BS ISO 21899:2020 pdf free.Biotechnology – Biobanking – General requirements for the validation and verification of processing methods for biological material in biobanks.
BS ISO 21899 This document specifies the validation and verification requirements applicable to a biobank to be able to demonstrate that it operates its processing of biological materials with validated and/or verified methods that are fit for purpose.This document is intended for use in the implementation and validation of processing methods for biological materials.
This document covers method validation and verification for the production of all biological materials.This document does not apply to biological material intended for food/feed production, laboratories undertaking food/feed analysis, and/or therapeutic use. Reference material production is not covered in this document. For the production requirements for
reference materials, see ISO 17034.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, Biotechnology一Biobanking 一General requirements for biobanking.<processing method> coefficient of variation (CV %) of a property value being measured in biological materials which are the processing (3.15) output from aliquots (3.1) of the same input biological material (e.g. volume, weight, concentration) Note 1 to entry: The reproducibility of a processing method (3.16) includes components arising from the processing method itself and from the analytical uncertainty of the testing method used to assess the reproducibility.Note 2 to entry: In general, for a given set of information, it is understood that the reproducibility of a processing method is associated with a stated measurand (3.9]. A modification of this measurand and the testing method
results in a modification of the associated reproducibility.6.1.1 When the customer (depositor or recipient) does not specify the processing method to be used,the biobank laboratory shall select processing methods that have been published either in international,regional or national standards, or by reputable technical organizations, or in relevant scientific texts orjournals, or as specified by the manufacturer of the equipment / commercial kit, and that are deemed fit for purpose.BS ISO 21899 pdf downlaod.