Medical and non-medical protection standards for ultrasound and infrasound

Abstract

Protection from inappropriate or hazardous exposure to ultrasound is controlled through international standards and national regulations. IEC standard 60601 part 1 establishes requirements for the mechanical, electrical, chemical and thermal safety for all electro-medical equipment. The associated part 2 standard for diagnostic medical ultrasonic equipment sets no upper limits on ultrasonic exposure. Instead, safety indices are defined that are intended to advise users on the degree of thermal and mechanical hazard. At present the display of these safety indices satisfies regulatory requirements in both the USA and Europe. Nevertheless there are reservations about the effectiveness of this approach to protection management. In the USA, there are national regulatory limits on diagnostic exposure, based on acoustic output from clinical equipment in use over 20 years ago. The IEC 60601 part 2 standard for therapeutic equipment sets 3 W cm(-2) as the limit on acoustic intensity. Transducer surface temperature is controlled for both diagnostic and therapy devices. For airborne ultrasound, interim guidelines on limits of human exposure published by the IRPA are now 2 decades old. A limit on sound pressure level of 100 dB for the general population is recommended. The absence of protection standards for infrasound relates to difficulties in measurement at these low frequencies.