Ultra Controlo Medical gas library

Standards

Which standard covers concentrator supply to a pipeline?

Which standard covers oxygen concentrator supply systems connected to a hospital pipeline?

Short answer

Oxygen concentrator (PSA) supply systems feeding a hospital pipeline are covered by ISO 7396-1:2016, which includes oxygen 93 among pipeline gases and revised the former dedicated standard, ISO 10083:2006, withdrawn in February 2016. Concentrators for a single patient follow ISO 80601-2-69 instead.

ISO 10083 is withdrawn

ISO 10083:2006 covered oxygen concentrator supply systems for use with a medical gas pipeline built to ISO 7396-1, for systems producing oxygen-enriched air of at least 90% oxygen. ISO withdrew it on 15 February 2016 and lists ISO 7396-1:2016 as the document that revised it. Specifications that still ask for ISO 10083 refer to a withdrawn standard.

What ISO 7396-1:2016 covers

ISO 7396-1 lists oxygen 93 among the pipeline gases and sets requirements for supply systems, distribution, control, monitoring and alarm systems. It describes three cases for oxygen supply: where all sources deliver oxygen, the concentration is above 99%; where all sources deliver oxygen 93, it may vary between 90% and 96%; and where the two are mixed, it can vary between 90% and above 99%. In Europe the reference is EN ISO 7396-1:2016 + A1:2019. A 4th ISO edition has been under publication since 23 September 2026, so check iso.org before citing the edition.

Single-patient concentrators are different

ISO 7396-1 excludes oxygen concentrators for domiciliary use and points to ISO 80601-2-69 for them. ISO 80601-2-69:2026, edition 3, replaced the 2020 edition in April 2026; the 2020 edition described its scope as concentrators that raise the oxygen concentration of gas delivered to a single patient.

Other documents a designer will meet

  • EIGA Doc 195, adopted by AIGA as 113/20: industry guidance on the planning, design, location, installation, operation, maintenance and quality management of oxygen 93 concentrator systems that supply a medical gas pipeline. It calls for three sources of supply, at least one of them independent of the electrical supply.
  • Ph. Eur. 2455: the monograph for the gas from a single-stage adsorption plant, defined at delivery into the pipeline, not at the outlet. USP Oxygen 93 Percent is the USP monograph for oxygen produced from air by the molecular sieve process.
  • WHO technical specifications for PSA oxygen plants (interim guidance, 8 June 2020; superseded by WHO's technical specifications of 31 December 2024): procurement requirements for plants supplying oxygen 93% ± 3.
  • HTM 02-01 (2026): its Part B scope still refers to pipelines connected to concentrator supply systems complying with BS 7634 and ISO 10083, although ISO 10083 is withdrawn.
  • CSA Z7396.1:22, the Canadian standard, which CSA Group describes as the governing standard for medical gas installations in health care institutions.

The ULTRAOX SC datasheet states that the plant complies with ISO 7396-1:2016.

More questions

Does ISO 80601-2-69 apply to a hospital PSA plant feeding a pipeline?

It is written for oxygen concentrators supplying a single patient; ISO 7396-1 excludes domiciliary concentrators and covers the supply systems of medical gas pipelines.

Which pharmacopoeia monograph applies to the gas?

Ph. Eur. 2455 Oxygen (93 per cent) covers oxygen from single-stage plants and Ph. Eur. 3098 Oxygen (98 per cent) from two-stage plants; the USP monograph is Oxygen 93 Percent. Which one applies depends on national law.

Sources

Ultra Controlo figures come from its technical datasheets. Third-party facts were read at the source on the date shown.

Reviewed: · Ultra Controlo engineering · Markdown version

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