I.S. EN 12689:1999
Current
The latest, up-to-date edition.
BIOTECHNOLOGY - GUIDANCE ON THE ASSESSMENT OF THE PURITY, BIOLOGICAL ACTIVITY AND STABILITY OF MICROORGANISM BASED PRODUCTS
Hardcopy , PDF
English
01-01-1999
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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
Provides guidance on assessment of technical specifications of microorganism based products (MBPs) for product quality evaluation. Also applies for purposes of product registration.
| DocumentType |
Standard
|
| Pages |
14
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| EN 12689:1998 | Identical |
| BS EN 12689:1998 | Identical |
| DIN EN 12689:1998-10 | Identical |
| UNI EN 12689 : 2000 | Identical |
| UNE-EN 12689:1999 | Identical |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.