Medical device electromagnetic interference-ANSI issues

Abstract

Medical Device Electromagnetic Interference (EMI) is an interaction that may occur between electrical medical devices and other sources of electromagnetic energy. The United States Food and Drug Administration (FDA) has federal responsibility for the safety and efficacy of electrical medical devices and is deeply involved in the subject interaction. The American National Standards Institute (ANSI) has administered and coordinated the United States private sector voluntary standardization system for 80 years. C63 is a United States voluntary committee devoted to developing standards in the technical area of Electromagnetic Compatibility (EMC). The C63 committee is accredited by ANSI as a standards developing organization. This means C63 meets strict criteria for a balanced membership to assure that all interested parties have an opportunity to share in the development of appropriate and timely EMC standards. The focus of C63 is to develop standards when there is a requirement having wide applications across many industries OR there is not an obvious candidate organization to develop the needed documents. At the present time, ANSI Accredited Standards Committee (ASC) C63 has a subcommittee, which includes members of the FDA, devoted entirely to developing standards and guides for Medical Device EMC Testing.