Draft Details

CSA Scope

201.1.1 *Scope
[Add the following paragraph]
This Standard applies to ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in accordance with CSA C22.1, Canadian Electrical Code, Part I.

ISO Scope:

IEC 60601-1:2005+Amd 1:2012+Amd 2:2020, Clause 1 applies, except as follows:

201.1.1 *Scope

IEC 60601-1:2005+Amd 1:2012+Amd 2:2020, 1.1 is replaced by:

This document 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 document specifies requirements for

— anaesthetic gas monitoring,

— carbon dioxide monitoring, and

— oxygen monitoring.

NOTE 1 An RGM can be either stand-alone ME EQUIPMENT or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.

This document is not applicable to an RGM intended for use with flammable anaesthetic agents.

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 document are not covered by specific requirements in this document except in IEC 60601-1:2005+Amd 1:2012+Amd 2:2020, 7.2.13 and 8.4.1.

NOTE 2 Additional information can be found in IEC 60601-1:2005+Amd 1:2012+Amd 2:2020, 4.2.