ISO 21709:2020 pdf download

ISO 21709:2020 pdf download.Biotechnology — Biobanking — Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines
1 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 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1 cell culture
growth of cells dissociated from the parent tissue by spontaneous migration or mechanical or enzymatic dispersal for propagation and consecutive passages in vitro
Note 1 to entry: Additional information can be found in Reference [6].
3.2
cell line
progeny of a primary culture (3.16) after it has been passaged beyond crises or beyond senescence
either spontaneously or after introduction of immortalizing factors
Note 1 to entry: A cell line is continuous for proliferation.
Note 2 to entry: Additional information can be found in Reference [7].
3.3 cell morphology
form and structure of the cell
Note 1 to entry: Morphology can be represented by a single parameter or a combination of two or more parameters.
3.4 cell strain
progeny of a primary culture (3.16) before it has been passaged beyond crises or beyond senescence or immortalized by introduction of immortalizing factors
Note 1 to entry: Not all the cell strains will continue proliferation to reach the cell lines.
3.5 cell type
classification used to distinguish among distinct cell forms
3.6 cryopreservation
process by which cells are maintained in a low temperature (e.g. −70 °C to −80 °C) at an inactive state so they can be revived later
3.7 derivative material
biological material that was derived from the original donation
EXAMPLE Derivative materials can be cell lines.