EN 12741:1999
(Main)Biotechnology - Laboratories for research, development and analysis - Guidance for biotechnology laboratory operations
Biotechnology - Laboratories for research, development and analysis - Guidance for biotechnology laboratory operations
This European Standard gives guidance for practice for biotechnology operations in research, development and analysis laboratories of containment levels 1, 2, 3 and 4 (see EN 12128 and prEN 12738). This European Standard aims at the protection of workers from biological hazards as well as the environment including plants and animals.
Biotechnik - Laboratorien für Forschung, Entwicklung und Analyse - Leitfaden für biotechnologische Laborpraxis
Diese Europäische Norm dient als Leitfaden für die biotechnische Betriebspraxis in Laboratorien für Forschung, Entwicklung und Analyse der Sicherheitsstufen 1, 2, 3 und 4 (siehe EN 12128 und prEN 12738). Ziel dieser Europäischen Norm ist der Schutz von Arbeitnehmern sowie der Umwelt (einschließlich Pflanzen und Tieren) vor biologischen Gefährdungen.
Biotechnologie - Laboratoires de recherche, développement et analyse - Guide pour les opérations de laboratoires biotechnologiques
La présente norme européenne décrit les éléments constituant les bonnes pratiques pour les opérations de laboratoires biotechnologiques en recherche, développement et analyse de niveaux de confinement 1, 2, 3 et 4 (voir EN 12128 et prEN 12738). La présente norme européenne a pour objectif la protection des opérateurs vis-à-vis des dangers biologiques ainsi que la protection de l'environnement, y compris celle des plantes et des animaux.
Biotehnologija - Raziskovalni, razvojni in analitiski laboratoriji - Navodilo za delovanje biotehnoloških laboratorijev
General Information
- Status
- Published
- Publication Date
- 20-Jul-1999
- 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 12741:1999 - "Biotechnology - Laboratories for research, development and analysis - Guidance for biotechnology laboratory operations" is a CEN European Standard that provides practical guidance for running biotechnology laboratories. It applies to laboratories operating at containment levels 1, 2, 3 and 4 and is intended to protect workers, the public and the environment (including plants and animals). The standard has been adopted nationally (e.g., SIST EN 12741:1999) and cross‑references related standards such as EN 12128 and prEN 12738.
Key Topics
The document focuses on operational and safety aspects of biotech lab work. Principal topics covered or addressed by the guidance include:
- Containment and laboratory classification - guidance relevant to containment levels 1–4 and how operations differ by level.
- Biosafety and biosecurity practices - principles to minimize biological hazards during research, development and analysis.
- Risk assessment and management - approaches for identifying, evaluating and controlling biological risks in lab procedures.
- Operational procedures and good laboratory practice (GLP) - recommendations for standard operating procedures, sample handling and documentation.
- Training and competence - staff qualification, training programs and roles/responsibilities for safe lab operations.
- Decontamination and waste management - safe handling, inactivation and disposal of biological materials to protect workers and the environment.
- Facility and equipment considerations - general guidance on laboratory layout, containment equipment use and maintenance.
- Emergency preparedness - planning and response measures for incidents involving biological hazards.
Note: EN 12741 provides guidance rather than prescriptive technical specifications; it should be used alongside applicable national regulations and specific containment standards.
Applications
EN 12741 is practical and relevant for:
- Laboratory managers and directors establishing or updating biotech lab operations and SOPs.
- Biosafety officers and EHS professionals conducting risk assessments and training.
- Researchers and technical staff seeking consistent safe‑work practices across containment levels.
- Facility designers and maintenance teams aligning layout and equipment choices with operational guidance.
- Regulatory compliance teams and auditors using the standard as a benchmark for best practice in biotechnology labs.
Common uses include drafting internal biosafety manuals, developing staff training curricula, preparing for audits, and informing procurement of containment equipment.
Related Standards
- EN 12128 - referenced for biological containment details.
- prEN 12738 - associated guidance referenced by EN 12741.
- National adaptations such as SIST EN 12741:1999 may provide the standard text in local language and adoption context.
Keywords: EN 12741, biotechnology laboratory operations, biotech labs, biosafety guidance, containment levels, CEN standard, laboratory guidance.
Frequently Asked Questions
EN 12741:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Laboratories for research, development and analysis - Guidance for biotechnology laboratory operations". This standard covers: This European Standard gives guidance for practice for biotechnology operations in research, development and analysis laboratories of containment levels 1, 2, 3 and 4 (see EN 12128 and prEN 12738). This European Standard aims at the protection of workers from biological hazards as well as the environment including plants and animals.
This European Standard gives guidance for practice for biotechnology operations in research, development and analysis laboratories of containment levels 1, 2, 3 and 4 (see EN 12128 and prEN 12738). This European Standard aims at the protection of workers from biological hazards as well as the environment including plants and animals.
EN 12741:1999 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 12741:1999 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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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija - Raziskovalni, razvojni in analitiski laboratoriji - Navodilo za delovanje biotehnoloških laboratorijevBiotechnik - Laboratorien für Forschung, Entwicklung und Analyse - Leitfaden für biotechnologische LaborpraxisBiotechnologie - Laboratoires de recherche, développement et analyse - Guide pour les opérations de laboratoires biotechnologiquesBiotechnology - Laboratories for research, development and analysis - Guidance for biotechnology laboratory operations11.100.01Labo
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記事のタイトル：EN 12741:1999 - バイオテクノロジー - 研究、開発、および分析のためのラボラトリー - バイオテクノロジー研究所の運営に関するガイドライン 記事の内容：この欧州標準は、1から4までの収容レベル（EN 12128およびprEN 12738を参照）を持つバイオテクノロジーの研究、開発、および分析のラボラトリーにおけるバイオテクノロジーの運営に関する指針を明示しています。この欧州標準は、作業者や植物および動物を含む環境を生物学的な危険から保護することを目的としています。
기사 제목: EN 12741:1999 - 생명공학 - 연구, 개발 및 분석을 위한 실험실 - 생명공학 실험실 운영에 대한 지침 기사 내용: 본 유럽 표준은 속단 수준 1, 2, 3 및 4의 생명공학 연구, 개발 및 분석 실험실에서의 생명공학 작업에 대한 실천 지침을 제공합니다 (EN 12128 및 prEN 12738 참조). 이 유럽 표준은 작업자와 식물 및 동물을 포함한 환경을 생물학적 위험으로부터 보호하기 위해 목표로 합니다.
The article discusses the European Standard EN 12741:1999, which provides guidance for biotechnology laboratory operations in research, development, and analysis settings. The standard is applicable to laboratories with different containment levels ranging from 1 to 4. Its main objective is to ensure the safety of workers and the environment, including plants and animals, from biological hazards.
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