ISO/CD 8934-2

Biotechnology --Cell viability analytical methods — Part 2: Experimental Designs and Statistical Analysis for Evaluating the Quality of Cell Count-Based Viability Methods

Scope

This document provides a set of experimental designs and statistical analyses for evaluating aspects of the quality of a cell count-based cell viability analytical method. A set of quality indicators are derived from measurements of a set of samples created using mixtures of diluent and cell viability quality control materials to evaluate performance characteristics of the cell viability analytical method.
These methods are primarily applicable to cell viability analytical methods that use differential cell count-based measurement processes. This method is suitable during cell viability method development, optimization, validation, evaluation and/or verification of cell viability measurement processes. This method is primarily applicable to eukaryotic cells.
NOTE          Several sector/application specific international and national standards for cell viability exist. Where applicable, consulting existing standards when operating within their scope can be helpful.