GOST ISO 18153-2011 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of assigned values for catalytic concentration of 体外.pdf

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1、 in vitro , (ISO 18153:2003, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 181532011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 (-)3 , (- 402011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJUZUA 4 13 2011 . 1332- ISO 181532011 1 2013 .5 ISO 18153:2003 In vit

2、ro diagnosticmedical devices Measurement of quantities in biological samples Metrological traceability of values forcatalytic concentration of enzymes assigned calibrators and control materials ( - in vitro. . - , ).C (IDT). 181532006. - ( ) 6 ( ) - . , . , 2012 -, II ISO 1815320111 12 13 24 34.1 .3

3、4.245 .65.1 .65.2 .75.3 75.4 7 () 8 () ( ) .9 () 10 11III ISO 181532011 , - , - . IS 17511 -, . , , , - . , ( ), . - ( -). - ( -) , , , , . . - , , . - . - ( ), , - , . - . (). , :- ( , ) -;- ;- ;- ;- ;- ;- ;- , ;- ;- ., - , : - ; . , . :) - ;IV ISO 181532011b) - , . - - . , , . ; - ; - ; . - , - ,

4、. . . - , ., -, , . -:- , ;- - , ;- () - () () , , - ( ). - , , -. , . - -. . , - , , -. IS 18153:2003.V ISO 181532011 in vitro , In vitro diagnostic medical devices. Measurement of quantities in biological samples.Metrological traceability of assigned values for catalytic concentration of enzymesin

5、 calibrators and control materials 201301011 , , . in vitro . :) ;b) , ;c) , - , ( );d) , , - - , ;e) , .2 :IS 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biologicalsamples Metrological traceability of values assigned to calibrators and control materials ( - in vitro.

6、 . - , ) (M), 19931) (GUM), 19932)1) , , : (International Bureau of Weights and Measures; BIPM), (InternationalElectrotechnical Commission; IEC), (International Federation of Clinical Chemistry and Laboratory Medicine; IFCC), - (International Organization for Standardization; ISO), (International Union of Pure and Applied Chemistry; IUPAC), (International Union of Pure and Applied Physics; IUPAP), - (International Organization of Legal Metrology; OIML). .2) , . GUM.1 ISO 181532011 3 :3.1 (analyte): , . 1

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