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STN EN 18000-1

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Electronic version (pdc file)

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Name: STN EN 18000-1
Validity: Valid
Number of pages: 36
Language:
EN
Paper: 17,20€
Electronic version a) Only read (without ability to print and copy) 15,48€
b) Without ability to print, with ability to copy (printscreen) 17,20€
c) With ability to print and copy (printscreen) 22,36€
Slovak title Diagnostická analýza zdravia zvierat. Kontrola diagnostických činidiel in vitro. Časť 1: Súbor aplikácií na počiatočnú kontrolu a kontrolu medzi dávkami
English title Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 1: Application file for the initial and the batch-to-batch control
Release Date: 01. 06. 2026
Date of withdrawal:
ICS: 11.220
Sorting character/National clasification code 96 9051
Level of incorporation: idt EN 18000-1:2026
Official Journal 05/26
Amendments
Replaced by:
Repleces:
Note in Official Journal:
Subject of the standard: 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 ...
Preview: Náhľad normy (PDF)