DIN EN IEC 63412-1:2025-02

This International Standard specifies test methods for evaluating the accuracy, precision, and performance of shear wave velocity measurements and provides a list of quantities and parameters for users of ultrasonic shear wave el3astography systems. The relevant measured quantity for the described method is the velocity of the shear waves propagating within the examined tissue. This is related to the elasticity of the tissue. Although ultrasound elastography is already used in clinical diagnosis, there is no IEC standard that describes the relevant metrological tools, the traceable characterization of elastography phantoms, and methods for EI system testing and quality assurance. The shear wave velocities determined depend on many factors, such as the device and method used, the measurement depth, the size and shape of the region of interest (ROI), the number of averaged samples, the position of the patient, the respiratory phase, the body mass index (BMI), nutrition, blood pressure, and also the experience of the operator. In order to further establish shear wave elastography, metrological evaluation of the method and devices is necessary. Thus, the proposed standard enables the comparison of elastography images and certain quantitative parameters as a function of time across different types of devices and patients.