ISO/DIS 20404
ISO/DIS 20404
недоступно на русском языке

This document provides minimum requirements, and general considerations for the design of packaging used to contain cells for therapeutic use.

This document is intended to help the supplier of packaging to design and manufacture packaging in consideration of enclosing, storage, transportation and utilization processes of cells for therapeutic use. This document is also intended to help the users of packaging to design and employ packaging in consideration of the above-mentioned processes.

This document is also applicable to packaging intended to contain final products of cells for therapeutic use, as well as their starting materials and intermediate materials.

This document does not specify:
a) receptacles used for processing cells in manufacturing processes, e.g., cell culture flask or bag;
b) shipping container, in which to contain package for transportation;
c) services performed with package, e.g. storage service.

NOTE 1 Examples of packaging, package and shipping container are illustrated in Annex A.
NOTE 2 International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Общая информация 

  •  :  Under development
  •  : 1
  •  : ISO/TC 276 Biotechnology
  •  :
    07.080 Biology. Botany. Zoology

Приобрести данный стандарт

Формат Язык
std 1 58 PDF
std 2 58 Бумажный
  • CHF58

Жизненный цикл

Появились вопросы?

Ознакомьтесь с FAQ

Работа с клиентами
+41 22 749 08 88

Часы работы:
Понедельник – пятница: 09:00-12:00, 14:00-17:00 (UTC+1)

Будьте в курсе актуальных новостей ИСО

Подписывайтесь на наши новости, обзоры, а также на информацию о продуктах.