生物技术.生物银行.人和小鼠多能干细胞的要求

[中文适用范围]： 本文件规定了人类和小鼠多能干细胞（PSC）生物样本库的要求，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、配送和运输。 本文件适用于对用于研究和开发的人类和小鼠 PSC 进行生物样本库的所有组织。 本文件不适用于用于人类体内应用、临床应用或治疗用途的细胞系。 注：国际、国家或地区法规或要求或其中的多个法规或要求也适用于本文件中涵盖的特定主题。 [外文原描述]： 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.