치과용 도재의 식약청 기준규격 개발
Development of KFDA standards for dental ceramics
신채민, 이정연, 방지영, 최재윤, 이상배, 임경미, 배우진, 노혜원, 오현주, 오헌진,
소속 상세정보
신채민 ( Shin Chae-Min ) - 식품의약품안전평가원 의료기기연구과
이정연 ( Lee Jung-Yeon ) - 식품의약품안전평가원 의료기기연구과
방지영 ( Bang Ji-Young ) - 식품의약품안전평가원 의료기기연구과
최재윤 ( Choi Jae-Yoon ) - 서울대학교 치과대학 치과생체재료과학교실
이상배 ( Lee Sang-Bae ) - 연세대학교 치과대학 치과생체재료공학교실
임경미 ( Lim Kyung-Mi ) - 식품의약품안전평가원 의료기기연구과
배우진 ( Bae Woo-Jin ) - 식품의약품안전평가원 의료기기연구과
노혜원 ( Roh Hye-Won ) - 식품의약품안전평가원 의료기기연구과
오현주 ( Oh Hyeon-Joo ) - 식품의약품안전평가원 의료기기연구과
오헌진 ( Oh Heon-Jin ) - 식품의약품안전평가원 의료기기연구과
KMID : 0362220100370020121
Abstract
Many kinds of dental ceramics have been used in the clinical dentistry as well as many new dental ceramic products have been introduced recently. If physico-chemical characteristics, performances and biocompatibilities of these products are not evaluated properly, it may cause multiple side effects. None the less the existing standards does not reflect current tendency in comparison with national standards and documentary. So it is necessary to prepare a revised standards of dental ceramics that is applicable to the evaluation of safety and effectiveness of dental ceramics by analyzing related national standards and documentaries and carrying out related evaluation test. Consequently, to provide a revised standards of dental ceramics that will be a foundation for evaluation of physico-chemical characteristic, performance and biocompatibility of dental ceramics, In this study we carried out all-inclusive analysis as to national standards(for example, KS, ISO, ANSI and so on) of dental ceramics and documentaries for present status of dental ceramics. And by the use of the result of above survey we conducted various tests like as chemical solubility, glass transition temperature, coefficient of thermal expansion, flexural test, cytotoxicity test and pyrogen test. In conclusion we could verify above national standards and test methods and then could suggest revised KFDA standards of dental ceramics.
키워드
dental ceramics; medical device; standard
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