IEC TS 63588 ED1

Ultrasonics - Field characterization - Specification and measurement of field parameters at high pressure therapeutic levels in water

Scope

IEC TS 63588:2026 is applicable to high intensity therapeutic ultrasound (HITU) devices, specifying:
– Devices and methods suitable for direct measurements of relevant parameters for high pressure levels in water;
– measurement methods at relatively high therapeutic field output levels;
– consideration of sidelobes and pre-focal maxima;
– parameters relevant to HITU transducers of different construction and geometry, including non-focusing, focusing with or without lenses, collimated, diverging and convergent transducers, multi-element transducers, scanning transducers and multiple sources.
This document supports the fulfilment of ultrasonic measurement requirements that will be specified in a future Technical Specification on measurement-based simulation of ultrasonic fields in water.
This document can be used in quality assurance, safety testing, and the standardization of communications regarding the clinical performance of HITU systems. Where possible, this document incorporates specifications from other related standards.
This document does not apply to the following types of devices, which are covered by other standards:
– lithotripters (see IEC 61846);
– surgical equipment (see IEC 61847);
– physiotherapy devices (see IEC 61689).