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KMID : 1142220190140020117
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Regulatory Research on Food, Drug & Cosmetic
2019 Volume.14 No. 2 p.117 ~ p.124
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A Study on Development of Electrical and Mechanical Safety Evaluation Guideline Applying IEC 61010-2-101 for in vitro Diagnostic (IVD) Medical Devices
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Lee Seung-Ro
Kim Ji-Eun
Kim Bo-Ra
kwak Joung-In
Park Ki-Dae
Kim Mi-Jeong
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Abstract
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In-Vitro Diagnostic (IVD) medical devices are required the application of the particular specification standard IEC 61010-2-101 as well as common specification standard IEC 61010-1. According to the amendment of IEC 61010-2-101; 2015, the self-testing IVD devices have been included in the scope of application. Revised edition informs a technical revision and the significant changes compared to the first edition. In particular, it added several requirements for manufacturer to provide instructions on equipment transport, storage and removal. To international harmonization of evaluation methods and safety of IVD devices, it is necessary to establish guidelines for electrical and mechanical safety evaluation conforming to international standards. In this study, electrical and mechanical safety evaluation method guideline of IVD medical device, which internationally harmonized and reflected the revised IEC 61010-2-101; 2015, is developed. The newly developed guideline for electrical and mechanical safety test method is expected to contribute to the enhancement of international competitiveness by securing reliability and an improvement of technology and quality of IVD medical device industry.
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KEYWORD
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In-vitro diagnostic, Self-testing, Medical device
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