Focusing primarily on safety this report updates the excellent Topic Group Report 37, published in 1983. The introduction of the Medical Devices Directive and many new and updated Standards since 1983 merited a guide encompassing these changes and their implications for clinical engineers and technologists. Many healthcare organisations carry out design, development and modification of electro-medical equipment and there has always been a professional and moral obligation to ensure this equipment presents the minimum risk to the patient and user. With these principles in mind this report has been the joint work of many experienced and practicing clinical engineers, technologists and physicists. If you want to know more about: • The background to electrical safety documentation • BS EN 60601 • Physiological effects of electricity • Constructional requirements • The Medical Devices Directive • Test protocols then this is the book for you!