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IEC 60601-2-40 Electromyographs and Evoked Response Equipment Testing

Medical electrical equipment – Part 2-40: the basic safety and essential performance of electromyographs and evoked response equipment

IEC 60601-2-40 Scope:

IEC 60601 2 40 and EN 60601 2 40 testing applies to the basic safety and essential performance of electromyographs and evoked response equipment, hereafter referred to as medical electronic equipment.

NOTE Myofeedback, equipment where the capturing of muscle contraction is based on electromyography, is within the scope of IEC 60601-2-40 testing.

The following medical electronic equipment is excluded:

  • Medical electronic equipment intended for transcutaneous electrical nerve stimulators;
  • Electrical muscle stimulators (medical electronic equipment covered by IEC 60601-2-10.)

Keystone Compliance assists manufacturers with IEC 60601-2-40 and EN 60601-2-40 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-40 test lab needs.