Ultra Controlo Medical gas library

Standards

WHO technical specifications for PSA oxygen plants

The WHO Technical specifications for PSA oxygen plants (interim guidance, 8 June 2020) specified minimum requirements for PSA plants producing medical oxygen 93% ± 3 from ambient air; WHO's Technical specifications for health facility based medical oxygen systems (31 December 2024) state that their oxygen generator plant specification supersedes them.

What the specification asked for

ItemWHO interim specification (2020)
ProductMedical oxygen 93% ± 3 from ambient air, by pressure swing adsorption
Low-purity alarmAlarm when the oxygen concentration is lower than 90%
Output pressureContinuous 300 to 600 kPa (3 to 6 bar)
Typical outputFrom 2 Nm³/h to 200 Nm³/h
Feed air compressorOil-free, or filtered oil-injected or oil-lubricated rotary screw; minimum 750 kPa
Life spanAt least 10 years, guaranteed by a letter from the manufacturer
Warranty and spares48 months, with option to extend; 3-year spare parts kit
InstallationConformity verified by a certified third party
ManufacturerCertified quality management system for medical devices, for example ISO 13485 or ISO 9001

Status: interim guidance

WHO published the document, reference WHO/2019-nCoV/PSA_Specifications/2020.1, on 8 June 2020 during the COVID-19 response. The text stated that, as interim guidance, it would expire two years after publication, yet WHO still hosts it. WHO's Technical specifications for health facility based medical oxygen systems, published on 31 December 2024, state that their oxygen generator plant specification supersedes this interim guidance. Cite it as WHO interim technical specifications (2020), not as a WHO approval of any plant or manufacturer. It also reflected the standards of its time: it referenced the 2018 edition of NFPA 99, whose current edition is 2027.

What it means for hospitals and buyers

  • Used as a tender checklist, each item should be checked against the current editions of the standards it cited and against national rules.
  • The purity band of 93% ± 3 is the oxygen 93 range of 90% to 96% used in ISO 7396-1 and in Ph. Eur. 2455; WHO's Foundations of medical oxygen systems (2023) repeats that generator plant purity should be 93% ± 3%.
  • A Global Fund briefing note (3 April 2024) shows why the band matters for capacity: a PSA plant giving 20 Nm³/h at 93% ± 3% would give 18 Nm³/h if set to 95% ± 1%.

Ultra Controlo products

Ultra Controlo is certified to ISO 13485:2016. Its ULTRAOX SC and ST datasheets state an oxygen purity of 94% (±1%) and an oxygen outlet pressure of 6 bar.

More questions

Is the WHO PSA specification still valid?

It was issued as interim guidance on 8 June 2020, stated that it would expire two years after publication and, according to WHO's technical specifications of 31 December 2024, is superseded by the oxygen generator plant specification in that document. Use it as a reference checklist, not as a current standard.

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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