Biotechnologie — Méthodes d'analyse de la viabilité cellulaire — Partie 1: Exigences générales et considérations

This document specifies the general requirements for cell viability analytical methods and for reporting cell viability. This document gives general guidelines for selecting and establishing fit for purpose cell viability analytical methods. This document specifies requirements for establishing standard operating procedures for cell viability analytical methods. This document also gives guidelines for managing sources of variability for cell viability measurements during pre-analytical, analytical, and post-analytical phases.

This document is applicable to cells in suspension, cells adhered to a substrate, and cells in complex matrices.

This document is primarily applicable to cell viability measurements of nucleated mammalian cells.

NOTE 1        Several sector/application-specific international and national standards for cell viability currently exist.

NOTE 2        When applicable, the user can consult existing standards when operating within their scope.