ISO 23511

En cours de publication (Edition 2, 2026)

Étapes finales du processus d’élaboration (jusqu’à sept semaines).

Remplacera ISO/TS 23511:2023

Résumé

This document specifies general principles, detection strategies and analytical methods for cell line identification of mammalian cells in the field of biotechnology. This document also specifies general requirements and key considerations for method selection, quality control parameters, data analysis and reporting in cell line identification.

This document is applicable to routine cell line cross-contamination testing in the fields of basic research, translational medicine studies and cell therapeutic product manufacturing. This document is also applicable to cell line identity confirmation to prevent cell misidentification in academic and industrial laboratories, cell banks and manufacturing sites. This document is primarily applicable to mammalian cells.

Informations générales

État actuel
: Projet

Date de publication
: 2026-07

Stade
: Norme internationale en cours de publication [60.00]
Edition
: 2
Comité technique :
ISO/TC 276/SC 1

ICS :
07.080
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