BSI 19/30366132 DC:2019 Edition
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BS ISO 21709. Biotechnology. Biobanking. Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
Published By | Publication Date | Number of Pages |
BSI | 2019 | 25 |
This document specifies process and quality requirements for the biobanking of mammalian (including human) cell lines. This document 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 is applicable to all organizations performing biobanking activities with mammalian cell lines used for research and development.
Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document.
This document does not apply to biological material intended for therapeutic use.
International, national or regional regulations or requirements can also apply to specific topics covered in this document.