GOST R 55954-2014 Medical electrical equipment Lung ventilators Technical requirements for public procurement《医疗电气设备 肺通气器 公共采购的技术要求》.pdf

1、 55954 2014 2014 559542014 II 1 - ( ) 2 11 , 3 - 28 2014 . 56- 4 1.02012 ( 8). ( 1 ) , - . () - - . , (gost.ru) , 2014 -, - 559542014 III 1 .1 2 .1 3 .2 4 , , 4 5 .10 6 , .11 () 12 .15 559542014 1 Medical electrical equipment. Lung ventilators. Technical requirements for public procurement 20150601

2、1 - ( ) (1, 2 3). - () (4 5). -. - , , - . 1 () - , 94 (. 2, . 22; . 2 . 34). - - , . 2 , . . 3 - , . - - , , . 2 - : 60601-1:2010 . 1. 559542014 2 50267.0.2-2005 . 1-2. -. . 60601-1-6-2007 . 1-6. - . IEC 60601-1-8-2011 . 1-8. . , - 80601-2-12-2013 . 2-13. - 15223-1-2010 . , , . 1. 60601-1-10:2007 .

3、 1-10. - . . - 80601-2-55:2011 . 2-55. 55719-2013 . - - , 1 , - , , . -, , - (). -, , , , , . , , , , - . 3 : 3.1 (emergency intake port): , , . 3.2 (ventilator): , - . 3.3 (sigh): . 3.4 (gas intake port): , - . 3.5 (high-pressure input port): , , 100 . 3.6 (low-pressure input port): , 100 . 3.7 (ex

4、haust port): , - . 3.8 (high technology medical aid): - , () - , -, , , 559542014 3 , - . 3.9 (highly technological medical equipment): , - . 3.10 (airway pressure), Paw: . 3.11 (ventilator breathing system), VBS: , , , -. 3.12 (delivered volume), Vdel: , . , . - ( ) . 3.13 (protection device): , ,

5、- . 3.14 , (flow-direction-sensitive component): , - , . 3.15 (maximum limited pressure), Plim max: . 3.16 (maximum working pressure), PW max: - . 3.17 (minimum limited pressure), PLIM min: - . 3.18 (monitoring equipment): , . 3.19 (manual ventilation port): , - . 3.20 (patient-connection port): - ,

6、 . 3.21 (positive end-expiratory pressure), PEEP: - . 3.22 (fresh gas): , - . 3.23 () , , - 21.07.2005 . 94 , , , , - , , , , (- ). 3.24 (breathing system filter), BSF: , , , . 559542014 4 4 , , 4.1 : - ; - . - (22022) (500,5) . . - . -. ( , ) - ( , .) 250 600 - 1000 . ( 10 ) 60 / 280 . 4.2 - : - TFT- -, ( ), , -, , , - , - , ; - ; - ,