1、 2-47 (I 60601-2-47:2001, D) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)30324.2.472012(I 60601-2-47:2001), 1.092 . 1.22009 . , - . , , -, 1 - ()2 (-)3 , (- 24 2012 . 41) : ( 3166) 00497 ( 3166) 00497 AZBYKGRU 4 1 2012 . 617- 30324.2.472012 (I 60601-2-47:2001) 1 2015
2、.5 IEC 60601-2-47:2001 Medical electrical equipment Part 2- 47: Particular requirements for the safety, includingessential performance, of ambulatory electrocardiographic systems ( . 2-47. - ) . , , / .C (D). 50267.472004 ( 60601-2-472001)6 - , - . () - . , , 2013 -, II 30324.2.472012 . .11 .12 25 .
3、36 , 3 . 410 .4 . .420 .4 . 521 .5 . 536 5 . .6 . .6 . 650 .751 13 . ; .19 . 1956 19 101 (36.201.1) .20 102 (36.201.1 36.202.2) .21 103 (51.5.1).21 104 (51.5) 22 105 (51.5.3) .23 106 (51.5.11) 23 L () .24 () 25 31 31III 30324.2.472012 , 30324.0 ( ). - . - . , , -, -. . (*), , , - . IEC 60601-2-47. ,
4、 - , - , . L 1.5 - , . - .IV 30324.2.472012 2-47 Medical electrical equipment. Part 2-47. Particular requirements for the safety, including essential performance,of ambulatory electrocardiographic systems 20150101 . , :1 , :1.1 2.101 ( ). :) , () . , . ;b) , . , - . , . , - (, ), - 30324.25 30324.27
5、.1.2 -.1 30324.2.472012(I 60601-2-47:2001) 1.3 , - . - : , - ; , ; , - ; , - . , , , - 101, , . ., ), bb) . . , . , - , , , - . , . , - .1.5 30324.1.22012 (IEC 60601-1-2:2001) . 1-2. . . -2 , :2.101 () (AMBULA-TORY ELECTROCARDIOGRAPHIC SYSTEM (EQUIPMENT) , - . .2.102 (AMBULATORY RECORDER) , , .2.103
6、 (PLAYBACK EQUIPMENT) , . .2.104 () ELECTROCARDIOGRAM (ECG) () (. 2.101 30324.25).2.106 (PATIENT ELECTRODE) , , (. 2.104 30324.25).2 30324.2.4720122.107 (NEUTRAL ELECTRODE) / , - (. 2.107 30324.25).2.108 (PATIENT CABLE) (), (. 2.109 30324.25).2.109 () () (LEAD WIRE(S), .2.110 (CONTINUOUS RECORDER), () .5 , :5.6 , .6 , , :6.1 ) () ()() ( ) () , , () - , , . , .() 101. 101 * 1) 2) 1 2 3 ) 1 .) 2 . 1985 . , - , .* .3 30324.2.4720126.8.2 ) :1) , , , - ;2) , , ;3) BF CF, , , ;4) , ,
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