ISO-15002 › Flow control devices for connection to a medical gas supply system
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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).
To find similar documents by classification:
11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)
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Document Number
ISO 15002:2023
Revision Level
3RD EDITION
Status
Current
Publication Date
Aug. 1, 2023
Committee Number
ISO/TC 121/SC 6