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KMID : 1142220180130020077
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 2 p.77 ~ p.83
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Study on Amendment for the Medical Device Standard Specifications of Dental Ceramics
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Kim Hyoung-Sik
Choi Ho-Joon
Nam Eun-Suk
Lim Chun-Il
Kim Mi-Jeong
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Abstract
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Recently, with the increase of aesthetic demand and the development of technology related to ceramic processing, the use of ceramic materials for prosthetics requiring aesthetic is increasing. Furthermore, with the latest amendment of the International Standard of dental ceramics, there has been a difference from the current Standard Specifications for Medical Devices, which was established to reflect previous International Standard. Accordingly, it is necessary to amend Standard Specification so as to reflect the current International Standard and to minimize confusion in the medical device industry. The purpose of this study was to develop an amendment of Standard Specification of dental ceramics that reflects the current International Standard. For this purpose, we surveyed domestic and foreign standards of dental ceramics. The current International Standard of dental ceramics is ISO 6872:2015, but the current Standard Specifications of dental ceramics is established with reference to ISO 6872:2008. The amended requirements and test methods in ISO 6872:2015 are applied to the draft of Standard Specifications of dental ceramics. Moreover, based on opinions from experts in the areas of industry, academy, research, and administration, we developed the draft of Standard Specifications of dental ceramics. The amendment of Standard Specifications of dental ceramics is considered to be helpful for market access and to enhancing domestic medical device industrial competitiveness.
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KEYWORD
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Dental ceramic material, standard specification for medical device, amendment international standard
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