1、 60601-2-212013 2-21 IEC 60601-2-21:2009 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IDT) 60601-2-212013 II 1 ( ) , 4 2 11 , 3 28 2013 . 623- 4 60601-2-21:2009 . 2-21. (IEC 60601-2-21:2009 Medical electri
2、cal equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers). , 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 60601-2-212 013 III , , , . 60601-1:2005 . 1. ( ). . . , , , , , - . . /, 2. : : - : ; - : ; - ( , ): . ; - , 3 : . : -
3、, , ; , 7 () 7.1, 7.2 .; - ; , 7.1, 7.2 7.2.1 7. , . , . . . , , G /, 2. : - , ; - , , ; - . (*) () , . , , http:/webstore.iec.ch , . : - ; - ; - - . 2-21 Medical electrical equipment. Part 2-21. Particular safety requirements considering essential performance for infant radiant warmers 20150201 201
4、.1 1), : 201.1.1 : , 201.3.209 ( - ). , . , . , , , 7.2.13 8.4.1 . - . 4.2 . , , , , . : - , , ; . 80601-2-35; - ; . 60601-2-19; - ; . 60601-2-20; - ; . 60601-2-50. 201.1.2 : , 201.3.204, , . 201.1.3 * : , 2 201.2 . 60601-1-2 60601-1-10 202 210 . 60601-1-3 . 60601-1 . 1) 60601-1:2005 . 1. ( ). 201.1
5、.4 : 1 60601-2-212013 60601-2-212013 2 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 , : : 60
6、601-1-2:2007 . 1-2. . . . : 60601-1-10:2007 . 1-10. . . (IEC 60601-1-10:2007, Medical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers) . 201.3 , : . : 60601-2-
7、212 013 3 201.3.201 (BABY CONTROLLED RADIANT WARMER): , , , , . , , , 60601-1-10. 201.3.202 (CONTROL TEMPERATURE): , . 201.3.203 (INFANT): 3 10 . 201.3.204 (INFANT RADIANT WARMER): , . 201.3.205 (MANUAL MODE): , , . 201.3.206 TM(MID-POINT AVERAGE TEMPERATURE): , (. 201.101). 1 201.101 60601-2-212013 4 201.3.207 * (PREWARM MODE): , ( ) . 201.3.208 (SKIN TEMPERATURE SENSOR): . 201.3.209 (STEADY TEMPERATURE CONDITION): , , , ,
