CSA Preface
This is the first edition of CAN/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 (first edition, 2011-12-15). It replaces the previous edition, published in 2007 as CAN/CSA-Z21647, Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (adopted ISO 21647:2004). For brevity, this Standard will be referred to as CAN/CSA-C22.2 No. 80601-2-55 throughout.
This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, with Canadian deviations).
This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Perioperative Safety under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology & Systems. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.
Scope
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.
