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KMID : 1142220110060010009
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Regulatory Research on Food, Drug & Cosmetic
2011 Volume.6 No. 1 p.9 ~ p.18
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A Study on the Development of Performance Test Method for High-Pressure Small Steam Sterilizers
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Cha Ji-Hun
Ryeom Tai-Kyung
Cho Eun-Jeong
Kwon Tae-Hee
Kim San
Hui Chan-Hoi
Kim Dong-Sup
Kim Chang-Min
Park Ki-Jung
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Abstract
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High-Pressure small steam sterilizers(sterilizer, moist heat) was widely used for infection control of microorganisms in medical institution. To ensure safety and performance of high-Pressure small steam sterilizers, capacity of chamber under 60 L, was important for hospital infection control. Among these steam sterilizers, performance test is more important to secure sterilizing ability for medical equipments. In this study, to develop performance test methods of high-Pressure steam sterilizers-small size(B type, N type and S type), were examined the following international standards ; KS P 6130 Table-top steam sterilizers, JIS T 7324 2005 : High-Pressure steam sterilizers for medical use(Small size), EN 13060 : 2004 + A1 : 2009 Small steam sterilizers, KS P 6131 Hospital steam sterilizers, JIS T 7322 : 2005 High-Pressure steam sterilizers for medical use. When considering KFDA's medical device classification and scope, the new main performance test methods that was developed for high pressure small steam sterilizers based on the EN 13060. Therefore, it can be applied to evaluate type B, type N and type S small steam sterilizer's performance in technical file. It can also improve the quality assurance of high-pressure steam sterilizers and increase the international competitive power of domestic product.
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KEYWORD
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High Pressure Small Steam Sterilizers, Standard, Performance
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