标准编号：ISO/TS 22859:2022
中文名称：生物技术 生物银行 来自脐带组织的人类间充质基质细胞的要求
英文名称：Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue
发布日期：2022-07
标准范围
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.
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