Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks (ISO 21899:2020) #
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.
Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from umbilical cord tissue (ISO/TS 22859:2022) #
This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from umbilical cord tissue (i.e. Wharton’s jelly), further referred to as hUC-MSCs, including the collection of umbilical cord tissue and associated data, isolation, culture characterisation, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organisations performing biobanking of hUC-MSCs used for research and development. This document does not apply to hUC-MSCs for the purpose of in vivo application in humans, clinical applications or therapeutic use.
Biotechnology – Biobanking – Requirements for human and mouse pluripotent stem cells (ISO 24603:2022) #
This document specifies requirements for the biobanking of human and mouse pluripotent stem cells (PSCs), including the collection of biological source material and associated data, establishment, expansion, characterisation, quality control (QC), maintenance, preservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organisations performing biobanking with human and mouse PSCs used for research and development. This document does not apply to cell lines used for in vivo application in humans, clinical applications or therapeutic use.
Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow (ISO 24651:2022) #
This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from bone marrow (hBM-MSCs), including the collection of bone marrow and associated data, isolation, culture, characterisation, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organisations performing biobanking with hBM-MSCs used for research. This document does not apply to hBM-MSCs for the purpose of in vivo application in humans, cell therapy, clinical applications, tissue engineering or therapeutic use.
Biotechnology — Provenance information model for biological material and data — Part 1: Design concepts and general requirements (ISO/TS 23494-1:2023) NEW #
This document specifies a general concept for a provenance information model for biological material and data and requirements for provenance data interoperability and serialisation. The provenance information model covers any information relevant to the quality and fitness for purpose of the biological material generated throughout the preanalytical phase of the materials life cycle from collection to analysis, data originating from analytical procedures applied to the biological material and results from further mathematical processing of the data.
