A Study on the Performance Evaluation Criteria and Methods of Abdominal Ultrasound Devices Based on International Standards

Abstract

The medical diagnostic ultrasound market has grown steadily in recent years, thanks to the increasing popularity of minimally invasive surgery among patients and active investments in the medical ultrasound market. In addition, the diagnostic ultrasound market is expected to continue to grow in the global market, given the importance of ultrasound and ongoing technological developments. In the case of the gallbladder, cases of gallstones and nonalcoholic fatty liver disease, all of which can be diagnosed with abdominal ultrasound, the number of domestic patients continues to increase every year. The safety of abdominal ultrasound has also been improved due to the national health insurance expanding its coverage to include gallstones and diseases such as those of the liver and gallbladder. However, no standards by which the performance of abdominal ultrasound can be evaluated have been explicitly established. Therefore, we aimed to assess the performance of abdominal ultrasound using criteria such as sound output level, operating frequency accuracy, resolution, maximum display depth, distance accuracy, time accuracy, and blood flow velocity accuracy. These criteria were derived by investigating the principles of ultrasound and the characteristics and structure of transducers, as well as by analyzing the specifications of abdominal ultrasound set by the International Electrotechnical Commission (IEC) 60601-2-37.