ГОСТ Р ИСО 17511—2022
Библиография
[1] IEC 60050-300:2001 International Electrotechnical Vocabulary — Electrical and electronic measurements and
measuring instruments — Part 311: General terms relating to measurements
[2]ISO Guide 31:2015, Reference materials — Contents of certificates, labels and accompanying documentation
[3] ISO Guide 35:2017, Reference materials — Guidance for characterization and assessment of homogeneity and
stability
[4] ISO/IEC Guide 98-3:2008, Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in
measurement (GUM:1995)
[5] ISO/IEC Guide 99:2007, International vocabulary of metrology — Basic and general concepts and associated terms
(VIM)
[
6
] ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results. Part 1: General principles
and definitions
[7]ISO 9000 Quality management systems — Fundamentals and vocabulary
[
8
]ISO 15189:2012, Medical laboratories — Requirements for quality and competence
[9] ISO 15195, Laboratory medicine — Requirements for the competence of calibration laboratories using reference
measurement procedures
[10] ISO/TR 16476:2016, Reference materials — Establishing and expressing metrological traceability of quantity values
assigned to reference materials
[11]ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories
[12]ISO 17034:2016, General requirements for the competence of reference material producers
[13]ISO 18113-1:2009, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling)
[14] ISO 18153:2003, In vitro diagnostic medical devices — Measurement of quantities in biological samples —
Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
[15]ISO 20391-1:2018, Biotechnology — Cell counting — Part 1: General guidance on cell counting methods
[16] ISO 20395:2019, Biotechnology — Requirements for evaluating the performance of quantification methods for
nucleic acid target sequences — qPCR and dPCR
[17] ISO 21151, {in development), In vitro diagnostic medical devices — Requirements for international harmonisation
protocols establishing metrological traceability of values assigned to calibrators and human samples
[18]CLSI Measurement Procedure Comparison and Bias Estimation Using Patient Samples — Approved Guideline.
EP09-A3. Clinical and Laboratory Standards Institute, Wayne, PA, 2013
[19] CLSI Evaluation of Commutability of Processed Samples — Approved Guideline. EP14-A3. Clinical and Laboratory
Standards Institute, Wayne, PA, 2014
[20] CLSI Characterization and qualification of commutable reference materials for laboratory medicine — Approved
Guideline. EP30-A. Clinical and Laboratory Standards Institute, Wayne, PA, 2010
[21]Global Harmonization Task Force (GHTF), Principles of IVD Medical Devices Classification, GHTF/SG1/N045: 2008
[22]Global Harmonization Task Force (GHTF), Definitions of the Terms Manufacturer, Authorised Representative,
Distributor and Importer, Document GHTF/SG1/N055: 2009
[23] ILAC P10, 01/2013 ILAC Policy on Traceability of Measurement Results. International Laboratory Accreditation
Cooperation (ILAC), PO Box 7507, Silverwater NSW 2128, Australia
[24]OIML V1 2013, Vocabulaire international des termes de metrologie legale (VIML), International Organization for
Legal Metrology
[25]Emons H. et al. New definitions on reference materials. Accred Qual Assur. 2006; 10(10):576—578
[26]Harmonization.net.
https://www.harmonization.net/media/1004/tool_box_2013.pdf
(accessed 19/03/2018)
[27] Joint Committee for Traceability in Laboratory Medicine (JCTLM) FAQs.
http://www.bipm.org/en/committees/jc/
jctlm/jctlm-faq.html, accessed 14 April 2016
[28]Joint Committee for Traceability in Laboratory Medicine (JCTLM).
https://www.bipm.org/jctlm
[29]WHO, Guidelines for the preparation, characterization and establishment of international and other standards and
reference reagents for biological substances. Techn Rep Ser 1990; No.800 (Annex 4): 181—214
50