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2、014III IN VITRO 1 In vitro diagnostic medical devices for fluorescent and immunofluorescent analysis of dried spot of newborns blood.Part 1.Instruments and accessories for fluorescent and immunofluorescent analysis of dried spot of newborns blood.Technical requirements for state to buy in 201506011
3、- in vitro - . , , .2 : 2.6012006 . 1515069 , . . , , - 30804.4.22013 (IEC 61000-4-2:2008) -. . 30804.4.42013 (IEC 61000-4-4:2004) -. . 5044492 , . 5108897 . - 51317.4.599 . . 51318.112006 ( 11:2004) -. , , () . - . 5135099 ( 61010-190) - . 1. 51522.12011 . . 1. 1 55992.12014 516092000 . . 523192005
4、 ( 61010-12001) -, . 1. 53133.12008 . . 1. - 53133.22008 . . 2. 55992.22014 in vitro - . 2. ( ) . 151932007 in vitro. . 151982009 . - in vitro. , - - , 1 , - . - , , . , - , (). , , , , , . , -, , , .3 :3.1 in vitro (in vitro diagnostic medical device): - , , , , -, , , , , , in vitro - , , , - , ,
5、, - , .1 , - , in vitro, in vitro.2 in vitro, in vitro.1, 3.13.2 in vitro (in vitro diagnostic instrument): -, in vitro.3, 3.262 55992.120143.3 in vitro (accessoryto an IVD medical device): , in vitr, - .9, 4; 10, , 1/1.23.4 (manufacturer): , -, , , , , - , .3, 3.363.5 (specimen): , , - .2, 3.5p , o
6、, - .3.6 (analytical portion): , -, . 151932007, 3.4 , . . - , .3.7 - (test-blank): () - ( - ), . - , . 6, 12.3.8 (dried spot of blood): - , -. - , - , , , , , , . , -, .3.9 (screening): - .3.10 (neonatal screening): - 11,12. 22 2006 185 - , , , 11.3.11 (fluoroimmunoassay): , in vitro , - (c. 3.19)., 5108897, 3.9 1, 133.12 (time-resolved fluoro-immunoassay): , - - 14.3 55992.120141 - -
