The most important principle of the IEC 60601-series is to ensure safety for
patients, users and others in normal use and normal condition as well as in a single fault condition. This is specifically important for life supporting and life-sustaining equipment where an interruption could cause a hazard for the patient.
Safety of the equipment should be considered part of the overall safety situation, comprised also of the safety of the equipment installation, equipment maintenance and the safety of equipment application.