ISO International Standard

Flow control devices for connection to a medical gas supply system

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 91701 of a medical gas pipeline system conforming with ISO 73961:2016;

b)    the pressure outlet of a regulator conforming with ISO 105241:2018; or

c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 105243 (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 606011.

This document applies to flow control devices for the following gases:


    oxygen 93 %;

    nitrous oxide;

    medical air;

    carbon dioxide;

    oxygen/nitrous oxide mixture 50/50 (% volume fraction);

    oxygen-enriched air;


    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 105241:2018); or

c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 105243).

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