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KMID : 1142220130080010031
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Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.31 ~ p.41
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A Study on the Development of Requirements for Medical Device used in Home Healthcare Environment
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Cha Ji-Hun
Kim Ji-Hye
Oh Hyeon-Joo
Hui Chan-Hoi
Park Ki-Jung
Lee Jae-Won
Cho Eun-Jeong
Kim San
Kwon Tae-Hee
Kang Shin-Jung
Hong Choong-Man
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Abstract
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Recently, due to increasing change to ubiquitous health environments, medical devices used by the expert in hospital are getting smaller and become high-tech in personal medical devices. Thus, recently, use of the medical devices has been increasing for helping people to manage their disease in home healthcare environment. In this study, we reveiwed related domestic and foreign standards for drawing proper requirements which can secure safety of the medical devices used in home healthcare environment. Finally, requirements and criteria for evaluation that can be applied to the medical devices used in home healthcare environment were developed and suggested. As a result, we expect to secure the safety of the user through protecting by managing possible risks of the medical device used in home healthcare environment.
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KEYWORD
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Home Healthcare, Medical device, Safety, Requirements
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FullTexts / Linksout information
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Listed journal information
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