ISO 15002:2023

Description

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).