Final Draft
International Standard
ISO/FDIS 25347
Biotechnology — Bioprocessing — General requirements for the purification of extracellular vesicles
Reference number
ISO/FDIS 25347
Edition 1
© ISO 2026
Proyecto final Norma internacional
En desarrollo
Este borrador está en fase de aprobación.

Resumen

This document specifies general requirements for the establishment of a fit for purpose purification process for extracellular vesicles (EVs) specifically for research and development. This document includes requirements for selection of purification methods and equipment, and for validation of the purification process.

This document provides requirements for purification equipment suppliers of EVs as well as requirements for purification equipment users.

This document is applicable to EV purification from cell culture supernatants. This document is also applicable to EV purification from body fluid.

Informaciones generales

  • Estado
     : En desarrollo
    Etapa
    : Texto final recibido o FDIS registrado para su aprobación formal [50.00]
  • Edición
     : 1
  • Comité Técnico :
    ISO/TC 276
    ICS :
    07.080 
  • RSS actualizaciones

Ciclo de vida

Objetivos de Desarrollo Sostenible

Esta norma contribuye a los siguientes Objetivos de Desarrollo Sostenible

3
Good Health and Well-being
4
Quality Education
8
Decent Work and Economic Growth
9
Industry, Innovation and Infrastructure
12
Responsible Consumption and Production

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