ISO 7396-1: pipelines for compressed medical gases and vacuum

Scope

ISO 7396-1:2016 sets requirements for the design, installation, function, performance, testing, commissioning and documentation of pipeline systems for compressed medical gases and vacuum in healthcare facilities. It covers the supply systems, the pipeline distribution, control systems, monitoring and alarm systems, and the non-interchangeability between components of different gas and vacuum services.

Oxygen 93 is in scope. Where every source of supply delivers oxygen 93, the oxygen concentration may vary between 90% and 96%. Where every source delivers oxygen, it is above 99%. Where oxygen 93 and oxygen are combined, the concentration can vary between 90% and above 99%.

Outside its scope: oxygen concentrators for domiciliary use (ISO 80601-2-69 applies), filling systems for transportable cylinders and cylinder bundles, and anaesthetic gas scavenging disposal systems, which are covered by ISO 7396-2.

Edition and status

• ISO 7396-1:2016 is edition 3, published in February 2016 by ISO/TC 121/SC 6 (178 pages). Amendment 1 was published in December 2017.
• ISO lists the 2016 edition at stage 90.92, to be revised. A 4th edition reached stage 60.00 (under publication) on 23 September 2026 and had not been published on 22 October 2026. Check iso.org before calling the 2016 edition current.
• In Europe the reference is EN ISO 7396-1:2016 + A1:2019, published nationally with a national prefix; DIN Media lists DIN EN ISO 7396-1:2019-06 as current, and NHS England guidance cites BS EN ISO 7396-1.
• Withdrawn predecessors: ISO 10083:2006 on oxygen concentrator supply systems, withdrawn in February 2016 and revised by ISO 7396-1:2016, and the European EN 737-3, replaced by EN ISO 7396-1.

What it means for hospitals and designers

• Sources of supply: the rule that a supply system has at least three sources of supply sits in ISO 7396-1. HTM 02-01 calls them primary, secondary and tertiary; the Portuguese ACSS ET 03/2006 calls them primary, secondary and reserve.
• Oxygen 93: design for the concentration ranges above. National rules may add conditions; the Portuguese ACSS, for example, recommends a separate or dedicated distribution network for oxygen 93.
• Surgical air: ACSS ET 03/2006 sets the pressure for surgical instruments at 8 bar +2/-1, in line with ISO 7396-1.
• National documents build on it: HTM 02-01 in England, ACSS ET 03/2006 in Portugal, the informative FD S90-155 in France, and in Saudi Arabia the SFDA adopted GSO ISO 7396-1:2016 identically as a national standard.

Related standards

ISO 7396-3 covers proportioning units for synthetic medical air as a source for these pipelines, ISO 9170-1 the terminal units, and EN 13348 the copper tube.

Ultra Controlo products

The ULTRAOX SC datasheet states that the oxygen plant complies with ISO 7396-1:2016, and the ULTRAAR SC datasheet states that the medical air plant is built to EN ISO 7396-1.