生物技术 生物样本库 源自多能干细胞的自然杀伤细胞的要求

[中文适用范围]： 1 范围 本文件规定了源自人类多能干细胞（hPSCs）的人天然杀伤（NK）细胞生物库管理的各项要求，包括NK细胞的分化、培养、鉴定、质量控制、储存、解冻及运输等方面的要求。关于生物样本源的采集、生物样本源及hPSCs运抵并接收至生物库的相关要求，以及hPSCs的建立、扩增与质量控制等内容，已在ISO 24603中予以规定。 本文件适用于所有开展用于生命科学研究与开发目的的人NK细胞生物库管理工作的组织。 本文件不适用于旨在人体体内应用、临床应用或治疗用途的人NK细胞。 注：国际、国家或地区的相关法规或要求（或其中多项）也可能适用于本文件所涵盖的特定主题。 [外文原描述]： This document specifies requirements for the biobanking of human natural killer (NK) cells derived from human pluripotent stem cells (hPSCs), including the requirements for the differentiaton, culture, characterization, quality control, storage, thawing and transport of NK cells. 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 human NK cells used for research and development in the life sciences. This document does not apply to human NK cells 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.