Medical electrical equipment and systems

Medical electrical equipment and systems

Red Overlay
Medical electrical equipment and systems
Medical electrical equipment and systems
Red Overlay

What is EN 60601?

EN 60601 is a group of standards covering the safety and essential performance of medical electrical equipment and related systems. It is equivalent to the international series of standards IEC 60601 and comprises over 70 individual standards.

  • EN 60601-1Part One or General Standard covers basic safety and essential performance for all medical electrical equipment.
  • EN 60601-2 Part Two or Particular Standards include the requirements for specific product groups (e.g., EN 60601-2-22 medical lasers)
  • Collateral Standards include requirements for specific aspects related to medical electrical equipment and systems (e.g., EN 60601-1-2 Electromagnetic disturbances).


EN 60601 leaflet