Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators First Edition
|Publication Date:||1 January 1987|
This Particular Standard specifies the requirements for the safety of NERVE AND MUSCLE 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 implanted 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 STINULATOR for pain relief.