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ANSI/ISO21647-04
Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors
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IEC 60601-1:1998, Clause 1, applies, except as follows.
Amendment (ass at the end of 1.1):
This International Standard specified particular requirements forthe basic safety and essential performance of respiratory gasmonitors (RGM) (as defined in 3.15) intended for continuousoperation 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 intendedfor use with flammable anesthetic agents.
The requirements of this International Standard which replace ormodify the requirements of IEC 60601-1:1998 and its Amendments 1(1991) and 2 (1995) are intended to take precedence over thecorresponding general requirements.
Environmental aspects are addressed in Annex CC.
NOTE Additional aspects of environmental impact are addressed inISO 14971.