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KMID : 1142220190140020105
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Regulatory Research on Food, Drug & Cosmetic
2019 Volume.14 No. 2 p.105 ~ p.116
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Application of ISO 10993-1(2018) for Biological Evaluation of Electrosurgical Electrode
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Kim Tae-Yeung
Hwang Yong-Il
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Abstract
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To support biological evaluation of medical devices to Ministry of Food and Drug Safety (MFDS), it is conducted according to the ‘Common Standard on Biological Safety of Medical Devices (MFDS Notification No. 2019-4)’ based on the international standard ISO 10993 series. Recently, ISO 10993-1 was revised in 2018 (5th edition), and it is necessary to revise the MFDS Notification in order to internationally harmonize medical device biological evaluation. In the revised ISO 10993-1 (2018), a toxicological risk assessment with a clinically established (previously predicated) medical device is presented to demonstrate the toxicological equivalence of reducing or exempting unnecessary biological endpoint. This study covers the application of ISO 10993-1(2018) for biological evaluation of the electrosurgical electrode, which is a popular approved medical device in MFDS.
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KEYWORD
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Medical Device, Electrosurgical electrode, Biological evaluation, ISO 10993-1, Toxicological risk assessment
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