ISO 24651:2022 PDF

Scope: This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from bone marrow (hBM-MSCs), including the collection of bone marrow and associated data, isolation, culture, characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking with hBM-MSCs used for research. This document does not apply to hBM-MSCs for the purpose of in vivo application in humans, cell therapy, clinical applications, tissue engineering or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

ISO 24651:2022 Referenced Document

ISO 20387:2018 Biotechnology - Biobanking - General requirements for biobanking
ISO 21709:2020 Biotechnology - Biobanking - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
ISO 8601-1 Date and time — Representations for information interchange — Part 1: Basic rules — Amendment 1: Technical corrections*， 2022-10-25 Update

2022 ISO 24651:2022 Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow