标准编号:ISO 21709:2020
中文名称:生物技术 生物库 哺乳动物细胞系建立、维护和鉴定的过程和质量要求
英文名称:Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
发布日期:2020-11
标准范围
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.