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CEN

EN 12297:1998

(Main)

Biotechnology - Equipment - Guidance on testing procedures for sterilizability

Biotechnology - Equipment - Guidance on testing procedures for sterilizability

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.

Biotechnik - Geräte und Ausrüstungen - Leitfaden für Verfahren zur Prüfung der Sterilisierbarkeit

Diese Europäische Norm gibt eine Anleitung für allgemeine Prüfverfahren zum Nachweis der Sterilisierbarkeit von in biotechnischen Verfahren verwendeten Geräten und Ausrüstungen (Bauteile und Apparateeinheiten) gegenüber Mikroorganismen. Diese Europäische Norm gibt eine Anleitung zur Bewertung der Sterilisierbarkeit biotechnischer Geräte und Ausrüstungen im Hinblick auf ein Entweichen von im Verfahren eingesetzten Mikroorganismen, die die Sicherheit der Beschäftigten gefährden können (arbeitsmedizinischer Aspekt) und/oder die nachteilige Wirkungen auf die Umwelt ausüben können.

Biotechnologie - Equipement - Guide des procédures d'essai pour le contrôle de la capacité à la stérilisation

La présente norme européenne donne des indications sur les procédures d'essai permettant d'évaluer la capacité à la stérilisation de microorganismes dans des équipements (composants individuels et unités d'équipement) mis en oeuvre dans les procédés biotechnologiques. La présente norme européenne donne des indications pour l'évaluation de la capacité à la stérilisation des équipements biotechnologiques vis-à-vis du rejet de microorganismes d'intérêt industriel susceptibles de porter atteinte à la sécurité des travailleurs (santé au travail) et/ou d'avoir des effets néfastes sur l'environnement.

Biotehnologija – Oprema - Navodilo o preskusnih postopkih za ugotavljanje sterilnosti

General Information

Status
Published
Publication Date
17-Mar-1998
ICS
07.080 - Biology. Botany. Zoology
07.100.01 - Microbiology in general
Technical Committee
CEN/TC 233 - Biotechnology
Drafting Committee
CEN/TC 233/WG 4 - Equipment
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 12297:1999 - Biotechnology - Equipment - Guidance on testing procedures for sterilizability

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija – Oprema - Navodilo o preskusnih postopkih za ugotavljanje sterilnostiBiotechnik - Geräte und Ausrüstungen - Leitfaden für Verfahren zur Prüfung der SterilisierbarkeitBiotechnologie - Equipement - Guide des procédures d'essai pour le contrôle de la capacité a la stérilisationBiotechnology - Equipment - Guidance on testing procedures for sterilizability07.080Biologija. Botanika. ZoologijaBiolo
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