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ISO 15002:2023

Flow control devices for connection to a medical gas supply system
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ISO 15002:2023

Flow control devices for connection to a medical gas supply system

PUBLISH DATE 2023
ISO 15002:2023

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).
SDO ISO: International Organization for Standardization
Document Number ISO 15002
Publication Date Aug. 1, 2023
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 121/SC 6
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