本文件规定了从脐带组织（即沃顿凝胶）衍生的人间充质干细胞（简称hUC-MSCs）生物银行的要求，包括脐带组织和相关数据的收集、分离、培养特性、质量控制、冷冻保存、储存、解冻、处置、分配和运输。 本文件适用于对用于研发的hUC MSC进行生物银行化的所有组织。 本文件不适用于在人体内应用、临床应用或治疗用途的hUC-MSC。 注意国际、国家或地区法规或要求，或其中多项，也可适用于本文件所涵盖的特定主题。

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.