EN ISO 15002:2024/prA1
(Amendment)Flow control devices for connection to a medical gas supply system - Amendment 1 (ISO 15002:2023/DAM 1:2026)
General Information
- Abstract
- Status
- Not Published
- Publication Date
- 02-Mar-2028
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 3 - Medical gas supply systems
- Current Stage
- 4020 - Submission to enquiry - Enquiry
- Start Date
- 13-Aug-2026
- Completion Date
- 13-Aug-2026
Overview
EN ISO 15002:2024/prA1 is an amendment to the international standard governing flow control devices for connection to medical gas supply systems. Developed by CEN and based on ISO 15002:2023/DAM 1:2026, this amendment enhances the safety, stability, and accuracy of flow control devices (FCDs) used in anaesthetic, respiratory, and reanimation equipment. These devices are critical in ensuring precise delivery of medical gases to patients, particularly in clinical settings where patient safety and compliance with regulatory requirements are paramount.
Key Topics
Stability of Indicated Flow:
The amendment refines requirements to ensure that flow control devices maintain consistent flow readings over time and under variable conditions. Stability must be maintained within:- ±10% deviation at atmospheric pressure over one hour.
- ±5% (or ±0.2 L/min) deviation when subjected to a back-pressure of 10 ± 1 kPa.
- ±10% (or ±0.4 L/min) deviation when back-pressure is removed.
Back-Pressure Effects:
- Recognizes that accessories like humidifiers, nebulizers, or long tubing can introduce back-pressure, significantly affecting flow accuracy.
- Emphasizes the need for FCDs, especially uncompensated types, to display reliable flow even under such conditions to prevent clinically significant dosing errors.
Test Methods:
- Specifies procedures (e.g., C.10) for verifying FCD stability under back-pressure, including details about necessary apparatus (pressure transducers, adjustable resistance, and fast-acting valves).
- Ensures consistent and repeatable evaluation of FCD performance for regulatory and quality assurance purposes.
Applications
EN ISO 15002:2024/prA1 applies wherever precise control and indication of medical gas flow are critical, including:
- Hospitals and Clinics: Ensures safe operation of anaesthetic and respiratory devices, protecting both patients and caregivers by minimizing the risk of incorrect gas dosing.
- Medical Gas Pipeline Systems: Standardizes connection interfaces and device performance throughout healthcare facilities.
- Respiratory Therapy and Emergency Care: Offers reliability in environments where quick response and accurate dosing of oxygen and other gases are essential.
- Device Manufacturing and Quality Assurance: Provides manufacturers with clear test protocols and performance expectations, leading to improved product design and regulatory compliance.
By adhering to these requirements, healthcare providers benefit from enhanced safety, reduced risk of device-related incidents, and greater confidence in the reliability of respiratory support equipment.
Related Standards
Several international standards support and complement EN ISO 15002:2024/prA1. Key related documents include:
- ISO 7396-1 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum.
- ISO 80601-2-13 - Medical electrical equipment - Requirements for anaesthetic workstations and their components.
- EN ISO 10524 Series - Pressure regulators for use with medical gases.
- ISO 11195 - Gas blenders for medical use.
- EN ISO 9170 - Terminal units for medical gas pipeline systems.
Adopting EN ISO 15002:2024/prA1 alongside these standards facilitates comprehensive compliance across all components and subsystems relating to the delivery of medical gases in healthcare environments.
By aligning medical gas flow control devices with the updated requirements in EN ISO 15002:2024/prA1, healthcare organizations and manufacturers can enhance patient safety, streamline regulatory processes, and ensure consistent performance in critical clinical applications.
Relations
- Effective Date
- 03-Dec-2025
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Frequently Asked Questions
EN ISO 15002:2024/prA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Flow control devices for connection to a medical gas supply system - Amendment 1 (ISO 15002:2023/DAM 1:2026)". This standard covers: Flow control devices for connection to a medical gas supply system - Amendment 1 (ISO 15002:2023/DAM 1:2026)
Flow control devices for connection to a medical gas supply system - Amendment 1 (ISO 15002:2023/DAM 1:2026)
EN ISO 15002:2024/prA1 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 15002:2024/prA1 has the following relationships with other standards: It is inter standard links to EN ISO 15002:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 15002:2024/prA1 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
Naprave za uravnavanje pretoka v priključitvi na sistem oskrbe z medicinskimi
plini - Dopolnilo A1 (ISO 15002:2023/DAM 1:2026)
Flow control devices for connection to a medical gas supply system - Amendment 1 (ISO
15002:2023/DAM 1:2026)
Durchflussregeleinrichtungen zum Anschluss an ein Versorgungssystem für
medizinische Gase - Änderung 1 (ISO 15002:2023/DAM 1:2026)
Dispositifs de contrôle du débit pour raccordement à un système d'alimentation en gaz
médicaux - Amendement 1 (ISO 15002:2023/DAM 1:2026)
Ta slovenski standard je istoveten z: EN ISO 15002:2024/prA1
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 15002:2023/
DAM 1
ISO/TC 121/SC 6
Flow control devices for connection
Secretariat: ANSI
to a medical gas supply system
Voting begins on:
AMENDMENT 1
2026-08-10
Dispositifs de contrôle du débit pour raccordement à un système Voting terminates on:
d'alimentation en gaz médicaux 2026-11-02
AMENDEMENT 1
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 15002:2023/DAM 1:2026(en)
DRAFT
ISO 15002:2023/DAM 1:2026(en)
Amendment
ISO 15002:2023/
DAM 1
ISO/TC 121/SC 6
Flow control devices for connection
Secretariat: ANSI
to a medical gas supply system
Voting begins on:
AMENDMENT 1
Dispositifs de contrôle du débit pour raccordement à un système Voting terminates on:
d'alimentation en gaz médicaux
AMENDEMENT 1
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
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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Website: www.iso.org
Published in Switzerland Reference number
ISO 15002:2023/DAM 1:2026(en)
ii
ISO 15002:2023/DAM 1:2026(en)
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