This International Standard specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT. This International Standard specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring.

NOTE 1 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 an RGM intended for use with flammable anaesthetic agents. Environmental aspects are addressed in Annex BB.

NOTE 2 Additional aspects of environmental impact are addressed in ISO 14971 and IEC 60601-1-9.

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an RGM (as defined in 201.3.210) and its ACCESSORIES. NOTE ACCESSORIES are included because the combination of the RGM and the ACCESSORIES needs to be safe. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of an RGM.