Development of supplementary table: A study by WG in safety investigation of electrical stimulus

Abstract

In order to consider the applicability of the medical practice in a study on a medical instrument, a supplementary table for evaluating its effect on the body structure and function has been developed. Specifically, a working group in safety investigation of electrical stimulus is developing the table about biomedical instrumentation and control using current flow in human body such as composition measurement by electrical impedance method, transcutaneous electrical stimulation, and functional electrical stimulation. The possible effects of excessive body conduction are skin injury, nerve injury, functional disturbance, pain, fibrillation, and so on. The working group has been widely investigated the range of safe body conduction based on the international and domestic standards and literatures. In this presentation, the author introduces a methodology for developing a supplementary table and its importance based on the investigated literatures about the safety and invasiveness of the electrical stimulus.