EN ISO 15002:2024

Flow control devices for connection to a medical gas supply system (ISO 15002:2023)

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

Durchflussregeleinrichtungen zum Anschluss an ein Versorgungssystem für medizinische Gase (ISO 15002:2023)

1.1   Dieses Dokument legt Anforderungen an Durchflussregeleinrichtungen fest, die vom Anwender entweder direkt über einen Stecker oder ein gasartspezifisches Verbindungsstück oder indirekt über ein Niederdruck-Schlauchleitungssystem nach ISO 5359 angeschlossen werden können an:
a)   eine Entnahmestelle nach ISO 9170 1 eines Rohrleitungssystems für medizinische Gase nach ISO 7396 1:2016;
b)   den Druckausgang eines Regelgeräts nach ISO 10524 1:2018; oder
c)   den Druckausgang eines Ventils mit integriertem Druckminderer (VIPR, en: valve with integrated pressure regulator) nach ISO 10524 3 (siehe 5.2 Gaseingänge).
1.2   Dieses Dokument ist für folgende Typen von Durchflussregeleinrichtungen (FCD, en: flow control device) anwendbar:
a)   Durchflussmessgeräte;
b)   Durchflussregeleinrichtungen mit Gerät zur Messung des Durchflusses nach dem Wirkdruckverfahren; und
c)   Durchflussregeleinrichtungen mit fester Blende.
ANMERKUNG   Durchflussregeleinrichtungen, die als medizinische elektrische Geräte eingestuft sind, können den zusätzlichen Anforderungen von IEC 60601 1 unterliegen.
1.3   Dieses Dokument ist für Durchflussregeleinrichtungen für folgende Gase anwendbar:
   Sauerstoff;
   Sauerstoff 93 %;
   Distickstoffoxid (Lachgas);
   medizinische Luft;
   Kohlenstoffdioxid;
   Sauerstoff-Distickstoffoxid-Gemisch 50/50 (Volumenanteil %);
   mit Sauerstoff angereicherte Luft;
   Helium;
   Xenon; und
   festgelegte Gemische der oben genannten Gase.
ANMERKUNG   Durchflussregeleinrichtungen können für andere Gase verfügbar sein.
1.4   Dieses Dokument ist nicht abwendbar für Durchflussregeleinrichtungen, die:
a)   zur Verwendung mit Gasen für den Antrieb chirurgischer Instrumente vorgesehen sind;
b)   fester Bestandteil eines Regelgeräts sind (siehe ISO 10524 1:2018); oder
c)   fester Bestandteil eines Ventils mit integriertem Druckminderer (VIPR) sind (siehe ISO 10524 3).

Dispositifs de contrôle du débit pour raccordement à un système d'alimentation en gaz médicaux (ISO 15002:2023)

Le présent document spécifie les exigences relatives aux dispositifs de contrôle du débit qui peuvent être raccordés par l’utilisateur soit directement, à l’aide d’une sonde ou d’un raccord spécifique au gaz, soit indirectement à l’aide d’un flexible de raccordement basse pression conforme à l’ISO 5359:
a)    à une prise murale conforme à l’ISO 9170‑1 d’un système de distribution de gaz médicaux conforme à l’ISO 7396‑1:2016;
b)    à la sortie en pression d’un détendeur conforme à l’ISO 10524‑1:2018; ou
c)    à la sortie en pression d’un robinet avec détendeur intégré (VIPR) conforme à l’ISO 10524‑3 (voir 5.2 Entrées de gaz).
Le présent document s’applique aux types de dispositifs de contrôle du débit suivants:
a)    débitmètres;
b)    dispositifs de contrôle du débit à indicateur de débit; et
c)    dispositifs de contrôle du débit à orifice fixe.
NOTE       Les dispositifs de contrôle du débit qui sont classés dans la catégorie des appareils électromédicaux peuvent être soumis aux exigences supplémentaires de l’IEC 60601‑1.
Le présent document s’applique aux dispositifs de contrôle du débit pour les gaz suivants:
—    oxygène;
—    oxygène à 93 %;
—    protoxyde d’azote;
—    air médical;
—    dioxyde de carbone;
—    mélange oxygène/protoxyde d’azote 50/50 (% en volume);
—    air enrichi en oxygène;
—    hélium;
—    xénon; et
—    mélanges spécifiés de gaz répertoriés ci-dessus.
NOTE       Les dispositifs de contrôle du débit peuvent être disponibles pour d’autres gaz.
Le présent document ne s’applique pas aux dispositifs de contrôle du débit qui sont:
a)    utilisables avec des gaz moteurs pour les instruments chirurgicaux;
b)    partie intégrante d’un détendeur (voir l’ISO 10524‑1:2018); ou
c)    partie intégrante d’un robinet avec détendeur intégré (VIPR) (voir l’ISO 10524‑3).

