GPDR
Privatumo politika
projektai-lsd Lietuvos akreditacijos ir standartizacijos agentūra
Standartų projektų portalas

Projekto 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 organizacija

ICS

07.080 - Biologija. Botanika. Zoologija

Technikos komitetas

TK 87 Biotechnologija

Užsienio technikos komitetas

ISO/TC 276

Komentarų skaičius

0

Komentavimo pradžia

2026-03-16

Taikymo 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.