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

《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》由会员分享，可在线阅读，更多相关《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（66页珍藏版）》请在麦多课文档分享上搜索。

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

3、, ME ME 14201.10 .14201.11 14201.12 .15201.13 17201.14 (PEMS) 17201.15 .17201.16 21201.17 .21201.101 * 21201.102 * 24201.103 * .25201.104 * 26201.105 * / 26201.106 * , .30201.107 * .31201.108 * .32201.109 * (U.S.) 34202 * . 38 .39 () 40 () 42 () 60601-2-4 60601-2-4:2010 .52 () .58 59 60 60601-2-4201

4、3IV :- : ;- : ;- ( , ): - . ;-, 3 : - . :- , , ; , 7 () 7.1, 7.2 . .;- ; , 201.7.1, 201.7.2 201.7.2.1 7. , . , . . - . , , G / ( 2). :- , - ;- , , - ;- . (*) () , - . - . :-,-,- -. :- 201.8.8.3 4: ;- 201.105 . - 10 ;- 201.101 ;- 201.6.1, 201.6.2, 201.6.4 - ;- 201.101.1 ;- 201.3.207 ;- 201.15.4.101 b

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): , , ,