生体医工学
Online ISSN : 1881-4379
Print ISSN : 1347-443X
ISSN-L : 1347-443X
臨床研究法と該当性判断のためのガイドライン特集論文
人体通電の影響と安全基準
吉元 俊輔青山 一真梶本 裕之西川 敦
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2020 年 58 巻 4-5 号 p. 147-159

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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.

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