GB 9706.226-2021 Active

This document specifies the basic safety and basic performance of the electroencephalograph (hereinafter referred to as ME device) defined in 201.3.63.
This document applies to ME devices used in clinical environments (e.g., hospitals, doctors' offices, etc.).
This document does not apply to other devices used in electroencephalography, such as:
——audiovisual stimulators;
——telemetry electroencephalographs;
——devices for storing and reproducing electroencephalographic data;
——dedicated ME devices for monitoring in electroconvulsive therapy;
——dynamic electroencephalographic recorders.
If a chapter or a clause explicitly states that it only applies to ME devices or ME systems, the title and the body of the chapter or clause will indicate this. If this is not the case, the relevant chapter or clause applies to both ME devices and ME systems.
Except for 7.2.13 and 8.4.1 of the general standard, the hazards caused by the intended physiological effects of ME devices or ME systems within the scope of this document are not specifically required in this document.
Note: See 4.2 of the general standard.