SIST EN 13091:2000

• Abstract:

  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.

• Status: Published
• Publication Date: 31-Oct-2000
• ICS: 07.080 - Biology. Botany. Zoology
• Technical Committee: BTH - Biotechnology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Nov-2000
• Due Date: 01-Nov-2000
• Completion Date: 01-Nov-2000
• Directive: 90/219/EEC - Contained use of genetically modified micro-organisms
• Directive:

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  90/220/EEC - Deliberate release into the environment of genetically modified organisms
• Directive:

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  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: EN 13091:1999 - Biotechnology - Performance criteria for filter elements and filtration assemblies

• Refers: SIST EN ISO 21920-2:2022 - Geometrical product specifications (GPS) - Surface texture: Profile - Part 2: Terms, definitions and surface texture parameters (ISO 21920-2:2021, Corrected version 2022-06)
• Effective Date: 28-Jan-2026
• Refers: SIST EN 12298:1999 - Biotechnology - Equipment - Guidance on testing procedures for leaktightness
• Effective Date: 28-Jan-2026
• Refers: SIST EN 1672-2:2021 - Food processing machinery - Basic concepts - Part 2: Hygiene requirements
• Effective Date: 28-Jan-2026
• Refers: SIST EN 12460:1999 - Biotechnology - Large-scale process and production - Guidance on equipment selection and installation in accordance with the biological risk
• Effective Date: 28-Jan-2026
• Refers: SIST EN 12296:1999 - Biotechnology - Equipment - Guidance on testing procedures for cleanability
• Effective Date: 28-Jan-2026
• Refers: SIST EN ISO 21920-3:2022 - Geometrical product specifications (GPS) - Surface texture: Profile - Part 3: Specification operators (ISO 21920-3:2021)
• Effective Date: 28-Jan-2026
• Refers: SIST EN 12297:1999 - Biotechnology - Equipment - Guidance on testing procedures for sterilizability
• Effective Date: 28-Jan-2026
• Referred By: SIST EN 12469:2000 - Biotechnology - Performance criteria for microbiological safety cabinets
• Effective Date: 28-Jan-2026

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.

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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