SRPS EN ISO 80601-2-55:2012

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011)

Scope

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.