EN ISO 80601-2-55:2011

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

Publication date:   Jun 18, 2012

General information

99.60 Withdrawal effective   Feb 28, 2018

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 21647:2009

NOW

WITHDRAWN
EN ISO 80601-2-55:2011
99.60 Withdrawal effective
Feb 28, 2018

REVISED BY

PUBLISHED
EN ISO 80601-2-55:2018