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KMID : 1142220180130020133
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 2 p.133 ~ p.141
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A Study on the Development of Performance Evaluation Guideline for Bone Plates in Maxillofacial Surgery
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Go Dong-Hyun
You Ji-Hye
Kim Eun-Kyo
Gyeon A-Hyeon
Lim Chun-Il
Seo Kyung-Won
Kim Mi-Jeong
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Abstract
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Bone plates in oral and maxillofacial surgery are used for fixation of fractured bone fragments after traffic or industrial accidents. Recently, they have also been used for plastic and cosmetic surgery in the facial region. Many forms of oral & maxillofacial fixation plate have been developed and marketed according to their specific applications. In response to this, domestic medical device notification and related international standards have been newly revised. According to this trend, we are revising and publishing the international harmonized ‘Performance evaluation guideline for bone plates in maxillofacial surgery’. In this work, the following items are researched: 1) the present status of releated international standards and guidelines, 2) identification of test methods suitable for bone plates in oral and maxillofacial fixation, and 3) research for feasibility study. There revised guidelines will contribute to enhancing the consistency of permission and the quality of medical devices.
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KEYWORD
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oral & maxillofacial fixation plates, safety, performance, guidelines
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