An EMC Standard for Medical Electronic Devices

Electromagnetic compatibility is a frequently overlooked and underrated fact of life during the development of new medical devices. Because of unanticipated electromagnetic interference, the greatest new lifesaving devices of all time could turn out to be ineffective or even dangerous when used in its intended environment. Consequently, the United States Department of Health, Education, and Welfare (HEW) awarded McDonnell Douglas Astronautics Company (MDAC)a contract to develop an Electromagnetic Compatibility Standard for Medical Devices. The major tasks in the aforementioned contract were to conduct a comprehensive literature search to determine if any existing EMC standards were directly applicable to medical electronic devices; perform a series of measurements in medical facilities to estimate the electromagnetic environments in which medical devices may be required to operate; develop an EMC standard based upon the literature search results and hospital survey program data; evaluate the standard on typical medical electronic devices; and review and coordinate the final drafts of the standard with the review committee. This paper describes the hospital survey program and the contents of the EMC Standard for Medical Devices.