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BSI BS EN 18000-1:2026

Animal health diagnostic analyses. Control of in vitro diagnostic reagents -- Application file for the initial and the batch-to-batch control
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BSI BS EN 18000-1:2026

Animal health diagnostic analyses. Control of in vitro diagnostic reagents -- Application file for the initial and the batch-to-batch control

PUBLISH DATE 2026
PAGES 36
BSI BS EN 18000-1:2026
This document specifies terms and definitions applicable to the EN 18000 series and requirements concerning information to be provided by applicants submitting animal health in vitro diagnostic reagents to control. This document is applicable to diagnostic reagents, as a priority for infectious (bacterial, viral, fungal or parasitic) or prion diseases and associated animal species for which harmonization of practices in this area is necessary, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. While all reagents designated by the competent authorities fall under the scope of this document, the authorities or any other animal health stakeholder can choose to derogate in specific and exceptional situations such as emerging, exotic or rare diseases. This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials. This document does not cover the step in which the user verifies a reagent (analysis method adoption).
SDO BSI: British Standards Institution
Document Number EN 18000-1
Publication Date Jan. 15, 2026
Language en - English
Page Count 36
Revision Level
Supercedes
Committee AW/469
Publish Date Document Id Type View
Jan. 15, 2026 BS EN 18000-1:2026 Revision