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KMID : 1142220130080010089
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Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.89 ~ p.95
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A Study for Standard Development of Sterile Single-Use Syringe for Insulin
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Lee Hui-Sung
Lee Chang-Hyung
Hwang Sun-Jin
Heo Ji-Yeon
Lee Chong-Ju
Bang Ji-Young
Park Nam-Jung
Kang Shin-Jung
Kim Hyeog-Ju
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Abstract
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Sterile single-use syringe for insulin is used for injecting insulin into panniculus adiposus. It is especially required for standard on quality. Because most of insulin-dependent diabetic patients are needed for insulin therapy for long time and they are injecting themselves with insulin at home. In this study, we investigated and analyzed the items used for approval of sterile single-use syringe in Korea and examined US and Japanese standards as well as international standards(ISO) for reference. Finally, we drew up the draft of standard for sterile single-use syringe. The draft of standard will enable medical devices safety and quality control can be expected.
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KEYWORD
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Sterile single-use syringes for insulin, Standard, Safety, Performance
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