ISO/TS 23105:2021 pdf – Biotechnology — Biobanking — Requirements for the biobanking of plant biological material for research and development.
1 Scope This document specifies requirements for the collection, preparation, preservation, transportation, storage, distribution and disposal of plant biological materials and associated data. This document is applicable only to biological material that can be used for further processing of biomolecules, e.g. nucleic acids, proteins and metabolites. This document is applicable to all organizations performing plant biobanking for research and development. 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 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminology databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https://www.iso .org/obp — IEC Electropedia: available at https://www.electropedia .org/ 3.1 associated data any information affiliated with biological material (3.4) including but not limited to research, phenotypic, clinical, epidemiologic, phytosanitary certificate and procedural data Note 1 to entry: Associated data can include metadata. [SOURCE: ISO 20387:2018, 3.3, modified — “phytosanitary certificate” and Note 1 to entry have been added.] 3.2 biobank legal entity or part of a legal entity that performs biobanking (3.3) [SOURCE: ISO 20387:2018, 3.5]
3.3 biobanking process of acquisitioning and storing, together with some or all of the activities related to collection, preparation, preservation (3.9), testing, analysing and distributing defined biological material (3.4) as well as related information and data [SOURCE: ISO 20387:2018, 3.6] 3.4 biological material <plant material biobanking> plant as a whole, or any substance derived or part obtained from the plant entity 3.5 dried spots card card containing chemicals that lyse cells, denature proteins and protect nucleic acids from nucleases as well as from oxidative and ultraviolet damage; can be used to process plant biological material (3.4) homogenates 3.6 life cycle consecutive and interlinked processes applied to biological material (3.4) and associated data (3.1) from collection, if applicable, acquisition or reception to distribution, disposal or destruction Note 1 to entry: This term refers to the biobanking ( 3.3) life cycle only. [SOURCE: ISO 20387:2018, 3.29] 3.7 plant genetic resource genetic material of plant origin, containing functional units of heredity (e.g. DNA or RNA), or elements thereof (e.g. mRNA, mtDNA) 3.8 plant biobank plant genetic resource bank plant gene bank plant BRC legal entity or part of a legal entity that performs the process of acquisitioning and storing, as well as some or all of the following activities: collection, preparation, preservation (3.9), testing, analysing and distributing defined plant genetic resource (3.7 ) as well as related information and data Note 1 to entry: “Plant BRC ” stands for “Plant Biological Resource Center ”. 3.9 preservation act of preventing or retarding biological or physical deterioration of biological material (3.4) [SOURCE: ISO 20387:2018, 3.34, modified — “act of preventing or retarding ” has replaced “act to prevent or retard ”.]
4 General requirements The biobank shall follow ISO 20387:2018, Clauses 4 to 7. The biobank shall establish, implement and maintain a quality management system in accordance with ISO 20387:2018, Clause 8. The biobank shall identify each biological material and associated data relevant to the application of this document. The biobank shall have procedures addressing biobanking for each type of biological material (e.g. whole plant, seeds, tuber, bulbs, scion wood, leaf, root, DNA, RNA) and associated data. This includes processes such as collection, acquisition, reception, characterization/evaluation, storage, preparation, preservation, rejuvenation and distribution. The biobank shall ensure the legitimate acquisition of biological material and its associated data, and the retention of any relevant documentation. If legitimate acquisition cannot be demonstrated, the biological material shall be discarded, according to documented procedures, and this shall be documented. NOTE 1 Such documentation can relate to relevant documents such as international treaties and agreements, and a phytosanitary certificate or passport. NOTE 2 Legitimate acquisition can refer to relevant regulation, permits or authorization. The biobank shall ensure that biorisk management procedures (e.g. ISO 35001, WHO guidance ) for potential plant pests and pathogens are established, documented, implemented and maintained, as appropriate. The biobank shall take measures to prevent cross contamination. The biobank or the legal entity of which it is a part shall ensure that human health and safety requirements are established, documented, implemented and maintained. The level of safety training required shall be determined using a comprehensive risk assessment of the biological and chemical materials, processes and equipment that is handled (see ISO 20387:2018, 188.8.131.52).