ISO/FDIS 18162
Resumen
This document specifies requirements for the biobanking of human neural stem cells (hNSCs) derived from human pluripotent stem cells (hPSCs), including the requirements for the differentiaton, culture, characterization, quality control, storage, thawing and transport of hNSCs. Requirements for the collection of biological source material, the transport to and reception of biological source material and hPSCs at the biobank, as well as the establishment, expansion and QC of hPSCs are covered in ISO 24603. This document is applicable to all organizations performing biobanking of hNSCs used for research and development in the life sciences. This document does not apply to hNSCs 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.
Informaciones generales
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Estado: En desarrolloEtapa: Envío de la prueba a la secretaría o inicio de la votación del FDIS: 8 semanas [50.20]
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Edición: 1Número de páginas: 25
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Comité Técnico :ISO/TC 276ICS :07.080
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