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SRPS EN 12689:2013

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

Jan 28, 2013

General information

90.93     Apr 11, 2022

90.00    Apr 11, 2027

ISS

E034-9

European Norm

07.080     07.100.01  

English  

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Scope

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/220/EEC

Deliberate release into the environment of genetically modified organisms

Directive 90/220/EEC
90/219/EEC

Contained use of genetically modified micro-organisms

Directive 90/219/EEC
90/679/EEC

Protection of workers from risks related to exposure to biological agents at work

Directive 90/679/EEC

Life cycle

NOW

PUBLISHED
SRPS EN 12689:2013
90.93 Standard confirmed
Apr 11, 2022

Related project

Adopted from EN 12689:1998