Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011)
SS-EN ISO 80601-2-55:2018
ISO 80601-2-55:2011 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) intended for continuous operation for use with a patient.
ISO 80601-2-55:2011 specifies requirements for:
- anaesthetic gas monitoring,
- carbon dioxide monitoring, and
- oxygen monitoring.
ISO 80601-2-55:2011 is not applicable to an RGM intended for use with flammable anaesthetic agents.