EN 12128:1998
(Main)Biotechnology - Laboratories for research, development and analysis - Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements
Biotechnology - Laboratories for research, development and analysis - Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements
This European Standard specifies minimum physical requirements for biological safety for laboratories at four reference physical containment levels which are appropriate for handling microorganisms of different risk groups. This European Standard primarily addresses the containment of microorganisms which can present a risk to human health. It applies to microbiology laboratories where the handling of microorganisms in bacteriology, mycology, virology, parasitology and/or genetic modification is carried out.
Biotechnik - Laboratorien für Forschung, Entwicklung und Analyse - Sicherheitsstufen mikrobiologischer Laboratorien, Gefahrenbereich, Räumlichkeiten und technische Sicherheitsanforderungen
Diese Europäische Norm legt die technischen Mindestanforderungen an die biologische Sicherheit in Laboratorien für vier definierte Sicherheitsstufen fest, die für den Umgang mit Mikroorganismen verschiedener Risikogruppen geeignet sind. Diese Europäische Norm bezieht sich in erster Linie auf die Abgrenzung von Mikroorganismen, die ein Risiko für die menschliche Gesundheit darstellen können.
Biotechnologie - Laboratoires de recherche, de développementet d'analyse - Niveaux de confinement des laboratoires de microbiologie, zones à risque, situations et exigences physiques de sécurité
La présente norme établit les exigences physiques minimum pour la sécurité biologique en laboratoire définissant quatre niveaux de confinement de référence pour la manipulation des microorganismes de différentes catégories de risque. La présente norme concerne avant tout le confinement des microorganismes qui peuvent présenter un risque pour la santé humaine. La présente norme s'applique aux laboratoires de microbiologie dans lesquels sont manipulés des microorganismes: en bactériologie, mycologie, virologie, parasitologie et/ou pour les modifications génétiques.
Biotehnologija - Raziskovalni, razvojni in analitski laboratoriji - Zadrževalne stopnje v mikrobioloških laboratorijih, področja tveganja, prostori in fizikalne varnostne zahteve
General Information
- Status
- Published
- Publication Date
- 17-Mar-1998
- Technical Committee
- CEN/TC 233 - Biotechnology
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 11-Apr-2022
- Completion Date
- 14-Apr-2025
Overview
EN 12128:1998 (CEN) defines minimum physical requirements for biological safety in microbiology laboratories. The standard establishes four reference physical containment levels appropriate for handling microorganisms of different risk groups and focuses on containment measures for agents that pose risks to human health. It applies to laboratories performing bacteriology, mycology, virology, parasitology and genetic modification work. EN 12128:1998 is used to guide laboratory design, facility upgrades and operational planning to reduce exposure and limit pathogen release.
Key topics and technical requirements
EN 12128:1998 addresses the core physical and spatial safety elements needed to contain biological hazards. Key topics include:
- Containment levels: specification of four reference physical containment levels to match microorganism risk categories and activities.
- Risk areas and localities: classification of laboratory zones according to hazard and access restrictions.
- Laboratory layout and segregation: principles for room arrangement to separate higher-risk activities from general areas.
- Physical safety features: requirements for controlled access, secure doors, and durable, easily decontaminated surfaces.
- Ventilation and airflow control: design intent for ventilation strategies to limit airborne dissemination (general principles rather than numerical values).
- Waste handling and decontamination: guidance on localities and physical provisions for safe storage, treatment and removal of biological waste.
- Utilities and services: placement and protection of laboratory services (drains, sinks, emergency showers) consistent with containment needs.
- Adaptation for genetic modification: considerations for handling recombinant organisms within designated containment levels.
Note: EN 12128:1998 provides minimum physical requirements and scope; it is intentionally high-level and intended to be used with local biosafety guidance and operational procedures.
