SIST EN 13095:2000

Biotechnology - Performance criteria for off-gas systems

This European Standard specifies performance criteria for off-gas systems 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 off-gas system 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 Ablufteinrichtungen

Diese Europäische Norm legt Leistungskriterien für Ablufteinrichtungen im Hinblick auf die potentiellen Risiken verwendeter Mikroorganismen für die Beschäftigten und die Umwelt fest. Diese Europäische Norm gilt, sobald der vorgesehene Einsatz von Ablufteinrichtungen den Gebrauch gefährlicher oder potentiell gefährlicher Mikroorganismen in biotechnischen Prozessen einschließt, und/oder wenn die Exposition der Beschäftigten oder der Umwelt gegenüber solchen Mikroorganismen aus Sicherheitsgründen einzuschränken ist.

Biotechnologie - Criteres de performance pour les systemes de traitement des effluents gazeux

La présente norme européenne spécifie les critères de performance applicables aux systèmes de traitement des effluents gazeux 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 lorsqu'il est prévu que le système de traitement des effluents gazeux implique l'utilisation de microorganismes dangereux ou potentiellement dangereux dans les procédés biotechnologiques et/ou lorsque l'exposition de l'opérateur ou de l'environnement à de tels microorganismes est limitée pour des raisons de sécurité.

Biotehnologija - Merila za brezplinske sisteme

General Information

• 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: Not Harmonized90/219/EEC - Contained use of genetically modified micro-organisms
• Directive:

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  Not Harmonized90/220/EEC - Deliberate release into the environment of genetically modified organisms
• Directive:

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  Not Harmonized90/679/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 13095:1999 - Biotechnology - Performance criteria for off-gas systems

Relations

• 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 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
• Refers: SIST EN 12296:1999 - Biotechnology - Equipment - Guidance on testing procedures for cleanability
• Effective Date: 28-Jan-2026

Overview

SIST EN 13095:2000 - Biotechnology - Performance Criteria for Off-Gas Systems is a European standard that establishes essential performance requirements for off-gas systems utilized in biotechnological processes. The standard is designed to address and mitigate the potential risks associated with the use of hazardous or potentially hazardous microorganisms, ensuring both worker safety and environmental protection. Applicable to installations where minimizing microbial exposure is critical, SIST EN 13095:2000 provides a framework for evaluating off-gas treatment systems in laboratories, production facilities, and other biotechnology-related operations.

Key Topics

• Performance Criteria: Defines the necessary performance characteristics for off-gas systems, focusing on efficiency in capturing and treating airborne microorganisms.
• Risk Reduction: Identifies measures to minimize the release of hazardous microorganisms into the workplace or the environment.
• Worker Safety: Highlights procedures and system design elements that protect staff from accidental exposure to microbial hazards.
• Environmental Protection: Addresses processes that prevent the unauthorized discharge of biological agents during biotechnological operations.
• Scope of Applicability: Applies to systems where hazardous microorganisms are used, including those classified as potentially harmful, and where regulatory or operational requirements limit exposure.

Applications

The SIST EN 13095:2000 standard is highly relevant for a range of industries and applications, such as:

• Biotechnology Laboratories: Ensuring safe handling of genetically modified or pathogenic microorganisms by reducing off-gas emissions.
• Pharmaceutical Manufacturing: Providing guidelines for containment and treatment of off-gas streams during the production of antibiotics, vaccines, and other biotechnological products.
• Industrial Bioprocesses: Supporting compliance in facilities using fermentation, cell culture, or other biological processes involving hazardous agents.
• Research Institutions: Mitigating researcher exposure and environmental impact through appropriate off-gas system selection and maintenance.
• Facilities Managing Biological Waste: Enhancing systems that treat off-gases from biowaste to prevent accidental microbial release.

Implementing SIST EN 13095:2000 helps organizations comply with European biosafety and biosecurity regulations, ensuring a safer working environment and contributing to environmental sustainability.

Related Standards

For a comprehensive safety strategy, consider integrating SIST EN 13095:2000 with the following related standards:

• EN 12741: Biotechnology - Laboratories - Guidance for containment of hazardous agents.
• EN 12128: Biotechnology - Laboratories - Containment levels for facilities.
• ISO 14644: Cleanrooms and associated controlled environments.
• ISO 14001: Environmental management systems - Requirements for organizations seeking to manage environmental responsibilities.

By aligning with SIST EN 13095:2000 and other relevant standards, biotechnology facilities demonstrate commitment to best practices in biosafety, occupational health, and environmental management.

Keywords: off-gas systems, biotechnology safety, hazardous microorganisms, bioprocessing, worker protection, environmental protection, SIST EN 13095:2000, European biosafety standards, laboratory safety, biosecurity.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija - Merila za brezplinske sistemeBiotechnik - Leistungskriterien für AblufteinrichtungenBiotechnologie - Criteres de performance pour les systemes de traitement des effluents gazeuxBiotechnology - Performance criteria for off-gas systems07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:
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