Medical electrical equipment - Particular requirements for the basic safety and essential performance of electroencephalographs
Medical electrical equipment - Particular requirements for the basic safety and essential performance of electroencephalographs
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201.1 Scope, object and related standards Clause 1 of the general standard 1 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 monito...
Другие стандарты BS