ISO 24651:2022 生物技术 生物库 对人间充质基质细胞的要求

标准编号：ISO 24651:2022

中文名称：生物技术 生物库 对人间充质基质细胞的要求

英文名称：Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow

发布日期：2022-08

标准范围

本文件规定了来自骨髓的人类间充质干细胞（hBM-MSCs）生物银行的要求，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、分配和运输。本文件适用于所有使用用于研究的hBM-MSC进行生物银行业务的组织。本文件不适用于人骨髓间充质干细胞在体内应用、细胞治疗、临床应用、组织工程或治疗用途。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 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.

标准预览图