What is EN 60601 Standard?
EN 60601 is a group of standards which cover the safety, essential performance and electromagnetic compatibility of medical electrical equipment and related systems. It is equivalent to the international standard IEC 60601 and comprises over 70 individual standards.
These start with EN 60601-1 ‘Part One’, which covers basic safety and essential performance for all medical electrical equipment, and then ‘Part Two’ or ‘Particular’ standards, which include the requirements for specific product groups (e.g. EN 60601-2-22 medical lasers).