1、 80601-2-12null2013 2-12 ISO 80601-2-12:2011Medical electrical equipment Part 2-12: Particular requirements for the basic safetyand essential performance of critical care ventilators(IDT) 80601-2-122013II1 - ( ) , 42 11 , 3 - 7 2013 . 70-4 80601-2-12:2011 . 2-12. - (ISO 80601-2-12:2011 Medical elect
2、rical equipment Part 2-12: Particular requirements for the basic safety and essential performance of critical care ventilators). - , 5 50267.122006 ( 60601-2-12:2001) 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , - - 80601-2-122013III201.1* , . 1201.2 . 3201.3 .6201.4 .8201.5 . 9201.6 10201.7 ,
3、10201.8 14201.9 , 14201.10 .18201.11 .18201.12 20201.13 . 31201.14 (PEMS) . 32201.15 32201.16 .34201.17* 34201.101 35201.102 VBS .36201.103 38201.104 38201.105* 38201.106 / . 39201.107 . 39201.108* .40202 . 1-2. . . . 41206 . 1-6. . . 41208 . 1-8. . , 42 C () 43 D () .49 AA () .50 BB () . . . . . .
4、. . . . . . . . . . . . . . . . . . . . . . . . . . 64 () .66 .69 , .71 80601-2-122013IV :- : ;- : ;- ( , ): - . ;- , 3 : - . :- , , -; , 7 () 7.1, 7.2 .;- ; , 201.7.1, 201.7.2 201.7.2.1 7. , . , . . - . , , G / ( 2). :- , - ;- , , - ;- . (*) () , . 80601-2-12 60601-2-12:2001. 80601-2-12 60601-2-12:
5、2001 60601-1. :- , - - , , , ;- - ;- - ( ) :- ;- ;- ;- ;- ( );- - ;- , , . 80601 :- 2-12. - ; 80601-2-122013V- 2-13. - ; - 2-55. - ;- 2-56. - ;- 2-61. - . 80601 :- 2-30. - ;- 2-35. - , , , ;- 2-58. - ;- 2-59. - ;- 2-60. - . 80601 60601.1 20150101201.1* , 60601-1, 1, :201.1.1 60601-1, 1, : - - ( ):-
6、, - . 1 - ;- - - . 2 , -, . , - - , . , , , . 3 - , . 80601-2-122013 2-12 Medical electrical equipment. Part 2-12. Particular requirements for the basic safetyand essential performance of critical care ventilators 80601-2-1220132 , . , -., , - 60601-1, 7.2.13 8.4.1. 4 60601-1, 4.2. - (continuous positive airway pressure, CPAP), , - , , - , , - (high-frequency jet ventilator, HFJV) (high-frequency oscillatory ventilator, HFOV) 26. , - - . - , ; 80601-2-13. - , - - ; 10561-21). - , -; 10561-32). - , , -, ;
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