scope:

General

This standard establishes certain requirements for portable, battery-powered, transcutaneous electrical nerve stimulators (TENS devices) that are used in the treatment of pain syndromes, that are intended for use on intact skin and mucous membranes, and that do not require surgical intervention or violation of the skin surface.

Inclusions

Labeling requirements for the stimulus generator and for patient leads and electrodes are within the scope of the standard. 2.2 Minimum safety and performance requirements for the stimulus generator, including limits on output characteristics, are also within the scope of this standard. 

Exclusions 

This standard does not cover requirements for the electroconductive medium (gel) used to establish electrical contact between the patient electrodes and the skin, nor does it cover performance requirements for TENS leads/electrodes.

This standard does not cover requirements for line-powered TENS devices, diagnostic stimulators, stimulators for muscle exercise, electrostatic stimulators, electromagnetically coupled stimulators, or electrosleep devices.

NOTE-For an explanation of the need for this standard, and the rationale for its provisions, see Annex B.