ISO FDIS 80601-2-61

Description / Abstract: 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.