Naprave za uravnavanje pretoka v priključitvi na sistem oskrbe z medicinskimi plini (ISO 15002:2023)

Ta dokument določa zahteve za naprave za uravnavanje pretoka, ki jih lahko uporabnik priključi bodisi neposredno, z uporabo sonde ali posebnega priključka za plin, bodisi posredno, z uporabo nizkotlačne povezovalne cevi v skladu s standardom ISO 5359 z naslednjim:
a)    s končnim delom (v skladu s standardom ISO 9170-1) napeljav za medicinske pline (v skladu s standardom ISO 7396-1:2016;)
b)    odprtino za tlak tlačnega regulatorja v skladu s standardom ISO 10524-1:2018; ali
c)    odprtino za tlak tlačnega regulatorja v sklopu ventila (VIPR) v skladu s standardom ISO 10524-3 (glej točko 5.2 – dovodni priključki za plin).
Ta dokument se uporablja za naslednje vrste naprav za uravnavanje pretoka (FCD):
a)    merilniki pretoka;
b)    naprave za uravnavanje pretoka z merilnikom pretoka; in
c)    naprave za uravnavanje pretoka s stalno obliko.
OPOMBA:       Za naprave za nadzor pretoka, ki so razvrščene kot medicinska električna oprema, lahko veljajo dodate zahteve standarda IEC 60601-1.
Ta dokument se uporablja za naprave za nadzor pretoka naslednjih plinov:
–    kisik;
–    93-odstotni kisik;
–    dušikov oksid;
–    medicinski zrak;
–    ogljikov dioksid;
–    mešanica kisika/dušikovega oksida 50/50 (% deleža prostornine);
–    s kisikom obogateni zrak;
–    helij;
–    ksenon; in
–    določene zmesi zgoraj navedenih plinov.
OPOMBA: Naprave za nadzor pretoka se lahko uporabljajo tudi za druge vrste plinov.
Ta dokument se ne uporablja za naprave za nadzor pretoka, ki:
a)    se uporabljajo s plini, ki omogočajo uporabo kirurških instrumentov;
b)    so sestavni del regulatorja tlaka (glej standard ISO 10524-1:2018); ali
c)    so sestavni del tlačnega regulatorja v sklopu ventila (VIPR) (glej standard ISO 10524-3).

General Information

• Status: Published
• Publication Date: 26-Mar-2024
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 27-Mar-2024
• Completion Date: 27-Mar-2024
• Ref Project: SIST EN ISO 15002:2024 - Flow control devices for connection to a medical gas supply system (ISO 15002:2023)

Relations

• Replaces: EN ISO 15002:2008/A1:2019 - Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 1 (ISO 15002:2008/Amd 1:2018)
• Effective Date: 08-Apr-2024
• Replaces: EN ISO 15002:2008 - Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
• Effective Date: 04-Oct-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2024
Nadomešča:
SIST EN ISO 15002:2008/A1:2020
Naprave za uravnavanje pretoka v priključitvi na sistem oskrbe z medicinskimi
plini (ISO 15002:2023)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
Durchflussregeleinrichtungen zum Anschluss an ein Versorgungssystem für
medizinische Gase (ISO 15002:2023)
Dispositifs de contrôle du débit pour raccordement à un système d'alimentation en gaz
médicaux (ISO 15002:2023)
Ta slovenski standard je istoveten z: EN ISO 15002:2024
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.

EN ISO 15002
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2024
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 15002:2008
English Version
Flow control devices for connection to a medical gas
supply system (ISO 15002:2023)
Dispositifs de contrôle du débit pour raccordement à Durchflussregeleinrichtungen zum Anschluss an ein
un système d'alimentation en gaz médicaux (ISO Versorgungssystem für medizinische Gase (ISO
15002:2023) 15002:2023)
This European Standard was approved by CEN on 23 March 2024.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15002:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 15002:2023 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 15002:2024 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic
equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2024, and conflicting national standards
shall be withdrawn at the latest by September 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15002:2008.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 15002:2023 has been approved by CEN as EN ISO 15002:2024 without any modification.

INTERNATIONAL ISO
STANDARD 15002
Third edition
2023-08
Flow control devices for connection to
a medical gas supply system
Dispositifs de contrôle du débit pour raccordement à un système
d'alimentation en gaz médicaux
Reference number
ISO 15002:2023(E)
ISO 15002:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 15002:2023(E)
Contents Page
Foreword .iv
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General requirements . 3
4.1 Risk management . 3
4.2 Usability . 3
4.3 Materials . 4
4.4 Oxygen compatibility . 4
4.5 Environmental conditions . 4
5 Design requirements .5
5.1 General . 5
5.2 Gas inlets . 6
5.3 Outlet connectors . 6
5.4 Mechanical strength . 6
5.5 Leakage . 6
5.6 Flow indication . 7
5.7 Accuracy . 7
5.8 Stability of indicated flow . 8
5.9 Continuous increase in flow . 8
5.10 Security of components . 8
5.11 Flow controls and flow selectors . 8
6 Packaging. 9
7 Information supplied by the manufacturer . 9
7.1 General . 9
7.2 Marking . 9
7.3 Instructions for use . 10
Annex A (informative) Rationale .11
Annex B (informative) Examples of flow control devices and gas supply inlets .13
Annex C (normative) Test methods.15
Annex D (informative) Hazard identification for risk assessment .20
Bibliography .22
iii
ISO 15002:2023(E)
Foreword
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