Addition:
This Particular Standard specifies the requirements for the safety of nerve and musc u: stimulators, as defined in Sub-clause 2.1.101, for use in the practice of physical medicine, hereinafter referred to as stimulator(s).
The following equipment is excluded:
— equipment intended to be implanted or to be connected to implanled electrodes,
— equipment intended for the stimulation of the brain (e.g. electroconvulsive therapy equipment),
— equipment intended for neurological research,
— cardiac pacemakers,
— body-worn equipment,
— stimulators intended for use during surgical procedures,
— equipment intended for averaged evoked potential diagnosis,
— equipment intended for electromyography,
— equipment intended for cardiac defibrillation,
— equipment intended only as a transcutaneous nerve and muscle stimulator for pain relief.