1、 61326-2-6 2014 , 2-6 IEC 61326-2-6:2012 Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-6: Particular requirements In vitro diagnostic (IVD) medical equipment (IDT) 61326-2-62014 II 1 ( ) 4 , / 65, - ( ) 2 306 3 11 2014 . 1526- 4 61326-2-6:2012 , -. . 2-6. .
2、 (IEC 61326-2-6:2012, Electrical equipment for measurement, control and laboratory use EMC requirements Part 2-6: Particular requirements In vitro diagnostic (IVD) medical equipment). 1.5 ( 3.5). , 5 6 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2015 , 61326-2-62014 III 61326-2-6:2012 65 65 . 61326-2
3、6:2012 , 2005 ., : 61326-1:2012. , 61326, 61326-1:2012 , , . 61326-1:2012 , , . , , 61321-1:2012 . : - , , , 101, , , 61326-1:2012; - 61326-1:2012, 101, ; - , . . 61326-2-62014 1 , 2-6 Electrical equipment for measurement, control and laboratory use. EMC requirements. Part 2-6. Particular requireme
4、nts. In vitro diagnostic (IVD) medical equipment 20160101 1 61326-1 , in vitro - . 2 , , . . ( ). 61326-1:2012 ( 2) : 61326-1:2012 , . . 1. (IEC 61326-1:2012, Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements) 14971:2007 . (ISO 14971:2007,
5、 Medical devices Application of risk management to medical devices) 3 61326-1, : 3.101 (in vitro diagnostic medical equipment): , , , , , . 1 , , . 61326-2-62014 2 3.102 , (analyte): . 1 : 24- , , , . 2 : , , , . . 18113-1:2009, 3.3 4.101 () . , (, , ). , . , , , , , , . 5 5.1 61326-1:2012 ( 5.1). 5
6、2 61326-1:2012 ( 5.2). 5.3 61326-1:2012 ( 5.3) : 5.3.101 , . (. . , ), () () () , () . 5.4 61326-1:2012 ( 5.4). 5.5 61326-1:2012 ( 5.5). 6 6.1 61326-1:2012 ( 6.1) : 6.1 . 101. , 101. . , . 6.2 61326-1:2012 ( 6.2) : 61326-2-62014 36.2 . . , . , ( ). , , . , , , . , 14971 , , 14971:2007 ( ) . , , , .
7、 , , , . , - . , , , , - . , , 101, , - , . 101 61000-4-2 2 4 ( ) 2 , 4 , 8 ( ) 61000-4-3 3 / ( 80 1 ) 3 / ( 1,4 2 ) 1 / ( 2,0 2,7 ) - ) 61000-4-8 3 / (50 , 60 ) d) 61000-4-11 0 % 1- 40 % 5/6 d)70 % 25/30 d) d) 61000-4-11 5 % 250/300 61000-4-4 1 (5/50 , 5 ) 61000-4-5 1 e)/ 2 f) - ( ) , 61000-4-6 3 ( 150 80 ) 61326-2-62014 4 101 61000-4-4 1 (5/50 , 5 ) 61000-4-5 1 e)/ 2 f) b), c) ( ) , 61000-4-6 3 ( 150 80 ) 61000-4-4 0,5 (5/50 , 5 ) 61000-4-5 /, b) , 61000-4-6 3 ( 150 80 ) 61000-4-4 1 (5/50 , 5 ) 61000-4-5 /, , , 61000-4-6 3 ( 150 80 ) ) , . - 1 /. b) , 3 . ) ,
