KS P ISO 17511-2010 In vitro diagnostic medical devices-Measurement of quantities in biological samples-Metrological traceability of values assigned to calibrators and control mate.pdf

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1、 KSKSKSKSKSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 17511 KS P ISO 17511:2010 2010 12 17 http:/www.kats.go.krKS P ISO 17511:2010 : ( ) ( ) () () ( ) : (http:/www.standard.go.kr) ： ：2005 2 28 ：2010 12 17 2010-0598 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS P ISO 17511:2010 i ii iii 1 1 2 1

2、 3 .2 4 8 4.1 .8 4.2 9 4.3 13 4.4 .14 5 15 5.1 .15 5.2 SI 1 1 15 5.3 (1 ) SI .16 5.4 (1 ) 17 5.5 (1 ) 18 5.6 19 5.7 20 6 20 7 21 8 .22 23 KS P ISO 17511:2010 ii 2003 1 ISO 17511, In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values a

3、ssigned to calibrators and control materials , . . KS P ISO 17511： 2005 . . , , . , , . KS P ISO 17511:2010 iii , ( .) . “ (3.1 )” “ (3.33 )” “ (3.23 )” . 98/79/EC “ ” “ ” . “ ” ( ) . , . 1. e) . . 1 2 ( ) , ( 1 ). . SI , . . , . / . . , . thyrotropin(thyroid stimulating hormone： TSH) . . 400 700 .

4、KS P ISO 17511:2010 iv , ( ) ( ) . . SI 5 . a) SI 1 ( ) 1 ( ) . , , , thyroid 25 30 . (4.2.2, 5.2, 1 2 ). b) SI 1) (3.12 )(1 ) (3.11 ) , HbA1C (5.3 3 ). 2) , 30 ( ) (haemostatic factor) (5.4 4 ). 3) ( ) , 300 , WHO (5.5 5 ). 4) , . 300 (5.6 6 ). ( ) , EN 12286 EN 12287 . b) 2), 3), 4) b) 1) . prEN I

5、SO 18153 . KS P ISO 17511:2010 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials 1 . . , ( ) . . a) , ( ) b) , , c) , d) e) f) , , . 2 . . ( ) . KS A ISO GUIDE 35, EN 375： 2001, Inform

6、ation supplied by the manufacturer with in vitro diagnostic reagents for professional use KS P ISO 17511:2010 2 Informational Vocabulary of Basic and General Terms in Metrology, 2nd edition, ISO, Geneva,1993 3 . 3.1 (accuracy of measurement) VIM： 1993, 3.5 1 . 2 , “ ” “ ” . 3 “ ” “ ” . 4 “ ” KS Q IS

7、O 3534 1 “ ” , , , . 5 “ ” “ (3.33 )” “ (3.23 )” . 98/79/EC . 3.2 (analyte) “24 ” “ ” . “ ” “ ” . (3.17 ). 3.3 (analytical specificity) 3.4 (bias of measurement) “ ” . 3.5 (calibration) , VIM： 1993, 6.11 “ ” “ ”(3.19 ) . KS P ISO 17511:2010 3 3.6 (calibration transfer protocol) 3.7 (calibrator) (cal

8、ibration material) 3.8 (CRM, certified reference material) . . VIM： 1993, 6.14 . 3.9 (commutability of a material) 3.10 (influence quantity) VIM： 1993, 2.7 3.11 (international conventional calibrator) (international conventional calibration material) SI . 3.12 (international conventional reference m

9、easurement procedure) SI . 3.13 (international measurement stanadard) (international standard) VIM： 1993, 6.2 KS P ISO 17511:2010 4 3.14 (matrix of a material system) (matrix) EN 12287： 1999, 3.3 3.15 (matrix effect) 1 . 2 “ ” ( ) . 3.16 (measurable quantity) (quantity) , VIM： 1993, 1.1 1 . 2 “ ” “

10、” (3.2 ). 3.17 (measurand) VIM： 1993, 2.6 3.2 3.18 (measurement procedure) VIM： 1993, 2.5 3.19 (measurement standard) , , , , VIM： 1993, 6.1 1 ( , KS P ISO 17511:2010 5 ). 2 “ ” “ ” “ ” . . 3.20 (method of measurement) , VIM： 1993, 2.4 . . 3.21 (metrological traceability) . . VIM： 1993, 6.10 1 ( ) .

11、 2 . . 3.22 (metrology) , . VIM： 1993, 2.2 3.23 (precision of measurement) ISO 3534 1： 1993, 3.14 1 “ ” “ ” . 2 “ ” “ ” . 3 “ ” . “ ” “ ” “ (run) ” . “ ” , , ( ) “ ” . KS P ISO 17511:2010 6 3.24 1 (primary reference material) 1 , 1 “1 ” “ (3.7 )” “1 ” . 2 3.26 3.25 1 (primary reference measurement p

12、rocedure) , SI . (CCQM) “1 ” . “1 ” VIM(3.19 ) . “ (definitive method)” VIM , (3.29 ) . 3.26 1 (primary measurement standard) 1 (primary standard) VIM： 1993, 6.4 1 . 3.27 (product calibrator) 3.28 (RM, reference material) , 1 VIM： 1993, 6.13 . 2 “ ” , . 3.29 (reference measurement procedure) . EN 12

13、286： 1998, 3.7 KS P ISO 17511:2010 7 3.30 2 (secondary measurement procedure) 2 (secondary standard) 1 VIM： 1993, 6.5 3.31 (true value of a quantity) (true value) VIM： 1993, 1.19 1 . 2 . 3 “the” “a” , (consistent) . 4 . . 3.32 (trueness control material) 3.33 (trueness of measurement) 1 ISO 3534 1：

14、1993, 3.12 . ( ), . 2 3.31 2 3 , . 4 . 3.34 (uncertainty of measurement) VIM： 1993, 3.9 1 , ( ) . 2 (A ) (B ) (10 ). , . KS P ISO 17511:2010 8 3.35 (validation) . KS Q ISO 9000, 3.8.5 3.36 (verification) . KS Q ISO 9000, 3.8.4 3.37 (working measurement standard) (working standard) , VIM： 1993, 6.7 4 4.1 4.1.1 , ( ) . , . a) ： choriogonadotropin(hCG) b) (： IFCC, ICSH) / (： ) (： ) c) CGPM, ISO, WHO, / (： ) d) CGPM, WHO, / (：mmol/L) 4.1.2