Skip to main content

ISO 15002:2023

Flow control devices for connection to a medical gas supply system

General information

Valid from 31.08.2023
Directives or regulations

Standard history

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).

Required fields are indicated with *

169.14 € incl tax
169.14 € incl tax
Standard monitoring

Customers who bought this item also bought


EVS-EN ISO 18082:2014/A1:2017

Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases - Amendment 1 (ISO 18082:2014/Amd 1:2017)
Newest version Valid from 18.09.2017
Main + amendment

EVS-EN ISO 10524-1:2019+A1:2023

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2018 + ISO 10524-1:2018/Amd 1:2023)
Newest version Valid from 15.11.2023

ISO/TS 21726:2019

Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
Newest version Valid from 01.02.2019

EVS-EN ISO 1456:2009

Metallic and other inorganic coatings - Electrodeposited coatings of nickel, nickel plus chromium, copper plus nickel and of copper plus nickel plus chromium
Newest version Valid from 08.10.2009