EN ISO 5367:2023/prA1:2026
(Amendment)Anaesthetic and respiratory equipment - Breathing sets and connectors - Amendment 1: Additional requirements for connectors for accessory access connection port (ISO 5367:2023/DAmd1:2026)
- Abstract
Additional requirements for connectors for accessory access connection port
- Status
- Not Published
- Publication Date
- 07-Feb-2028
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 4 - Tracheal tubes and other equipment
- Current Stage
- 4020 - Submission to enquiry - Enquiry
- Start Date
- 20-Aug-2026
- Completion Date
- 20-Aug-2026
EN ISO 5367:2023/prA1:2026 is Amendment 1 to EN ISO 5367:2023 for anaesthetic and respiratory equipment. It adds requirements for connectors used on accessory access connection ports in breathing sets, covering connector type, sealing, marking, instructions for use, and the handling of multiple adjacent accessory ports.
What does EN ISO 5367:2023/prA1:2026 specify?
EN ISO 5367:2023/prA1:2026 specifies additional requirements for connectors for accessory access connection ports on breathing sets. In practice, it tells manufacturers how these accessory ports are to be designed, identified, and documented so that connection mistakes are less likely and the port behaves consistently in use.
The amendment fits into the structure of the base standard by adding text in clause 6.3.7, a further requirement in 6.3.8, and notes under the flow resistance tables in 6.5. It also adds informative Annex A, which explains the reasons behind the new requirements.
| Annex | What it covers |
|---|---|
| Annex A | Rationale for the accessory connection port requirements and for the STPD clarification |
What are the key requirements of EN ISO 5367:2023/prA1:2026?
The amendment centers on the design and identification of accessory access connection ports. For manufacturers and test labs, the practical effect is that the port cannot be treated as an ordinary open fitting - it needs a specified connector style, sealing arrangement, marking, and supporting instructions.
Accessory connection ports on breathing sets
Clause 6.3.7 requires accessory connection ports on breathing sets to use an L2 socket connector that conforms with ISO 80369-7. They also need a captive means of sealing, such as a tethered cap or plug, so that the seal stays with the device and is available when the port is not in use.
The same clause requires marking. The port must show either ISO 7000-1641 or, where marking is the main risk control, the safety sign ISO 7010-M002. In practice, this means the connector must be visibly identified so users can recognize the port’s purpose and the need for caution.
The instructions for use must include a warning about the possibility of inadvertent connection to another Luer connector when the device uses a Luer connector for non-intravascular or non-hypodermic access. That warning is meant to push users to apply local risk controls in routine clinical use.
Verification of conformity
Clause 6.3.7 says conformity is checked by inspection and, where applicable, by the tests in ISO 80369-7:2021. For a manufacturer, that means both the physical configuration and the connector performance may need to be demonstrated.
More than one adjacent accessory port
Clause 6.3.8 covers breathing sets that use two or more adjacent accessory connection ports with different intended applications. In that case, an alternative connector design may be used, but it must be evaluated as an alternative small-bore connector in accordance with ISO 80369-1.
This matters where adjacent ports could otherwise be confused, such as on a Y-adapter. The note points to risk control measures such as a permanently attached line, colour coding, and marking.
Flow resistance values
Clause 6.5 adds notes beneath the resistance tables so that air flow is expressed as STPD, meaning Standard Temperature and Pressure Dry. For users of the standard, this clarifies the reference condition for comparing resistance values across breathing accessories and devices.
What terms does EN ISO 5367:2023/prA1:2026 define?
- Accessory access connection port - a connection point on a breathing set intended for accessory use, such as gas measurement.
- L2 socket connector - the connector type required for accessory connection ports under clause 6.3.7.
- Captive means of sealing - a seal, such as a tethered cap or plug, that stays attached to the device.
- Luer connector - the connector type discussed in the warning and rationale for respiratory applications.
- Alternative small-bore connector - the design category used when evaluating alternative connector designs under ISO 80369-1.
- STPD - Standard Temperature and Pressure Dry, the condition used to express air flow in the added notes.
Who uses EN ISO 5367:2023/prA1:2026?
EN ISO 5367:2023/prA1:2026 is used by manufacturers of anaesthetic and respiratory equipment, especially makers of breathing sets and connectors. It is also relevant to design engineers, quality managers, regulatory teams, and test laboratories that need to design, verify, label, and document accessory ports.
