GOST IEC 60601-2-7-2011 Medical electrical equipment Part 2-7 Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators《医用电气设备 第2-7部分 诊断X射线发生.pdf

1、 2-7 (IEC 60601-2-7:1998, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)IEC 60601-2-72011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJUZ 4 13 2011 . 1280- IEC 60601-2-72011 - 1 2013 .5 IEC 60601-2-7:1998 Medi

2、calelectrical equipment Part 2-7: Particular requirements for the safety of high-voltage generators of diagnosticX-ray generators ( . 2-7. ). - . (IDT). 60601-2-720066 ( ) - . , - . - C, 2013 -, II IEC 60601-2-72011 I 11 .11.1 .11.2 .11.3 .22 32.101 , .43 .45 .46 , .56.1 56.7 66.8 6 2 .810 .8 3 915

3、/ 1016 .1019 1019.3 .1020 .1120.3 1120.4 .11 4 12 5 .1229 1229.1 , , .1236 .15 6 . 15 7 1642 16 8 .1650 1650.1 .1650.101 1650.102 , 1750.103 2050.104 .2050.105 2151 23 9 ; .23 10 .2356 2356.7 .2357 , .2357.10 23 () 26 () c162R 10 c162R 20ISO497 .30 () .31 () .33III IEC 60601-2-72011 IEC 60601-2-7:19

4、98 . 2-7. - . :- , , ;- , , , , ;- ;- , , .IV IEC 60601-2-72011 2-7 Medical electrical equipment. Part 2-7. Particular requirements for the safety of high-voltage generators of diagnosticX-ray generators 20130101 1 :1 :1.1 , :- , ;- . , , . :- ( IEC 60601-2-15);- ;- .1.2 , .1 , , -, , .2 , , , . , ,

5、 . , , . , , .1 IEC 60601-2-72011 3 , , - IEC 513.4 , - (), 60 (1990), 1121),:) , , , , - ( ).b) , -, , - . ( ) - ( ), ( ).c) - . , , . , ( - ).5 , , IEC 60601-1-3. , , .6 , , 3, , .1.3 ( ) - IEC ( ), IEC 60601-1:1988 -. 1. , 1 (1991) 2 (1995) . , - . - : -. . -. , , - 101, , . ., aa), bb) . . , , -

6、 , . - , - , . , , .1.3.101 ,- IEC 60601-1-3, .2 IEC 60601-2-720111) ICRP60: ( ICRP,. 21, 1-3, 1990 .). . IEC 60601-1-3 : , IEC:IEC 60407:1973 Radiation protection in medical X-ray equipment 10 kV to 400 kV ( - 10 400 ).IEC 60407:1975 Radiation protection in medical X-ray equipment 10 kV to 400 kV.

7、First supplement:Sub-clause 7.5.5: Equipment for dental radiology ( IEC 60407). IEC:IEC 60417:1997 Graphical symbols for use on equipment; Supplement 15 ( , : , ).IEC 60601-2-15:1988 Medical electrical equipment; part 2: particular requirements for the safety of capacitordischarge X-ray generators (

8、 . 2: - ).IEC 60601-2-28:1993 Medical electrical equipment Part 2: Particular requirements for the safety of X-ray sourceassemblies and X-ray tube assemblies for medical diagnosis ( . 2. - ).IEC 60601-2-32:1994 Medical electrical equipment Part 2: Particular requirements for the safety of associated

9、equipment of X-ray equipment ( . 2: - ).IEC 60613:1989 Electrical, thermal and loading characteristics of rotating anode X-ray tubes for medical diagnosis( . , - ).IEC 60664-1:1992 Insulation coordination for equipment within low-voltage systems; part 1: principles, requirementsand tests ( . 1: , ).IEC 60788:1984 Medical radiology Terminology ( . ).ISO 497:1973 Guide to the choice of series of preferred numbers and of series containing more rounded values ofpreferred numbers ( , . ).ISO 3665:1976 Photography; Intra-oral dental radiographic film; Specification (