DIN Standards Committee Food and Agricultural Products
Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 1: Application file for the initial and the batch-to-batch control
Abstract
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).
Begin
2022-12-26
WI
00469001
Planned document number
FprEN 18000-1
Responsible national committee
NA 057-02-03 AA - Animal health
Responsible european committee
CEN/TC 469/WG 1 - Reagents and methods
draft standard
Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 1: Application file for the initial and the batch-to-batch control
2023-09
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Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 1: Application file for the initial and the batch-to-batch control
2024-09
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Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 1: Application file for the initial and the batch-to-batch control
2025-05
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