SIST EN 13095:2000
(Main)Biotechnology - Performance criteria for off-gas systems
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
- 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
Overview
EN 13095:1999 - Biotechnology: Performance criteria for off-gas systems (CEN) defines the performance expectations for off‑gas systems used in biotechnological processes where hazardous or potentially hazardous microorganisms are present. The standard is intended to reduce risks to worker safety and environmental protection by specifying how off‑gas systems should perform when containment or exposure restrictions are required.
Key Topics
This standard focuses on performance criteria rather than prescriptive construction details. Key technical topics and requirements commonly addressed include:
- Scope of application - where off‑gas systems are required because of hazardous microorganisms or restricted exposure zones.
- Containment and emissions control - performance objectives to limit release of viable microorganisms to the workplace and environment.
- Filtration and treatment performance - criteria for components such as filters or gas‑treatment units in terms of functionality and reliability (without prescribing specific technologies).
- Monitoring and detection - requirements for systems or procedures to detect failures or breaches in off‑gas containment.
- Validation and testing - provisions for performance verification, routine testing and acceptance criteria to demonstrate the off‑gas system meets intended safety goals.
- Operation and maintenance - expectations for maintenance, inspection schedules and documented procedures to sustain performance over time.
- Risk-based application - alignment of off‑gas performance with the hazard level of the microorganisms in use and local safety requirements.
(EN 13095 emphasizes performance outcomes and safety risk mitigation rather than mandating exact components or brands.)
Applications
EN 13095 is practical for organizations that design, operate or regulate bioprocesses involving potentially infectious or environmentally hazardous microorganisms:
- Biotechnology and pharmaceutical manufacturers
- Research laboratories and pilot plants working with microorganisms
- HVAC and process engineers specifying off‑gas treatment systems
- Equipment manufacturers developing off‑gas filtration or decontamination modules
- Health & safety officers, biosafety committees and regulatory agencies assessing containment measures
Implementing EN 13095 helps organizations demonstrate due diligence in protecting workers and the environment from airborne biological hazards and supports compliant facility design, commissioning and operation.
Related Standards
EN 13095 is part of a broader suite of biosafety, ventilation and environmental protection practices. Related areas include:
- Biosafety guidance (levels of containment and laboratory practices)
- HVAC and industrial ventilation standards for cleanrooms and containment
- Standards for filter testing, monitoring and environmental emissions
For project implementation, reference EN 13095 alongside applicable national biosafety regulations and ventilation/HVAC standards to ensure complete compliance.
Keywords: EN 13095, off‑gas systems, biotechnology, performance criteria, microorganism risk, worker safety, environmental protection, CEN.
Frequently Asked Questions
SIST EN 13095:2000 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Biotechnology - Performance criteria for off-gas systems". This standard covers: 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.
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.
SIST EN 13095:2000 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 13095:2000 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.
SIST EN 13095:2000 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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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