Hospitals, purchasing teams, and biomedical engineers can use it when assessing whether breathing sets fit their safety practices, especially where gas measurement or other accessories connect to the breathing system.
What changed in EN ISO 5367:2023/prA1:2026 from the previous edition?
EN ISO 5367:2023/prA1:2026 is Amendment 1 to EN ISO 5367:2023. The changes stated in the amendment are:
- new requirements for accessory access connection ports in 6.3.7
- a requirement for alternative connector design evaluation when two or more adjacent accessory ports have different intended applications in 6.3.8
- notes added to the resistance tables in 6.5 to express air flow as STPD
- Annex A with rationale for the connector and STPD clarifications
Which standards are used with EN ISO 5367:2023/prA1:2026?
EN ISO 5367:2023/prA1:2026 refers to ISO 80369-7:2021 for connector conformity and tests, and to ISO 80369-1 for evaluating alternative small-bore connector designs. It also cites ISO 7000-1641 and ISO 7010-M002 for marking, IEC 60601-1:2005+AMD1:2012+AMD2:2020 for the referenced symbol tables, ISO 14971 for risk management principles in the rationale, and ISO 4135:2022 for the STPD definition.
What does the EN ISO 5367:2023/prA1:2026 document contain?
The amendment adds text to clause 6.3.7 and clause 6.3.8, plus notes under the flow resistance tables in 6.5. It includes an inspection-based conformity check and references to tests where applicable, so the document supports both design verification and product assessment.
Annex A gives the rationale behind the requirements. It explains why ISO 80369-7 Luer connectors remain in use for certain respiratory applications, and why resistance values are clarified using STPD conditions.
Relations
- Effective Date
- 26-Nov-2025
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Frequently Asked Questions
EN ISO 5367:2023/prA1:2026 is a draft published by the European Committee for Standardization (CEN). Its full title is "Anaesthetic and respiratory equipment - Breathing sets and connectors - Amendment 1: Additional requirements for connectors for accessory access connection port (ISO 5367:2023/DAmd1:2026)". This standard covers: Additional requirements for connectors for accessory access connection port
Additional requirements for connectors for accessory access connection port
EN ISO 5367:2023/prA1:2026 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 5367:2023/prA1:2026 has the following relationships with other standards: It is inter standard links to EN ISO 5367:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 5367:2023/prA1:2026 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-2026
Anestezijska in dihalna oprema - Dihalni seti in priključki - Dopolnilo A1: Dodatne
zahteve za priključke za priključni priključek za dodatno opremo (ISO
5367:2023/DAmd1:2026)
Anaesthetic and respiratory equipment - Breathing sets and connectors - Amendment 1:
Additional requirements for connectors for accessory access connection port (ISO
5367:2023/DAmd1:2026)
Anästhesie- und Beatmungsgeräte - Atemsets und Verbindungsstücke - Änderung 1
(ISO 5367:2023/DAmd 1:2026)
Matériel d'anesthésie et de réanimation respiratoire - Ensembles respiratoires et
raccords - Amendement 1: Exigences supplémentaires relatives aux raccords destinés
aux orifices de raccordement pour accessoires (ISO 5367:2023/DAmd1:2026)
Ta slovenski standard je istoveten z: EN ISO 5367:2023/prA1:2026
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.
DRAFT
Amendment
ISO 5367:2023/
DAM 1
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Breathing sets and
connectors
Voting begins on:
2026-08-19
AMENDMENT 1: Additional
Voting terminates on:
requirements for connectors for 2026-11-11
accessory access connection port
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 has not been edited by the ISO Central Secretariat.
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STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
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NOTIFICATION OF ANY RELEVANT PATENT
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Reference number
ISO 5367:2023/DAM 1:2026(en)
DRAFT
ISO 5367:2023/DAM 1:2026(en)
Amendment
ISO 5367:2023/
DAM 1
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Breathing sets and
connectors
Voting begins on:
AMENDMENT 1: Additional
Voting terminates on:
requirements for connectors for
accessory access connection port
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 has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
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
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Published in Switzerland Reference number
ISO 5367:2023/DAM 1:2026(en)
ii
ISO 5367:2023/DAM 1:2026(en)
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