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KMID : 1142220140090010045
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 1 p.45 ~ p.50
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A Study on Development of Standard of Needle-Based Injection Systems
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Lee Hui-Sung
Lee Chang-Hyung
Lee Chong-Ju
Bang Ji-Young
Park Nam-Jung
Kang Shin-Jung
Kim Hyeog-Ju
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Abstract
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Needle-based injection systems are medical devices which are used for injecting anesthesia liquid, insulin or other therapies for treatment of chronic diseases. Those are especially required for standard on quality. Because patients having a chronic disease require repetitive administration and correct insulin dose is directly related to the lives of people with diabetes. International standards(ISO) for needle-based injection systems are set up for criteria and test methods. But standard for dental cartridge syringe is only arranged in MFDS(Ministry of Food and Drug Safety). Therefore standards for needle-based injection systems will be immediately developed for quality control and reviewing technical document of medical devices. In this study, we investigated and analyzed the items used for approval of needle-based injection systems in Korea and examined japanese industrial standards (JIS) as well as international standards(ISO) for reference. Finally, we drew up the draft of standard for needlebased injection systems. The draft of standard will enable medical devices safety and quality control can be expected.
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KEYWORD
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Needle-based injection systems, Standard, Safety, Performance
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