ISO/TS 20388:2021 PDF

This document specifies requirements for the collection, reception, preparation, preservation, transport, storage, distribution, destruction and disposal of biological materials obtained from animals, excluding humans. Such resources include solid tissues, fluid samples and associated cells, excretory products and associated data.

This document is applicable to biological material or associated data, or both, that can be used for research and development and to biomolecules derived from the biological material, e.g. nucleic acids, proteins and metabolites.

This document is applicable to all organizations performing biobanking for research and development.

This document does not apply to biological material intended for food or feed production, laboratories undertaking analysis for food or feed production, or therapeutic use, or multiple of them.

This document does not apply to the establishment of cell lines derived from animal biological material.

NOTE°°°°° International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.