ISO 15002:2023: flow control devices for a medical gas supply system

Edition and status

ISO 15002:2023 is edition 3, published in August 2023 (22 pages, ISO/TC 121/SC 6, stage 60.60). It replaced ISO 15002:2008 and its Amendment 1:2018, both withdrawn. A draft amendment, ISO 15002:2023/DAmd 1, is under development: on 23 October 2026 ISO showed it at DIS ballot (stage 40.20), in the enquiry phase with ISO members. Older documents cite the standard under a different title; the 2019 WHO-UNICEF guide, for example, lists "ISO 15002 Flow-metering devices for connection to terminal units of medical gas pipeline systems".

What it covers

The standard specifies requirements for flow control devices (FCDs) that the user connects directly, by a probe or a gas-specific connector, or indirectly by a low-pressure hose assembly conforming with ISO 5359, to one of three points:

• a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
• the pressure outlet of a regulator conforming with ISO 10524-1:2018;
• the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3.

It applies to flowmeters, flowgauge FCDs and fixed orifice FCDs, for oxygen, oxygen 93%, nitrous oxide, medical air, carbon dioxide, oxygen/nitrous oxide mixture 50/50, oxygen-enriched air, helium, xenon and specified mixtures of these gases. Flow control devices classed as medical electrical equipment can also be subject to IEC 60601-1.

What it does not cover

• Flow control devices for use with gases for driving surgical tools.
• Flow control devices that are an integral part of a regulator, which ISO 15002 refers to ISO 10524-1:2018.
• Flow control devices that are an integral part of a VIPR, which it refers to ISO 10524-3.

Relation to other standards

• Terminal units: ISO 9170-1:2017. Pipelines: ISO 7396-1:2016, which ISO expects to be replaced within the coming months.
• Regulators: ISO 10524-1:2018, with Amendment 1 published in October 2023; ISO expects ISO 10524-3:2019 to be replaced by ISO/FDIS 10524-3.
• Hoses: ISO 5359:2014, with Amendment 1:2017, whose revision is at DIS ballot.
• The WHO-UNICEF specifications for oxygen therapy devices (2019) list ISO 15002 among the product standards for oxygen cylinders and their accessories and recommend compliance with the latest available version.