Name: EN 12689:1998
Brand: CEN

Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products

Published date

22-07-1998

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Definitions
3 General considerations
4 Validity of purity assessment
5 Validity of biological activity assessment of product
6 Validity of stability assessment
Annex A (informative) Bibliography

This European Standard gives guidance on assessment of technical specifications of microorganism based products (MBPs) for product quality evaluation. It is also applicable for purposes of product registration. NOTE 1: In this European Standard, the technical specifications are considered to be purity, biological activity and stability of microorganism based product. This European Standard describes criteria and factors considered for the validity of the assessment of the technical specifications.

Committee	CEN/TC 233
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
NBN EN 12689 : 1998	Identical
SN EN 12689 : 1999	Identical
BS EN 12689:1998	Identical
UNE-EN 12689:1999	Identical
NEN EN 12689 : 1998	Identical
NS EN 12689 : 1ED 1999	Identical
DIN EN 12689:1998-10	Identical
UNI EN 12689 : 2000	Identical
NF EN 12689 : 1998	Identical
I.S. EN 12689:1999	Identical
PN EN 12689 : 2001	Identical

ISO 7218:2007	Microbiology of food and animal feeding stuffs General requirements and guidance for microbiological examinations
EN 12682:1998	Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the functional expression of the genomic modification
EN 12687:1998	Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the genomic modification
EN 12683:1998	Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification
EN 1619:1996	Biotechnology - Large-scale process and production - General requirements for management and organization for strain conservation procedures
EN 12685:1998	Biotechnology - Modified organisms for application in the environment - Guidance for the monitoring strategies for deliberate releases of genetically modified microorganisms, including viruses
ISO 6887:1983	Microbiology General guidance for the preparation of dilutions for microbiological examination
ISO 4833:2003	Microbiology of food and animal feeding stuffs Horizontal method for the enumeration of microorganisms Colony-count technique at 30 degrees C
EN 12686:1998	Biotechnology - Modified organisms for application in the environment - Guidance for the sampling strategies for deliberate releases of genetically modified microorganisms, including viruses