IEC 60601-1:1998, Clause 1, applies, except as follows.
Amendment (add at the end of 1.1):
This International Standard specifies particular requirements for the basic safety and essential performance of
respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans.
This International Standard specifies requirements for
aa) anaesthetic gas monitoring,
bb) carbon dioxide monitoring,
cc) oxygen monitoring.
This International Standard is not applicable to monitors intended for use with flammable anaesthetic agents.
The requirements of this International Standard which replace or modify the requirements of
IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the
corresponding general requirements.
Environmental aspects are addressed in Annex CC.
NOTE Additional aspects of environmental impact are addressed in ISO 14971.
BS EN ISO 21647:2004 history
2018BS EN ISO 80601-2-55:2018 Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors
2012BS EN ISO 80601-2-55:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of respiratory gas monitors
1970BS EN ISO 21647:2009 Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors
2004BS EN ISO 21647:2004 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors