EVS-EN ISO 80601-2-61:2026

ISO 80601-2-61 applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans (hereafter referred to as ME equipment). It includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements in ISO 80601-2-61 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 the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions. It also includes 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. This is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.

ISO 80601-2-61:2026 text has been approved in Europe as EN ISO 80601-2-61:2026 without any changes.