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.

(MI) The mechanical index is an estimate of the maximum amplitude of the pressure pulse in tissue. It is an indicator of the likelihood of mechanical bioeffects (streaming and cavitation). The mechanical index of the ultrasound beam is the amount of negative acoustic pressure within a ultrasonic field and is used to modulate the output signature of US contrast agents and to incite different microbubble responses.
The mechanical index is defined as the peak rarefactional pressure (negative pressure) divided by the square root of the ultrasound frequency.
The FDA ultrasound regulations allow a mechanical index of up to 1.9 to be used for all applications except ophthalmic (maximum 0.23). The used range varies from 0.05 to 1.9.
At low acoustic power, the acoustic response is considered as linear. At a low MI (less than 0.2), the microbubbles undergo oscillation with compression and rarefaction that are equal in amplitude and no special contrast enhanced signal is created. Microbubbles act as strong scattering objects due to the difference in impedance between air and liquid, and the acoustic response is optimized at the resonant frequency of a microbubble.
At higher acoustic power (MI between 0.2-0.5), nonlinear oscillation occurs preferentially with the bubbles undergoing rarefaction that is greater than compression. Ultrasound waves are created at harmonics of the delivered frequency. The harmonic response frequencies are different from that of the incident wave (fundamental frequency) with subharmonics (half of the fundamental frequency), harmonics (including the second harmonic response at twice the fundamental frequency), and ultra-harmonics obtained at 1.5 or 2.5 times the fundamental frequency. These contrast enhanced ultrasound signals are microbubble-specific.
At high acoustic power (MI greater than 0.5), microbubble destruction begins with emission of high intensity transient signals very rich in nonlinear components. Intermittent imaging becomes needed to allow the capillaries to be refilled with fresh microbubbles. Microbubble destruction occurs to some degree at all mechanical indices. A mechanical index from 0.8 to 1.9 creates high microbubble destruction. The output signal is unique to the contrast agent.

(TI) The definition of the thermal index is the ratio of the total acoustic power to that required raising a maximum temperature increase of 1 °C under defined assumptions. A thermal index of 1 indicates the acoustic power achieving a temperature increase of 1 °C. A thermal index of 2 has the doubled power but would not necessarily indicate a peak temperature rise of 2 °C. The temperature rise is dependent on tissue type and is particularly dependent on the presence of bone.
Classifications of thermal indices:
For fetal ultrasound, the highest temperature increase would be expected occurring at bone. Therefore, TIB gives the worst-case conditions. If the ultrasound system can exceed an index of 1, the mechanical index and thermal index must be displayed. The displayed indices are based on the manufacturer's data.

See also Cranial Bone Thermal Index, Bone Thermal Index, Soft Tissue Thermal Index.

(TIS) The bone thermal index is an exposure model for the case that the ultrasound beam heats primarily soft tissue.

(TIB) The bone thermal index is an exposure model for the case that the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone.
The longitudinal waves of ultrasound are reflected and transformed into transverse waves, creating a heating effect. Muscle and bone absorb more energy at interfaces with other heterogeneous tissues.

See also Sheer Wave.

(TIC) The cranial bone thermal index is an exposure model for the case that the ultrasound beam passes through bone near the beam entrance into the body.

A quantity (considering for attenuation) that is measured in water using standard methods and then multiplied by a derating factor. This calculates the attenuation of the ultrasound area of the tissue between the probe and a particular location in the body along the axis of the sound beam.
The 'Guidelines for the Safe Use of Diagnostic Ultrasound' of the Government of Canada recommend a derating factor of 0.3 dB/cm-MHz.

See also Attenuation Coefficient.

Classification by the Food and Drug Administration of medical devices according to potential risks like e.g. ultrasonic heating. The US FDA 510k document provides guidance in the preparation of a regulatory submission to prevent hazards.