Back

ISO 23033:2021

Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products

General information

Valid from 27.08.2021
ICS Groups
07.080 Biology. Botany. Zoology
Directives or regulations
None

Standard history

Status
Date
Type
Name
27.08.2021
Main
ISO 23033:2021
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.

Required fields are indicated with *

*
*
*
PDF
197.98 € incl tax
Paper
197.98 € incl tax
Standard monitoring
English (PDF 976 KB)

Related products

Main

EVS-EN 12469:2000

Biotechnology - Performance criteria for microbiological safety cabinets
Newest version Valid from 01.11.2000
Main

EVS-EN 12128:1999

Biotechnology - Laboratories for research, development and analysis - Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements
Newest version Valid from 01.01.2000
Main

EVS-EN ISO 20387:2020

Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018)
Newest version Valid from 02.10.2020
Main

EVS-EN 12740:2000

Biotechnology - Laboratories for research, development and analysis - Guidance for handling, inactivating and testing of waste
Newest version Valid from 01.01.2000

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English