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KMID : 1142220130080010013
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Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.13 ~ p.22
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A Study on Development of Evaluation Method for Safety and Performance of Dental Handpieces
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Kim San
Jang Moo-Young
Hwang Yoon-Su
Lee Jae-Won
Cho Eun-Jeong
Cha Ji-Hun
Park Ki-Jung
Hong Choong-Man
Kim Hyeog-Ju
Kang Shin-Jung
Oh Hyeon-Joo
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Abstract
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Dental handpiece is the medical device mainly used in the hospital for dental health care in our daily lives. Therefore, it is considered to be important to secure the safety and performance of dental handpiece in the aspect of user and consumer. Thus, this study tried to secure the item, standard and method to evaluate the safety and performance of dental handpiece which coincide with the international standard. In order to perform this, differences between each standard were drawn through reviewing relative domestic and foreign standards, and finally, the evaluation items for safety and performance could be confirmed according to the driving system (electric/pneumatic) through validation on proposed test items. Through the result of this study, it is expected that it will work for the enhancement in quality of domestic dental handpiece and contribute to the security of international-level safety and competitiveness
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KEYWORD
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Line powered dental drill system handpiece, Pneumatically-powered dental drill system handpiece, Safety, Effectiveness, Performance evaluation test
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