SIST EN ISO 15002:2024/oprA1:2026

• Status: Not Published
• Public Enquiry End Date: 30-Oct-2026
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 04-Sep-2026
• Due Date: 22-Jan-2027
• Ref Project: EN ISO 15002:2024/prA1 - Flow control devices for connection to a medical gas supply system - Amendment 1 (ISO 15002:2023/DAM 1:2026)

• Amends: SIST EN ISO 15002:2024 - Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
• Effective Date: 03-Dec-2025

Overview

SIST EN ISO 15002:2024/oprA1:2026 is an amendment to the international standard ISO 15002, focusing on flow control devices for connection to a medical gas supply system. Published as a draft by the Slovenian Institute for Standardization (SIST), this amendment aims to clarify and enhance requirements for the stability and reliability of flow control devices (FCDs) in the delivery of medical gases. FCDs play a critical role in clinical practice, ensuring that patients receive safe and accurate dosages of medical gases even when downstream equipment creates back-pressure.

By incorporating feedback from industry, healthcare professionals, and technical experts, this amendment strengthens safety measures and helps ensure consistency across medical environments.

Key Topics

• Stability of Indicated Flow:
  The amendment details updated criteria regarding the stability of the indicated flow on medical gas FCDs. Devices must maintain the prescribed setting within a ±10% margin over one hour under atmospheric outlet pressure.

• Response to Back-Pressure:
  Flow control devices are now required to maintain accurate indication and delivery of medical gas when exposed to a downstream back-pressure of (10 ± 1) kPa. Specific performance limits are set for deviations in indicated flow both when the back-pressure is applied and when it is removed.

• Clinical Accessories and Hazard Prevention:
  The amendment addresses issues caused by various clinical accessories (such as humidifiers and nebulizers) that can create back-pressure downstream of the FCD, which can lead to discrepancies between indicated and delivered flows. Enhanced requirements help mitigate risks of incorrect dosages resulting from back-pressure effects.

• Test Methods:
  New standardized test procedures and apparatus for evaluating stability of flow indication under back-pressure are described, ensuring manufacturers can demonstrate compliance and regulators can verify device safety.

Applications

• Hospital Medical Gas Systems:
  Used where precise and reliable flow control of medical gases is critical, such as in anesthesia, respiratory therapy, and intensive care units.

• Home Healthcare:
  Relevant for portable or home-use flow control devices connected to oxygen or other medical gas delivery systems.

• Medical Device Manufacturing:
  Provides essential requirements for design, testing, and quality assurance processes to ensure compliance with updated international standards.

• Healthcare Regulatory Compliance:
  Essential reference for demonstrating conformity with safety and performance requirements in national and international regulations for medical gas devices.

Related Standards

• ISO 15002:2023 – The base standard specifying general requirements for flow control devices for medical gas supply systems.
• ISO 7396 series – Medical gas pipeline systems, including installation and maintenance requirements.
• EN ISO 10524 – Pressure regulators for medical gases.
• ISO 80601-2-13 – Particular requirements for basic safety and essential performance of anesthetic workstations and their components.
• EN ISO 9170 – Terminal units for medical gas pipeline systems.

SIST EN ISO 15002:2024/oprA1:2026 aligns with these standards to provide a comprehensive regulatory and technical framework for medical gas flow control systems, reinforcing patient safety and device performance in all healthcare settings.

---

By adhering to these updated requirements, stakeholders in healthcare and medical device industries ensure safer, more reliable delivery of medical gases, improving patient outcomes while supporting global standardization efforts for medical gas systems.

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
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: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO 15002:2023/DAM 1:2026(en)
ii
ISO 15002:2023/DAM 1:2026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject
...