Features and Trends of IEC Particular Standards for Medical Equipment Related to Diagnostic X-ray Based on IEC 60601-1:2005 Ed. 3.0 |
Kim, Hyun-Ji
(Department of radiologic science, Korea University)
Kim, Jung-Min (Department of radiologic science, Korea University) Choi, In-Seok (Department of radiologic science, Korea University) Yoon, Yong-Su (Department of radiologic science, Korea University) Seo, Deok-Nam (Department of radiologic science, Korea University) Kim, Jung-Su (Department of radiologic science, Korea University) Kim, Dae-Young (Korea Testing Laboratory) Park, Sung-Yong (Korea Testing Laboratory) |
1 | IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests 3rd Ed, 2007. 03. 30. |
2 | IEC 60601-1-3 General requirements for basic safety and essential performance -Collateral Standard: Radiation protection in diagnostic X-ray equipment 2nd Ed, 2008. 01. 22. |
3 | IEC 60601-2-44 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography 3rd Ed, 2009. 02. 25. |
4 | IEC 60601-2-45 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic device 3rd Ed, 2011. 02. 11. |
5 | IEC 60601-2-54 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy 1st Ed, 2009. 06. 29. |
6 | 최인석, 김정민, 정회원 외: 진단용엑스선장치 제조품질관리에 관한 국내.외 규격의 동향, 방사선기술과학, 32(1), 1-16, 2009. |
7 | 식품의약품안전청 고시 제 2012-91호, 의료기기의 전기.기계적 안전에 관한 공통기준규격, 2012. 8. 24 고시. |
8 | 식품의약품안전청 고시 제 2011-8호, 전자의료기기 기준규격, 2011. 2. 21 고시. |
9 | IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance 3rd Ed, 2005. 12. 15. |