1、 60601-2-28 2013 228 - IEC 60601228:2010 Medical electrical equipment Part 2-28: Particular requirements for basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IDT) 2014 60601-2-282013 II 1 - ( ) 2 411 , 3 8 2013 . 1538- 4 60601228 : 2010 . 228. (IEC60601228:2010,
2、 Medical electrical equipment. Part 228: Particular requirements for basic safety and essential performance of X-ray tube assemblies for medical diagnosis) , A 5 60601-2-282013 III 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 60601-2-282013 IV 60601228 . 228. , 62 62 , . 60601228, 1995 . . 6060
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4、 6060113 203. 6060112, 6060116, 6060118, 6060119, 60601110, 60601111 . 60601 . 101) 6060112 , . - . 1) 606011 . 1. . 60601-2-282013 2 102) 6060116 6060118 , . . 103) 60601110 60601111. 201.1.4 : 60601 , - , - , . . 606011 . - . 201 (, 201.1 - 1 ) 20 , (-) (-) - (, 202.4 4 6060112, 203.4 4 6060113 .)
5、 . , - . , - . , . , , 201.101. , - 3.1 3.139, 201.3.201. , BB ., - ), bb) . , , 20, , , 202 6060112, 203 6060113 . , - , . - , - , ; , - -, , - . 201.2 2 , : : 6060113:2008 . 13. - . . (IEC 6060113:2008, Medical electrical equip-ment Part 13: General requirements for basic safety and essential perf
6、ormance Collateral Standard: Radiation protection in diagnostic X-ray equipment) : 60336 . - (IEC 60336, Medical electrical equipment X-ray tube assemblies for medical diagnosis Characteris-tics of focal spots) 60522 . (IEC 60601-2-282013 3 60522, Determination of the permanent filtration of X-ray t
7、ube assemblies) 60613:2010 (IEC 60613:2010, Electrical and loading characteristics of X-ray tube assemblies for medical diagnosis) / 60788:2004 . (IEC/TR60788:2004, Medical electrical equipment Glossary of defined terms) 201.3 , , - , 60613 / 60788. 201.4 4 , : 201.4.3 . , - , . 201.4.11 4.11 . 201.
8、5 5 , : 201.5.7 : , , , . , . . 201.6 6 , : 201.6.2 : I. 201.7 , 7 , : 201.7.1 60601-2-282013 4 201.7.1.1 , - 7.1.1 . , . 201.7.2 201.7.2.5 , : , 7.2.5 , , 201.7.9.3.101. 201.7.2.11 7.2.11 . . : 201.7.2.101 . , - : ; ; . , - . 201.7.2.102 : ; ; ; , ; ; 60522; (-) (-) (-) (-) 60336. , (1995), , , 201.7.9.3.101. 201.7.3 201.7.3.2 7.3.2
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