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).

Edition	2023
Published Date	2023
Published By	International Standardization Organisation
Page Count	22