GOST R IEC 60601-2-19-2011 Medical electrical equipment Part 2-19 Particular safety requirements for essential performance of infant incubators《医疗电气设备 第2-19部分 婴儿保育箱必要性能的详细安全性要求》.pdf

1、 2-19 IEC 60601-2-19:2009Medical electrical equipment Part 2-19: Particular requirements for the basicsafety and essential performance of infant incubators(IDT) 60601-2-192011 27 2002 . 184- , 1.02004 . 1 - ( ) -, 42 11 , 3 28 2011 . 347-4 60601-2-19:2009 . 2-19. - (IEC 60601-2-19:2009 Medical elect

2、ricalequipment Part 2-19: Particular requirements for the basic safety and essential performance of infantincubators). - , 5 50267.1996 - , - . () . - , , 2012 , - - II 60601-2-192011201.1 .1201.1.1 .1201.1.2 .1201.1.3* 2201.1.4 .2201.2 2201.3 3201.4 .4201.4.1 .4201.4.3* .4201.5 .5201.6 5201.7 , 520

3、1.8 7201.9 , .7201.10 8201.11 8201.12 9201.13 14201.14 (PEMS).14201.15 14201.16 .16201.17 .16202 . .17210 (PCLCS) . 17 .18 () .19 () 24 25 27 60601-2-192011III, , , - . 60601-1:2005 - . 1. - ( ). . - ., , , - , -, - . . :- : ;- : ;- ( , ): - . ;- , 3 : - . :- , , -; , 7 () 7.1, 7.2 . .;- ; , - 7.1,

4、7.2 7.2.1 7. , . , . . - . , , G / ( 2). :- , - ;- , , - ;- . (*) () , - . , , http:/webstore.iec.ch , - . :- ;- ;- - .IV 60601-2-192011 2-19 Medical electrical equipment.Part 2-19. Particular safety requirements for essential performance of infant incubators 20130101201.1 1), :201.1.1 : - , - 201.3

5、.209 ( ). , . , ., , - , 7.2.13 8.4.1 . . 4.2 . , - , , , , - . :- , , (. 80601-2-35 3);- (. 60601-2-21 2);- (. 60601-2-20 1);- (. 60601-2-50 4).201.1.2 : - , 201.3.208, , .1) 60601-1:2005 . 1. - ( ).1 60601-2-192011201.1.3 * : , - 2 201.2 . 60601-1-2 60601-1-10 202 210 . 60601-1-3 . 60601-1 .201.1.

6、4 : 60601 , -, , - , . . 60601-1 . - . 201 (, 201.1 - 1 ) 20x, x-() () (, 202.4 4 60601-1-2, 203.4 - 4 60601-1-3 . .). :- ;- ;- - ., , , -, 201.101. , 3.1 3.189, , 201.3.201. - , aa), bb) . . , , -, 20x, , , 202 60601-1-2, 203 60601-1-3 . . , . , - , . , - , , - .201.2 2 , : 60601-1-2:2007 . 1-2. -

7、. . . (IEC 60601-1-2:2007, Medical electrical equipment Part 1-2:General requirements for basic safety and essential performance Collateral standard: Electromagneticcompatibility Requirements and tests)2 60601-2-192011: 60601-1-10:2007 . 1-10. - . . (IEC 60601-1-10:2007, Medical electricalequipment

8、Part 1-10: General requirements for basic safety and essential performance CollateralStandard: Requirements for the development of physiologic closed-loop controllers) .201.3 , : . .:201.3.201 (AIR CONTROLLED INCUBATOR): , , - .201.3.202 (AVERAGE INCUBATOR TEMPERATURE): , - (. 201.102).201.3.203 (AVERAGE TEMPERATURE):