EN 12884:1999

Biotechnology - Performance criteria for centrifuges

This European Standard specifies performance criteria for centrifuges used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment.

Biotechnik - Leistungskriterien für Zentrifugen

Die vorliegende Europäische Norm legt Leistungskriterien für Zentrifugen, die bei biotechnischen Verfahren angewendet werden, im Hinblick auf die potentiellen Risiken durch die verwendeten Mikroorganismen für die Beschäftigten oder die Umwelt fest.

Biotechnologie - Critères de performance pour les centrifugeuses

La présente norme européenne spécifie les critères de performance applicables aux centrifugeuses utilisées dans des procédés biotechnologiques compte tenu des risques potentiels, pour les opérateurs et l'environnement, liés aux microorganismes utilisés.

Biotehnologija – Merila za delovaje centrifug

General Information

• Status: Published
• Publication Date: 16-Feb-1999
• Withdrawal Date: 30-Aug-1999
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 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
• Start Date: 02-May-2018
• Completion Date: 14-Apr-2025
• Directive: 90/219/EEC - Contained use of genetically modified micro-organisms
• Directive: 90/220/EEC - Deliberate release into the environment of genetically modified organisms
• Directive: 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 12884:1999 - Biotechnology - Performance criteria for centrifuges

Overview

EN 12884:1999 - published by CEN - is the European standard titled "Biotechnology - Performance criteria for centrifuges". It specifies performance criteria for centrifuges used in biotechnological processes with respect to the potential risks posed by microorganisms to workers and the environment. The standard provides a framework for evaluating centrifuge designs and operation where biological containment and biosafety are critical.

Key topics

The standard focuses on performance criteria related to microbiological risk control. While the full text defines the official requirements, key technical topics typically addressed under this scope include:

• Biological containment and aerosol control to minimise release of microorganisms during operation, loading and unloading.
• Leakage and sealing performance of rotors, lids and sample holders to prevent escape of contaminants.
• Decontamination and cleaning provisions to support safe maintenance and routine sanitation.
• Operational safety and maintenance requirements that affect microbial risk (inspection, balancing, emergency procedures).
• Performance verification and testing to demonstrate that a centrifuge meets the criteria for safe use with biological materials.
• Documentation and labeling for safe use, maintenance instructions and risk information relevant to biotechnology applications.

(These topics reflect the standard’s stated scope - performance criteria for centrifuges used in biotechnological processes - and what laboratories and manufacturers evaluate against such a standard.)

Applications

EN 12884:1999 is directly relevant to:

• Biotech and pharmaceutical laboratories that process microorganisms or biologically active materials.
• Equipment manufacturers and OEMs designing centrifuges intended for biological applications who need to demonstrate containment performance.
• Laboratory safety officers and biosafety committees assessing equipment suitability for specific containment levels.
• Procurement and validation teams selecting and qualifying centrifuges for R&D, production, or clinical laboratories.
• Testing and certification bodies that evaluate centrifuge performance against European safety expectations.

Using this standard helps reduce occupational exposure, support environmental protection, and provide objective criteria for selecting and validating centrifugation equipment in biotechnology.

Related standards

EN 12884:1999 sits alongside other European and international standards covering laboratory equipment safety, biosafety management and equipment validation. Users should consult complementary standards on laboratory safety, biocontainment and equipment testing for a complete compliance and risk-management approach.

Keywords: EN 12884:1999, biotechnology centrifuge standard, centrifuge performance, centrifuge biosafety, CEN standard, biological containment, laboratory equipment standards.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija – Merila za delovaje centrifugBiotechnik - Leistungskriterien für ZentrifugenBiotechnologie - Criteres de performance pour les centrifugeusesBiotechnology - Performance criteria for centrifuges07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 12884:1
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