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KMID : 1142220190140010083
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Regulatory Research on Food, Drug & Cosmetic
2019 Volume.14 No. 1 p.83 ~ p.89
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Development of the guidance of Medical Device Standards - Focus on 'Electrically powered infusion pump'
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Kim Ji-Hyun
Kim Sung-Min
Lim Hong-Seok
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Abstract
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Since Medical Device Standards require high difficulty level and expertise, related industry employee including medical devices industry has had difficulties in carrying out technical document and testing. This may cause problems with the approval of companies, which may affect the medical device industry. In this study, guidances and reports related to national and international medical devices were investigated, and a the only format of medical devices standards guidance was derived. It also describes the definitions of key terms used in the standard, the test purpose for each standard item, detailed test method principle, and test notes. Based on these, we derived a guidance(draft) for Medical Device Standards and organized the expert consultation body to review the contents and the guidance to secure the reliability and validity of the commentary. Therefore, the guidance of Medical Device Standards developed through this study will help the manufacturers who have difficulty understanding and applying the standards to improve the clear understanding of each item. By lowering the barriers to entry into the medical device market, it is expected to be helpful. In order to increase the importance of infusion pump safety, the results of explaining the 'Electrically powered infusion pump' as an example are presented. In this study, the manufacturer of the Electrically powered infusion pump can understand the difficult part of understanding and application, be interpreted through the guidance Medical Device Standards.
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KEYWORD
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Medical Device Standards, a guidance of Medical Device Standards, purpose of testing, guideline
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FullTexts / Linksout information
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Listed journal information
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