International Electrotechnical Commission (IEC) and Food and Drug Administration (FDA) efforts to develop standards for ultrasound physiotherapy

Abstract

Ultrasound physiotherapy devices produce acoustic energy, typically in the low MHz range, to generate deep heat for relief of pain and spasms, and have been used since the 1940’s. The IEC and the FDA have an interrelated history of developing standards for these devices. The IEC produced the first such standard “Testing and calibration of ultrasound therapeutic equipment”(1963). The FDA, with the IEC document as guide, developed its own “Ultrasonic Therapy and Surgery Products Performance Standard”(1978, 2012). Then the IEC, with FDA involvement and using many of the FDA’s concepts, produced “Medical electrical equipment—Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment (1984, 2000, 2009) and “Ultrasonics—Physiotherapy systems—Field Specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz” (1996, 2007, 2013). FDA personnel are also currently leading an IEC effort to write a standard dealing with new, lower frequency physiotherapy. The FDA is also committed to harmonizing FDA regulations with IEC standards whenever possible. This presentation recounts the history of these efforts and examines some similarities and differences among the documents.