GOST R IEC 60601-2-50-2012 Medical electrical equipment Part 2-50 Particular requirements for the basic safety and essential performance of infant phototherapy equipment《医疗电气设备 第2-.pdf

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1、 60601-2-50 2012 2-50 IEC 60601-2-50:2009 Medical electrical equipment. Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (IDT) 2014 60601-2-502012 II 1 ( ) , 4 2 11 , 3 1 2012 . 682- 4 60601-2-50:2009 . 2-50. (IEC 60601-2-50:2009 Medi

2、cal electrical equipment Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment), Corr. 1 - 2010. , 5 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 60601-2-502012 III , , , . 60601-1:2005 . 1. ( ). . . , , , , , - . . /, 2. : - : ; - :

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4、 performance of infant phototherapy equipment 20140701 201.1 4 , : 201.1.1 : , 201.3.203 ( ). , . , . , , , 7.2.13 8.4.1 . . 4.2 . , , , , , . : - , , ; . 80601-2-35; - ; . 60601-2-19; - ; . 60601-2-20; - ; . 60601-2-21. 201.1.2 : , 201.3.203, , . 201.1.3 : , 2 201.2 . 60601-2-502012 2 60601-1-2 , 2

5、02. 60601-1-3 60601-1-10 . 60601-1 . 201.1.4 : 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 ,

6、 : : 60601-1-2:2007 . 1-2. . . . (IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests) 201.3 , : . , , , 201.101. 60601-2-502012 3 : 201.3.76 (PATIENT): ,

7、201.3.202, , 201.3.203. : 201.3.201 (EFFECTIVE IRRADIATED AREA): , , , . , . 60 x 30 , . 201.3.202 (INFANT): 10 . 201.3.203* (INFANT PHOTOTHERAPY EQUIPMENT): , 400 550 . 201.3.204 , Ebi (TOTAL IRRADIANCE FOR BILIRUBIN, Ebi): , 400 550 ( ). 201.101 , AAP (American Academy of Pediatrics) C ( ) () , ( ) ( ) E ( ) Ebi ( 400 550 ) Eeff E EL G2 () ( ) ( ) ( 700 1 ) - ( 700 1400 ) - ( 1,4 3 ) - ( 3 8 ) ( ) ( ) (