WHO technical specifications for health facility oxygen systems (2024)

What it covers

The document gives minimum criteria that buyers can use when planning and procuring the equipment of medical oxygen systems inside health facilities. It is organised in three sections with eight specification tables in total:

• Oxygen source equipment: oxygen generator plants (PSA, VSA, VPSA), cylinder filling stations fed from on-site plants, and containerized housing for oxygen generator plants.
• Oxygen storage equipment: high-pressure oxygen cylinders (shells and primary valves), vacuum insulated evaporator (VIE) systems and cryogenic liquid oxygen cylinders.
• Oxygen distribution components: oxygen distribution manifolds, and pipeline components for medical oxygen (alarms, valves and their assemblies, piping and fittings, terminal units).

Each table covers name and coding, purpose of use, technical and physical characteristics, utility requirements, accessories and spares, packaging, environment, training and installation, warranty and maintenance, decommissioning, safety and standards, and documentation. The tables are generic and contain fields to be completed for each project.

What it does not cover

• Requirements for the production, acquisition or patient delivery of medical oxygen, which is a medicine.
• Technical guidance on system design (selection, sizing and configuration), installation, testing and commissioning, operations and maintenance, and decommissioning. For an overview of these, WHO points to its Foundations of medical oxygen systems (2023).
• Bedside oxygen concentrators and oxygen therapy devices, for which WHO refers to the WHO-UNICEF technical specifications and guidance for oxygen therapy devices (2019).
• Dewar tanks, ISOtainers/ISOtanks, hyperbaric chambers and products specific to other medical gases.

Status and relation to earlier WHO documents

• It was developed with an Expert Working Group, which met on 13 November and 15 December 2023, and a public consultation between 6 February and 15 March 2024.
• The oxygen generator plant specification states that it supersedes WHO's Technical specifications for PSA oxygen plants: interim guidance (2020), a document that itself said it would expire two years after publication.
• The cylinder specification supersedes only the cylinder (shell and valve) specifications of two earlier documents: the WHO-UNICEF oxygen therapy devices specifications and WHO's Priority medical devices list for the COVID-19 response (interim guidance).
• National and regional standards, where they exist, take precedence over the international standards it lists.

Examples from the oxygen generator plant table

Using it in a tender

WHO says the generic specifications should be adapted to the project before being treated as binding, and that a vendor whose offer deviates must provide justification. In the document, warranty means a guarantee from commissioning covering manufacture-related issues or defects; it does not include after-sales service such as operation, preventive maintenance or repair. For the regulation of air and product tanks, it suggests alternatives such as the EU Pressure Equipment Directive 2014/68/EU where national requirements are absent.