Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

201.1 Scope and object

IEC 60601-1:2005, Clause 1 applies, except as follows:

201.1.1 * Scope

Replacement:

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.

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 particular standard, except in 7.2.13 and 8.4.1 of the general standard (IEC 60601-1).

NOTE 3 See also 4.2 of the general standard.

201.1.2 Object

Replacement:

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.