ISO/DIS 22859

En desarrollo

Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.

Reemplazará ISO/TS 22859:2022

Resumen

This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from umbilical cord tissue (i.e. Wharton’s jelly), further referred to as hUC-MSCs, including the collection of umbilical cord tissue and associated data, isolation, culture characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport.

This document is applicable to all organizations performing biobanking of hUC-MSCs used for research and development.

This document does not apply to hUC-MSCs 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.