SIST EN 12687:1999
(Main)Biotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis 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 genomic modification
This European Standard gives guidance on the steps that should be followed during the analysis of the genetic modification of interest: - to analyse and describe the genetic modification of interest as it exists in the GMO (genomic modification); - to detect and/or identify the GMO accurately. This European Standard gives guidance on the factors and criteria considered by the experimenter for the selection of the appropriate method(s) and the validity of experimental results for the analysis of the genetic modification of interest.
Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Charakterisierung des gentechnisch veränderten Organismus durch Untersuchung der Genomveränderung
Diese Europäische Nom gibt eine Anleitung zu den Schritten, denen bei der Untersuchung der interessierenden Genomveränderung gefolgt werden sollte: - bei der Untersuchung und Beschreibung der beabsichtigten genetischen Veränderung, wie sie im GVO vorliegt (Genomveränderung); - bei der exakten Durchführung von Nachweis und/oder Identifizierung des GVO.
Biotechnologie - Organismes modifiés disséminés dans l'environnement - Guide pour la caractérisation de l'organisme génétiquement modifié par l'analyse de la modification génomique
La présente norme européenne fournit un guide relatif aux étapes qu'il convient de suivre lors de l'analyse de la modification génétique digne d'intérêt: - pour analyser et décrire la modification génétique digne d'intérêt telle qu'elle existe dans l'organisme génétiquement modifié (modification génomique); - pour détecter et/ou identifier avec précision l'organisme génétiquement modifié.
Biotehnologija - Spremenjeni organizmi za uporabo v okolju - Navodilo za ugotavljanje značilnosti gensko spremenjenega organizma z analizo spremenjenega genoma
General Information
Overview
EN 12687:1998 (CEN) is a European Standard providing guidance for the characterization of genetically modified organisms (GMOs) intended for application in the environment. It focuses on the analysis of the genomic modification itself - how to analyse and describe the genetic change as it exists in the organism and how to detect and identify the GMO accurately. The standard guides experimenters on factors and criteria for selecting appropriate analytical methods and assessing the validity of experimental results.
Key Topics
- Scope of genomic characterisation
Guidance on documenting the genetic modification of interest as present in the GMO (the genomic modification), including what aspects to consider when describing the modification. - Detection and identification
Principles for reliably detecting and/or identifying the GMO in environmental or laboratory samples to support monitoring, traceability and regulatory needs. - Method selection criteria
Factors to consider when choosing analytical approaches, including suitability for the modification under study and the intended purpose of the analysis. - Result validity and quality considerations
Guidance on assessing experimental validity, reproducibility and interpretability of analytical results to ensure robust conclusions. - Practical experimenter guidance
Recommendations for documenting procedures and decision-making steps so results can be evaluated by third parties (regulators, risk assessors, laboratories).
Applications
- Environmental release assessment and monitoring of GMOs
- Laboratory characterisation and traceability of released or experimental organisms
- Compliance testing and documentation for regulatory submissions
- Study design for research on GMO behaviour and stability in environmental contexts
Who Uses This Standard
- Regulatory bodies and risk assessors evaluating environmental applications of GMOs
- Accredited laboratories conducting GMO detection or genomic characterisation
- Biotechnology companies preparing dossiers for environmental use or release
- Academic and applied researchers working on GMO ecology, monitoring and molecular characterisation
Related Standards
EN 12687:1998 complements other European and international standards and guidelines addressing GMO detection, biosafety assessment and laboratory quality systems. Users should consult current national and international standards (CEN/ISO and national standards) relevant to analytical methods, validation and biosafety for complete compliance and best practice.
EN 12687:1998 is a practical reference for anyone responsible for the genomic analysis, detection or documentation of GMOs intended for environmental application, helping ensure method selection and result interpretation follow recognised, transparent criteria.
Frequently Asked Questions
SIST EN 12687:1999 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 genomic modification". This standard covers: This European Standard gives guidance on the steps that should be followed during the analysis of the genetic modification of interest: - to analyse and describe the genetic modification of interest as it exists in the GMO (genomic modification); - to detect and/or identify the GMO accurately. This European Standard gives guidance on the factors and criteria considered by the experimenter for the selection of the appropriate method(s) and the validity of experimental results for the analysis of the genetic modification of interest.
This European Standard gives guidance on the steps that should be followed during the analysis of the genetic modification of interest: - to analyse and describe the genetic modification of interest as it exists in the GMO (genomic modification); - to detect and/or identify the GMO accurately. This European Standard gives guidance on the factors and criteria considered by the experimenter for the selection of the appropriate method(s) and the validity of experimental results for the analysis of the genetic modification of interest.
SIST EN 12687:1999 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.
SIST EN 12687:1999 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.Biotechnik - Veränderte Organismen zum Einsatz in der Umwelt - Leitfaden für die Charakterisierung des gentechnisch veränderten Organismus durch Untersuchung der GenomveränderungBiotechnologie - Organismes modifiés disséminés dans l'environnement - Guide pour la caractérisation de l'organisme génétiquement modifié par l'analyse de la modification génomiqueBiotechnology - Modified organisms for application in the environment - Guidance for the characterization of the genetically modified organism by analysis of the genomic modific
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