ISO/NP 8934-2

Biotechnology --Cell viability analytical methods — Part 2: Experimental Designs and Statistical Analysis for Evaluating the Quality of Cell Count-Based Viability Methods ISO/NP 8934-2

Scope

This proposed International Standard 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 a cell concentration series experimental design a viability spike-in series experimental design 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.