ГОСТ РЕН 13612—2010
Документы Европейского комитета клинических лабораторных стандартов
Guidelines for the Evaluation of Analysers in Clinical Chemistry. 1986. vol. 3. no. 2.
Guidelines fora User Laboratory to Evaluate and Select a Kit for its Own Use: 1986. vol. 3 no. 3
Guidelines for the Evaluation of Diagnostic Kits. Pari 2: General Principles and Outline Procedures for the Evaluation of Kits
for Qualitative Tests. 1990. no. 1
Guidelines for Multi-centre Evaluation of Analysers for the Measurement of Blood pH. pC02, and p02
Guidelines for the Identification and Distribution of Patient Samples In the Medical Laboratory: 1990. vol. no. 5
Документы Национального комитета клинических лабораторных стандартов (США)
NCCLS. Evaluation of the Llneanty of Quantitative Analytical Methods: A StatisticalApproach: Proposed Guideline. Second
Edition. NCCLS Document EP6-P2. Wayne. PA: NCCLS; 2001.
NCCLS. Interference Testing in Clinical Chemistry: Proposed Guideline. NCCLS Document EP7-P. Wayne. PA: NCCLS.
1986
NCCLS. Blood Gas and pH Analysis and Related Measurements; Approved Guideline. NCCLS
DocumentC46-A. Wayne. PA: NCCLS; 2001
NCCLS. Immunopreclpltm Analyses: Procedures for Evaluating the Performance of Materials;Approved Guideline.Second
Edition. NCCLS Document 0I2-A2. Wayne. PA: NCCLS; 1993.
NCCLS. Ancillary (Bedside) Blood Glucose Testing In Acute and Chronic Care Facilities; Approved Guideline. NCCLS
DocumentC30-A. Wayne. PA:NCCLS; 1994
NCCLS. Specifications for Immunological Testing for Infectious Diseases; Approved Guideline. Second Edition. NCCLS
Document I/LA18-A2. Wayne. PA: NCCLS; 2001
NCCLS. Laboratory Statistics .Standard Deviation. A Report. NCCLS Document EP13-R. Wayne. PA NCCLS: 1995
NCCLS. Method Comparison and Bias Estimation Using Patient Samples. Approved Guideline. NCCLS Document EP9-A
Wayne. PA. NCCLS. 1995
NCCLS. How to Define and Determine Reference Intervals in the Clinical Laboratory. Approved Guideline. Second Edition.
NCCLS Document C28-A2. Wayne. PA: NCCLS; 2000
NCCLS. Uniformity of Claims For in Vitro Diagnostic Tests; Proposed Guideline. NCCLS Document EP11-P. Wayne, PA:
NCCLS; 1996
NCCLS. Detection and Quantitation of Rubella igG Antibody; Evaluation and Performance Criteria for Multiple Component
Test Products. Specimen Handling, and Use of Test Products in the Clinical Laboratory; Approved Guideline. NCCLS
Document I/LA6-A. Wayne. PA: NCCLS: 1997
NCCLS. Preliminary Evaluation of Quantitative Clinical Laboratory Methods: Approved Guideline. NCCLS Document
EP10-A. Wayne. PA: NCCLS;1998
NCCLS. User Demonstration of Performance for Precision and Accuracy; Approved Guideline. NCCLS Document EP15-A.
Wayne. PA. NCCLS: 2001
NCCLS. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline. NCCLS Document
EPS-А. Wayne. PA. NCCLS:1999
NCCLS. ClmicalEvaluationof Immunoassays. Approved Guideline. NCCLS DocumentI/LA21-A. Wayne. PA: NCCLS; 2001
NCCLS. Quality Management for Unit-Use Testing; Proposed Guideline. NCCLS Document ЕР 18-P. Wayne. PA. NCCLS:
1999
NCCLS. Evaluation of Matrix Effects; Approved Guideline. NCCLS Document EP14-A. Wayne. PA: NCCLS: 2001
NCCLS. User Protocol for Evaluation of Qualitative Test Performance. Proposed Guideline. NCCLS Document EP12-P.
Wayne. PA. NCCLS: 2000
Другие источники
Directive 98/79/EC of the European Parliamentand of the Council of 27 October 1998 on in vitro diagnostic medicaldevices.
1998. No L 331
Convention for the protection of human rights and dignity of the human being with regard to the application of biology and
medicine: Convention on human rights and biomedicine. Council of Europe. European Treaty Series. No. 164. Oviedo.
04.IV.1997
R. S. Galen. S. R. Gambmo. Beyond normality: the predictive value and efficiency of medical diagnosis. John Wiley & Sons,
New York. 1975
Standardisation Efforts for Evaluating Instruments in Clinical Chemistry. Eds. M.H. Khayat. N. Montalbetti. G. Cenotti, P. A
Bonmi: AMNEC Advances In Clinical Chemistry, vol. 1. Dolphin Publishers. Milano. 1982,255.262
Evaluation of Instruments In Clinical Chemistry. Clm.Chem. Newsletter 3.1983.3.13
G. H. White. C. G. Fraser. The Evaluation Kit for Clinical Chemistry: a Practical Guide for the Evaluation of Methods.
Instruments and Reagent Kits.. J.Autom.Chem., vol. 6.1984.122.141
W. Bablok. H. Passing. Application of StatisticalProcedures in Analytical Instrument Testing. J. Autom. Chem.. vol. 7.1985.
74.79
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