Medical electrical equipment and systems

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).

EN 60601-1 applies to all medical electric equipment and medical electrical systems. Medical electrical equipment is defined in the standard as electrical equipment, which:

• has an applied part – the part of the medical electrical equipment that, in normal use, necessarily comes into physical contact with the patient for the medical electrical equipment or system to perform its function
• transfers energy to or from the patient or detects such energy transfer to or from the patient

The medical electrical equipment should be provided with only one connection to a particular mains supply and the intended use, as described by the manufacturer, should be in the diagnosis, treatment, or monitoring of a patient, or to alleviate or compensate for disability, disease or injury.

Examples of devices classed as medical electrical equipment include:

• Cardiac defibrillators
• High frequency surgical equipment
• Infant incubators and warmers
• Medical lasers
• Patient monitors
• Patient ventilators
• Ultrasound equipment – diagnostic and therapeutic