What is EN 60601 Standard?
EN 60601 is a family of standards whose scope covers the safety, essential performance and electromagnetic compatibility of Medical Electrical Equipment and Systems. It is technically equivalent to the international standard IEC 60601 and the family comprises over 70 separate Standards.
The “Part 1” standard, EN 60601-1 covers basic safety and essential performance for all Medical Electrical Equipment and the “Part 2” or “Particular” standards cover requirements for specific product groups (e.g. EN 60601-2-22 for Medical Lasers).