ISO 80601-2-69:2026 Oxygen concentrator equipment

What the standard covers

The 2026 edition applies to transit-operable and non-transit-operable oxygen concentrators, including concentrators integrated into or used with other medical devices, ME equipment or ME systems. ISO's examples include a concentrator with an oxygen conserving or humidifier function, one used with a flowmeter stand, one that is part of an anaesthetic system for areas with limited supplies of electricity and anaesthetic gases, and one with an integrated liquid reservoir or gas cylinder filling function.

It also applies to accessories that can affect the basic safety or essential performance of the concentrator, such as masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.

What it does not cover

ISO 80601-2-69 does not specify requirements for oxygen concentrators for use with a medical gas pipeline system. Hospital pipeline systems, including supply systems in which all sources deliver oxygen 93, are covered by ISO 7396-1, which in turn excludes oxygen concentrators for domiciliary use.

Edition in force and status

• ISO 80601-2-69:2026 is the third edition, published in April 2026 (68 pages, ISO/TC 121/SC 3).
• The second edition, ISO 80601-2-69:2020 (November 2020, 62 pages), was marked for revision on 19 May 2023 and withdrawn on 10 April 2026; it had replaced ISO 80601-2-69:2014.
• The 2020 edition described its scope as concentrators intended to increase the oxygen concentration of gas delivered to a single patient, typically in the home healthcare environment, and noted that they can also be used in professional healthcare facilities.

Related standards

• ISO 7396-1: pipeline systems for compressed medical gases and vacuum.
• ISO 10083: the former standard for oxygen concentrator supply systems used with a pipeline, withdrawn on 15 February 2016 and revised by ISO 7396-1:2016.