Reference details
- Reference
- EN 12306:1997
- Official title
- Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination
- Organisation
- CEN
- Publisher status in source
- PublishedThis is the status recorded in the source, not a statement that this is the latest edition.
- Source access
- 19 October 2026
Research and application
Begin with the official scope and the product configuration. The title identifies a subject; it does not establish every product, use condition or legal requirement covered by the publication.
Product research routes
- In vitro diagnostic products
Specimens, intended purpose and analytical and clinical performance for diagnostic devices and systems.
- Agriculture and forestry products and equipment
Product and machinery requirements shaped by field conditions, operators, materials and biological processes.
Questions for the evidence file
- Intended purpose
- Assay configuration
- Performance study design
- Calibration and traceability
- Sample handling
- Operating conditions
Record the exact edition and associated amendments, the assessed object, the evidence examined and the limits of the conclusion. Explore IESQ research for detailed product and standard studies.
Legal citation
No Commission citation record has been linked to this reference in the IESQ index. That is an index result, not a conclusion that the standard is uncited. Consult the relevant Commission list and Official Journal acts.
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