CSA Preface
This is the second edition of 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 (second edition, 2017-12). It supersedes the previous edition, published in 2014 as CAN/CSA-C22.2 No. 80601-2-61 (adopted ISO 80601-2-61:2011). 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+AMD1:2012, Clause 1 applies, except as follows:
201.1.1 * Scope
Replacement:
This document 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 and the EMERGENCY MEDICAL SERVICES ENVIRONMENT.
This document 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 document are not covered by specific requirements in this document except in 201.11 and in 7.2.13 and 8.4.1 of the general standard.
NOTE 1 See also 4.2 of the general standard. The general standard is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
This document can also be applied to ME EQUIPMENT and their ACCESSORIES used for compensation or alleviation of disease, injury or disability.
This document is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use.
This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the PATIENT ENVIRONMENT.
NOTE 2 ME EQUIPMENT that provides selection between diagnostic and monitoring functions is expected to meet the requirements of the appropriate document when configured for that function.
This document is applicable to PULSE OXIMETER EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply PULSE OXIMETER EQUIPMENT for those environments of use.
This document is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.
201.1.2 Object
Subclause 1.2 of the general standard is replaced by:
The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for PULSE OXIMETER EQUIPMENT [as defined in 201.3.217] and its ACCESSORIES.
NOTE ACCESSORIES are included because the combination of the PULSE OXIMETER MONITOR and the ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of PULSE OXIMETER EQUIPMENT.
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