WHO-UNICEF technical specifications for oxygen therapy devices (2019)

Edition and status

The guide is part of the WHO medical device technical series. WHO dates it 14 January 2019; it has 163 pages (ISBN 9789241516914). UNICEF developed it in collaboration with WHO, within a collaboration on oxygen therapy systems that began in 2017 and continued into 2019, with funding from the Bill & Melinda Gates Foundation. WHO's publication page, read on 23 October 2026, lists this 2019 edition.

What it covers

Chapters 3 to 8 cover oxygen sources, devices for oxygen regulation and conditioning, oxygen delivery devices, pulse oximetry, devices for quality power supply and oxygen analysers. Annex 1 holds 15 technical specification tables, from oxygen cylinders (Table A1.1) and oxygen concentrators (Table A1.2) through Thorpe tube flowmeters, flowmeter stands, reusable non-heated bubble humidifiers, nasal cannulae, nasal catheters, oxygen tubing, three types of pulse oximeter, solid-state voltage stabilizers and surge suppressors, to electrochemical and ultrasonic oxygen analysers (Table A1.15). The guide says these specifications require adaptation to create procurement specifications for purchasing in a local setting.

Its definition of medical oxygen sets a minimum of 82% pure oxygen, free from any contamination. It names compressed gas cylinders, oxygen concentrators and oxygen plants as the three most common sources of medical oxygen in health facilities in low-resource settings, with bulk-stored liquid oxygen as a fourth, less common source. It notes that plants may not be suitable as a primary level oxygen source, and the 2019 text states that the high cost of centralized sources with copper pipelines and the specialized maintenance they need currently make these systems unsuitable for many district-level hospitals in low-resource settings.

What it does not cover

• Only products required for basic oxygen therapy are described, meaning administration by nasal cannula, nasal catheter or face mask. Devices for respiratory support or surgical environments, heated humidification, blenders, bubble CPAP, CPAP and mechanical ventilation are outside its scope.
• Detailed guidance on concentrators is left to WHO's Technical specifications for oxygen concentrators (2015), although Annex 1 includes a concentrator specification table.
• Clinical guidance is not covered in detail; the guide refers to Oxygen therapy for children (WHO, 2016).
• Oxygen plants are described as a source in Chapter 3, but Annex 1 has no specification table for oxygen plants or pipeline systems. WHO's PSA plant specifications are a separate document.

Relation to other standards

For oxygen cylinders and their accessories the guide lists ISO 13485 and ISO 14971 for the manufacturer, and ISO 10524, ISO 15002 and ISO 32 for the product, recommending compliance with the latest available version. Its concentrator table cites ISO 80601-2-69: 2014; ISO now lists ISO 80601-2-69:2026, published in April 2026, as the current edition.