本文件规定了哺乳动物（包括人类）细胞系生物库的工艺和质量要求。它描述了生物库处理细胞系的基本程序的要求，如细胞系的建立、接收、识别、繁殖、保存、储存、质量控制和分配。 本文件可供使用用于研发的哺乳动物细胞系开展生物银行活动的组织、生物银行用户、使用同行评估和认证机构的组织和计划使用。 本文件不适用于治疗用生物材料。 注:国际、国家或地区法规或要求也可适用于本文件涵盖的特定主题。

This document specifies process and quality requirements for the biobanking of mammalian (including human) cell lines. It describes requirements for the fundamental procedures of the biobank handling cell lines, such as establishment, reception, identification, propagation, preservation, storage, quality control, and distribution of cell lines. This document can be used by organizations performing biobanking activities with mammalian cell lines used for research and development, biobank users, organizations and schemes using peer-assessment and accreditation bodies. This document does not apply to biological material intended for therapeutic use. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.