충격파 성능평가 규정 및 가이드 라인

○ 국제표준규격 IEC 61846(1998) “Ultrasonics – Pressure pulse lithoripters-Characteristics of fields

○ 국제표준규격 IEC 60601-2-36:2014 Medical electrical equipment – Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

○ 안내서-0784-01(2017.8) 체외충격파쇄석기의 안전성 및 성능 평가 시험방법 안내서, 식품의약품안전평가원.

○ 안내서-0580-01(2015.2) 체외충겨파치료기 기술문서 작성을 위한 가이드라인, 식품의약품안전평가원.

○ 국제의료충격파치료학회(ISMST, www.shockwavetherapy.org)

○ 의료기기의 전기·기계적 안전에 관한 공통기준규격 가이드라인 (2013.7), 식품의약품안전평가원.

○ Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock

Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, WARNINGS AND PRECAUTIONS

○ Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock

Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi, FDA Guidance(2008)

○ 국제표준규격 IEC 63045 (2020) Ultrasonic- Non-focusing and weakly focusing pressure pulse sources-Characteristics of fields.