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

ISO 15002:2023, Flow control devices for connection to a medical gas supply system, is the International Organization for Standardization (ISO) standard for flowmeters, flowgauge and fixed orifice devices connected to medical gas pipeline terminal units or regulator outlets; the third edition, published in August 2023, is current, and an amendment is at DIS ballot.

## 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 It replaced ISO 15002:2008 and its Amendment 1:2018, both withdrawn.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](https://library.ultracontrolo.com/standards/iso-9170-1/). Pipelines: [ISO 7396-1:2016](https://library.ultracontrolo.com/standards/iso-7396-1/), which ISO expects to be replaced within the coming months.
- Regulators: [ISO 10524-1:2018](https://library.ultracontrolo.com/standards/iso-10524/), 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](https://library.ultracontrolo.com/standards/iso-5359/), with Amendment 1:2017, whose revision is at DIS ballot.
- The [WHO-UNICEF specifications for oxygen therapy devices (2019)](https://library.ultracontrolo.com/standards/who-unicef-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.

### Does ISO 15002 cover regulators with a built-in flowmeter?

No. Flow control devices that are an integral part of a regulator are excluded and referred to ISO 10524-1:2018, and those integral to a VIPR are referred to ISO 10524-3.

### Which devices does ISO 15002:2023 cover?

Flowmeters, flowgauge FCDs and fixed orifice FCDs connected to a pipeline terminal unit, a regulator outlet or a VIPR outlet.

### Is ISO 15002:2008 still valid?

No. ISO lists ISO 15002:2008 and its 2018 amendment as withdrawn; the current edition is ISO 15002:2023.

## Sources

- [ISO 15002:2023, Flow control devices for connection to a medical gas supply system (iso.org)](https://www.iso.org/standard/75973.html)
- [ISO 15002:2023/DAmd 1, Amendment 1, under development (iso.org)](https://www.iso.org/standard/93475.html)
- [WHO-UNICEF technical specifications and guidance for oxygen therapy devices (2019), PDF (WHO IRIS)](https://iris.who.int/server/api/core/bitstreams/5a996b5a-6803-486e-bccb-98efc398118d/content)
- [ISO 7396-1:2016, Medical gas pipeline systems, Part 1 (iso.org)](https://www.iso.org/standard/60061.html)
- [ISO 10524-1:2018 and Amd 1:2023 (iso.org)](https://www.iso.org/standard/67190.html)
- [ISO 10524-3:2019 (iso.org)](https://www.iso.org/standard/66691.html)
- [ISO 5359:2014 (iso.org)](https://www.iso.org/standard/59953.html)
- [ISO 9170-1:2017 (iso.org)](https://www.iso.org/standard/67451.html)

Reviewed: 2026-10-23. Ultra Controlo engineering. https://library.ultracontrolo.com/standards/iso-15002/