SIST EN 12683:1999
(Main)Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification
Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification
This European Standard provides guidance for factors and criteria considered by the experimenter for the valid design, execution and evaluation of an analysis of the molecular stability of the genomic modification with respect to life cycle, heritability and external factors. It describes the steps in the characterization of a GMO that should be followed to ensure the validity of the analysis of the molecular stability of the genomic modification. The type of molecular stability analysis is dependent on the objectives of the experiment.
Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Charakterisierung des gentechnisch veränderten Organismus durch Untersuchung der molekularen Stabilität der Genomveränderung
Diese Europäische Norm gibt eine Anleitung für Faktoren und Kriterien, die vom Experimentator für die zuverlässige Planung, Ausführung und Auswertung einerUntersuchung der molekularen Stabilität der Genomveränderung im Hinblick auf Lebenßyklus, Vererbung und äußere Faktoren zu berücksichtigen sind. Sie beschreibt Schritte, die bei der Charakterisierung eines GVO befolgt werden sollten, um die Validität der Untersuchung der molekularen Stabilität der Genomveränderung sicherzustellen. Die Art der Untersuchung der molekularen Stabilität ist von den Zielen des Versuchs abhängig.
Biotechnologie - Organismes modifiés disséminés dans l'environnement - Guide pour la caractérisation de l'organisme génétiquement modifié par l'analyse de la stabilité moléculaire de la modification génomique
La présente norme européenne donne des indications relatives à des facteurs et des critères qui sont pris en considération par l'expérimentateur lors de la conception, de l'exécution et de l'évaluation d'une analyse de la stabilité moléculaire de la modification génomique compte tenu du cycle de vie, du caractère héréditaire et des facteurs extérieurs. Elle décrit les étapes de caractérisation d'un organisme génétiquement modifié qu'il convient de suivre pour garantir la validité de l'analyse de la stabilité moléculaire de la modification génomique.
Biotehnologija - Spremenjeni organizmi za uporabo v okolju - Navodilo za ugotavljanje značilnosti gensko spremenjenega organizma z analizo molekularne stabilnosti spremenjenega genoma
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 12683:1998 (CEN) - Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification - provides practical guidance for designing, executing and evaluating analyses of the molecular stability of genomic modifications in genetically modified organisms (GMOs). The standard focuses on ensuring valid, reproducible characterization with respect to an organism’s life cycle, heritability of the modification and relevant external factors that can affect genomic stability. The type and scope of molecular stability analysis are determined by the specific objectives of the experiment.
Key topics and requirements
- Scope of analysis - guidance on matching the molecular stability analysis to experimental objectives (monitoring, risk assessment, registration).
- Design considerations - factors and criteria experimenters should consider when planning studies to assess genomic modification stability.
- Execution and sampling - recommended approaches to sampling across life cycle stages and generations to detect possible rearrangements, loss or instability.
- Heritability assessment - evaluation of transmission of the genomic modification through successive generations.
- External factors - consideration of environmental or operational conditions (e.g., stresses, selective pressures) that may influence molecular stability.
- Validity and evaluation - steps for data interpretation, controls, reproducibility and documenting the validity of the stability analysis.
- Tailored methods - statement that the specific molecular techniques and the depth of analysis depend on study goals; the standard describes procedural steps rather than prescribing individual laboratory methods.
Applications
- Environmental release studies and post-release monitoring of GMOs.
- Pre-market characterization for regulatory dossiers and biosafety assessments.
- Research projects assessing stability and heritability of introduced traits.
- Quality assurance and validation of molecular monitoring programs for modified organisms used in environmental applications.
Who uses this standard
- Molecular biologists and environmental biotechnologists conducting GMO characterization.
- Biotech companies developing environmental GMOs (e.g., bioremediation strains).
- Regulatory authorities and risk assessors evaluating molecular stability data.
- Contract research organizations (CROs), environmental monitoring labs and biosafety officers.
Related standards and guidance
- Complements other CEN/ISO and national standards and regulatory frameworks on biotechnology, biosafety and molecular analysis. Users should consult applicable local GMO regulations and relevant molecular-method standards when implementing EN 12683:1998.
Keywords: EN 12683:1998, molecular stability analysis, genomic modification, GMO characterization, heritability, life cycle, environmental biotechnology, CEN standard.
Frequently Asked Questions
SIST EN 12683:1999 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the molecular stability of the genomic modification". This standard covers: This European Standard provides guidance for factors and criteria considered by the experimenter for the valid design, execution and evaluation of an analysis of the molecular stability of the genomic modification with respect to life cycle, heritability and external factors. It describes the steps in the characterization of a GMO that should be followed to ensure the validity of the analysis of the molecular stability of the genomic modification. The type of molecular stability analysis is dependent on the objectives of the experiment.
This European Standard provides guidance for factors and criteria considered by the experimenter for the valid design, execution and evaluation of an analysis of the molecular stability of the genomic modification with respect to life cycle, heritability and external factors. It describes the steps in the characterization of a GMO that should be followed to ensure the validity of the analysis of the molecular stability of the genomic modification. The type of molecular stability analysis is dependent on the objectives of the experiment.
SIST EN 12683:1999 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 12683:1999 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 12683:1999 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.Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Charakterisierung des gentechnisch veränderten Organismus durch Untersuchung der molekularen Stabilität der GenomveränderungBiotechnologie - Organismes modifiés disséminés dans l'environnement - Guide pour la caractérisation de l'organisme génétiquement modifié par l'analyse de la stabilité moléculaire de la modification génomiqueBiotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically
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