WG 14 - TC 87/WG 14

IEC TS 63070:2019 is applicable to ultrasonic equipment designed for the medical field of application. It covers both diagnostic and therapeutic (physiotherapy and HITU) equipment.
This document describes transducer evaluation by the infrared imaging technique using a split TMM-phantom for qualitative and quantitative estimation of temperature distributions in tissue-mimicking material, resulting from absorption of ultrasound and from heating of the transducer itself.
This document also describes a method to measure transducer-surface temperature, while the transducer is driven under the still-air condition.

IEC/TR 62799:2013(E), which is a technical report, provides background information for users of IEC 62359 to understand the relative merits of several of the potential replacements for the thermal index as described in IEC 60601-2-37 and IEC 62359. The report discusses parameters related to thermal aspects of diagnostic ultrasonic fields; and methods for the determination of an exposure parameter relating to temperature rise in theoretical tissue-equivalent models, resulting from absorption of ultrasound. The report is intended to be used:
- by those involved in the development and maintenance of IEC 62359;
- manufacturers of medical electrical equipment for risk assessment;
- and health care regulatory authorities, test houses and other organizations responsible for implementing standards for medical electrical equipment.

This Technical Specification describes means to allow "attenuated" acoustic quantities to be calculated under conditions where the associated acoustic measurements, made in water using standard procedures, may be accompanied by significant finite-amplitude effects. This Technical Specification establishes: - the general concept of the limits of applicability of acoustic measurements in water resulting from finite-amplitude acoustic effects; - a method to ensure that measurements are made under quasi-linear conditions in order to minimise finite-amplitude effects; - the definition of an acoustic quantity appropriate for establishing quasi-linear conditions; - a threshold value for the acoustic quantity as an upper limit for quasi-linear conditions; - a method for the estimation of attenuated acoustic quantities under conditions of nonlinear propagation in water.

This Technical Specification is applicable to medical diagnostic ultrasonic fields. This Technical Specification establishes: - the important characteristics and terminology for test objects containing an embedded thermal sensor to determine ultrasonic heating; - requirements for defining particular types of test object for specific applications; - examples of design features which will ensure that the performance specifications are achieved; - validation procedures; - general test methods for using test objects to determine standardised temperature rises.