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ISO 20391-2:2019
Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance
Translate name
STANDARD published on 28.8.2019
The information about the standard:
Designation standards: ISO 20391-2:2019
Publication date standards: 28.8.2019
SKU: NS-969485
The number of pages: 53
Approximate weight : 159 g (0.35 lbs)
Country: International technical standard
Category: Technical standards ISO
The category - similar standards:
Annotation of standard text ISO 20391-2:2019 :
Description / Abstract: 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.
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