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KMID : 1142220130080010117
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Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.117 ~ p.126
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A Study on the Electrical and Mechanical Safety Test Method of In-Vitro Diagnostic Medical Device
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Park Su-Kang
Lim Il-Kwon
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Abstract
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In general, the safety evaluation of the electrical medical device IEC60601-1 standard to be applied. However, In-Vitro Diagnostic(IVD) medical device is applied Safety requirements for electrical equipment for measurement, control, and laboratory use-Part 1 : General requirements for the U.S. FDA, European CE certification. International Standard IEC61010-1 is enhanced the safety evaluation items including fire or explosion, electric shock, burns, toxic and hazardous gases in a laboratory environment. Therefore, the safety of medical devices used in the laboratory evaluation of the appropriate standard. Therefore, to the international harmonization of In-Vitro Diagnostic medical device commonly used in a laboratory environment, the difference between the main test item objectively demonstrated through testing of standard IEC60601 and IEC61010-1 standard. Accordingly, the validity of IEC60601-1 standard applies of In-Vitro Diagnostic medical device is proposed and used by study reference for the establishment of common standards for the safety assessment of In-Vitro Diagnostic medical device.
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KEYWORD
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In-Vitro Diagnostic medical deviceIn general, the safety evaluation of the electrical medical device IEC60601-1 standard to be applied. However, s, IEC61010-1, Laboratory, Safety
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