ISO/DIS 25347
Biotechnologija. Biologinis apdorojimas. Ekstraląstelinių pūslelių gryninimo bendrieji reikalavimai
Standarto projektas Viešoji apklausaProjekto etapai
1. CD study/ballot initiated
2. Viešoji apklausa
Nuo 2026-03-16
iki 2026-05-11
3. Closure of enquiry
Organizacija
ISO Tarptautinė standartizacijos organizacijaICS
07.080 - Biologija. Botanika. ZoologijaTechnikos komitetas
TK 87 BiotechnologijaUžsienio technikos komitetas
ISO/TC 276Komentarų skaičius
0Komentavimo pradžia
2026-03-16Taikymo sritis
This document specifies general requirements for the establishment of a fit for purpose purification process for extracellular vesicles (EVs) specifically for research and development. It includes the selection of the purification method, equipment and 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. It is also applicable to EV purification from body fluid. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.