General Information

Abstract

Additional requirements for connectors for accessory access connection port

Status
Not Published
Publication Date
12-Mar-2028
Current Stage
4020 - Submission to enquiry - Enquiry
Start Date
20-Aug-2026
Completion Date
20-Aug-2026

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EN ISO 5367:2023/oprA1:2026

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Overview

EN ISO 5367:2023/prA1:2026 is a proposed amendment to the existing standard on anaesthetic and respiratory equipment, specifically addressing breathing sets and connectors. Developed by CEN and based on ISO 5367, this amendment introduces additional requirements for connectors designed for accessory access connection ports. These updates focus on enhancing patient safety, clarifying connector specifications, and aligning with international risk management and device compatibility practices.

Covering the needs of medical device manufacturers, clinical engineers, and regulatory bodies, this draft standard aims to prevent inadvertent misconnections, improve labeling and user awareness, and ensure reliable performance in critical care and anaesthetic settings.

Key Topics

  • Connector Specifications:
    The amendment establishes that accessory connection ports-used for applications like gas measurement-must:

    • Use L2 socket connectors compliant with ISO 80369-7 (commonly Luer connectors).
    • Include a 'captive means of sealing' such as a tethered cap or plug.
    • Be properly marked, using specified symbols or safety signs, to ensure clear identification and risk mitigation.
  • Instructions for Use and Warnings:
    The amendment mandates updated warnings in product instructions, highlighting that using Luer connectors for non-intravascular or hypodermic purposes can result in hazardous misconnections, and that special user actions are needed to manage these patient safety risks.

  • Multiple Accessory Ports:
    In devices featuring more than one adjacent accessory connection port (e.g., for pressure monitoring and gas sampling), an alternative connector design may be used if justified by a risk management file. Design features to aid safety can include:

    • Permanently attached lines
    • Colour-coded ports
    • Distinct markings
  • Flow Resistance Data:
    Added notes clarify that air flow resistance in breathing tubes and sets should be expressed in STPD (Standard Temperature and Pressure Dry) conditions. This harmonizes reporting conditions across manufacturers and helps healthcare providers compare device performance consistently.

Applications

The requirements outlined in EN ISO 5367:2023/prA1:2026 support safe and effective use of breathing sets and connectors in a range of clinical scenarios, including:

  • Anaesthesia delivery systems
    Ensuring that breathing sets and connectors are compatible, safe, and clearly identified reduces the risk of device misconnections during surgery and emergency care.

  • Respiratory care and critical care settings
    Enhanced labeling and design reduce confusion during device setup and routine use, supporting patient safety in complex care environments such as intensive care units.

  • Gas sampling and monitoring
    By stipulating Luer-compatible connections and safe designs for accessory ports, the amendment supports the integration of gas analysis or pressure monitoring accessories, while addressing risk management and misconnection prevention.

  • Medical device manufacturing and procurement
    The amendment provides clear guidelines for manufacturers and purchasers of respiratory equipment, ensuring compliance with the latest safety standards and facilitating market access for products within the European Union and internationally.

Related Standards

For comprehensive compliance and best practices in anaesthetic and respiratory equipment, consider the following related standards:

  • ISO 5367:2023 - Core requirements for breathing sets and connectors
  • ISO 80369-7:2021 - Specifications for small-bore connectors, including Luer connectors, used in medical devices
  • ISO 80369-1 - General requirements for small-bore connectors
  • ISO 14971 - Application of risk management to medical devices
  • IEC 60601-1 - General requirements for basic safety and essential performance of medical electrical equipment
  • ISO 4135:2022 - Reference definitions for conditions such as STPD

By integrating the requirements of this proposed amendment, healthcare technology providers and users can support safer respiratory care and align with the latest international standards.

Relations

Effective Date
26-Nov-2025

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EN ISO 5367:2023/oprA1:2026

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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.
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 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
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 5367:2023/DAM 1:2026(en)
ii
ISO 5367:2023/DAM 1:2026(en)
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