EN 12689:1998

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

Publication date:   Aug 3, 2001

General information

90.93 Standard confirmed   Apr 11, 2022

CEN

CEN/TC 233 Biotechnology

European Norm

07.080   Biology. Botany. Zoology | 07.100.01   Microbiology in general

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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 legislation

Legislation related to this standard

90/220/EEC

Deliberate release into the environment of genetically modified organisms

90/219/EEC

Contained use of genetically modified micro-organisms

90/679/EEC

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

Life cycle

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PUBLISHED
EN 12689:1998
90.93 Standard confirmed
Apr 11, 2022