Biotechnology - Performance criteria for vessels - Part 4: Bioreactors

This European Standard specifies performance criteria for bioreactors used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of bioreactors includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

Biotechnik - Leistungskriterien für Behälter - Teil 4: Bioreaktoren

1 Anwendungsbereich
Diese Europäische Norm legt Leistungskriterien für bei biotechnischen Verfahren verwendete Bioreak-
toren im Hinblick auf potentielle Gefährdungen für die Beschäftigten und die Umwelt fest, die von den im
Verfahren verwendeten Mikroorganismen ausgehen.
Diese Europäische Norm gilt, sobald die vorgesehene Anwendung von Bioreaktoren den Gebrauch
gefährlicher oder potentiell gefährlicher Mikroorganismen in biotechnischen Verfahren einschließt, oder
wenn die Exposition der Beschäftigten oder der Umwelt gegenüber solchen Mikroorganismen aus
Sicherheitsgründen eingeschränkt wird.

Biotechnologie - Critères de performance des récipients - Partie 4: Bioréacteurs

Domaine d'application
La présente Norme européenne spécifie les critères de performance des bioréacteurs utilisés dans les procédés biotechnologiques vis-à-vis des dangers potentiels que les microorganismes utilisés représentent pour l'opérateur et pour l'environnement.
La présente Norme européenne s'applique lorsqu'il est prévu que les bioréacteurs impliquent l'utilisation de microorganismes dangereux ou potentiellement dangereux dans les procédés biotechnologiques ou lorsque l'exposition de l'opérateur ou de l'environnement à de tels microorganismes est limitée pour des raisons de sécurité.

Biotehnoogija - Merila za delovanje posod - 4. del: Bioreaktorji

General Information

Publication Date
Withdrawal Date
Technical Committee
Drafting Committee
Current Stage
9060 - Closure of 2 Year Review Enquiry - Review Enquiry
Start Date
Completion Date

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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnoogija - Merila za delovanje posod - 4. del: BioreaktorjiBiotechnik - Leistungskriterien für Behälter - Teil 4: BioreaktorenBiotechnologie - Criteres de performance des récipients - Partie 4: BioréacteursBiotechnology - Performance criteria for vessels - Part 4: Bioreactors07.100.01Mikrobiologija na splošnoMicrobiology in general07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 13311-4:2001SIST EN 13311-4:2002en01-januar-2002SIST EN 13311-4:2002SLOVENSKI

SIST EN 13311-4:2002

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13311-4March 2001ICS 07.080; 07.100.01English versionBiotechnology - Performance criteria for vessels - Part 4:BioreactorsBiotechnologie - Critères de performance des récipients -Partie 4: BioréacteursBiotechnik - Leistungskriterien für Behälter - Teil 4:BioreaktorenThis European Standard was approved by CEN on 4 February 2001.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2001 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13311-4:2001 ESIST EN 13311-4:2002

Page 2EN 13311-4:2001ContentsPageForeword.3Introduction.41Scope.42Normative references.43Terms and definitions.44Hazards.45Performance classes.46Classification and verification of performance.57Marking and packaging.58Documentation.5Annex A (informative)
Guidance on test methods for determiningleaktightness of bioreactors.6Annex B (informative)
Typical hazards and preventive measures.7Bibliography.10SIST EN 13311-4:2002

Page 3EN 13311-4:2001ForewordThis European Standard has been prepared by Technical Committee CEN/TC 233"Biotechnology", the secretariat of which is held by AFNOR.This European Standard shall be given the status of a national standard, either bypublication of an identical text or by endorsement, at the latest by September 2001, andconflicting national standards shall be withdrawn at the latest by September 2001.This European Standard has been prepared under a mandate given to CEN by theEuropean Commission and the European Free Trade Association.This standard is one of a series of European Standards concerned with performance criteriafor vessels. These standards are:EN 13311-1, Biotechnology - Performance criteria for vessels - Part 1: General performancecriteria.EN 13311-2, Biotechnology - Performance criteria for vessels - Part 2: Pressure protectiondevices.EN 13311-3, Biotechnology - Performance criteria for vessels - Part 3: Glass pressurevessels.EN 13311-4, Biotechnology - Performance criteria for vessels - Part 4: Bioreactors.EN 13311-5, Biotechnology - Performance criteria for vessels - Part 5: K

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