SIST EN 12738:1999
(Main)Biotechnology - Laboratories for research, development and analysis - Guidance for containment of animals inoculated with microorganisms in experiments
General Information
- Abstract
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.
- 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.
Relations
- Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Refers
SIST EN 12347:1999 - Biotechnology - Performance criteria for steam sterilizers and autoclaves - Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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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 has the following relationships with other standards: It is inter standard links to SIST ISO 3864:1995, SIST ISO 7000:1995, SIST EN IEC 61010-2-040:2022, SIST EN 12128:1999, SIST CR 12894:1999, SIST EN 1060-1:2000/A1:2002, SIST CR 12739:1999, SIST EN 12740:1999, SIST EN 12469-5:2026, SIST EN 12469-1:2026, SIST EN 12469-2:2026, SIST EN 12347:1999, SIST EN 12741:1999. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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.
SIST EN 12738:1999 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 - 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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