Final Draft
International Standard
ISO/FDIS 18162
Biotechnology — Biobanking — Requirements for human neural stem cells derived from pluripotent stem cells
Reference number
ISO/FDIS 18162
Edition 1
Projet final Norme internationale
ISO/FDIS 18162
85207
Indisponible en français
Projet au stade approbation.

Résumé

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.

Informations générales

  •  : Projet
    : Epreuve envoyée au secrétariat ou mise au vote du FDIS: 8 semaines [50.20]
  •  : 1
  • ISO/TC 276
    07.080 
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