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)
General Information
- Abstract
- Status
- 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
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 08-Jul-2026
- Completion Date
- 08-Jul-2026
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.
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 11-Jun-2025
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Frequently Asked Questions
EN ISO 5361:2023/A1:2026 is a amendment 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 1:2026, 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-september-2026
Anestezijska in dihalna oprema - Sapnični (endotrahealni) tubusi in priključki -
Dopolnilo A1: Ponovna uvedba dimenzij S1 iz tretje izdaje (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)
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)
Ta slovenski standard je istoveten z: EN ISO 5361:2023/A1:2026
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.
EN ISO 5361:2023/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2026
EUROPÄISCHE NORM
ICS 11.040.10
English Version
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 - Anästhesie- und Beatmungsgeräte - Trachealtuben und
Sondes trachéales et raccords - Amendement 1: Verbindungsstücke - Änderung 1: Wiedereinführung
Rétablissement des dimensions S1 de la troisième der Abmessungen der dritten Auflage von S1 (ISO
édition (ISO 5361:2023/Amd 1:2026) 5361:2023/Amd 1:2026)
This amendment A1 modifies the European Standard EN ISO 5361:2023; it was approved by CEN on 29 November 2025.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CEN members are the national standards bodies 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5361:2023/A1:2026 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 5361:2023/A1:2026) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This Amendment to the European Standard EN ISO 5361:2023 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by January 2027, and
conflicting national standards shall be withdrawn at the latest by January 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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 website.
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 5361:2023/Amd 1:2026 has been approved by CEN as EN ISO 5361:2023/A1:2026
without any modification.
International
Standard
ISO 5361
Fourth edition
Anaesthetic and respiratory
2023-01
equipment — Tracheal tubes and
connectors
AM
...