Standards Development

Scope

This International Standard is applicable to medical ultrasonic equipment capable of inducing a biologically-relevant temperature rise.

This document establishes:

• the important characteristics, calculations and terminology for determining temperature rise for diagnostic, therapeutic and surgical ultrasound equipment

• requirements for temperature rise measurements for each type of medical ultrasound equipment;

• general test methods for in still air and using test objects to determine standardized temperature rises.

• validation procedures. This document does not address methods for simulation of temperature rise. 

Purpose

The purpose of this international standard is to provide guidance for temperature measurements for diagnostic ultrasound and ultrasound physiotherapy equipment. The justification for the standard is that currently there are no guidelines for equipment and methods to determine thermal safety of medical ultrasound equipment. The document is supposed to support the safety requirements posed by SC 62B and SC 62D standards on safety and elementary performance of medical ultrasonic equipment.