KS P ISO 18153-2010 In vitro diagnostic medical devices-Measurement of quantities in biological samples-Metrological traceability of values for catalytic concentration of enzymes a体外.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS P ISO 18153 KS P ISO 18153 :2010 2010 12 17 http:/www.kats.go.krKS P ISO 18153:2010 ： ( ) ( ) () () ( ) ： (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 18153:2010 i ii iii 1 1 2

2、 1 3 .1 4 .3 4.1 .3 4.2 .4 5 .6 5.1 .6 5.2 6 5.3 7 5.4 7 A() (IFCC) 1 8 B() (CRM) 9 10 KS P ISO 18153:2010 ii 2003 1 ISO 18153, In vitro diagnostic medical devicesMeasurement of quantities in biological samplesMetrological traceability of values for catalytic concentration of enzymes assigned to cal

3、ibrators and control materials , . . KS P ISO 18153：2005 . . , , . , , . KS P ISO 18153:2010 iii 98/97/EC (reference measurement materials) (reference measurement procedures) . “ ” prEN ISO 17511 , . . SI . ( .) , . , SI “ (mole per second cubic metre)”, (CGWM) “ (katal per cubic metre)” , . 1 , 1 ,

4、 . . , , . . , ( ), . “IFCC NADH (creatine kinase) ” . 1 , . ( ) pH . (EQA： external quality assessment) . . . . a) KS P ISO 18153:2010 iv b) . “ ” a) 20 . . . . , , , . , . . . . “ ” b) . . 1. 2. - 3. , () () (inter-procedure ratio) ( ). . ( ) . . . . KS P ISO 18153：2010 In vitro diagnostic medical

5、 devicesMeasurement of quantities in biological samplesMetrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials 1 (trueness) . . . a) b) c) ( ) d) , , e) f) 2 . . ( ) . KS P ISO 17511, International Vocabulary of Basic and General Terms

6、 in Metrology, 2nd edition, Geneva：ISO, 1993 Guide to the Expression of Uncertainty in Measurement, 1st edition, Geneva：ISO, 1993 3 KS P ISO 18153:2010 2 . 3.1 (analyte) “ 1 ” “ 1” . (measurand) (3.5 ). 3.2 (catalytic activity) Z E 1 IUPAC/IFCC 1995：9.101.3 . 2 “ ” . 3 “ ” . 4 SI “ (katal)” (kat) “

7、” (mols 1 ) . 5 . 6 (：“ ” “ ”) . , “ ” . , “ IFCC NADP + ” . 3.3 - (catalytic-activity concentration) (catalytic concentration) b E . 1 IUPAC/IFCC 1995：9.104.2 . 2 SI “katal per cubic meter” “mole per second cubic meter”(katm 3 mols 1 m 3 ). “ ” . 3 “ ” “ ” . 3.4 (commutability of a material) 3.5 (m

8、easurand) VIM：1993, 2.6 KS P ISO 18153:2010 3 3.1 3.6 (metrological traceability) ( ) VIM：1993, 6.10 1 . 2 . “ ” . 4 4.1 4.1.1 KS P ISO 17511 “ ” ( “ ” “ ” ) . 1 . 1 1 . (CCQM) 1 1 . 4.1.2 . 1 ( , ). 1 ( , (co-factor), , ) , . . 2 . . 4.1.3 SI 1 . ( ) . KS P ISO 18153:2010 4 4.2 . KS P ISO 17511 . ：

9、ARML ：Accredited reference measurement laboratory( , ) BIPM ：International Bureau of Weights and Measures() CGPM ：General Conference on Weights and Measures() IOs ：International scientific organixations(：IFCC ) ML ：Manufacturess laboratory ( ) NMI ：National metrology institute() u c (y) . u c (y) .

10、a , , b . 1 SI 4.2 4.2.1 SI “ ” “ ”(katm 3 mols 1 m 3 ) 1 , . a) CGPM SI c) 1 b) 1 d) 2 f) h) e) 2 b g) i) j) / IOs aIOs aNMI, ARML ARML, ML ARML,ML ML ML u c (y) KS P ISO 18153:2010 5 1 “ ” ( ) () . 2 “ ” , “ ”katL 1 kat/Lmols 1 L 1 (mol/s)/L . 3 U “ ” ( “ ”), 1 U1 molmin 1 16.66710 9kat . 1 U/L 16

11、.66710 9kat/L. . 4.2.2 , 1 , . SI ( , ) . . GUM：1993 . 1 , . 2 1 (IFCC) . 1 , . 3 (IFCC) 1 30 37 . 37 ALT, AST, CK, y-GT, LDH 1 . 1 A . 4.2.3 1 1 ( 4.2.2 ), . 1 1 . 2 1 BCR , “ ” “ (IRMM：Institute of Reference Materials and Measurements)” (IFCC) . B . 4.2.4 2 1 (4.2.3 ). 1 . 4.2.2 . 1 2 1 . 4.2.2 1

12、. 2 2 . 4.2.5 2 2 (4.2.4 ). KS P ISO 18153:2010 6 1 2 . 2 . 3 2 . 4.2.6 , 1 2 . 2 (4.2.4 ). 4.2.7 2 (4.2.4 ) 1 (4.2.2 ). (5.3 ). . 4.2.8 (4.2.7 ). . 4.2.9 (4.2.8 ). . 4.2.10 (4.2.9 ). 1 . 5 5.1 . 1 . . 2 . 5.2 5.2.1 , KS P ISO 18153:2010 7 . 1 (alanine aminotransferase)(EC 2.6.1.2) (pyridoxal phosphate) . (co-factor) . 2 -(amylase)(EC 3.2.1.1) . . 5.2.2 , . . . . 5.3 5.3.1 ( ) . x y , . 1 (x, y) y , . 2 , . 5.3.2 . , . . 5.4 , . KS P ISO 18153:2010 8 A () (IFCC) 1 (IFCC)