1、 , () INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION (ISC) 2-51 (IEC 60601-2-51:2003, IDT) 2013 IEC 60601-2-51 2011 IEC 60601-2-512011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 40-2011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU 4 13 2011 . 1305- IEC 60601-2-51
2、2011 1 2013 . 5 IEC 60601-2-51:2003 Medical electrical equipment Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs ( . 2-51. ). (IDT). 60601-2-512008 6 ( ) . , . C, 2013 , IEC 60601-2-512011
3、V . IEC 60601-1:1988 . 1. , 1 1991 . 2 1995 ., ( ). , , . . , , , . , . (*) , . : - , 2, ; - . IEC 60601-2-512011 1 2-51 Medical electrical equipment. Part 2-51. Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocar
4、diographs -2013-01-01 . 1 , : *1.1 , 2.101, 2.111, 2.117, 2.123 2.126 ( ), . IEC 60601-2-25 1 1999 . 1.2 , IEC 60601-2-25, . : - ; IEC 60601-2-512011 2- , , , , ; - , , , , ; - , , (, ) ; - , . , , , (, ), . 1.3 IEC 60601-1 . 1. 1 1991 . 2 1995 . ( ), IEC 60601-2-25 . 2. 1 1999 . : IEC 60601-1-2 . 1
5、. . 2. . . , IEC 60601-1-4 . 1. . 4. . . , . IEC 60601-2-512011 3 , . : ; ; . , , , , 101; , ., ), bb) . . , , , . - , , . . 2 , : 2.101 : , , / . / . 2.102 (CAL): , . 2.103 : , . IEC 60601-2-512011 42.104 () : , R, L F-. 2.105 : - / - , , . 2.106 : , , , , , . . , ( ) , ( ), . 2.107 : , -. 2.108 :
6、(, ), , , . . 2.109 : , , . 2.110 (): , (. 2.108). 2.111 : , . 2.112 (): ( ), (. 109). ( ) . 2.113 (): , - () -, , . 2.114 () : (), () () . IEC 60601-2-512011 52.115 (): () , () (. 110). 2.116 : . 2.117 : - -. , . . 2.118 : , / , . 2.119 (, ): () , . 2.120 : , 10 /. 2.121 : , . 2.122 : () . 2.123 : , . 2.124 : (, L- F- ). 2.125 : , (/). 2.126 : . 2.127 : . 2.128 : , e ( 37 %) . . . IEC 60601-2-512011 62.129 : , : - -: ( ); - -: ; - QRS-: QRS ( ); - QRS-: QRS; - -: ( ). 4 , : 4.6 ) ,
