Siyoung Lee, “체외진단용의료기기[I.V.D]에 대한 안전성 평가 방법에 대한 연구,” 아주대학교 공학석사 학위 논문, 2014. > Paper

Generally, in case of the Electrical Medical equipment, the announcement of the KFDA accord with IEC60601-1(Medical

electricalequipment - Part 1: General requirements for safety) is applied for the electrical and mechenical safety evaluation. The I.V.D

is being appiled the stnadard that mentioned above in domestic situation. However, in case of EU or USA situation, the IEC61010-1

is being applied for the CE-marking or FDA apploval in the item of I.V.D. Therefore, through the study of international standard

IEC61010-1(Safety requirements for eletrical equipment for measurement, control and laboratory use- Part 1: General requirement),

the paper is proposed that evaluation method of I.V.D and need to apply of IEC61010-1.