Biotechnology - Performance criteria for vessels - Part 3: Glass pressure vessels

This European Standard specifies performance criteria for glass pressure 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 glass pressure vessels 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 3: Druckbehälter aus Glas

1 Anwendungsbereich
Diese Europäische Norm legt Leistungskriterien für bei biotechnischen Verfahren verwendete Druck-
behälter aus Glas 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 Druckbehältern aus Glas 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.
Diese Europäische Norm gilt auch für in der Biotechnik verwendete Druckbehälter, die aus anderen zer-
brechlichen Werkstoffen, wie Acrylatpolymeren oder Porzellan, hergestellt sind.
Diese Europäische Norm gilt nicht für kleine Bauteile aus Glas, die in ein Gerät eingebaut sind, wie
Schaugläser.
Wenn wesentliche Teile eines Gerätes aus Glas oder anderen zerbrechlichen Werkstoffen hergestellt
sind, sollte diese Europäische Norm in Verbindung mit anderen einschlägigen Normen verwendet werden.

Biotechnologie - Critères de performance des récipients - Partie 3: Récipients sous pression en verre

Domaine d'application
La présente norme européenne spécifie les critères de performance des récipients sous pression en verre 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 récipients sous pression en verre 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.
La présente norme européenne s'applique également aux récipients sous pression utilisés dans les procédés biotechnologiques, qui sont fabriqués dans d'autres matériaux fragiles tels que les polymères acrylate ou la porcelaine.
Elle ne s'applique pas aux éléments en verre de petites dimensions qui font partie intégrante de l'équipement, comme les voyants.
Il convient d'utiliser la présente norme européenne conjointement avec d'autres normes lorsque les récipients comportent d'importantes parties en verre ou des parties fabriquées en d'autres matériaux fragiles.

Biotehnologija - Merila za delovanje posod - 3. del: Steklene tlačne posode

General Information

Status
Published
Publication Date
20-Mar-2001
Technical Committee
Drafting Committee
Current Stage
9093 - Decision to confirm - Review Enquiry
Due Date
04-Mar-2018
Completion Date
02-May-2018

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Leistungskriterien für Behälter - Teil 3: Druckbehälter aus GlasBiotechnologie - Criteres de performance des récipients - Partie 3: Récipients sous pression en verreBiotechnology - Performance criteria for vessels - Part 3: Glass pressure vessels07.100.01Mikrobiologija na splošnoMicrobiology in general07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 13311-3:2001SIST EN 13311-3:2002en01-januar-2002SIST EN 13311-3:2002SLOVENSKI

STANDARD
SIST EN 13311-3:2002

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13311-3March 2001ICS 07.080; 07.100.01English versionBiotechnology - Performance criteria for vessels - Part 3: Glasspressure vesselsBiotechnologie - Critères de performance des récipients -Partie 3: Récipients sous pression en verreBiotechnik - Leistungskriterien für Behälter - Teil 3:Druckbehälter aus GlasThis 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 13311-3:2001 ESIST EN 13311-3:2002

Page 2EN 13311-3:2001ContentsPageForeword.................................................................................................................3Introduction.....................................................................................................................41Scope.........................................................................................................................42Normative references.................................................................................................43Terms and definitions................................................................................................44Hazards.......................................................................................................................55Performance classes...................................................................................................56Classification and verification of performance..........................................................67Marking and packaging...............................................................................................68Documentation............................................................................................................6Annex A (informative)

Guidance on test methods for determining leaktightness ofglass pressure vessels......................................................................................................7Annex B (informative)

Information on glass pressure vessels.......................................8Bibliography........................................................................................................................9SIST EN 13311-3:2002

Page 3EN 13311-3:2001ForewordThis 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 13311-6, Biotechnology - Performance criteria for vessels - Part 6: Chromatographycolumns.Annexes A and B are informative.This standard includes a bibliography.According to the CEN/CENELEC Internal Regulations, the national standards organizationsof the following countries are bound to implement this European Standard: Austria, Belgium,Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the UnitedKingdom.SIST EN 13311-3:2002

Page 4EN 13311-3:2001IntroductionGlass pressure vessels are used in a wide variety of biotechnological processes, and varyconsiderably in scale and function. Glass pressure vessels used in biotechnology caninclude for example fermenters and feed vessels, reaction vessels, centrifuge tubes andbuckets, chromatography columns, sampling bottles, rotary evaporators, jacketedhomogenizers/cell disrupters and vessels used in cryogenic procedures.The mechanical safety of pressure vessels which can include glass vessels is described inEN 1595 (see [2]) or for example a national pressure vessel code (see [1]).Use of this European Standard will aid the equipment manufacturer in the classification ofglass pressure vessels with regard to safe performance in biotechnological processes. Theclassification is easily understandable and readily utilizable for the user and the regulatoryauthorities.1ScopeThis European Standard specifies performance criteria for glass pressure vessels used inbiotechnological processes with respect to the potential hazards to the worker and theenvironment from microorganisms in use.This European Standard applies where the intended use of glass pressure vessels includeshazardous or potentially hazardous microorganisms used in biotechnological processes orwhere exposure of the worker or the environment to such microorganisms is restricted forreasons of safety.This European Standard also applies to pressure vessels used in biotechnological processesthat are made of other brittle materials such as acrylate polymers or porcelain.This European Standard does not apply to small glass parts which form an integral part ofequipment such as sight glasses.This European Standard should be used in conjunction with other relevant standards whensubstantial parts of glass or from other brittle materials are present.2Normative referencesThis European Standard incorporates by dated or undated reference, provisions from otherpublications. These normative references are cited at the appropriate places in the text andthe publications are listed hereafter. For da

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