Standards Development

Scope

This Technical Specification 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 Technical Specification is intended to support the ultrasonic measurement requirements given in IEC xxxxx

These specifications would have use in quality assurance, safety testing, and the standardization of communications regarding the clinical performance of HITU systems. Where possible, this technical specification incorporates specifications from other related standards. 

Purpose

This Technical Specification provides guidance and requirements for the use of hydrophones for measurements in high pressure fields. Where possible, existing IEC standards (e.g. IEC 62127-1, -2, and -3) are referenced, but this additional Technical Specification is required to cover issues not covered in any other IS or TS, including:

1) detection and mitigation of cavitational effects on measurements

2) necessary performance of spot-checks of hydrophones between measurements, to verify that they have not been damaged

3) usage of specialized hydrophones, such as fiber-optic hydrophones and robust piezoelectric hydrophones