prEN IEC 63440:2026

This document is applicable to medical ultrasonic equipment capable of inducing a temperature increase at the patient contact surface.
This document supports the safety standards through providing the details of temperature measurements required to confirm with safety requirements therein. It establishes:
– the important characteristics, calculations and terminology for determining temperature rise for diagnostic and physiotherapy ultrasound equipment;
– requirements for temperature rise measurements for each type of medical ultrasound equipment;
– general test methods for still air and using test objects to determine standardized temperature.
This document does not address methods for simulation of temperature.