BS ISO 20391-2:2019 - Biotechnology. Cell counting. Experimental design and statistical analysis to quantify counting method performance
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BS ISO 20391-2:2019

Biotechnology. Cell counting. Experimental design and statistical analysis to quantify counting method performance

Status : Current   Published : September 2019

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This document provides a method for evaluating aspects of the quality of a cell counting measurement process for a specific cell preparation through a set of quality indicators derived from a dilution series experimental design and statistical analysis. The quality indicators are based on repeatability of the measurement and the degree to which the results conform to an ideal proportional response to dilution. This method is applicable to total, differential, direct and indirect cell counting measurement processes, provided that the measurement process meets the criteria of the experimental design (e.g. cells are suspended in a solution).

This method is most suitable during cell counting method development, optimization, validation, evaluation and/or verification of cell counting measurement processes.

This method is especially applicable in cases where an appropriate reference material to assess accuracy is not readily available. This method does not directly provide the accuracy of the cell count.

This method is primarily applicable to eukaryotic cells.

NOTE

Several sector/application specific international and national standards for cell counting exist. Where applicable, consulting existing standards when operating within their scope can be helpful.




Standard NumberBS ISO 20391-2:2019
TitleBiotechnology. Cell counting. Experimental design and statistical analysis to quantify counting method performance
StatusCurrent
Publication Date05 September 2019
Normative References(Required to achieve compliance to this standard)ISO 20391-1
Informative References(Provided for Information)ISO/IEC Guide 99:2007, ISO 3534-1, ISO/IEC 25062, ISO/IEC Guide 98-3:2008, DIN 58932-1, ISO 16732-1:2012, ISO 8655-1:2002, ISO 9000:2015, ISO 5725-2:2019, ISO 8655-6:2002, ISO 15198:2004, BS ISO 5725-2:2019, ISO 8655-2:2002, ISO 5725-1:1994
International RelationshipsISO 20391-2:2019
Draft Superseded By18/30341474 DC
DescriptorsPerformance, Analysis, Experimental design, Counting, Biotechnology
ICS07.080
Title in FrenchBiotechnologie. Dénombrement des cellules Conception expérimentale et analyse statistique pour quantifier les performances de la méthode de dénombrement
CommitteeBTI/1
ISBN978 0 580 94246 4
PublisherBSI
FormatA4
DeliveryYes
Pages62
File Size3.148 MB
Price£254.00


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