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SRPS EN 12297:2013

Biotechnology - Equipment - Guidance on testing procedures for sterilizability

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 general testing procedures to assess the sterilizability for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the sterilizability of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.

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 12297:2013
90.93 Standard confirmed
Apr 11, 2022

Related project

Adopted from EN 12297:1998