EN 12306:1997
(Main)Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination
Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination
This European Standard provides guidance for a quality control procedure of a diagnostic kit to assure that the assay results will fulfil the intended purpose of the test by both manufacturers and users. This European Standard applies to diagnostic kits used in agriculture, plant and animal pest and disease control monitoring of feed and environmental contamination due to microorganisms.
Biotechnik - Leitfaden zur Qualitätsüberwachung von Diagnostikpackungen zur Verwendung in der Landwirtschaft, bei der Schädlingsbekämpfung, Bekämpfung von Krankheiten bei Pflanzen und Tieren sowie bei Kontaminationen der Umwelt
Diese Europäische Norm stellt Anleitungen für die Durchführung der Qualitätsüberwachung von Diagnostikpackungen auf, um sicherzustellen, daß die Analysenergebnisse den von den Herstellern und Anwendern vorgesehenen Zweck der Prüfung erfüllen. Diese Europäische Norm gilt für Diagnostikpackungen, die in der Landwirtschaft zur Überwachung von Schädlingen und Krankheiten von Pflanzen und Tieren, zur Überwachung von Futtermitteln sowie zur Überwachung der durch Mikroorganismen verursachten Kontaminationen der Umwelt verwendet werden.
Biotechnologie - Guide pour le contrôle de qualité des trousses de diagnostic utilisées en agriculture pour la surveillance des maladies et des agents nuisibles pour les plantes et les animaux et des contaminations environnementales
La présente norme présente un guide pour une procédure de contrôle de la qualité d'une trousse de diagnostic permettant aux fabricants comme aux utilisateurs de garantir que les résultats d'essai correspondent bien à l'objectif attendu. La présente norme européenne s'applique aux trousses de diagnostic utilisées en agriculture, pour la surveillance des maladies et des agents nuisibles pour les plantes et les animaux, le contrôle de l'alimentation animale et de la contamination environnementale dues à des microorganismes.
Biotehnologija - Navodilo za kontrolo kakovosti diagnostičnih kompletov, ki se uporabljajo v kmetijstvu, kontrola rastlinskih in živalskih škodljivcev, kontrola obolenj in onesnaževanja okolja
General Information
Overview
EN 12306:1997 (CEN) - "Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination" - provides European guidance for establishing a quality control procedure for diagnostic kits. The standard is intended to ensure that assay results from diagnostic kits fulfil the intended purpose of the test and is addressed to both manufacturers and users of kits applied to agriculture, plant and animal pest and disease control, and the monitoring of feed and environmental contamination by microorganisms.
Key topics and requirements
The standard gives guidance on quality control elements needed to assure reliable diagnostic performance. Key topics typically covered include:
- Quality control procedure design - establishing a QC framework to confirm that kits perform as intended.
- Performance verification & validation - guidance on demonstrating kit accuracy, sensitivity and specificity in intended use contexts.
- Batch release and routine QC - recommendations for checks at production and during shelf life to maintain consistent performance.
- Controls and reference materials - use of positive/negative controls and traceable reference materials to monitor assay integrity.
- Stability and storage - guidance on conditions affecting kit performance and monitoring of expiry/stability.
- Documentation and labelling - requirements for recording QC results, traceability and clear user instructions.
- User responsibilities - guidance for end‑users on implementing QC procedures in the field or laboratory.
Note: EN 12306 supplies guidance rather than prescriptive test specifications - it helps design and document QC systems to support reliable use of diagnostics.
Practical applications
EN 12306 is applicable where diagnostic kits are used for:
- Agricultural disease surveillance (plant pathogen detection)
- Animal health and pest control monitoring
- Feed safety testing for microbial contamination
- Environmental monitoring of microbial contaminants
Adopting the guidance helps reduce false positives/negatives, supports consistent batch-to-batch performance, and improves confidence in surveillance and control programmes.
Who should use this standard
- Diagnostic kit manufacturers developing QC and release procedures
- Contract and in‑house testing laboratories implementing kit QC
- Regulatory and plant/animal health authorities assessing kit suitability
- Environmental and feed safety monitoring organisations
Related standards
The document references other standards related to farming and forestry, biology, botany and zoology. As a CEN guidance, EN 12306 complements other sectoral and quality management standards used in diagnostic manufacturing and laboratory practice.
Keywords: EN 12306, diagnostic kits, quality control, agriculture diagnostics, plant disease monitoring, animal pest control, environmental contamination monitoring, CEN standard.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Leitfaden zur Qualitätsüberwachung von Diagnostikpackungen zur Verwendung in der Landwirtschaft, bei der Schädlingsbekämpfung, Bekämpfung von Krankheiten bei Pflanzen und Tieren sowie bei Kontaminationen der UmweltBiotechnologie - Guide pour le contrôle de qualité des trousses de diagnostic utilisées en agriculture pour la surveillance des maladies et des agents nuisibles pour les plantes et les animaux et des contaminations environnementalesBiotechnology - Guidance for quality control of diag
...
Frequently Asked Questions
EN 12306:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination". This standard covers: This European Standard provides guidance for a quality control procedure of a diagnostic kit to assure that the assay results will fulfil the intended purpose of the test by both manufacturers and users. This European Standard applies to diagnostic kits used in agriculture, plant and animal pest and disease control monitoring of feed and environmental contamination due to microorganisms.
This European Standard provides guidance for a quality control procedure of a diagnostic kit to assure that the assay results will fulfil the intended purpose of the test by both manufacturers and users. This European Standard applies to diagnostic kits used in agriculture, plant and animal pest and disease control monitoring of feed and environmental contamination due to microorganisms.
EN 12306:1997 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 07.100.99 - Other standards related to microbiology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12306:1997 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.
You can purchase EN 12306:1997 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...