CSA Preface
This is the first edition of CAN/CSA-C22.2 No. 80601-2-61, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-61 (first edition, 2011-04-01). It replaces the previous edition, published in 2007 as CAN/CSA-Z9919, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (adopted ISO 9919:2005). For brevity, this Standard will be referred to as CAN/CSA-C22.2 No. 80601-2-61 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.
201.1 Scope, object and related standards
IEC 60601-1:2005, Clause 1 applies, except as follows:
201.1.1 * Scope
Subclause 1.1 of The general standard is replaced by:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary for NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER.
These requirements also apply to PULSE OXIMETER EQUIPMENT, including PULSE OXIMETER MONITORS, PULSE OXIMETER PROBES and PROBE CABLE EXTENDERS, which have been REPROCESSED.
The intended use of PULSE OXIMETER EQUIPMENT includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of PATIENTS in professional healthcare institutions as well as PATIENTS in the HOME HEALTHCARE ENVIRONMENT.
This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended for use in laboratory research applications nor to oximeters that require a blood sample from the PATIENT.
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 standard except in 201.11 and in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This standard can also be applied to PULSE OXIMETER EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability.
This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use.
This International Standard is not applicable to remote or slave (secondary) devices that display SpO2 values that are located outside of the PATIENT ENVIRONMENT.
201.1.2 Object
Subclause 1.2 of The general standard is replaced by:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for PULSE OXIMETER EQUIPMENT [as defined in 201.3.216] and its ACCESSORIES.
NOTE ACCESSORIES are included because the combination of the PULSE OXIMETER MONITOR and the ACCESSORIES needs to be safe. ACCESSORIES can have a significant impact on the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT.
