ISO 15001:2003
Issue date: 2003 05 21
Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 15001:2003 specifies minimum requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications which can come in contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa.
ISO 15001:2003 is applicable to anaesthetic and respiratory equipment which are within the scope of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.
Aspects of compatibility that are addressed by ISO 15001:2003 include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition.
