical engineers and procurement teams in hospitals who assess device interoperability and select equipment for anaesthesia and critical care.
- Anesthesiologists, intensivists and airway device specialists who rely on standardized tube geometry to reduce risks (e.g., endobronchial intubation) and to optimize clinical procedures.
- Quality and compliance teams responsible for technical documentation, testing and conformity with international medical device standards.
Related standards
- ISO 5361:2023 (base standard) - this amendment applies to and modifies Table 1 of that document.
- EN ISO 5361:2023/prA1 - the CEN publication identifying the European adoption of the amendment.
- ICS classification: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
Keywords: tracheal tubes, endotracheal tube dimensions, S1 dimensions, anaesthetic and respiratory equipment, ISO 5361, medical device standards, paediatric intubation, connectors, airway devices.
Frequently Asked Questions
SIST EN ISO 5361:2023/oprA1:2025 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1: Reinstatement of third edition S1 dimensions (ISO 5361:2023/DAM 1:2025)". This standard covers: Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1: Reinstatement of third edition S1 dimensions (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)
SIST EN ISO 5361:2023/oprA1:2025 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.
SIST EN ISO 5361:2023/oprA1:2025 has the following relationships with other standards: It is inter standard links to SIST EN ISO 5361:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 5361:2023/oprA1:2025 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
CP 401 • Ch. de Blandonnet 8
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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