EN 12689:1998
Current
The latest, up-to-date edition.
Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products
22-07-1998
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 |
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