1、 55952 2014 2014 559522014 II 1 - ( ) 2 11 , 3 - 28 2014 . 54- 4 1.02012 ( 8). ( 1 ) , - . () - - . , (gost.ru) , 2014 -, - 559522014 III 1 .1 2 1 3 2 4 , , .3 5 8 6 , 10 .12 559522014 1 Medical electrical equipment. Electrocardiographic monitoring equipment. Technical requirements for public procur
2、ement 20150601 1 - - () (1, 2 3). . - () (4 5). -. - , , , , -. 1 () - , 94 (. 2 . 22, . 2 . 34). - , - . 2 - . . 3 - , . - , , . 2 : 50267.0.2-2005 . 1-2. -. . 60601-1-2010 . 1. 559522014 2 IEC 60601-1-8-2011 . 1-8. . , - 60601-2-27-2013 . 2-27. - ; 55719-2013 . - . - , 1 , - . , , . -, , - (). -,
3、, , , , . , , , , - . 3 : 3.1 , (high technology medical aid): , () , -, , , - , - . 3.2 , (highly technological medical equipment): , - . 3.3 (gain indicator): - , . 3.4 (patient cable): , . 3.5 (gain): . 3.6 (neutral electrode): - / , . 3.7 (non-permanent display): - ( ). 3.8 (common mode rejectio
4、n, CMR): - , , , , ., , (- ) , ( ), - . 3.9 (lead): . 3.10 (lead selector): . 559522014 3 3.11 (permanent display): - (). , -. 3.12 (lead wire): , c - , . 3.13 () , , - 21.07.2005 94 -, , , , - , , , , (- ). 3.14 (noise): , -. 3.15 () (electrocardiographic (ECG) monitoring equip-ment): , , , - / . 3
5、.16 (electrode): , . 3.17 () (electrocardiogram): . 4 , , 4.1 : - - ; - . 4.2 4.2.1 - 220 (10 %), 50 . . - . . - 1. - . : - I, II, III RLF-; - I, II, III, aVR, aVF, aVL V . 12 4.2.2 . 5 - - , , . 4.2.3 - / - , , , , - ( ) . 559522014 4 60601-1. 4.2.4 / - 30 , - , , - . -, , - , - , . . 4.2.5 300 + 300 - 5 5 , 320 / , , 10 % . 4.2.6 , 5 - 300 . 4.2.7 , , , - 30 , , 10 . 4.2 8 - , N, - 5 % -. 4.2.9 () ( ) - 2,5; 5; 10; 20; 40 /. - 5%. 10 /. 10% 1 , 5 , 30 60 . 4.2.10 - 50; 25; 12,5 6,25 /. 5%. 25 / ,
