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ISO 21899:2020

Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks

Publication date:   Jun 15, 2020

General information

60.60 Standard published   Jun 15, 2020

ISO

ISO/TC 276 Biotechnology

International Standard

07.080   Biology. Botany. Zoology

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Scope

This document specifies the validation and verification requirements applicable to a biobank to be able to demonstrate that it operates its processing of biological materials with validated and/or verified methods that are fit for purpose.
This document is intended for use in the implementation and validation of processing methods for biological materials.
This document covers method validation and verification for the production of all biological materials. This document does not apply to biological material intended for food/feed production, laboratories undertaking food/feed analysis, and/or therapeutic use.
Reference material production is not covered in this document. For the production requirements for reference materials, see ISO 17034.

Life cycle

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PUBLISHED
ISO 21899:2020
60.60 Standard published
Jun 15, 2020