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KMID : 1142220210160010037
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 1 p.37 ~ p.48
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A Study on the Safety and Essential Performance Evaluation Factors of Surgical Robots in Korea the Introduction of International Standards
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Park Jun-Hyun
Woo Jae-Hyun
Kim Sung-Min
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Abstract
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In this study, the domestic and international research trends, item classification, and applicable standards of surgical robots were analyzed to derive the limits of the standards applied to surgical robots, and the survey and analysis were conducted on the introduction of IEC 80601-2-77, the standard for surgical robots, which will be introduced in the future. Based on the survey and analysis, the survey was distributed and analyzed to domestic industry, academia, and research institutes by adding the definitions of terms, specifications, and application methods for domestic introduction of IEC 80601-2-77 assessment items. Through this, a checklist was prepared for domestic companies and research institutes with little or no experience in developing surgical robots, and the details of surgical robots that cannot be applied to IEC 80601-2-77 were confirmed. Further research will also be conducted to specify the limits so that they can be applied properly when introduced into the actual standards through the FDA's example so that they can be applied not only in the process of regulatory affairs but also in the direction of proposing the requirements in the design, and to suggest the application of guidelines that can be applied from product design to the regulatory affairs process.
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KEYWORD
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Medical Device, Surgical Robot, IEC 80601-2-77, Evaluation Elements, Guideline
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