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SIST

SIST EN 12689:1999

(Main)

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

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

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.

Biotechnik - Leitfaden zur Bewertung der Reinheit, biologischen Aktivität und Stabilität von Produkten, die auf Mikroorganismen basieren

Diese Europäische Norm gibt im Hinblick auf die Beurteilung der Produktqualität eine Anleitung zur Bewertung technischer Spezifikationen von Produkten, die auf Mikroorganismen basieren (MBPs). Sie ist auch für Zwecke der Registrierung von Produkten anwendbar. ANMERKUNG 1: In dieser Europäischen Norm werden die Reinheit, biologische Aktivität und Stabilität von Produkten, die auf Mikroorganismen basieren, als technische Spezifikationen betrachtet.

Biotechnologie - Guide pour l'évaluation de la pureté, l'activité biologique et la stabilité des produits a base de microorganismes

La présente norme européenne donne des indications relatives a l'évaluation des spécifications techniques des produits a base de microorganismes pour l'évaluation de la qualité des produits. Elle s'applique également a l'enregistrement des produits. NOTE 1: Dnas la présente norme, la pureté, l'activité biologique et la stabilité sont considérées comme les spécifications techniques d'un produit a base de microorganismes. La présente norme européenne décrit les criteres et les facteurs qui sont pris en considération pour la validité de l'évaluation des spécifications techniques.

Biotehnologija - Navodilo za ocenjevanje čistosti, biološke aktivnosti in obstojnosti mikrobioloških proizvodov

General Information

Status
Published
Publication Date
30-Nov-1999
ICS
07.080 - Biology. Botany. Zoology
07.100.01 - Microbiology in general
Technical Committee
BTH - Biotechnology
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Dec-1999
Due Date
01-Dec-1999
Completion Date
01-Dec-1999
Directive
90/219/EEC - Contained use of genetically modified micro-organisms
90/220/EEC - Deliberate release into the environment of genetically modified organisms
90/679/EEC - Protection of workers from risks related to exposure to biological agents at work
Mandate
M/BC/CEN/91/19 - Mandate for CEN on biotechnology
Ref Project
EN 12689:1998 - Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Leitfaden zur Bewertung der Reinheit, biologischen Aktivität und Stabilität von Produkten, die auf Mikroorganismen basierenBiotechnologie - Guide pour l'évaluation de la pureté, l'activité biologique et la stabilité des produits a base de microorganismesBiotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products07.100.01Mikrobio
...

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