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KMID : 1142220180130020105
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 2 p.105 ~ p.112
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The Study on the Development of Evaluation Guideline for Reusable Medical Devices
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Shin Seung-Woo
Kim In-A
Yu Woo-Jin
MIn Hyo-Ki
Kim Dong-Bin
Kong Seok-Kyoung
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Abstract
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Reusable Medical Devices is a medical device that is used for more than one patient or for a patient to perform reprocessing such as cleaning, disinfection, or sterilization for use in multiple procedures. Reprocessing methods, such as Washing, disinfection, and sterilization, should be proven effectiveness to preventing cross infection between patients, which can be proved by validation and the like. Guidelines and test standards for reprocessing validation are published in advanced countries such as the United States, but there is not enough information on specific validation techniques in South Korea. For this purpose, this study provides the technical understanding necessary for cleaning, disinfection and sterilization validation, and describes overseas related information and validation techniques for technical application of scientific validation. As a result of this study, it is expected that used not only as reference data but also as technical data for domestic and foreign certification when conduct the reprocessing validation such as cleaning, disinfection, and sterilization.
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KEYWORD
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Reusable Medical Devices, Cleaning validation, Disinfection validation, Sterilization validation
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