CENELEC - EN 60601-2-40
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
|Publication Date:||1 January 2019|
|ICS Code (Other medical equipment):||11.040.99|
|ICS Code (Diagnostic equipment):||11.040.55|
|ICS Code (Transfusion, infusion and injection equipment):||11.040.20|
This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
NOTE Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is within the scope of this particular standard.
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 is excluded:
ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10.)