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전동식 부항기에 대한 안전성 및 성능평가 가이드라인 개발연구
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  • 전동식 부항기에 대한 안전성 및 성능평가 가이드라인 개발연구
저자명
이승호,김은정,신경훈,남동우,강중원,이승덕,이혜정,이재동,김갑성,Yi. Seung-Ho,Kim. Eun-Jung,Shin. Kyung-Hoon,Nam. Dong-Woo,Kang. Jung-Won,Lee. Seung-Deok,Lee
간행물명
大韓鍼灸學會誌= The journal of Korean Acupuncture & Moxibustion Society
권/호정보
2009년|26권 6호|pp.101-110 (10 pages)
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대한침구학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

Objectives : We developed and proposed a guideline for safety and performance assessment of electric cupping apparatus(Class 2 medical device). Methods : We drafted the guideline for safety and performance assessment of electric cupping apparatus by referring the existing standards and guideline, based on online questionnaire for Korean medical doctors and measurement data from commercially available products. Physical dimension of cups and inner vacuum pressure were acquired for the measurement in order to achieve the purposes. Results : This guideline only can be applied to electric cupping apparatus for enhancing blood circulation by employing negative pressure generated by electricity. Seven items of appearance and label, operation test of pump, variation test of input electricity, vacuum level test, vacuum sustain test, cup-size dependent test, noise level test are suggested for evaluation subjects and methods required for electric cupping devices. Requirements for the design and development of electric cupping devices are suggested: vacuum level indicator, vacuum generation rate, pressure control, valve detachment stability, cup comparability, safety measure, surge protection, user friendliness, instruction for use (IFU). Conclusions : We proposed a guideline for safety and performance assessment of electric cupping apparatus to improve the quality of relating products and aid the commercialization of them, by aiming higher industrial competitiveness of the medical device sectors in Korea. Discussion with related institutes such as industry, academy and government is further required. Public hearings also need to be held prior to the establishment of a final guideline and standard.