ASA 124th Meeting New Orleans 1992 October

1aEA1. The single European market and its influence on measurement and specification standards for ultrasonics.

Roy C. Preston

Div. of Radiation Sci. and Acoust., Natl. Phys. Lab., Teddington, Middlesex TW11 0LW, UK

The Single European Market and European Directives will have an enormous impact on all aspects of commercial activities worldwide. In acoustics, Directives dealing with noise at work, machinery noise, and medical devices will have greatest impact. In ultrasonics, the General Medical Device Directive will deal with medical ultrasonic equipment and will lay down comprehensive essential safety requirements that will require manufacturers to comply with standards published by the Comite Europeen de Normalisation Electrotechnique (CENELEC), in most cases based on International Electrotechnical Commission (IEC) standards. The initial thrust is to establish ``horizontal'' standards or ``generic'' standards that will apply to a wide range of equipment. At the specific product level, ``vertical'' standards will be required dealing with specific aspects of safety for a product type. For instance, standards will be prepared for diagnostic ultrasonic equipment, therapeutic ultrasonic equipment, and extracorporeal lithotripters. IEC Technical Committee 62: Electrical Equipment in Medical Practice is responsible for the preparation of these standards. These standards will themselves make reference to technical standards dealing with methods of measurement and characterization of ultrasonic fields prepared by Technical Committee 87: Ultrasonics. The current status of standards, either already published or being developed by Technical Committee 87, will be reviewed with particular emphasis on their applicability to the EC Medical Device Directive.