SIST EN ISO 5361:2023/A1:2026

• Status: Published
• Public Enquiry End Date: 27-Oct-2025
• Publication Date: 20-Jul-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• 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
• Ref Project: EN ISO 5361:2023/A1:2026 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors - Amendment 1: Reinstatement of third edition S1 dimensions (ISO 5361:2023/Amd 1:2026)

• Amends: SIST EN ISO 5361:2023 - Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023)
• Effective Date: 01-Sep-2026

SIST EN ISO 5361:2023/A1:2026 is the Slovenian adoption of EN ISO 5361:2023/A1:2026, published by SIST. It is an amendment to the standard for anaesthetic and respiratory equipment - tracheal tubes and connectors, and it reinstates the third edition S1 dimensions used for tube sizing. In practice, it updates the dimensional data that manufacturers, testers, and other users of tracheal tubes rely on when specifying, checking, or comparing designs.

What does SIST EN ISO 5361:2023/A1:2026 specify?

SIST EN ISO 5361:2023/A1:2026 specifies one targeted change to EN ISO 5361:2023: it replaces the dimensional table in Clause 6.3.1.6 for tracheal tubes. The amendment is focused on the sizing data, not on a full rewrite of the base standard.

The amended table covers basic dimensions for tracheal tubes in millimetres and separates tubes for a general patient population from tubes designed specifically for neonatal and paediatric patients. It also keeps the standard’s designated size structure, so readers can match the correct size category to the intended use.

The document is organised as a short amendment with a European foreword and an endorsement notice, followed by the amended table text. The note under the table points to Annex A.7 in the base standard for the rationale, and the footnote refers to Annex A and Annex B for the paediatric context.

What are the key requirements of SIST EN ISO 5361:2023/A1:2026?

Clause 6.3.1.6 is the operative part of this amendment. SIST EN ISO 5361:2023/A1:2026 replaces Table 1, so the revised dimensions become the reference point for design, verification, and product description.

• The table gives the basic dimensions of tracheal tubes in millimetres. In practice, this is the sizing basis that drawings, gauges, and product labels need to follow.
• The table covers designated sizes from 2.0 to 11.0. That tells users which tube sizes are included in the reinstated S1 set.
• Separate dimension columns are given for the general patient population and for neonatal and paediatric patients. This matters because the same nominal size may have different allowable lengths depending on the intended patient group.
• The table includes the standard’s dimension labels, including Dimension A and Dimension C. Users need to keep those labels straight when comparing tube length and cuff position data.
• The footnote links the paediatric dimensions to clinical literature. It states that a shorter Dimension C may reduce the likelihood of endobronchial intubations for paediatric patients, which explains why the paediatric values are treated separately.
• The note points to Annex A.7 for the rationale behind the table. That helps engineers and quality teams understand why the sizing set was reinstated.
• The amendment reinstates the third edition S1 dimensions. For organizations maintaining legacy designs, this is the key change to check against previous product definitions.

What terms does SIST EN ISO 5361:2023/A1:2026 define?

• S1 dimensions - the sizing set reinstated by this amendment for tracheal tubes.
• Designated size - the size designation used in Table 1 to identify a tracheal tube.
• Dimension A - the minimum length of the tube.
• Dimension C - the table dimension linked to the distance from the patient end of the tube to the machine end of the inflatable cuff.
• Neonatal and paediatric patients - the patient group that has its own column set in the amended table.
• General patient population - the patient group for which a separate set of table values is given.
• Oral/nasal - the table category used for tubes intended for oral or nasal use.

Who uses SIST EN ISO 5361:2023/A1:2026?

SIST EN ISO 5361:2023/A1:2026 is used by people who design, make, test, specify, or review tracheal tubes and connectors. That includes medical device engineers, quality and regulatory teams, test laboratories, and technical buyers working with anaesthetic and respiratory equipment.

It is also relevant to organizations that need to compare current products with the reinstated S1 dimensions, especially when neonatal and paediatric tube geometry is involved. In practice, these users look at the amendment to confirm dimensional compliance, update specifications, or review product drawings.

What changed in SIST EN ISO 5361:2023/A1:2026 from the previous edition?

SIST EN ISO 5361:2023/A1:2026 modifies EN ISO 5361:2023 by replacing Table 1 in Clause 6.3.1.6. The stated change is the reinstatement of the third edition S1 dimensions.

The amendment also keeps the table note that points to Annex A.7 for the rationale and the footnote that connects the paediatric dimension discussion with Annex A and Annex B.

Which standards are used with SIST EN ISO 5361:2023/A1:2026?

This amendment is applied together with EN ISO 5361:2023, which it modifies. The text approved by CEN is identical to ISO 5361:2023/Amd 1:2026.

What does the SIST EN ISO 5361:2023/A1:2026 document contain?

The document contains the European foreword, the endorsement notice, and the short amendment text. Its technical content is concentrated in the replacement of Table 1 in Clause 6.3.1.6.

Table 1 provides the revised basic dimensions for tracheal tubes and shows how those dimensions vary by designated size and patient group. The note and footnote add the rationale and the paediatric clinical context without repeating the full background material.

The table also refers to Figure 1 in the base standard, so users can relate the numeric dimensions to the tube geometry shown there. That makes the amendment useful for design review, dimensional checking, and product documentation.

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
...