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ISO/DIS 24088-1 Viešoji apklausa

Komentavimo iki data 2026-11-03

Biotechnologija. Mikroorganizmų biobankai. 1 dalis. Bakterijos ir archėjos

This document specifies requirements for the biobanking of bacteria and archaea. It includes management of microbial material associated data as well as biosafety and biosecurity requirements. This document is applicable to all organizations performing biobanking with bacteria and archaea used for research and development. This document does not apply to processing methods for microbial materials intended for food/feed production, laboratories undertaking food/feed analysis or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

ISO/DIS 21709 Viešoji apklausa

Komentavimo iki data 2026-11-01

Biotechnologija. Biobankai. Proceso ir kokybės reikalavimai, taikomi žinduolių ląstelių linijų nustatymui, išlaikymui ir apibūdinimui

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.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

ISO/DIS 18209-1 Viešoji apklausa

Komentavimo iki data 2026-11-03

Biotechnologija. Parazitų biobankai. 1 dalis. Helmintai

This document provides requirements for the biobanking of helminths as parasitic resources including the collection, safeguarding, classification, proliferation, preservation, storage and distribution of helminths. This document sets requirements for the quality of helminths and their associated data, the data collection, and safety management when handling the helminths as a source of human disease infection. This document is applicable to all organizations performing biobanking with helminths used for research and development. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

ISO/DIS 24603 Viešoji apklausa

Komentavimo iki data 2026-11-02

Biotechnologija. Biobankai. Reikalavimai, keliami žmogaus ir pelių pliuripotentėms kamieninėms ląstelėms

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, characterization, quality control (QC), maintenance, preservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations 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. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

ISO/DIS 25802 Viešoji apklausa

Komentavimo iki data 2026-11-03

Biotechnologija. Imunomagnetinių rutuliukų gamybos ir kokybės kontrolės reikalavimai

This document specifies requirements for the production and quality control of immunomagnetic beads. This document also gives general quality attributes for immunomagnetic beads, together with common methods for evaluating these quality attributes for end-use. This document is applicable to the research and development of immunomagnetic beads, and to the application field of immunomagnetic beads, e.g., cell sorting, protein purification, and microbial separation. NOTE For manufacturing of cell-based therapeutic products, users can refer to applicable standards such as ISO 20399.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

ISO/DIS 24651 Viešoji apklausa

Komentavimo iki data 2026-10-23

Biotechnologija. Biobankai. Iš kaulų čiulpų gautoms žmogaus mezenchiminėms stromos ląstelėms keliami reikalavimai

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, characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations 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. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

ISO/DIS 22859 Viešoji apklausa

Komentavimo iki data 2026-10-23

Biotechnologija. Biobankai. Iš virkštelės audinių gautoms žmogaus mezenchiminėms stromos ląstelėms keliami reikalavimai

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 characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport..This document is applicable to all organizations 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. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

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