UNE-EN IEC 80601-2-26:2020

Replacement:

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This standard is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.

This standard does not cover requirements for other equipment used in electroencephalography such as:

phono-photic stimulators;

EEG data storage and retrieval;

ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or 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 follows:

The clause or subclause applies to ME EQUIPMENT, as default. If the corresponding safety measure or function is intentionally, by decision of the manufacturer, not completely integrated into the ME EQUIPMENT, but has to be realized in an ME SYSTEM, the manufacturer of the ME EQUIPMENT has to specify in its accompanying documents which functionality and safety requirements have to be provided by the connected ME SYSTEM to fulfil that clause or subclause. The ME SYSTEM, then, has to be verified accordingly.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 183 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.