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GOST 8 627-2013 State system for ensuring the traceability of measurements In vitro diagnostics medicine test systems for measurement of quantities in biological samples Part 1 Hae量.pdf

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1、 IN VITRO, 1 , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)8.62720131 - . . ( . . -) 2 (-), 206 , 206.5 - 3 , ( 28 2013 . 58-) : ( 3166) 00497 ( 3166) 00497 AMBYKGMDRUTJUZUA - 4 22 2013 . 1750-8.6272013 - 1 2015 .5 -, - . () . , - - , 2015 -, II 8.62720131 .12 13 24 .25

2、 .26 .37 38 .39 4 () , 5 () .6 7III 8.6272013 IN VITRO, 1 State system for ensuring the iniformity of measurements. In vitro diagnostics medicine test systemsfor measurement of quantities in biological samples. Part 1. Haematology analysers. Verification procedure1 , ( ), , , c17715 % c17710 % , - .

3、 1).2 : 177074 ( 104283, 478880) . -, , , . 670972 . 2831189 . - 2849890 . - , 1 , - . - (), () . , , , , .1) - .1 8.6272013 201508013 3.1 , - 1. 1 1 8.12 8.23 1)8.34 8.41) , .3.2 , - .4 4.1 , 2. 2 ; , () () 7, 8- -67 1. : 1 . . -34- 2 10 % 100 %. 4 28498 0 50 . -: 0,1 . : 962420101). .1 28311 1770

4、67091) , .4.2 1:2.4.3 , 2, 2.4.4 , .5 , . , - .2 8.62720136 :- .(20c177 5) ;- 30%80%;- (101,3 c177 4,0) .7 :- ;- , -, ;- - (, ), , - ;- , -, , - , ;- ,- , 30 .8 8.1 8.1.1 :- () , ;- , .8.1.2 :- ,-, , ;- ;- ;- .8.1.3 8.1.1 8.1.2 .8.2 8.2.1 :- -;- ;- .8.2.2 - . , .8.2.3 . -, . - , , .3 8.62720138.3 8.

5、3.1 ( ) - , - ( ) , 1). .8.3.2 :- , , - ( , .);- , .8.3.3 - .8.3.4 , - .8.4 8.4.1 , , (, ).8.4.2 .8.4.3 (RB) (WBC) (HGB), - . (RB) (WBC) - (HGB) -.8.4.4 , , .8.4.5 c100i, %, c100i=XnXXiiinic45c61c229 010c215 100,(1) i i- ;n i- (n =3);i 0 , , .8.4.6 , - , .9 9.1 , .9.2 2) .9.3 2) .1) 3.2) 4.4 8.6272013 () , .1

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