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KMID : 1123420180120010001
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Journal of Korean Society for Prosthetics and Orthotics
2018 Volume.12 No. 1 p.1 ~ p.9
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A Study on the Improvement of the Safety and Quality Regulation for Orthoses and Prostheses
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Ko Myeong-Han
Yi Jin-Bok
Kim Jang-Hwan
Kim Dong-A
Seo Won-San
Kim Hye-Won
Son Byung-Chang
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Abstract
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The study was conducted to identify the problems of the quality regulation for the orthoses and prostheses and to suggest the measure of improvement. The national quality regulation system for orthoses and prostheses haven’t covered the ready-made products and the prostheses other than limb prostheses. And the orthotist and prosthetist certification system as the quality regulation system for the custom orthoses and prostheses has been controversial whether enough or not. When it was compared with the abroad, the orthoses and prostheses would better be classified and managed as medical devices. For the certification system, it is needed to advance the level and the refresher course. Also the effort for elimination the subcontracts in custom fabrication could help to improve the quality
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KEYWORD
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Quality regulation, Safety, Prosthesis, Orthosis, Medical device
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FullTexts / Linksout information
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Listed journal information
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