ISO 15002:2023

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 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).