标准摘要
[中文适用范围]： 本文件规定了从人类多能干细胞（hPSCs）衍生的人类神经干细胞（hPSC-NSCs）进行生物银行化的要求，包括分化、培养、特征化、质量控制（QC）、储存、解冻和运输hPSC-NSCs的要求。ISO 24603涵盖了生物材料的收集、运输到生物银行以及接收生物源材料和hPSCs，以及hPSC的建立、扩展和QC的要求。 本文件适用于所有执行用于生命科学领域研究和开发的人类神经干细胞（hPSC-NSCs）生物银行化的组织。 本文件不适用于以人类体内应用、临床应用或治疗用途为目的的人类神经干细胞（hPSC-NSCs）。 [外文原描述]： This document specifies requirements for the biobanking of human neural stem cells (hPSC-NSCs) derived from human pluripotent stem cells (hPSCs), including the requirements for the differentiaton, culture, characterization, quality control (QC), storage, thawing and transport of hPSC-NSCs. 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 hPSC-NSCs used for research and development in the life sciences. This document does not apply to hPSC-NSCs 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.
英文名称Biotechnology — Biobanking — Requirements for human neural stem cells derived from pluripotent stem cells