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ISO 21709:2020

Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines

General information
Valid from 20.11.2020
Directives or regulations
None

Standard history

Status
Date
Type
Name
08.09.2021
Amendment
20.11.2020
Main
This document specifies process and quality requirements for the biobanking of mammalian (including human) cell lines. It describes requirements for the fundamental procedures of the biobank handling cell lines, such as establishment, reception, identification, propagation, preservation, storage, quality control, and distribution of cell lines.
This document can be used by organizations performing biobanking activities with mammalian cell lines used for research and development, biobank users, organizations and schemes using peer-assessment and accreditation bodies.
This document does not apply to biological material intended for therapeutic use.
NOTE     International, national or regional regulations or requirements can also apply to specific topics covered in this document.
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