Oprema za anesteziju i respiratorna oprema — Kompatibilnost sa kiseonikom

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

Ovim standardom se utvrđuju zahtevi za kompatibilnost materijala s kiseonikom, komponentama i sredstvima za anestezionu i respiratornu aplikaciju.

ISO 15001:2010 specifies requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa. Additionally, ISO 15001:2010 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. Aspects of compatibility that are addressed by ISO 15001:2010 include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages. ISO 15001:2010 is applicable to anaesthetic and respiratory equipment that is 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.

SRPS EN ISO 15001:2012 zamenjuje SRPS EN ISO 15001:2011 - 23.05.2012

oprema za anesteziju, oprema za disanje, medicinska oprema, javno zdravlje