EN ISO 15002:2024/prA1

• Status: Not Published
• Publication Date: 30-Jan-2028
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• 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
• Ref Project: SIST EN ISO 15002:2024/oprA1:2026 - Flow control devices for connection to a medical gas supply system - Amendment 1 (ISO 15002:2023/DAM 1:2026)

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

EN ISO 15002:2024/prA1 is a CEN draft amendment to ISO 15002 for flow control devices for connection to a medical gas supply system. It updates how these devices are checked for stable indicated flow, including behaviour under downstream back-pressure, so manufacturers, test laboratories, and users of medical gas equipment can verify performance in practice.

What does EN ISO 15002:2024/prA1 specify?

EN ISO 15002:2024/prA1 is an amendment document, so it changes selected parts of the base standard rather than restating the whole subject. The amendment replaces subclause 5.8, adds rationale text in A.6, adds a new test method in C.10, and adds one item to Annex D.

Part	What it covers
5.8	Stability of indicated flow
A.6	Rationale for the back-pressure-related requirements
C.10	Test method for stability of indicated flow when subjected to back-pressure
D	Example text on downstream equipment that can create back-pressure

In practice, the amendment focuses on whether a flow control device still indicates the expected flow when the outlet is open to atmosphere and when downstream equipment changes the outlet pressure. That matters because humidifiers, nebulizers, and long tubing can alter the flow seen at the device.

What are the key requirements of EN ISO 15002:2024/prA1?

Stability of indicated flow at atmosphere

EN ISO 15002:2024/prA1 replaces 5.8.1 with a requirement that a flow control device, once set, must stay within a defined deviation from the setting over a 1 hour period when the outlet is at atmospheric pressure. Conformance is checked by the test in C.9.

For a buyer or quality manager, this is the baseline stability check. It shows whether the device holds its setting during normal use without downstream restriction.

Behaviour with downstream back-pressure

EN ISO 15002:2024/prA1 replaces 5.8.2 with a second requirement for devices set at 50 % of the marked range. When downstream back-pressure of 10 ± 1 kPa is applied, the indicated flow must stay within a tighter deviation limit, and when that back-pressure is removed, the device must still remain within a defined deviation from the original setting.

This matters because accessories downstream of the device can make the indicated flow differ from the actual flow being delivered. The amendment states that these requirements apply only to flowmeters and flow gauge FCDs, so readers should check whether their product falls into that category before applying the test.

Test method C.10

EN ISO 15002:2024/prA1 adds C.10, which gives the method for checking the back-pressure requirement. The test uses a stable medical gas supply, adjustable downstream resistance, a fast-acting valve for venting to atmosphere, and a pressure transducer at the outlet.

For practice, this tells a test lab how to set up the device and what to observe: the device is adjusted to 50 % full scale, back-pressure is applied, the reading is allowed to stabilise, and then the outlet is vented to atmosphere again while the control setting is left unchanged.

Safety rationale in Annex A.6 and example in Annex D

EN ISO 15002:2024/prA1 adds explanatory text in A.6 and a new downstream-equipment example in Annex D. The rationale explains why accessories such as humidifiers, nebulizers, and long tubing matter: they can create back-pressure and lead to a clinically significant difference between indicated and delivered flow.

That helps users understand why the amendment tightens behaviour under back-pressure and why clinical setup, not just the device alone, affects the delivered gas flow.

What terms does EN ISO 15002:2024/prA1 define?

• Flow control device (FCD) - A device used to control flow in connection with a medical gas supply system.
• Flowmeter - A type of FCD for which the back-pressure-related requirement in 5.8.2 applies.
• Flow gauge FCD - A flow control device with a flow indication gauge; it is also covered by 5.8.2.
• Indicated flow - The flow value shown by the device setting or display.
• Marked range - The full flow range marked on the device; 50 % of this range is the mid-range test setting used in 5.8.2 and C.10.
• Downstream back-pressure - Pressure at the outlet caused by equipment or tubing downstream of the device.
• Atmospheric pressure - The outlet condition used in the basic stability check in 5.8.1.

Who uses EN ISO 15002:2024/prA1?

EN ISO 15002:2024/prA1 is used by manufacturers of medical gas flow control devices, test laboratories, and quality or regulatory teams that verify product performance. It is also relevant to hospital engineering, biomedical maintenance, and purchasing staff who need to compare devices and check supplier claims.

In practice, these users apply it when designing devices, planning type tests, setting up verification rigs, or assessing whether a product will behave as expected with downstream accessories in anaesthetic and respiratory equipment.

What changed in EN ISO 15002:2024/prA1 from the previous edition?

This amendment updates the standard with new and revised requirements for stability of indicated flow, adds a dedicated back-pressure test method, and expands the explanatory material on why back-pressure matters in use. It also adds a downstream-equipment example to Annex D.

What does the EN ISO 15002:2024/prA1 document contain?

The amendment contains replacement text for subclause 5.8, rationale text in A.6, and a new test method in C.10. C.10 includes the test principle, apparatus, procedure, and an example apparatus figure.

It also contains explanatory text that links the technical requirement to clinical use, especially where humidifiers, nebulizers, or long tubing are fitted downstream. For test and verification work, the document provides the setup and sequence needed to check indicated flow stability with and without back-pressure.

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
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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
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BE CONSIDERED IN THE LIGHT OF THEIR
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NATIONAL REGULATIONS.
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RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
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Published in Switzerland Reference number
ISO 15002:2023/DAM 1:2026(en)
ii
ISO 15002:2023/DAM 1:2026(en)
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