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CEN

EN 12460:1998

(Main)

Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk

Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk

This European Standard gives guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant.

Biotechnik - Verfahren in Großmaßstab und Produktion - Leitfaden zur Auswahl und Installation von Geräten und Ausrüstungen entsprechend dem biologischen Risiko

Diese Europäische Norm gibt Anleitungen für die Auswahl von und die Risikoanalyse bei biotechnischen Geräten und Ausrüstungen und deren anschließende Zusammenstellung zu einer Anlage, um dadurch die jeweils entsprechenden Sicherheitsstufen in Bezug auf biologische Sicherheit zu erreichen. Dies schließt den Nachweis der korrekten Installation, der Funktion und der Wartung ein. Sie gilt auch für die Einführung eines neuen biotechnischen Verfahrens oder bei wesentlichen Veränderungen an einer bestehenden Anlage.

Biotechnologie - Procédé à grande échelle et production - Guide pour la sélection et l'installation des équipements en fonction du risque biologique

La présente norme européenne donne des indications sur la sélection et l'analyse de risque des équipements biotechnologiques, et de leur assemblage ultérieur dans une installation en vue d'obtenir des niveaux de confinement appropriés pour la biosécurité. Ceci comprend la vérification de l'installation, le fonctionnement et la maintenance. Elle s'applique également lorsqu'un nouveau procédé ou des modifications importantes sont introduits dans une installation existante.

Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Navodilo za izbiro in postavitev opreme glede na biološko tveganje

General Information

Status
Published
Publication Date
17-Feb-1998
ICS
07.080 - Biology. Botany. Zoology
Technical Committee
CEN/TC 233 - Biotechnology
Drafting Committee
CEN/TC 233/WG 2 - Large-scale process and production
Current Stage
9093 - Decision to confirm - Review Enquiry
Completion Date
11-Apr-2022
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
SIST EN 12460:1999 - Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk

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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija - Procesi in proizvodnja v industrijskem obsegu - Navodilo za izbiro in postavitev opreme glede na biološko tveganjeBiotechnik - Verfahren in Großmaßstab und Produktion - Leitfaden zur Auswahl und Installation von Geräten und Ausrüstungen entsprechend dem biologischen RisikoBiotechnologie - Procédé a grande échelle et production - Guide pour la sélection et l'installation des équipements en fonction du risque biologiqueBiotechnology - Large-scale proce
...

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