1、 151932015 IN VITRO . ISO 15193:2009In vitro medical devices Measurement of quantities in samples of biologicalorigin Requirements for content and presentation of reference measurementprocedures(IDT) 1 - - . . , 42 380- in vitro3 27 2015 . 298-4 15193:2009 - in vitro. . - (ISO 15193:2009 In vitro me
2、dicaldevices Measurement of quantities in samples of biological origin Requirements for content andpresentation of reference measurement procedures). - 1.52012 ( 3.5). - - , 5 151932007 1.02012 ( 8). ( 1 ) , -.() - . , - (www.gost.ru) , 2015 , - - II 1519320151 .12 13 24 .34.1 34.2 44.3 .44.4 44.5 ,
3、 , 44.6 54.7 54.8 .64.9 74.10 .74.11 .84.12 84.13 .94.14 104.15 124.16 124.17 .124.18 .124.19 134.20 .13 () , - 14 () ( ).1515III 151932015 , , , / , / . , :) , , , ;b) , ;) ( ), - ;d) . , , -, , , , , . , , , :- , -;- ;- -. / 15. 3 .IV 151932015 IN VITRO . In vitro medical devices. Measurement of q
4、uantities in samples of biological origin.Requirements for content and presentation of reference measurement procedures 201606011 in vitro . 1 , , , - , -, . , - . - () () . , , -, . , - , . 2 . ( ).2 - 1): 15194 in vitro. - . - (ISO 15194, In vitro diagnostic medical devices Measurement of quantiti
5、es in samples ofbiologicalorigin Requirementsforcertifiedreferencematerialsandthecontentofsupportingdocumentation) / 98-3:2008 (GUM 1995) ISO/IEC Guide 98-3:2008, Guide to the expression of incertainty in measurement (GUM 1995) / 99:2007 . (VIM) ISO/IEC Guide 99:2007, International vocabulary of met
6、rology Basic and general concepts and associated terms (VIM)1) . - ( ).1 151932015 3 / 99 / 98-3:3.1 (primary sample): , - . , , .3.2 (laboratory sample): , .3.3 (analytical sample): , . , .3.4 (analytical portion): , -, , . , - , . , , .3.5 (analytical solution): , .3.6 (matrix): , .3.7 (reference
7、measurement procedure): - , , , - , - ( ).1 / 99, 2.7.2 a 12 13.3 , , - , ( ), , , .4 - .3.8 (analytical sensitivity): , .1 .2 / 99 .3.9 (analytical specificity): , .3.10 (analytical interference): , , , - .3.11 (influence quantity): , - , , . / 99, 2.52.3.12 (mesurand): , .2 1519320151 / 99, 2.3.2 . . - , .3.13 (detection limit, limit of detection): , , c98 c97 - .1 c97 c98 - 0,05.2 LOD.3 .4 / 99, 4.18.3.14 (calibrator): , . / 99, 5.12.4 4.1 , 1 . , , , . 1 - 4.2 4.3 4.4 , , 4.5 4.6 4.7 4,8 4.9 4.10 4.11 4.12 4.13 4.143
