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 have to depend on standards to ensure essential performance and 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. Since the publication of EN 60601-1:2006/A11:2011, the IEC Subcommittee has been collecting issues from a variety of sources including comments from national committees and questions submitted. Those issues selected for inclusion on the final "short list" are addressed in this consolidated version.
In this consolidated version you can also find:
— the relationship between EN 60601-1 and the essential requirements of EU Directive 90/385/EEC on active implantable medical devices,
— normative references to international publications with their corresponding European publications,
— the relationship between EN 60601-1 and the essential requirements of EU Directive 93/42/EEC on medical devices.
For certain types of medical electrical equipment, these requirements are either supplemented or modified by special requirements of a collateral or particular standard.
