DIN EN ISO 15001:2012-06

This Standard specifies 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. Additionally, this Standard gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of combustion and/or decomposition. This Standard 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.