Appareils électromédicaux - Partie 2-26: Exigences particulières pour la sécurité de base et les performances essentielles des électroencéphalographes

Clause 1 of the general standard1 applies, except as follows:

201.1.1 * Scope

Replacement:

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS (EEG) as defined in 201.3.63, hereafter referred to as ME EQUIPMENT. This Standard is applicable to ME EQUIPMENT used in a clinical environment (e.g., hospital, physician's office, etc.).

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

 phono-photic stimulators

 electroencephalographic telemetry

 EEG data storage and retrieval

 ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy

 ambulatory electroencephalographic recorders

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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

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 201.3.63.