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전기식 온구기에 대한 안전성 및 성능 평가 가이드라인 개발 연구
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  • 전기식 온구기에 대한 안전성 및 성능 평가 가이드라인 개발 연구
저자명
이승호,강중원,남동우,김은정,이혜정,김갑성,이재동,Yi. Seung-Ho,Kang. Jung-Won,Nam. Dong-Woo,Kim. Eun-Jung,Lee. Hye-Jung,Kim. Kap-Sung,Lee. Jae-Dong
간행물명
大韓鍼灸學會誌= The journal of Korean Acupuncture & Moxibustion Society
권/호정보
2010년|27권 1호|pp.75-86 (12 pages)
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대한침구학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Objectives : We developed and proposed a guideline for safety and performance assessment of electric moxibustion apparatus (class II medical device). Methods : We drafted the guideline for safety and performance assessment of electric moxibustion apparatus by referring the existing standards, guidelines and measurement data from commercially available products. Temperature characteristics such as maximum temperature and ramp time, and physical characteristics such as weight, noise and diameter were measured. User friendliness was also evaluated for commercial devices. Results : This guideline only can be applied to the electric moxibustion apparatus where moxa is being heated by electricity for medical proposes. Maximum temperature of higher than $50^{circ}C$ can be achieved mostly. Ramp rate of temperature seems to be reliable. Control of temperature is needed to be improved. Moxa and its derivative products seem to be regulated for reliable temperature performance for clinical application. Requirements for design and development of electric moxibustion apparatus are suggested : temperature indicator, temperature control and its accuracy, safety measure, surge protection, user friendliness and instruction for use (IFU). Design recommendation of the reduction of noise level and energy loss are suggested for better products. Conclusions : We proposed a guideline for safety and performance assessment of electric moxibustion apparatus to improve the quality of relating products and aid their commercialization 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.