scope:

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).