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KMID : 1142220170120020117
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Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 2 p.117 ~ p.127
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A Study on Developing Safety and Performance Evaluation Guideline for Extracorporeal Shockwave Lithotripsy System
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Lee Chong-Ju
Kim Jae-Young
Song Gil-Soo
Choi Sung-Hye
Park Chang-Won
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Abstract
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Extracorporeal shockwave lithotripsy system(ESWL), a medical device used for urinary and kidney stone treatment, has witnessed growth of the market as the number of stone patients has recently increased worldwide due to change of diet. Contrary to the expansion of the demand, however, test methods for evaluating performance of the system has not been established yet. Since performance of extracorporeal shockwave lithotripsy system is directly related to that of shockwave, it is necessary to develop methods of evaluating performance of shockwave. However, it has been revealed that there is no country that provides specific guidelines to test shockwave performance in the world. Thus, this research developed a guideline for evaluating safety and performance of extracorporeal shockwave lithotripsy system. The study investigated measures to evaluate performance of shockwave through literature review on the principle of extracorporeal shockwave lithotripsy system & mechanism of generating shockwave, relevant standards and approval status at home and abroad, etc. The guideline, the outcome of this research, presents explanation and detailed test methods for additional items of IEC
60601-2-36:2014, the latest international standard of extracorporeal shockwave lithotripsy system for safety test. For performance test, the test items and suggested test methods were developed by referring to Korean approval documents of ESWL, FDA guidance and IEC 61846:1998. Moreover, the final guideline has been completed through modification and supplementation process by a consultative group including experts from manufacturing and importing companies, authorized testing institutes and academia. This study aims to suggest a guideline for evaluating safety and performance of extracorporeal shockwave lithotripsy system in accordance with the growing technology.
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KEYWORD
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Extracorporeal Shockwave Lithotripsy System, Safety, Performance, Guideline
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