1、 55991.52014 5 , -. 1 - ( )2 380 - 3 2 2014 . 285-4 1.02012 ( 8). ( 1 ) , -. () . , - - (gost.ru) , 2014 , - - II 55991.520141 12 13 , 24 44.1 , 44.2 .44.3 .54.4 .54.5 , 54.6 .54.7 .54.8 , .54.9 , 54.10 54.11 .64.12 , .64.13 , .64.14 . 64.15 , 64.16 , , .64.17 65 , , - . . 75.1 , 75.2 , - 75.3 .75.4
2、 .85.5 , 85.6 .85.7 .85.8 , 85.9 .85.10 , .85.11 , .9III 55991.520145.12 . 95.13 , 95.14 , , .95.15 96 .9 () - .10 11IV 55991.52014 5 , - . In vitro diagnostics medical devices. Part 5. Automatic analyzers for blood gas, metabolite and acid-base balanceassessment. Technical requirements for public p
3、rocurement 201506011 () , - . , - - , - .2 : 1899680 . ISO 90002011 . 529052007 ( 15190:2003) . 151892009 . - - - - , 1 , . , , . , - , - (). , - , , , , . , -, , , .1 55991.52014 3 , :3.1 , - : , - .3.2 : , .1 :) ;) , , ;) ;) - ;) , ;) (, , 1 ), . 52361, 17.3.3 : , 8. , - , . , ; . , . 53022.22008
4、2, 3.23.4 : : , , , , , , , , , -, .3.5 : , , , . ISO 90002011, 3.8.51 , , , , .2 - .3.6 : , - .3.7 : , , , - , , .3.8 : , - 10. .3.9 : , - 3.3.10 : ( ) 7.2 55991.520141 , -, . , .2 , - . () () .3 , , .4 , - (), , - , , . 33.11 : , . - , , -, , . 4.12-97. - . III. 4. -: - . . () - .3.12 : : , -, .3.13 : -, .3.14 : .:1 (-) .2 .3 (SOP).3.15 : , - .3.16 : , - .3.17 : , , , . 61 , , , () , ( ) .2 , , -, ( ) ; -, -.(),. . . - , ,