ГОСТ Р ИСО 18113-2—2015
Библиография
(1] ISO 17511. In vitro diagnostic medical devices — Measurement of quantities In biological samples — Metrolo
gical traceability of values assigned to calibrators and control materials
(2]ISO 18113-3. In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) —
Part 3: In vitro diagnostic instruments for professional use
(3] ISO 18153. In vitro diagnostic medical devices — Measurement of quantities In biological samples — Metrolo
gical traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
(4]ISO/IEC Directives. Part 2. Rules for the structure and drafting of International Standards
(5]EN 375:2001. Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
(6]CLSl C28-A2: How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved
Guideline — Second Edition. CLSl; Wayne. PA. USA. 2000
(7]CLSl GP10-A; Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic
(ROC) Plots. Approved Guideline. CLSl; Wayne. PA. USA. 1995
(8] Directive 98/79/EC of the European Parliament and the Counc* of 27 October 1998 on in vitro diagnostic medical
devices. Official Journal of the European Union L331, 7 December. 1998
(9]Global Harmonization Task Force (GHTF), Labelling for Medical Devices. Final Documenl GHTF/SG1/N43:20O5,
3 June 2005
(10JDYBKAER. R. and SOLBERG. H E.. Approved recommendations (1987) on the theory of reference values.
Part 6. Presentation of observed values related to reference values. J. Clin. Chem. Clin. Biochem.. 25. pp.
657—662. 1987
[11JGALEN, R.S. and GAMBINO. S.R.. Beyond Normality. The Predictive Value and Efficiency of Medical Diagnoses.
Wiley Biomedical Publication. 1975
(12JPETITCLERC. C. and SOLBERG. H.E.. Approved recommendation (1987) on the theory of reference values.
Part 2. Selection of individuals for the production of reference values. J. Clin. Chem. Clin. Biochem.. 25. pp.
639—644, 1987
(13)POULSEN. O.M.. HOLST. E. and CHRISTENSEN. J.M.. Calculation and application of coverage intervals for
biologicalreference values (Technical Report) — A supplement to the approved IFCC recommendation (198 7)on
the theory of reference values. Pure Appl. Chem.. 69(7) pp. 1601— 1611. 1997
(14)SOLBERG. H.E., Approved recommendation (1986) on the theory of reference values. Part 1. The concept of
reference values. Clin. Chlm. Acta.,167. pp. 111— 118. 1987
(15) SOLBERG. H E.. Approved recommendations (1987) on the theory of reference values. Part 5. Statistical
treatment of collected reference values. Determination of reference limits. J. Clin. Chem. Clin. Biochem.. 25. pp.
645—6S6. 1987
(16)SOLBERG. H.E. and PETITCLERC. C.. Approved recommendation (1988) on the theory of reference values.
Part 3. Preparation of Individuals and collection of specimens for the production of referencevalues. Clin. Chim.
Acta.. 177(3). pp. S3— S11.1988
(17) SOLBERG. H.E. and STAMM. D. Approved recommendation on the theory of reference values. Part 4. Control of
analytical variation in the production, transfer, and application of reference values. Eur. J. Clin. Chem. Clin.
Biochem.. 29. pp. 531—535. 1991
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