ГОСТ ISO 18153-2011
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(180 18153:2003, IDT)
1 2 3 UZ UA 4 5 6 1 2 3 4 4.1 4.2 5 5.1 5.2 5.3 5.4 - - - - - - - - - - а?)
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In vitro diagnostic medical devices. Measurement of quantities in biological samples.Metrological traceability of assigned values for catalytic concentration of enzymesin calibrators and control materials
1 а?) Ь?) с?) d) е?) 2 ISO 17511:2003 In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials ( 1 > 3 3.1 3.2 3.3 3.4 3.5 [ 3.6 [ 4 4.1 4.1.1 4.1.2 4.1.3
" 4.2 4.2.1
4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.2.7 4.2.8 4.2.9 4.2.10 5 5.1 5.2 5.2.1 5.3 5.3.1 5.3.2 5.4 1 Bergmeyer H.LL, Horder 2 Bergmeyer H.U., Herder M., Rej R. Approved recommendation (1985) on IFCC methods for the measurement of catalytic concentration of enzymes. Part 3. IFCC method for alanine aminotransferase (L-alanine:2-oxoglutarate aminotransferase, EC 2.6.1.2). [ 3 Shaw L.M., Stromme J.H., London J.L., Theodorsen L. IFCC methods for the measurement of catalytic concentration of enzymes. Part 4. IFCC method for y-glutamyltransferase [y-glutamyl)-peptide amino acid y-glutamyltransferase, EC 2.3.2.2]. [ 4 Tietz N.W., Rinker A.D., Shaw L.M. IFCC methods for the measurement of catalytic concentration of enzymes. Part 5. IFCC method (proposed) for alkaline phosphatase (orthophosphoric-monoester phosphohydrolase, alkaline optimum, EC 3.1.3.1). [ 5 Horder M., Elser R.C., Gerhardt W., Mathieu M., Sampson E.J. Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part 7. IFCC method for creatine kinase (ATP:creatine N-phosphotransferase, EC 2.7.3.2). [ 6 Bais R., Philcox M. Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part 8. IFCC method for lactate dehydrogenase (L-lactate: NAD + oxidoreductase, EC 1.1.1.27). [ 7 Lorentz K. Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part 9. IFCC method fora-amylase (1,4-a-D-glucan 4-glucanohydrolase, EC 3.2.1.1). [ - IDT — [1] IUPAC/IFCC. Compendium of terminology and nomenclature of properties in clinical laboratory sciences (Recommendations 1995). (Edited by Rigg J.C., Brown S.S., Dybkaer R., Olesen H.) Oxford: Blackwell Science Ltd, 1995:xi+ 290 pp
[2] EN 12286: 1998 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Presentation of reference measurement procedures ( [3] EN 12286:1998/ [4] EN 12287:1999 In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Description of reference materials ( [5] Directive 98/79/ [6] European Committee for Clinical Laboratory Standards (ECCLS). Standard for enzyme calibration materials and control materials. ECCLS Document No. 5. 1998:ii+ 33 pp/
[7] Fasce C.F., Rej R., Copeland W.H., Vanderlinde R.E. A discussion of enzyme reference materials: applications and specifications. Clin. Chern. 1973; 19:5—9
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[9] Ferard G., Edwards J., Kanno T., Lessinger J.M., Moss D.W., Shiele F., et al. Validation of an enzyme calibrator — An IFCC guideline. Clin. Biochem. 1998; 31(6): 495—500
[10] Ferard G., Edwards J., Kanno T., Lessinger J.M., Moss D.W., Shiele F., et al. Interassay calibration as a major contribution to the comparability of results in clinical enzymology. Clin. Biochem. 1998; 31(6): 489—94
[11] Henderson A.R., Krishnan S., Webb S., Cheung C.M., Nazir D.J., Richardson H. Proficiency testing of creatine kinase and creatine kinase-2: the experience of the Ontario Laboratory Proficiency Testing Program. Clin. Chern. 1998; 44: 124—33
[12] Lessinger J.M., Dourson J.L., Ferard G. Importance of standardization of lipase assays by using appropriate calibrators. Clin. Chern. 1996; 42:1979—83
[13] Lessinger J.M., Dourson J.L., Ferard G. Importance of the definition of catalytic properties for the commutability of an enzyme reference material: example of lipase. Fresen J.AnaL Chern. 1998; 360: 494—7
[14] Lessinger J.M., Ferard G., Grafmeyer D., Labbe D., Maire I., Schiele F., et al. Usefulness of reference materials in calibration of enzyme activities. Eur J.Clin. Chern. Clin. Biochem. 1995; 33: 858—64
[15] Lessinger J.M., Ferard G., Grafmeyer D., Labbe D., Maire I., Schiele F., et al. Amelioration de la coherence des resultates en enzymologie clinique: Etude multicentrique concernant les activites gammaglutamyltransferase, phosphatase alcaline et amylase. Ann. Biol. Clin. 1995; 53: 147—54
[16] Moss D.W. Enzyme reference materials. Their place in diagnostic enzymology. J IFCC 1994; 6:6—9
[17] Moss D.W., Maire I., Calam D.H., Gaines Das R.E., Gella F.J., et al. Reference materials in clinical enzymology: preparation, requirements and practical interests. Ann. Biol. Clin. 1994; 54: 189—98
[18] Ricos C., Juvany R., Jimenez C.V., Perich C., Minchinela J., Hernandez A., et al. Procedure for studying commutability validated by biological variation. Clin. Chim. Acta. 1997; 268: 73—83