This document specifies general requirements for the basic safety and essential performance of transcutaneous electrical acupoint stimulators (TEAS) with a focus on devices intended to stimulate acupoints on the human body.

It applies to all types of TEAS specifically designed for acupoint-related therapeutic usage, only in the context of professional traditional Chinese medicine (TCM) healthcare services.

It is not applicable to invasive electro-acupuncture stimulators for the application of electric currents via acupuncture needles inserted into the body.