GOST R IEC 60601-1-6-2014 Medical electrical equipment Part 1-6 General requirements for basic safety and essential performance Collateral standard Usability《医疗电气设备 第1-6部分 基本安全和基本性.pdf

1、 60601-1-6 2014 1-6 IEC 60601-1-6:2010 Medical electrical equipment. Part 1-6. General requirements for basic safety and essential performance. Collateral standard: Usability (IDT) 2014 60601-1-62014 II 1 , 4 2 436 - 3 - 28 2014 . 58- 4 60601-1-6:2010 . 1-6. - . . (IEC 60601-1-6:2010 Medical electri

2、cal equipment. Part 1-6. General requirements for basic safety and essential perfor-mance Collateral standard: Usability) - , - A. 5 1.02012 ( 8). ( 1 ) , -. () - . , - (gost.ru) , 2014 -, - 60601-1-62014 III 1 , 1 1.1 * 1 1.2 .1 1. 3 1 1.3.1 60601-1 .1 1.3.2 2 2 .2 3 .2 4 3 4.1 * 3 4.2 * .3 5 , 623

3、66:2007 3 () .4 () 60601-1-6:2006 62366:2007 .6 () , 62366:2007, 17 () 20 24 60601-1-62014 IV - 60601-1-6, 62 -, , 62 - . 60601-1 . 1. , . , 62366:2007. : 62A/682/FDIS 62A/689/RVD - , . /, 2. 60601 : - (, ), - , (, ). : - : . - , 62366:2007: - ( , ): . . - , 3 -: . : , , ; , 4 4.1, 4.2 .; ; , 4.1 4.

4、2. , . , . . - . , , H / ( 2). : , - ; , , - ; . (*) () , . 60601-1-62014 V B.1 60601-1-6:2006 62366:2007. - 60601-1-6:2006 62366:2007. C.1 - 62366 -, 9241, 62366. 60601 . , , , http:/webstore.iec.ch - . : , , , /. 60601-1-62014 VI . , - ( ), . , - -, . - , , , - . -. - . - () , . , , . - . - . - .1

5、 62366:2007. . - - . 1.3 60601-1:2005 , - - . - 60601-1:2005 2006 . - , 62A , - 2006 2007 , 60601-1-1 60601-1-4. , - 60601-1:2005. , 62A 210 - 62366:2007, . 62366 60601-1-6, , 60601-1-6. , 62366:2007, -, . 2008 62 - 62366, 60601-1 62366. - 60601-1:2005, - , - 62366:2007. - 60601-1 62366. , , , 4 5 ,

6、 60601-1 62366. () -, , , . , 14155-1 - . 60601-1-62014 1 1-6 Medical electrical equipment. Part 1-6. General requirements for basic safety and essential performance. Collateral standard. Usability 20150601 1 , 1.1 * - , , , , , . - , , - , . - , , -. , , , , (. .5.9 62366:2007), , , 14971, , (. . 4.1.2 62366:2007). 1.2 , , - -. 1. 3 1.3.1 60601-1 60601-1. 60601-1 , , : 60601-1; 60601-1-62014 2 60601-1-6; - . 1.3.2 . 2