ISO/FDIS 20012:2025

This document specifies requirements for the biobanking of human natural killer (NK) cells derived from human pluripotent stem cells (hPSCs), including the requirements for the differentiaton, culture, characterization, quality control, storage, thawing and transport of NK cells. Requirements for the collection of biological source material, the transport to and reception of biological source material and hPSCs at the biobank, as well as the establishment, expansion and QC of hPSCs are covered in ISO 24603. This document is applicable to all organizations performing biobanking of human NK cells used for research and development in the life sciences. This document does not apply to human NK cells for the purpose of in vivo application in humans, clinical applications 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.