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KMID : 1142220100050010057
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Regulatory Research on Food, Drug & Cosmetic
2010 Volume.5 No. 1 p.57 ~ p.64
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The development of Standards of Diagnostic Medical X-ray Protective Apron · glove, Screens · glass Plates
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Kim Eun-Ju
Choi Go-Eun
Lee Byung-Young
Ryeom Tai-Kyung
Cha Ji-Hun
Kim Dong-Sup
Park Ki-Jung
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Abstract
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It is emphasized that the performance and safety of Diagnostic medical X-ray protective medical devices as the health inspection and an X-ray examination are increased. The purpose of this study is to revise and develop the standards to evaluate the safety and function of x-ray protective apron·glove, screens·glass plates which are basic and widely used protective devices. The standards for X-ray protective apron·glove, screens have enacted based on KS standards which enacted on 1970's. We revise the standards for X-ray protective apron· glove, screens and develop the standards of X-ray protective glass. We examined the international standards such as protective devices against diagnostic medical X-radiation Part 3 : Protective clothing and protective devices for gonads and Part 2 : Protective glass plates. The new standards were confirmed by the test of some commercial protective devices. It will be applied to enact the revise the electronic medical device standards. So it can be applied to evaluation of safety and performance on technical file. It can also be improve the quality of protective devicesagainst adiagnostic medical X-radiation (apron· glove, screens·glass plates) and increase the international competitive power of domestic product.
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KEYWORD
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diagnostic medical X-ray protective apron·glove, screens·glass plates, Medical device standard
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