1、 1-1 (IEC 60601-1-1:2000, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)IEC 60601-1-12011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 (-)3 , (- 29 2011 . 40) : ( 3166) 00497 ( 3166) 00497 BYKZKGRU 4 13 2011 . 1323- IEC 60601-1-12011 - 1 2013 .5 IEC 60601-1-1:2000 Medic
2、alelectrical equipment Part 1-1: General requirements for safety Collateral standard Safetyrequirements for medical electrical systems ( . 1-1. - . . - ). (IDT). - . 60601-1-120076 - , - . () - . , , 2014 -, II IEC 60601-1-12011 . .11 .12 13 .26 , 2 . 310 .3 . .316 .317 319 .4 . .422 4 . 5 . .5 . .5
3、44 , , , , , . . 549 .5 . .5 . ; 552 5 . 556 557 , 658 659 .7 () .8 BBB () .12 () .14 DDD () 15 EEE () 16 FFF () .17 () .19III IEC 60601-1-12011 IEC 60601-1-1:2000 . 1. . 1. (IEC 60601-1-1:2000 Medicalelectrical equipment Part 1: General requirements for safety Collateral standard Safety requirement
4、sfor medical electrical systems), 62 . , - , / . , - . - . .IEC 60601-1-1 IEC 60601-1 - . 1. ( ). - , , (). , , , - . - :- ;- ;- ;- . (, ), - , - (, ). , . , -, 201; AAA, BBB . . :- , , , , ;- ;- , 2 , -, . . , , *. , . EEE , AAA,BBB, DDD, FFF GGG . IEC 60601-1-1:2000 CENELEC - .IV IEC 60601-1-12011
5、 1-1 Medical electrical equipment. Part 1-1. General requirements for safety.Safety requirements for medical electrical systems 20130101 . 1 *1.201 ( ), 2.201. - , .2 , , - IEC 60601-1 ( ). - , . :*2.201 (MEDICAL ELECTRICAL SYSTEM): - , , , - . , (. BBB FFF).*2.202 , (PATIENT ENVIRONMENT): , , (. -
6、201).*2.203 (SEPARATION DEVICE): , , .*2.204 (MULTIPLE PORTABLE SOCKET-OUTLET): , -, . , .*2.205 (FUNCTIONAL CONNECTION): , , .1 IEC 60601-1-12011 3 *3.201 . :- , , , , , - , , - , ( DDD). 3.201.1, 3.201.2, 3.201.3 3.201.4., , , , 3.201.1 3.201.2, , .3.201.1 - . .3.201.2 - , (. DDD). , - . .*3.201.3 10.2.2.201 - . , , . .*3.201.4 - . , , - . , ., , , . :- , , - , .6 , *6.8.201 ( ) , - . :a) - (. 6.8 );b) ;c) :- , , , - ;2 IEC 60601-1-12011- , - ;- , , ;- , - ;- ,
