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
