1、 60601-2-4null2013 2-4 IEC 60601-2-4:2010Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators(IDT) 60601-2-42013II1 - ( ) , 42 11 , 3 - 8 2013 . 1491-4 60601-2-4:2010 - . 2-4. - (IEC 60601-2-4:2010 Medical electrical
2、equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators). - , 5 50267.492 ( 601-2-483) 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , - - 60601-2-42013III201.1 , , 1201.2 .2201.3 3201.4 4201.5 ME 5201.6 ME ME 5201.7 , ME 5201.8 .9201.9
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5、) - ;- 201.15.4.3.103 - ;- 201.102.3.1, 201.102.3.2 - ;- 202.6.2.2.1 ESD 60601-1-2, .1 20150101 201.1 , , 1 , :201.1.1 : ( ) . , . , , ., , , - , 7.2.13 8.4.1 . . 4.2 . , - , ( 60601-2-27 2). - , , , AED - . . - , . , , , , - . , .201.1.2 : -, 201.3.202. 60601-2-42013 2-4 Medical electrical equipmen
6、t. Part 2-4. Particular requirements for the basic safety and essential performance of cardiac defibrillators 60601-2-420132201.1.3 : , - 2 2 . 60601-1-2 , 202. - 60601-1 .201.1.4 : 60601 , -, , - , . 60601-1 . 60601-1 . - . - 201 (, 201.1 1 ) 20x, x () () (, 202.4 4 60601-1-2, 203.4 - 4 60601-1-3 .
7、). :- ;- ;- - ., , , -, 201.101. , ., aa), bb) . , , -, 20x, , , 202 60601-1-2, 203 60601-1-3 . . , . , 60601-1 , . , 60601-1 , , .201.2 . 2 , : 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
8、Collateral standard: Electromagnetic compatibility Requirements and tests ) 60601-2-420133: 61000-4-2 (EMC). 4-2. -. (IEC 61000-4-2(2008), Electromagnetic compatibility (EMC) Part 4-2: Testing and measurement techniques Electrostatic discharge immunity test) 15223-1:2007 . , - , . 1. - (ISO 15223-1:2007, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements )201.3 , : . . 201.3.201 ; AED (AUTOMATED EXTERNAL DEFIBRILLATOR): , , ,
