1、 60601-2-45 2014 2-45 IEC 60601-2-45:2011 Medical electrical equipment Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices (IDT) 2015 60601-2-452014 II 1 ( ) , 4 2 011 , 3 12 2014 . 2077- 4 60601-2-45
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7、Standard: Requirements for environmentally conscious design). 60601-1-10:2007 . 1-10. . . (IEC 60601-1-10:2007, Medical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop con
8、trollers). 60601-1-11:2010 . 1-11. . . , (IEC 60601-1-11:2010, Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environ
9、ment). 60601-2-452014 3 3.1 3.139, 201.3.201. , BB ., ), bb) . , , , , 20, () () , , 202 60601-1-2, 203 60601-1-3 . , , . , ; , . 201.2 . 37. 2 , : : 60601-1-2:2007 . 1-2. . . . (IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performanc
10、e Collateral standard: Electromagnetic compatibility Requirements and tests) 60601-1-3:2008 . 1-3. . . (IEC 60601-1-3:2008, Medical electrical equipment P art 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-ray equipment)
11、 : 60336:2005 . . (IEC 60336:2005, Medical electrical equipment X- ray tube assemblies for medical diagnosis Characteristics of focal spots) 60613:2010 (IEC 60613:2010, Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis) / 60788:2004 . (IEC/TR 60788:2004, Medical electrical equipment Glossary of defined terms) 61223-3-2:2007 () . 3-2. . (IEC 61223-3-2:2007, Evaluation and routine testing in medical imaging departments Part 3-2: Acceptance tests Imaging performance of mammographic X-ray equipment) 62220-1-2:2007 .
