1、2014 2-54 IEC 60601-2-54:2009Medical electrical equipment Part 2-54: Particular requirements for basic safety and essential performance of the X-ray equipment for radiography and radioscopy(MOD) 50267.2.54 2013 ( 60601-2- 54:2009) 50267.2.542013 II1 - ( ) , 42 411 - , 3 - 7 2013 . 76-4 - 60601-2-54:
2、2009 . 2-54. - (IEC 60601-2-54:2009 Medical electrical equipment Part 2-54: Particular requirements for basic safety and essential performance of the X-ray equipment for radiography and radioscopy). - , 5 1.02012 ( 8). - ( 1 - ) , -. () - . , - (gost.ru)null , 2014 , - - 50267.2.542013 III201.1 , .1
3、201.2 2201.3 3201.4 4201.5 4201.6 4201.7 , 4201.8 7201.9 , 9201.10 12201.11 12201.12 , .13201.13 13201.14 (PEMS) 13201.15 .13201.16 13201.17 13202 . 13203 13 () .45 () .47 A () 50 51 52 50267.2.542013 IV 60601-2-54:2009 2-54: - - , 62 - 62 , . , - , 60601-2-54:2009 ( 203.5.2.4.5.101, 203.6.2.1.101,
4、203.6.3.1, 203.6.4.5, 203.7.1.), - . - -. 60601-2-54 60601-12005. 60601-2-7 60601-2-32, 60601-2-28:1993 ( -), 60601- 12005 , , 60601- 1 2005.- :- , (, 7 7.1, 7.2 . .);- (, 7.1, 7.2 7.2.1 - 7). - . . , - , . - H / , 2. :- , ;- , , ;- - . (*) , , . 50267.2.542013 1 20150101201.1 , 1 1) :201.1.1 : - ,
5、 60601-2-43 , -, . , , - , , . . () - , (). - , () . , , . .201.1.2 : - - .201.1.3 : , 2 - 201.2 . 60601-1-2 60601-1-3 202 203 . 60601-1-8 60601-1-10 . - 60601-1 .1) 60601-12005 . 1. - . 2-54 Medical electrical equipment. Part 2-54. Particular requirements for basic safety and essential performance
6、 of the X-ray equipment for radiography and radioscopy 50267.2.542013 2 - , 60601-1-8, 60601-1-8 .201.1.4 : 60601 , -, , , , - . - . . , 60601-1 . . - 201 ( 201.1 1 ) - 20x, x (-) (-) (-, 202.4 4 - 60601-1-2, 203.4 4 60601-1-3, . .). : ; - ; - ;, , , , , 201.101. , 3.1 3.139, , 201.3.201. AA, BB . .
7、 - aa), bb) . ., , , - , , 20x, x (, 202 60601-1-2, 203 60601-1-3 . .). , - . , , - , ; - , - , .201.2 . 2 , : 60336 . (IEC 60336, Medical electrical equipment X-ray tube assemblies for medical diagnosis Characteristics of focal spots) 60580:2000 . - (IEC 60580:2000, Medical electrical equipment Do
8、se area product meters) / 60788:2004 . (IEC / TR 60788:2004, Medical electrical equipment Glossary of defined terms) 50267.2.542013 3 60806 . - (IEC 60806, Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis) 62220-1:2003 . - . 1. (IEC 6222
9、0-1:2003, Medical electrical equipment Characteristics of digital X-ray imaging devices Part 1: Determination of the detective quantum efficiency): 60601-1-2:2007 . 1-2. . . - . (IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests) 60601-1-3:2008 . 1-3. - . : -
