Electrical Safety

Abstract

Electrical safety assessment is mandatory for most electrical equipment in almost all countries. For medical devices, electrical safety is regarded in medical safety standards. There is a broad range of medical devices, so the regulations of different countries (European directives, U.S. Food and Drug Administration (FDA) regulations, etc.) provide a classification of medical devices based on the risk. The medical safety assessment depth depends on the equipment class. Many medical devices safety standards in different countries are usually based on the IEC 60601 family standards, so more or less the tests for safety assessment are the same everywhere. In this article, after a brief revision of the effects of electrical current in the human body, we describe the classification of medical devices in Europe (from the medical devices European directives) and in United States (from the FDA). Finally, some IEC 60601 electrical safety topics are explained.