IEC 80601-2-26:2019

Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

Publication date:   May 22, 2019

General information

60.60 Standard published   May 22, 2019

IEC

ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care

International Standard

11.040.55   Diagnostic equipment

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Scope

This part of the 80601 International Standard applies to the basic safety and essential performance of electroencephalographs as defined in 201.3.204, hereafter also referred to as me equipment or me system. This document is applicable to electroencephalographs intended for use in professional healthcare facilities, the 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.

Life cycle

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PUBLISHED
IEC 80601-2-26:2019
60.60 Standard published
May 22, 2019

CORRIGENDA / AMENDMENTS

Amended by
IEC 80601-2-26:2019/DAmd 1