Applications and users
This standard is practical for:
- Laboratory designers and architects planning new or renovated microbiology facilities
- Biosafety officers and facility managers setting physical controls and classifying risk areas
- Research institutions, clinical labs and biotech companies handling bacteriology, virology, mycology, parasitology or genetic modification
- Equipment and HVAC suppliers aligning products to containment-level requirements
- Regulators and auditors assessing compliance with European laboratory safety expectations
EN 12128 helps ensure laboratory layouts, access control and physical barriers align with the biological risk of stored and handled organisms.
Related standards
EN 12128:1998 complements national biosafety regulations and other European and international laboratory safety standards. Use it alongside operational biosafety guidance, local legislation, and applicable CEN/ISO laboratory safety documents when specifying detailed technical systems, procedures and performance criteria.
Keywords: EN 12128, containment levels, microbiology laboratories, biological safety, laboratory design, biosafety, genetic modification, bacteriology, virology, mycology, parasitology, CEN standard.
Frequently Asked Questions
EN 12128:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Laboratories for research, development and analysis - Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements". This standard covers: This European Standard specifies minimum physical requirements for biological safety for laboratories at four reference physical containment levels which are appropriate for handling microorganisms of different risk groups. This European Standard primarily addresses the containment of microorganisms which can present a risk to human health. It applies to microbiology laboratories where the handling of microorganisms in bacteriology, mycology, virology, parasitology and/or genetic modification is carried out.
This European Standard specifies minimum physical requirements for biological safety for laboratories at four reference physical containment levels which are appropriate for handling microorganisms of different risk groups. This European Standard primarily addresses the containment of microorganisms which can present a risk to human health. It applies to microbiology laboratories where the handling of microorganisms in bacteriology, mycology, virology, parasitology and/or genetic modification is carried out.
EN 12128:1998 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 12128:1998 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.
You can purchase EN 12128:1998 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Laboratorien für Forschung, Entwicklung und Analyse - Sicherheitsstufen mikrobiologischer Laboratorien, Gefahrenbereich, Räumlichkeiten und technische SicherheitsanforderungenBiotechnologie - Laboratoires de recherche, de développementet d'analyse - Niveaux de confinement des laboratoires de microbiologie, zones a risque, situations et exigences physiques de sécuritéBiotechnology - Laboratories for research, development and analysis - Containment levels of microbiology laboratories, areas of risk, localities and physical safety requirements07.100.01Mikrobiologija na splošnoMicrobi
...
The article discusses the European Standard EN 12128:1998, which sets out the physical requirements for biological safety in laboratories. These requirements are based on four levels of containment, each suitable for handling microorganisms of different risk groups. The standard mainly focuses on the containment of microorganisms that pose a threat to human health. It applies to microbiology labs that handle microorganisms in fields like bacteriology, mycology, virology, parasitology, and genetic modification.
記事のタイトル：EN 12128:1998 - バイオテクノロジー - 研究、開発、および分析のためのラボ - マイクロバイオロジーのラボの運用レベル、リスク領域、場所、および物理的安全要件 記事の内容：このヨーロッパ標準では、異なるリスクグループの微生物の取り扱いに適した4つの参照物理的閉じ込めレベルに対する生物学的安全性の最小限の物理的要求事項を定めています。このヨーロッパ標準は、主に人間の健康にリスクをもたらす可能性のある微生物の閉じ込めに焦点を当てています。細菌学、菌学、ウイルス学、寄生虫学、および/または遺伝子改変の分野で微生物を取り扱うマイクロバイオロジーのラボに適用されます。
기사 제목: EN 12128:1998 - 생물공학 - 연구, 개발 및 분석용 실험실 - 미생물학 실험실의 존엄성 수준, 위험 지역, 위치 및 물리적 안전 요구사항 기사 내용: 이 유럽 표준은 다른 위험 그룹의 미생물을 처리하는 데 적합한 4개의 참조 물리적 존엄성 수준에 대한 생물 안전의 최소 물리적 요구사항을 명시한다. 이 유럽 표준은 주로 인간 건강에 위험을 가질 수 있는 미생물의 존엄성을 다룬다. 이는 세균학, 진균학, 바이러스학, 기생충학 및/또는 유전자 변형 분야에서 미생물을 다루는 미생물학 실험실에 적용된다.
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...