GOST R IEC 60601-2-45-2014 Medical electrical equipment Part 2-45 Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammogr.pdf

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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

2、:2011 . 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) , 5 1 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2015 , 60601-2-452014 III 201.1 ,

3、1 201.2 3 201.4 . 4 201.5 6 201.6 6 201.7 , . 6 201.8 . 9 201.9 , - 11 201.10 .13 201.11 14 201.12 14 201.13 .14 201.14 () .14 201.15 14 201.16 .15 201.17 .15 202 . .15 203 .15 () 34 34 () 35 .37 .38 60601-2-452014 IV , 60601-1:2005 ( ) . , , . . , , . 2-45, . (*), , , . 60601-2-452014 1 . 2-45 Medi

4、cal electrical equipment. Part 2-45. Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices 201601 01 201.1 , 1 1) : 201.1.1* : , , , . 1 , . : - ; - ; - ; - , ; - ; - , ; - ; - ; - , ( ). , . , , . 2 60601-2-7 606

5、01-2-32 . 1) 60601-1:2005 . 1. (IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance) ( ). 60601-2-452014 2 201.1.2 : , . 201.1.3 : , 2 201.2 . 60601-1-2 60601-1-3 202 203 . 60601-1-8, 60601-1-9, 60601-1-10 60601-1-11 2). 201.1.4 : 60

6、601 , , , . . 60601-1 . . 201 (, 201.1 1 ) 20, () () (, 202.4 4 60601-1-2, 203.4 4 60601-1-3 .). : - , ; - , ; - , . , , , , 201.101. , 2) 60601-1-9:2007 . 1-9. . . (IEC 60601-1-9:2007, Medical electrical equipment Part 1-9: General requirements for basic safety and essential performance Collateral

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 .

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