scope:

IEC 60601-1:2005, Clause 1 applies, except as follows: 201.1.1 * Scope Subclause 1.1 of the general standard is replaced by: This International Standard specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of RESPIRATORY GAS MONITORS, RGM, hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT. This International Standard specifies requirements for: a) anaesthetic gas monitoring, b) carbon dioxide monitoring, and c) oxygen monitoring. NOTE An RGM can be either standalone ME EQUIPMENT or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator. This International Standard is not applicable to RESPIRATORY GAS MONITORS intended for use with flammable anaesthetic agents. The requirements of this International Standard which replace or modify the requirements of IEC 60601-1:2005 are intended to take precedence over the corresponding general requirements. Environmental aspects are addressed in Annex DD. NOTE Additional aspects of environmental impact are addressed in ISO 14971 and IEC 60601-1-9. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the General Standard.