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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 .
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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
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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) , ,
