GOST R IEC 60601-2-4-2013 Medical electrical equipment Part 2-4 Particular requirements for the basic safety and essential performance of cardiac defibrillators《医疗电气设备 第2-4部分 心脏电去颤.pdf

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

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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 .

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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): , , ,