SIST 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
- Public Enquiry End Date
- 27-Oct-2025
- Publication Date
- 20-Jul-2026
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 17-Jul-2026
- Due Date
- 21-Sep-2026
- Completion Date
- 21-Jul-2026
Overview
SIST EN ISO 5361:2023/A1:2026 is an amendment to the internationally recognized ISO 5361:2023 standard, which specifies requirements for anaesthetic and respiratory equipment, with a focus on tracheal tubes and connectors. This amendment is primarily concerned with the reinstatement of the S1 dimensions from the third edition, ensuring alignment and compatibility for manufacturers and healthcare providers. The update was developed in cooperation with international bodies including ISO, CEN, and national standardization institutions to guarantee uniform guidelines for airway management devices across clinical settings.
Key Topics
- Tracheal Tubes and Connectors: The standard applies to devices used to secure and maintain a patient’s airway during anaesthesia or other medical procedures, specifically tracheal (endotracheal) tubes and their connectors.
- S1 Dimensions: Amendment 1 reinstates the dimension parameters (S1) from the third edition, addressing the basic sizing requirements and length specifications for tracheal tubes utilized in both adult and pediatric patient populations.
- Patient Safety and Interchangeability: By standardizing critical dimensions, the amendment supports patient safety, reduces risk of device incompatibility, and enhances global interchangeability.
- Reference Table Update: The amendment includes a revised table outlining basic dimensions for tracheal tubes, with options for neonatal, paediatric, and general patient populations, ensuring optimal fit and function.
Applications
The practical implementation of SIST EN ISO 5361:2023/A1:2026 is integral to various healthcare and clinical environments, including:
- Hospitals and Surgical Centers: Standardized tracheal tubes and connectors are vital in operating rooms for airway management during anaesthesia.
- Emergency and Intensive Care: In critical care and emergency scenarios, rapid and accurate selection of compatible airway devices is essential for life-saving interventions.
- Medical Device Manufacturing: The amendment provides clear dimensional requirements for manufacturers, supporting regulatory compliance, product development, and quality assurance initiatives.
- Training and Education: Medical professionals and technical staff benefit from the standardization, facilitating globally consistent training and reducing the risk of device-related complications.
- Regulatory Reference: Health authorities and procurement agencies use this standard to specify requirements in public tenders and certifications.
Related Standards
Organizations applying or referencing SIST EN ISO 5361:2023/A1:2026 may also find relevance in these connected standards:
- ISO 5361:2023: The parent standard specifying fundamental requirements for tracheal tubes and connectors used during anaesthesia and respiratory care.
- ISO 8836: Covers suction catheters for use with tracheal tubes and tracheostomy tubes.
- ISO 80369-series: Addresses small-bore connectors for liquids and gases in healthcare applications, enhancing patient safety by standardizing connections.
- EN 1789: Relevant for medical equipment used in ambulances, supporting compliance in prehospital environments.
SIST EN ISO 5361:2023/A1:2026 plays a key role in promoting safety, compatibility, and global harmonization in the selection and use of anaesthetic and respiratory equipment. By reinstating critical S1 dimensions for tracheal tubes, healthcare stakeholders are better positioned to ensure effective airway management and reduce the likelihood of device-related complications.
Relations
- Effective Date
- 01-Sep-2026
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Frequently Asked Questions
SIST EN ISO 5361:2023/A1:2026 is a amendment 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/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)
SIST 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.
SIST EN ISO 5361:2023/A1:2026 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/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
...