This report identifies fundamental considerations to be taken into account in developing standards to ensure the safety of medical electrical equipment. NOTE - This report follows closely recommendations of ISO/IEC Guide 51' and expands on matters which are unique to, or critical in, the application of medical electrical equipment. This report is primarily intended to be used by: – those who prepare standards for the design, installation and use of medical electrical equipment; – health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment; - manufacturers of medical electrical equipment; – those who assemble systems which include medical electrical equipment. This report may also be of assistance to: – users or operators of medical electrical equipment; – hospital administrators; – non-technical personnel involved in the procurement of medical electrical equipment; – educators and students. – hospital and clinical engineers responsible for the construction of patient care facilities or for the procurement or maintenance of medical electrical equipment;