SIST EN 12738:1999
(Main)Biotechnology - Laboratories for research, development and analysis - Guidance for containment of animals inoculated with microorganisms in experiments
Biotechnology - Laboratories for research, development and analysis - Guidance for containment of animals inoculated with microorganisms in experiments
This European Standard, in order to protect the worker and/or the environment, gives guidance on minimum physical biosafety measures for the containment of animals deliberately inoculated with microorganisms, including genetically modified microorganisms, which can present a risk to human or animal health or the environment. This European Standard does not apply to the containment of animals which have not been deliberately inoculated with microorganisms.
Biotechnik - Laboratorien für Forschung, Entwicklung und Analyse - Leitfaden für die Einschließung von Tieren, die im Rahmen von Experimenten mit Mikroorganismen beimpft werden
Mit dem Ziel des Schutzes der Beschäftigten und/oder der Umwelt dient diese Europäische Norm als Leitfaden hinsichtlich der technischen Mindestmaßnahmen zur Erlangung der biologischen Sicherheit bei der Einschließung absichtlich mit Mikroorganismen (einschließlich gentechnisch veränderter Mikroorganismen) infizierter Tiere, die ein Risiko für die Gesundheit von Mensch und Tier oder für die Umwelt darstellen können. Diese Europäische Norm gilt nicht für die Einschließung von Tieren, die nicht absichtlich mit Mikroorganismen infiziert wurden.
Biotechnologie - Laboratoires de recherche, développement et analyse - Guide pour le confinement des animaux inoculés avec des microorganismes utilisés a des fins expérimentales
La présente norme européenne fournit un guide des mesures physiques minimales de sécurité biologique pour le confinement des animaux volontairement inoculés avec des microorganismes, y compris des microorganismes génétiquement modifiés, et pouvant présenter des risques pour la santé de l'homme et des animaux et pour l'environnement, afin de protéger les travailleurs et/ou l'environnement. La présente norme européenne ne s'applique pas au confinement des animaux qui n'ont pas été volontairement inoculés avec des microorganismes.
Biotehnologija - Raziskovalni, razvojni in analitski laboratoriji - Navodilo za vzdrževanje poskusnih živali, cepljenih z mikroorganizmi
General Information
- Status
- Published
- Publication Date
- 30-Nov-1999
- Technical Committee
- BTH - Biotechnology
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 01-Dec-1999
- Due Date
- 01-Dec-1999
- Completion Date
- 01-Dec-1999
Overview
EN 12738:1999 (CEN) provides guidance on minimum physical biosafety measures for the containment of animals deliberately inoculated with microorganisms - including genetically modified microorganisms (GMMs) - used in research, development and analytical experiments. The standard’s primary objective is to protect workers and the environment. It explicitly does not apply to animals that have not been deliberately inoculated with microorganisms.
Key Topics
The standard focuses on practical, facility-level containment guidance rather than experimental protocols. Key topics covered or implied by the scope include:
- Minimum physical biosafety measures for animal containment environments
- Guidance relevant to animals deliberately inoculated with microorganisms and GMMs
- Protection of worker health and environmental safety
- Applicability limited to laboratories for research, development and analysis
Note: EN 12738:1999 gives high-level requirements and guidance; organizations typically interpret these requirements into local procedures, engineering controls and operational practices appropriate to their specific risks.
Applications
EN 12738:1999 is useful wherever animals are deliberately inoculated with microorganisms in experimental settings. Typical practical applications include:
- Designing or upgrading animal containment facilities in biotechnology laboratories
- Informing risk assessments and containment planning for animal inoculation studies
- Developing or validating standard operating procedures (SOPs) for animal handling, containment and waste management
- Supporting institutional review and biosafety committee decisions on experimental containment levels
- Training programs for facility managers, animal care staff and biosafety officers on containment expectations
Who would use this standard:
- Laboratory managers and facility designers in biotech, pharma and academic research
- Institutional Biosafety Committees (IBCs) and biosafety officers
- Animal facility technicians and veterinary staff involved in inoculation experiments
- Regulators and auditors assessing compliance with European biosafety expectations
Related Standards
EN 12738:1999 sits within the broader body of European and international guidance on laboratory biosafety and biotechnology facilities. Users commonly reference other CEN/ISO standards and national regulations governing:
- Laboratory biosafety and containment engineering
- Handling of genetically modified organisms (GMOs)
- Animal welfare and laboratory animal care
Using EN 12738:1999 together with local regulations and complementary biosafety standards helps organizations implement practical, compliant containment measures for experiments involving inoculated animals.
Frequently Asked Questions
SIST EN 12738:1999 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Biotechnology - Laboratories for research, development and analysis - Guidance for containment of animals inoculated with microorganisms in experiments". This standard covers: This European Standard, in order to protect the worker and/or the environment, gives guidance on minimum physical biosafety measures for the containment of animals deliberately inoculated with microorganisms, including genetically modified microorganisms, which can present a risk to human or animal health or the environment. This European Standard does not apply to the containment of animals which have not been deliberately inoculated with microorganisms.
This European Standard, in order to protect the worker and/or the environment, gives guidance on minimum physical biosafety measures for the containment of animals deliberately inoculated with microorganisms, including genetically modified microorganisms, which can present a risk to human or animal health or the environment. This European Standard does not apply to the containment of animals which have not been deliberately inoculated with microorganisms.
SIST EN 12738:1999 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 11.100.01 - Laboratory medicine in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 12738:1999 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 analitski laboratoriji - Navodilo za vzdrževanje poskusnih živali, cepljenih z mikroorganizmiBiotechnik - Laboratorien für Forschung, Entwicklung und Analyse - Leitfaden für die Einschließung von Tieren, die im Rahmen von Experimenten mit Mikroorganismen beimpft werdenBiotechnologie - Laboratoires de recherche, développement et analyse - Guide pour le confinement des animaux inoculés avec des microorganismes utilisés a des fins expérimentalesBiotechnology - Laboratories for research, development and analysis - Guidance for
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