UNE-EN IEC 80601-2-26:2020/A1:2024

201.1.1 * Scope

Replacement:

175 This part of the 80601 International Standard applies to the BASIC SAFETY and

176 ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also

177 referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to

178 ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the

179 EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.

This document 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 electroconvulsive 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. For ME EQUIPMENT with the

corresponding safety measure or function not completely integrated into the ME EQUIPMENT but

instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the

ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the

ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly.

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.

NOTE See also 4.2 of the general standard.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and

ESSENTIAL PERFORMANCE requirements for ELECTROENCEPHALOGRAPHS as defined in 201.3.204.