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CEN

EN ISO 15002:2024

(Main)

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

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)

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)

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

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Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 15002:2024
01-februar-2024
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: prEN ISO 15002
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 15002:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 15002:2024

---------------------- Page: 2 ----------------------
oSIST prEN ISO 15002:2024
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 2023

---------------------- Page: 3 ----------------------
oSIST prEN ISO 15002:2024
ISO 15002:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2023 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 15002:2024
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 .
...

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