ANSI / ISO21647 - 04

    Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors


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    ANSI / ISO21647

    1. Scope

    IEC 60601-1:1998, Clause 1, applies, except as follows.
    Amendment (ass at the end of 1.1):
    This International Standard specified 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 anesthetic agents.
    The requirements of this International Standard which replace or modify the requirements of IEC 60601-1:1998 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.


    ANSI / ISO21647

    Citing ASTM Standards
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