标准摘要
[中文适用范围]： 本文件规定了源自骨髓的人间充质基质细胞（hBM-MSC）生物样本库的要求，包括骨髓和相关数据的收集、分离、培养、表征、质量控制、冷冻保存、储存、解冻、处置、分发和运输。 本文件适用于所有使用用于研究的 hBM-MSC 进行生物样本库的组织。 本文件不适用于人类体内应用、细胞治疗、临床应用、组织工程或治疗用途的 hBM-MSC。 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 mesenchymal stromal cells derived from bone marrow (hBM-MSCs), including the collection of bone marrow and associated data, isolation, culture, characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking with hBM-MSCs used for research. This document does not apply to hBM-MSCs for the purpose of in vivo application in humans, cell therapy, clinical applications, tissue engineering 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 mesenchymal stromal cells derived from bone marrow