GOST R ISO 15194-2013 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content o.pdf

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1、 15194 2013 in vitro ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation (IDT) 2014 151942013 II 1 - . . . , 4 2 380 in vitro 3 28 2013 . 621- 4 15194:2

2、009 in vitro. . (ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and content of supporting documentation). , 5 15194 - 2007 1.02012 ( 8). ( 1 ) , . () . , (gost.ru) , 2014 , 151942013 III , ,

3、, / . , , , . . , , , , , , , . . : ) , ; b) , ; , , , , ( ), , , , c) . , , , . , . / 15 7. - 15194:2002. 151942013 1 in vitro In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting

4、 documentation 20140801 1 , 17511. , , , , . . . . , in vitro, . 2 : 31 ( )1. 5725-2 ( ) . 2. 17511:2003 in vitro - , 18153 in vitro - , 31 34 35 1 31 80000 80000. 151942013 2 / 98-3:2008 (GUM 1995) / 99:2007 (VIM) 3 , / 99, : 3.1 (primary measurement standard): , . - , . 1 / 99, 5.4. 2 , . 3 17511

5、18153. 3.2 (secondary measurement standard): , . 1 , . 2 / 99, 5.5. - NIST. 1951b, , NIST 1911, . 3 . 4 . 17511 18153. 3.3 () , (international conventional calibrator, international conventional calibration material): , , . 1 . 2 17511, 3.11. 3.4 , (reference material, RM): , , , . 1 , , . 2 . / 99,

6、 5.13. 151942013 3 1 - , , . 2 - , , . 3 . . 4 . , , . , () . 5 . , , : - ; - , ; - . 3.5 (certified reference material, CRM): , , , . 1 / 99, 5.14. - , , , . 2 , , . . 3 . 3.6 ( ) matrix (of a material system): . 3.7 (matrix effect): , , , , . 1 . 2 , . . 3.8 (commutability of a reference material): , , , . 1 , , , . 2 , , , (), . 151942013 4 3 / 99, 5.15. 3.9 (report): , , . 4 4.1 4.1.1 . - (

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