本文件规定了人和小鼠多能干细胞（PSC）生物银行的要求，包括生物源材料和相关数据的收集、建立、扩增、表征、质量控制（QC）、维护、保存、储存、解冻、处置、分发和运输。 本文件适用于所有使用用于研发的人和鼠PSC进行生物银行业务的组织。 本文件不适用于体内应用、临床应用或治疗应用的细胞系。 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 and mouse pluripotent stem cells (PSCs), including the collection of biological source material and associated data, establishment, expansion, characterization, quality control (QC), maintenance, preservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking with human and mouse PSCs used for research and development. This document does not apply to cell lines used for 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.