Use of IEC 60601 Standards; Medical Electrical Equipment; Draft Guidance; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Use of IEC 60601 Standards; Medical Electrical Equipment.'' The purpose of the draft guidance document is to provide guidance to the Office of Device Evaluation (ODE) reviewers on the use of the International Electrotechnical Commission (IEC) 60601 series of standards, including declarations of conformity to the standards, during the evaluation of premarket submissions for electrical medical devices.