EN 13091:1999
(Main)Biotechnology - Performance criteria for filter elements and filtration assemblies
Biotechnology - Performance criteria for filter elements and filtration assemblies
This European Standard specifies performance criteria for filter elements and filtration assemblies used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the filter elements or filtration assemblies includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
Biotechnik - Leistungskriterien für Filterelemente und Filtrationseinrichtungen
Diese Europäische Norm legt Leistungskriterien für die in biotechnischen Verfahren verwendeten Filtrationseinrichtungen und Filterelemente im Hinblick auf potentielle Risiken für die Beschäftigten und die Umwelt fest, die von den im Verfahren verwendeten Mikroorganismen ausgehen.
Biotechnologie - Critères de performance pour les éléments filtrants et les filtres
La présente norme européenne spécifie les critères de performance applicables aux éléments filtrants et aux filtres utilisés dans les procédés biotechnologiques eu égard aux risques potentiels, liés aux microorganismes utilisés, pour les opérateurs et l'environnement. La présente norme européenne s'applique lorsque l'utilisation des éléments filtrants et des filtres fait intervenir des microorganismes dangereux ou potentiellement dangereux, utilisés dans les procédés biotechnologiques et/ou lorsque l'exposition des opérateurs ou de l'environnement à ces microorganismes est réduite pour des raisons de sécurité.
Biotehnologija - Merila za sestavne dele filtrov in montažo priprave za filtracijo
General Information
Overview
EN 13091:1999 (CEN) - Biotechnology - Performance criteria for filter elements and filtration assemblies - defines performance criteria for filter elements and filtration assemblies used in biotechnological processes where microorganisms present potential risks to workers or the environment. The standard applies when the intended use involves hazardous or potentially hazardous microorganisms and/or where exposure to such organisms is restricted for safety reasons. EN 13091 helps ensure filtration solutions contribute to effective microbial containment and occupational/environmental protection in biotech operations.
Key Topics
- Scope and applicability: When filter elements and filtration assemblies must meet defined performance criteria because of hazardous microbial use or controlled exposure.
- Performance criteria: Framework-level requirements for assessing filtration performance relative to microbial risk (filtration efficiency, suitability for intended use, and protection goals are addressed conceptually).
- Risk-based use: Emphasis on matching filter selection and assembly design to the biological hazard and exposure control needs.
- Worker and environmental protection: Criteria focused on reducing potential release or exposure of microorganisms during biotechnological operations.
- Documentation and intended use: Importance of specifying intended use and conditions to determine whether EN 13091 applies.
Applications
EN 13091 is practical for organizations and activities that handle or process biological agents and need assurance that filtration components meet performance expectations for biosafety:
- Biotech and pharmaceutical manufacturers selecting filtration elements for processes involving microorganisms
- Facility designers and engineers specifying filtration assemblies for containment and process integrity
- Health & safety officers and biosafety managers assessing exposure controls and containment measures
- Suppliers and OEMs of filtration products seeking to demonstrate suitability for biotechnological use
- Test laboratories and validation teams that support risk assessments and performance verification
Benefits
- Supports consistent, risk-aware selection of filtration components in biotechnology
- Helps reduce worker and environmental exposure to hazardous microorganisms
- Provides a harmonized European benchmark for documenting intended use and performance expectations
Related standards
EN 13091 complements other CEN/ISO standards and guidance on biosafety, air and liquid filtration, and containment practices. Users should consider adjacent standards on biosafety management, process validation and filter testing when developing a comprehensive filtration and containment strategy.
Keywords: EN 13091, biotechnology filtration, filter elements, filtration assemblies, microbial containment, biosafety filters, CEN standard.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija - Merila za sestavne dele filtrov in montažo priprave za filtracijoBiotechnik - Leistungskriterien für Filterelemente und FiltrationseinrichtungenBiotechnologie - Criteres de performance pour les éléments filtrants et les filtresBiotechnology - Performance criteria for filter elements and filtration assemblies07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istovet
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Frequently Asked Questions
EN 13091:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Performance criteria for filter elements and filtration assemblies". This standard covers: This European Standard specifies performance criteria for filter elements and filtration assemblies used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the filter elements or filtration assemblies includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
This European Standard specifies performance criteria for filter elements and filtration assemblies used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the filter elements or filtration assemblies includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
EN 13091:1999 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 07.100.01 - Microbiology in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13091:1999 is associated with the following European legislation: EU Directives/Regulations: 90/219/EEC, 90/220/EEC, 90/679/EEC; Standardization Mandates: M/BC/CEN/91/19. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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