ISO/FDIS 80601-2-61

This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as MEequipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender.

These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products).

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.

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 says 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 MEequipment or MEsystems within the scope of this document are not covered by specific requirements in this document except in 201.11.1.2.2, IEC60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.

NOTE2 See also IEC60601-1:2005+AMD1:2012+AMD2:2020, 4.2.

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 for use in laboratory research applications nor to oximeters that require a blood sample from the patient.

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.

NOTE3 MEequipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this 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 to pulse oximeter equipment for those environments of use.

This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.