- 著者
-
吉元 俊輔
青山 一真
梶本 裕之
西川 敦
- 出版者
- 公益社団法人 日本生体医工学会
- 雑誌
- 生体医工学 (ISSN:1347443X)
- 巻号頁・発行日
- vol.58, no.4-5, pp.147-159, 2020-09-10 (Released:2020-10-30)
- 参考文献数
- 46
Studies about electrical current passing through the body such as bioelectricity measurement, electrical excitation, and electrical stimulus have contributed to the field of medical and biological engineering. To evaluate the applicability of the Clinical Trials Act, stimulus conditions are needed to be designed based on the understanding of safety criteria provided by various organizations, as well as the effects of the electricity applied to the human body. Because electrical current causes various effects such as perception, pain, injury, and fibrillation, safety design is essential. This paper summarizes the effects and safety criteria of the electricity applied to the human body based on the available guidelines. Furthermore, effects and criteria of the electricity applied to the head are discussed. Finally, we present an example of the stimulus evaluation to confirm the applicability of the Clinical Trials Act.