Electrical safety testing of medical equipment in Japan.
In Japan, the manufacture and sale of medical electrical equipment requires the permission and license of the Ministry of Health and Welfare. Electrical safety tests must be conducted at an official institution. This paper presents the statistical results of a series of 404 safety tests of medical devices, reports the electrical safety problems encountered, and suggests electrical design considerations for safety.
Ezawa
M
M
Industrial Research Institute of Kanagawa Prefecture, Yokohama, Japan.
D004560:Electricity; D004582:Electronics, Medical / Q000592:standards*; D004869:Equipment Safety; D007564:Japan; D007878:Legislation as Topic; D008284:Maintenance and Engineering, Hospital / Q000592:standards*