Regulations governing the output of diagnostic ultrasound have been largely set by the USA's Food and Drug Administration (FDA), although the International Electrotechnical Commission (IEC) is currently in the process of setting internationally agreed standards.
The relevant national societies for ultrasound users (e.g. American Institute of Ultrasound in Medicine (AIUM), British Medical Ultrasound Society (BMUS)) usually have safety committees who offer advice on the safe use of ultrasound. In 1992, the AIUM, in conjunction with the National Electrical Manufacturers Association (NEMA) developed the Output Display Standard (ODS), including the thermal index and mechanical index which have been incorporated in the FDA's new regulations.
Within Europe, the Federation of Societies of Ultrasound in Medicine and Biology (EFSUMB) also addresses safety and has produced safety guidelines (through the European Committee for Ultrasound Radiation Safety). The World Federation (WFUMB) held safety symposia in 1991 (on thermal issues) and 1996 (thermal and non-thermal issues), at which recommendations were proffered.
The FDA ultrasound safety regulations from 1993 combine an overall limit of spatial peak time averaged intensity (I-SPTA) of 720 mW/cm2 for all equipment. A system of output displays allows users to employ effective and judicious levels of ultrasound appropriate to the examination. The output display is based on two indices, the mechanical index (MI) and the thermal index (TI).

See also ALARA Principle, and Radiological Society of North America.

The company is a member of the Bracco Group, a highly innovative health care group and world leader in global integrated solutions for the diagnostic imaging field. The Bracco Group is headquartered in Milan, Italy. Its North American operations consist of Bracco Diagnostics and Bracco Research USA, both located in Princeton, New Jersey. Bracco Diagnostics is one of the fastest growing developers and marketers of diagnostic pharmaceuticals in North America, with products for various imaging applications, including Isovue® (iopamidol) X-ray contrast agent, ProHance®, (gadoteridol), MRI contrast agent, and nuclear medicine products.
Gadoteridol has been available in Europe and the USA for several years. Holder of the Marketing Authorization: Bracco International B.V. - Strawinskylaan 3051 - 1077 ZX Amsterdam The Netherlands. (Contact: Kirk Deeter, Phone: +NL-303-838-8708)

The Bracco Group is the world's leading provider of global diagnostic imaging solutions, with net sales of more than 1 billion euro, of which more than 64% from international sales; it has operations in 115 countries and about 3,500 employees, of whom more than 600 work in R&D. Bracco invests around 15% of its turnover in R&D and has a portfolio of 1,500 patents worldwide. The Bracco Group deploys an integrated approach to diagnostic imaging, with an offer that encompasses contrast media, its core business where it is one of the world's top players, biomedical equipment from Esaote, one of the world's primary producers of magnetic resonance and ultrasonographic medical equipment, contrast media delivery systems from Acist Medical Systems, a top US company in advanced contrast media injection systems, and medical application software from EBIT-AET and Singapore's Volume Interactions, the leading developer of advanced medical software. Bracco has formed a high-level international research network, whose three centers in Milan, Geneva and Princeton study and develop products for the latest-generation diagnostic techniques, from X-rays and computerized axial tomography to magnetic resonance and echo contrast.

Ultrasound Contrast Agents: