ГОСТ Р ИСО 18113-4—2015
Библиография
[1] ISO 15197. In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for
self-testing In managing diabetes mellitus
[2] ISO 17593. Clinical laboratory testing and in vitro medical devices — Requrements for in vitro momtonng
systems for self-testing of oral anticoagulant therapy
[3] ISO 18113-5. In vitro diagnostic medical devices — Information supplied by the manufacturer
(labelling) — Part 5: In vitro diagnostic instruments for self-testing
[4]ISO/IEC Directives. Part 2. Rules for the structure and drafting of International Standards
[5]EN 376.2002. Information supplied by the manufacturer with In vitro diagnostic reagents for selftesting
[6] CLSi C28-A2. How to Define and Determine Reference Intervals In the Clinical Laboratory; Approved
Guideline — Second Edition. CLSI; Wayne. PA. USA, 2000
[7] CLSI GP10-A. Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic
(ROC) Plots; Approved Guideline. CLSI; Wayne. PA. USA. 1995
[8| Directive 98/79/EC of the European Parliament and the Council 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). LabeBing for Medical Devices. Final Document GHTF/SG1/N43:2005,
3 June 2005
(10) BACKINGER, C.L. and KINGSLEY. P.A.. Wnte It Right; Recommendations for Developing User Instruction
Manuals for Medical Devices Used in Home Health Care. Rockville. MD. U.S. Food and Drug Administration.
Center for Devices and Radiological Health. HHS Pub. FDA 93-4258 (August 1993). Available at;
www.fda.gov/cdrh/dsma/897.pdf
(11) DYBKAER. 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
(12) GALEN. R.S. and GAMBINO. S.R.. Beyond Normality; The Predictive Value and Efficiency of Medical Diagnoses.
Wiley Biomedical Publication. 1975
(13) PETlTCLERC. 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
(14) POULSEN. O.M.. HOLST. E. and CHRISTENSEN. J.M.. Calculation and application of coverage intervals for
biological reference values <Technical Report) — a supplement to the approved IF CC recommendation (198 7)on
the theory of reference values. Pure Appl. Chem.. 69(7). pp. 1601-1611.1997
(15) 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
(16) 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. Clm. Chem. Clin. Biochem., 25. pp.
645—656. 1987
(17) SOLBERG. H.E. and PETlTCLERC. C.. Approved recommendation (1988) on the theory of reference values.
Part 3. Preparation of Individuals and collection of specimens for the production of reference values. Clin. Chim.
Acta., 177(3). pp. S3—S11 1988
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) 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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