CSA C22.2 NO. 80601-2-61:21 PDF Download

The CSA C22.2 NO. 80601-2-61:21 standard is the Canadian adoption of the ISO 80601-2-61 standard. It is one of the standards issued by the CSA Group under Part II of the Canadian Electrical Code.

This standard specifically addresses the requirements for basic safety and essential performance of pulse oximeter equipment. It applies to pulse oximeter monitors, pulse oximeter probes, and probe cable extenders intended for use on humans. The standard also covers the reprocessed pulse oximeter equipment. The intended use of pulse oximeter equipment includes estimating arterial oxygen hemoglobin saturation and pulse rate of patients in various healthcare environments, such as professional healthcare institutions, home healthcare, and emergency medical services.

While this standard does not apply to pulse oximeter equipment intended for laboratory research applications or oximeters that require a blood sample from the patient, it can be applied to medical electrical equipment and their accessories used for compensation or alleviation of disease, injury, or disability.

The standard also specifies that hazards inherent in the intended physiological function of the medical electrical equipment or medical electrical systems are not covered by specific requirements, except for certain clauses mentioned in the standard.