GOST R IEC 60601-2-44-2013 Medical electrical equipment Part 2-44 Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography《.pdf

《GOST R IEC 60601-2-44-2013 Medical electrical equipment Part 2-44 Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography《.pdf》由会员分享，可在线阅读，更多相关《GOST R IEC 60601-2-44-2013 Medical electrical equipment Part 2-44 Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography《.pdf（40页珍藏版）》请在麦多课文档分享上搜索。

1、 60601-2-44 2013 2-44 IEC 60601-2-44:2009 Medical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (IDT) 2014 60601-2-442013 II 1 - ( ) , 4 2 411 , 3 - 08 2013 . 1393- 4 60601-2-44 : 2009 . 244. - (EC 60

2、601-2-44:2009 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography) - , - A 5 1.02012 ( 8). ( 1 ) , -. () - . , (gost.ru) , 2014 -, - 60601-2-442013 III 201.1 , . 1 201.2 3 201.3 3 201.4 . 8 201.5

3、8 201.6 . 9 201.7 , . 9 201.8 .11 201.9 13 201.10 16 201.11 16 201.12 .16 201.13 17 201.14 () 17 201.15 17 201.16 .17 201.17 .17 203 17 .30 AA () 30 () CTDIvol (CTDIvol ) .30 () .31 .32 .35 60601-2-442013 1 2-44 Medical electrical equipment Part 2-44 Particular requirements for the basic safety and

4、essential performance of X-ray equipment for computed tomography 201501 01 201.1 , 1 1), : 201.1.1 : - ( ). - , . , , . 1 . 4.2 . , , () , . - , -, , - (). 2 , 60601-2-7 60601-2-32, 60601-1:2005 ( 3), . , 60601-2-7 60601-2-32 - . 201.1.2 : - (. 201.3.201) . 1) 60601-1:2005, . 1. . 60601-2-442013 2 1

5、 , , -, . 2 - . , -, , . - , , - . , , - . 3 , , - 60601-1-2010. 4 - , , ( ), 103, 2007, 203, 122) : a) : , , - , ; b) : , - , ; c) : - , , , ; d) -, . . , , . 5 , , ICRP, , . 201.1.3 : , - 2 201.2 . 60601-1-3 203. 60601-1-8, 60601-1-9 60601-1-103) . 60601-1 . 201.1.4 : 60601 , - , , - - . . - “201“

6、 (, 201.1 - 1 ) “20x“, x () (, 202.4 4 60601-1-2; 203.4 4 60601-1-3, .). : 2) 3) 60601-1-10, 1-10: - : - 60601-2-442013 3 - “ , - ; - “ , - ; - “ , - , . , , , , 201.101. , , 3.1 3.139, 201.3.201. - AA, BB ., aa), bb), . , , , , - 20x, “x“ , , 202 60601-1-2, 203 60601-1-3 . “ “ , , . , , , , , -, ,

7、. , - , , , -, , . 201.2 . 2 , : : 60601-1-3:2008 . 1-3: - . . (IEC 60601-1-3:2008 Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation pro-tection in diagnostic X-ray equipment) : 60601-1:2005 . 1: - (IEC 60601-1:2005

8、Medical electrical equipment Part 1: General requirements for basic safety and essential performance) 61223-3-5 . 3-5: . (IEC 61223-3-5. Evaluation and routine testing in medical imaging departments Part 3-5, Acceptance tests - Imaging performance of computed tomography X-ray equipment) 12052, (DICOM), (ISO 12052, Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management) 201.3 , - 60601-1, 60601-1-3 / 60788, - : 101 . . 102 60601-1-3 -, , : - ; - . 60601-2-442013 4 : 201.3.201 : , - .