BS ISO 21709:2020 pdf free.Biotechnology一Biobanking一Process and quality requirements for establishment, maintenance and characterization of mammalian cell lines.
BS ISO 21709 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.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一Biobanking一General requirements for biobanking ISO 20391-1, Biotechnology一Cell counting一Part 1: General guidance on cell counting methods ISO 20391-2, Biotechnology一Cell counting一Part 2: Experimental design and statistical analysis to quantify counting method performance.The biobank shall consult an ethics review committee, which is responsible for the investigation and evaluation of any related ethical principles/requirements. The biobank shall comply with ISO 20387:2018, 4.1.6. The biological material, which is the source of the cell line, shall be collected, transported, and handled according to internationally accepted procedures. The biobank shall be aware of and able to demonstrate compliance with relevant national, regional and international approved ethics, laws and regulations relating to the biological material held in the biobank. Further ethical requirements related to the informed consent are included in 4.6. The biobank shall meet the organizational structure, resource, process, and quality requirements described in ISO 20387:2018, Clauses 5, 6 and 7, in addition to those in this document. BS ISO 21709 pdf download.