EVS-EN 60601-1:2006

EN 60601-1 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. It is recognized that many items of medical electrical equipment and responsible organizations must depend on standards to ensure essential performance as well as basic safety. Such areas include the accuracy with which the equipment controls the delivery of energy or therapeutic substances to the patient, or processes and displays physiological data that will affect patient management.

EN 60601-1 can also be applied to equipment used for compensation or alleviation of disease, injury or disability. For certain types of medical electrical equipment, these requirements are either supplemented or modified by special requirements of a collateral or particular standard. The international standard has been approved in Europe as EN 60601-1:2006 without any changes.