Clause 1 of the general standard1 applies, except as follows:
201.1.1 Scope
Replacement:
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
NOTE 1 Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is within the scope of this particular standard.
NOTE 2 EMG/EP equipment is intended for diagnostic and monitoring applications.
NOTE 3 If the ME EQUIPMENT supports both ELECTROMYOGRAPHY and EVOKED RESPONSE STIMULATION, clauses for electrical, auditory, and visual stimulators are applicable. In case the equipment supports ELECTROMYOGRAPHY, but not EVOKED RESPONSE STIMULATION, clauses concerning solely requirements for stimulators are NOT within scope.
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.
The following ME EQUIPMENT are excluded:
- ME EQUIPMENT intended for therapeutic application
- ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10.)
Required fields are indicated with *
