Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (Adopted ISO 80601-2-55:2018, second edition, 2018-02, with Canadian deviations)
This is the second edition of CSA C22.2 No. 80601-2-55, Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-55 (second edition, 2018-02). It supersedes the previous edition, published in 2014 as CAN/CSA-C22.2 No. 80601-2-55 (adopted ISO 80601-2-55:2011). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.
This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, including Amendment 1:2012, with Canadian deviations).
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
Scope and object
IEC 60601-1:2005+Amd 1:2012, Clause 1 applies, except as follows:
IEC 60601-1:2005+Amd 1:2012, 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, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+Amd 1:2012, 4.2.
IEC 60601-1:2005+Amd 1:2012, 1.2 is replaced by:
The object of this document 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.