The level of requirements presented in the EN 18000 series has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonization of practices in this area is needed, 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.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this standard cannot be validly evaluated in accordance with international requirements, due e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials.
This second part describes the control, in the above-described framework, of in vitro reagents for immunological analyses with a qualitative expression of results used in animal health. It involves control organizations (CO) and applicants (including their subcontractors, when relevant).