ISO 20391-1:2026Published

Biotechnology — Cell counting — Part 1: General requirements and recommendations for cell counting analytical methods

Biotechnologie — Dénombrement des cellules — Partie 1: Exigences générales et recommandations relatives aux méthodes analytiques de dénombrement des cellules

Abstract / scope

This document provides standard terminology related to cell counting for biotechnology. This document describes counting of cells in suspension (generally cell concentration) and cells adhered to a substrate (generally area density of cells). This document provides key considerations for general counting methods (including total and differential counting, and direct and indirect counting) as well as for fit for purpose method selection, sources of variability in the measurement process, and data analysis and reporting.

This document is applicable to the counting of all cell types – mammalian and non-mammalian (e.g. bacteria, yeast) cells.

NOTE            Several sector or application-specific international and national standards for cell counting currently exist. When applicable, the user can consult existing standards when operating within their scope (e.g. specific measurement techniques or applications).

Life cycle

Replaces

ISO 20391-1:2018WithdrawnBiotechnology — Cell counting — Part 1: General guidance on cell counting methodsInternational Standard · Published 19 Jan 2018 · ISO/TC 276/SC 1