Standards
ISO 15001:2010 Compatibility with oxygen
ISO 15001:2010, Anaesthetic and respiratory equipment: Compatibility with oxygen, is the ISO standard for the oxygen compatibility of materials, components and devices that can come into contact with oxygen above 50 kPa, such as medical gas pipeline systems and pressure regulators; ISO last confirmed the 2010 edition in March 2022.
What the standard covers
ISO 15001 sets requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications that can come into contact with oxygen, in normal condition or in single fault condition, at gas pressures greater than 50 kPa. It also gives general guidelines for selecting materials and components from available oxygen compatibility data and for carrying out a risk analysis, including the toxicity of products of combustion or decomposition.
The aspects it addresses are cleanliness, resistance to ignition and the toxicity of combustion or decomposition products, at the design, manufacturing, maintenance and disposal stages. It applies to anaesthetic and respiratory equipment within the scope of ISO/TC 121, for example medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.
Edition in force and status
ISO 15001:2010 is the second edition, published in June 2010 (40 pages, ISO/TC 121/SC 6), and replaced ISO 15001:2003. ISO confirmed it at its systematic reviews on 15 March 2016 and 11 March 2022.
Where it is cited
- Under HTM 02-01 (2026), the NHS England guidance, liquid or gel sealing media should be used only if they have been tested and proven safe under the tests specified in BS EN ISO 15001.
- The 2020 WHO interim technical specifications for PSA oxygen plants (superseded by WHO's technical specifications of 31 December 2024) asked for all pressurized vessels to be cleaned according to ISO 15001, ASTM G93 or equivalent; that interim guidance stated that it would expire 2 years after its publication.
Related standards and terms
- ISO 7396-1: pipeline systems for compressed medical gases and vacuum.
- ISO 11197: medical supply units.
- Oxygen cleaning of pipes and components.
More questions
Does ISO 15001 apply to medical gas pipelines?
Yes. Its scope lists medical gas pipeline systems among the anaesthetic and respiratory equipment it applies to.
At what pressure does ISO 15001 apply?
It applies to materials, components and devices that can come into contact with oxygen at gas pressures greater than 50 kPa, in normal condition or in single fault condition.
Sources
- ISO 15001:2010, Compatibility with oxygen (iso.org)
- NHS England, HTM 02-01 (2026), Part A: Design, installation, validation and verification
- NHS England, HTM 02-01 (2026), Part B: Operational management
- WHO, Technical specifications for PSA oxygen plants, interim guidance (8 June 2020)
- WHO, Technical specifications for health facility based medical oxygen systems (31 December 2024), note on the oxygen generator plant specification (supersedes the 2020 interim PSA specifications)
Ultra Controlo figures come from its technical datasheets. Third-party facts were read at the source on the date shown.