DANSK DSF/ISO/DIS 24651 PDF

This document specifies requirements for the collection, isolation, culture, expansion, characterization, quality control, cryopreservation, storage, distribution and transport of human mesenchymal stromal cells derived from bone marrow (hBM-MSCs) for biobanking. 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 research topics covered in this document.