YY 9706.240-2021 Medical electrical equipment—Part 2-40:Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
YY 9706.240-2021 Medical electrical equipment—Part 2-40:Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Basic Information
Scope
Replacement:
This part specifies the basic safety and basic performance requirements for myoelectric and evoked response equipment (hereinafter referred to as ME equipment). This part applies to the basic safety and basic performance requirements of ME equipment.
Note: Myoelectric feedback equipment, which captures muscle contractions based on myoelectrography, falls within the scope of this standard.
If a clause or sub-clause is specifically intended to apply only to ME equipment or only to ME systems, the title and content of the clause or sub-clause will indicate this. Otherwise, the clause or sub-clause applies to both ME equipment and ME systems.
The following ME equipment is excluded:
ME equipment intended for transcutaneous nerve electrical stimulation and muscle electrical stimulation (see YY 9706.210).