EN 60601-1 applies to all Medical Electrical Equipment and Medical Electrical Systems. Medical Electrical Equipment is defined in the standard as electrical equipment having an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which is:
- Provided with not more than one connection to a particular supply mains; and
- Intended by its manufacturer to be used: in the diagnosis, treatment, or monitoring of a patient; or for compensation or alleviation of disease, injury or disability.
This includes a wide range of medical devices, for example:
- High Frequency Surgical Equipment
- Cardiac Defibrillators
- Patient Monitors
- Therapeutic and Diagnostic Ultrasound Equipment
- Medical Lasers
- Patient Ventilators
- Infant Incubators and Warmers
Testing to show compliance with EN 60601-1 requires a detailed understanding of the requirements together with dedicated test equipment. For the latest changes to the standard see EN 60601-1 3rd Edition Position Paper. These include the introduction of extensive Risk Management requirements that need to be addressed.