ISO 23033:2021

недоступно на русском языке

Опубликовано (Версия 1, 2021)

ISO 23033:2021

CHF 155

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Тезис

This document provides general requirements for the testing of cellular therapeutic products intended for human use.

This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose.

Such considerations can be used to establish critical quality attributes for a cellular therapeutic product.

This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.

This document is not applicable to tissues used in transplantation.

Общая информация

Текущий статус
: Опубликовано

Дата публикации
: 2021-08

Этап
: Опубликование международного стандарта [60.60]
Версия
: 1
Технический комитет :
ISO/TC 276/SC 1

ICS :
07.080
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