UNE-EN ISO 80601-2-61:2019

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 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.

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.

This document is not applicable to pulse haemoglobin monitors.

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.