ISO 15001:2003 PDF

Scope: This International Standard 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. This International 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. Aspects of compatibility that are addressed by this International Standard include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition.

ISO 15001:2003 Referenced Document

ISO 14971:2000 Medical devices - Application of risk management to medical devices

2010 ISO 15001:2010 Anaesthetic and respiratory equipment - Compatibility with oxygen
2003 ISO 15001:2003 Anaesthetic and respiratory equipment - Compatibility with oxygen