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Regulatory standards and calibration procedures for shock wave devices
Journal article   Peer reviewed

Regulatory standards and calibration procedures for shock wave devices

Mark E. Schafer
The Journal of the Acoustical Society of America, v 114(4), pp 2453-2453
Oct 2003
DOI: https://doi.org/10.1121/1.4779540

Abstract

In order to bring any shock wave device into commercial use, i.e., clinical practice, it must receive regulatory approval from either the U.S Food and Drug Administration (FDA) or the appropriate national agency. A key part of this process involves the complete temporal and spatial description of the shock wave field. This device characterization presents a number of formidable measurement challenges, principally due to the destructive effects of shock waves on the measurement sensor, and shock wave variability (especially for electrohydraulic systems). This presentation reviews the measurement and regulatory approaches used for characterizing shock wave devices, including FDA and international measurement standards. The current approach is a compromise between the desire for a complete characterization of all possible parameters, and the realities of making the measurements. The complete measurement process will be described, including equipment, procedures and pitfalls. Polyvinylidene Fluoride (PVDF) membrane hydrophones have been the key enabling technology, providing sufficient temporal bandwidth and minimal effective sensor area, all at reasonable cost. Other types of sensors, both good and bad, have been used for these measurements. The talk will also present case studies of measurements of several lithotripters measured over the last 15 years.

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