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KMID : 0357520160390020263
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Journal of Radiological Science and Technology
2016 Volume.39 No. 2 p.263 ~ p.271
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A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices : Bone Absorptiometric X-ray System
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Lee Seung-Youl
Kim Jae-Ryang
Kim Eun-Rim
Lee Jun-Ho
Lee Chang-Hyung
Park Chang-Won
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Abstract
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The market size of the bone absorptiometric X-ray system and the number of its approval by Ministry of Food and Drug Safety (MFDS) has annually increased, with a trend of increasing aging population and osteoporosis patients. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for the bone absorptiometric X-ray system for manufacturers, importers and reviewers. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination and analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for the bone absorptiometric X-ray system was discussed, collecting their opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples to civil petitioner, when they write the technical documents.
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KEYWORD
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Bone absorptiometric X-ray system, DXA, Technical documents for electrical medical devices, Medical device regulation
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