Biotechnology - Performance criteria for vessels - Part 1: General performance criteria

This European Standard specifies performance criteria for vessels 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 the equipment 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 1: Allgemeine Leistungskriterien

1 Anwendungsbereich
Diese Europäische Norm legt Leistungskriterien für die in biotechnischen Verfahren verwendeten Behäl-
ter 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 der Geräte und Ausrüstungen den
Gebrauch gefährlicher oder potentiell gefährlicher Mikroorganismen in biotechnischen Verfahren ein-
schließt, oder wenn die Exposition der Beschäftigten oder der Umwelt gegenüber solchen Mikroorganis-
men aus Sicherheitsgründen eingeschränkt wird.

Biotechnologie - Critères de performance des récipients - Partie 1: Critères généraux de performance

1 Domaine d'application
La présente Norme européenne spécifie les critères de performance des récipients utilisés dans les procédés biotechnologiques par rapport aux 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 l'équipement considéré implique 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.
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Biotehnologija - Merila za delovanje posod - 1. del: Splošna merila za delovanje

General Information

Status
Published
Publication Date
20-Mar-2001
Withdrawal Date
29-Sep-2001
Technical Committee
Drafting Committee
Current Stage
9060 - Closure of 2 Year Review Enquiry - Review Enquiry
Start Date
02-Dec-2023
Completion Date
02-Dec-2023

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EN 13311-1:2002
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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija - Merila za delovanje posod - 1. del: Splošna merila za delovanjeBiotechnik - Leistungskriterien für Behälter - Teil 1: Allgemeine LeistungskriterienBiotechnologie - Criteres de performance des récipients - Partie 1: Criteres généraux de performanceBiotechnology - Performance criteria for vessels - Part 1: General performance criteria07.100.01Mikrobiologija na splošnoMicrobiology in general07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 13311-1:2001SIST EN 13311-1:2002en01-januar-2002SIST EN 13311-1:2002SLOVENSKI
STANDARD



SIST EN 13311-1:2002



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13311-1March 2001ICS 07.080; 07.100.01English versionBiotechnology - Performance criteria for vessels - Part 1:General performance criteriaBiotechnologie - Critères de performance des récipients -Partie 1: Critères généraux de performanceBiotechnik - Leistungskriterien für Behälter - Teil 1:Allgemeine LeistungskriterienThis 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 13311-1:2001 ESIST EN 13311-1:2002



Page 2EN 13311-1:2001ContentsPageForeword.3Introduction.41Scope.42Normative references.43Terms and definitions.54Hazards.85Performance classes.86Classification and verification of performance.117Marking and packaging.128Documentation.12Bibliography.13SIST EN 13311-1:2002



Page 3EN 13311-1:2001ForewordThis 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: Kill tanks.EN 13311-6Biotechnology - Performance criteria for vessels - Part 6: Chromatographycolumns.This standard includes a
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