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의료기기로서 앱 허가제 확립을 위한 동향 분석  

Yoon, Yeo-Hoon (경북대학교)
Kim, Il-Kon (경북대학교)
Yi, Byoung-Kee (삼성서울병원)
Publication Information
Communications of the Korean Institute of Information Scientists and Engineers / v.29, no.4, 2011 , pp. 69-77 More about this Journal
Keywords
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1 식품의약안전청-모바일 PACS 시스템 허가 심사 가이드라인, http://www.kfda.go.kr, Accessed in 2011.
2 AAMI - http://www.aami.org/about/, Accessed in 2011
3 IEC - http://www.iec.ch/about/, Accessed in 2011
4 ISO - http://www.iso.org/about/, Accessed in 2011
5 ASTM - http://http://www.astm.org/ABOUT/overview.html, Accessed in 2011
6 FDA Press Announcements - http://www.fda.gov/, Accessed in February 2011.
7 AAMI & FDA International Conference Presentation Slides, Hyatt Dulles, VA, USA, March 23-24, 2011.
8 ISO 14155 - http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=45557, Accessed in January 2011.
9 Christy Foreman, U.S. FDA, "Assessing the Impact of the New 510(k) on the Use of Standards", Accessed in February 2011.
10 ASTM F2761-09 - http://www.astm.org/SNEWS/SO_2009/quigley_so09.html, Accessed in October 2011.
11 신재용, "의료분야에 아이패드 등의 스마트패드 활용방안" 정보통신산업진흥원 IT기획 시리즈 모바일 애플리케이션 & 미디어 태블릿6, pp.18-19, 2011