|
KMID : 1142220130080010053
|
|
Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.53 ~ p.67
|
|
|
A Study on the Development of Test Method for Risk Management of Medical Electrical Devices in IEC 60601-1(3rd)
|
|
Kim Dae-Young
Lee Ho-Sung
Kang Beum-Sun
Park Ho-Joon
Kim San
Kwon Tae-Hee
Cha Ji-Hun
Lee Jae-Won
Oh Hyeon-Joo
|
|
|
Abstract
|
|
|
|
International Electrotechnical Commission published the standard of IEC 60601-1:2005 in 2005, and European Union(EU) adopted the standard and make mandatory requirement of Test for CE marking from the June in 2012, also Unite state will adopt from January in 2014. All the testing houses dealed with the electrical medical device must make full use of the standard. but they do not fully develop the test methods for risk management of the electrical medical devices regarding the IEC 60601-1:2005(3rd). However it is important to develop the test methods for the companies exporting the medical electrical devices in European Unit. In the Study the 125 test methods are developed by analysing and evaluating the IEC 60601-1 3rd edition and IEC guideline(IECEE OD 2044). With result. it can be applied the Risk Management in the standard when the domestic companies manufacture the medical devices. Consequentially It can also improve the quality of electrical medical device and increase the international competitive power of domestic product.
|
|
|
KEYWORD
|
|
|
International Electrotechnical Commission, IEC 60601-1 3rd edtion, Risk Management, Test Method
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|