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EN60601

EN60601 is a series of European standards that specifically address the safety and performance requirements of medical electrical equipment. It is titled “Medical electrical equipment” and is published by the International Electrotechnical Commission (IEC) under the EN 60601 designation in Europe.

The EN60601 series consists of multiple parts, each focusing on different aspects of medical electrical equipment. Some key parts of the standard include:

  • EN60601-1: General Requirements for Safety: This is the foundation of the series and sets out the general safety requirements for all medical electrical equipment. It covers aspects such as electrical insulation, protection against electrical shock, mechanical hazards, electromagnetic compatibility (EMC), and other safety considerations.
  • EN60601-1-2: EMC Requirements: This part specifies the electromagnetic compatibility requirements for medical electrical equipment, ensuring that it can operate without interference from or causing interference to other devices or systems.
  • EN60601-2-X: Specific Equipment Standards: These parts address specific types of medical electrical equipment, such as electrocardiographs, infusion pumps, surgical lamps, patient monitors, and more. Each part outlines the particular safety and performance requirements for that specific type of equipment.
  • EN60601-1-6: Usability Engineering: This part focuses on the usability and user interface design of medical electrical equipment. It addresses aspects such as user interaction, labeling, alarms, and other factors that contribute to the safe and effective use of the equipment.
  • EN60601-1-8: Alarm Systems: This part deals with alarm systems used in medical electrical equipment. It defines requirements for alarm generation, presentation, and response to ensure that alarms are effective in alerting healthcare professionals to critical situations.

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