ISO 21709:2020
Biotechnology - Biobanking - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
- Standard No.
- ISO 21709:2020
- Release Date
- 2020
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 21709:2020/Amd 1:2021
- Latest
- ISO 21709:2020/Amd 1:2021
- Scope
- 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 peerassessment 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.
ISO 21709:2020 Referenced Document
- ISO 20387:2018 Biotechnology - Biobanking - General requirements for biobanking
- ISO 20391-1 Biotechnology - Cell counting - Part 1: General guidance on cell counting methods
- ISO 20391-2 Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance
ISO 21709:2020 history
- 2021 ISO 21709:2020/Amd 1:2021 Biotechnology - Biobanking - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines; Amendment 1
- 2020 ISO 21709:2020 Biotechnology - Biobanking - Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
