DIN Standards Committee Food and Agricultural Products
Animal health diagnostic analyses - Control of in-vitro diagnostic reagents - Part 2: Reagents for immunological techniques; German and English version prEN 18000-2:2023
Abstract
This document describes the control of in-vitro reagents for immunological analyses with a qualitative expression of results used in animal health. It involves control organisations, users and applicants (including its sub-contractors, when relevant). The reagents are controlled when the regulations or authorities so require. Depending on the context of the analysis implementation (e.g. regulation) of reagents, the control may include an initial conformity control and several conformity controls of batches. Certain steps of the reagent control may be subcontracted by the control organisation, provided that it makes sure that the subcontractors possess the necessary skills (accreditation) and are independent. This document describes the minimum requirements for each of the steps of the control, without defining the criteria of conformity, which shall be defined beforehand by the control organisation according to the state of art (e.g., existing disease test specific standards, consensus conference recommendations, scientific literature, etc.). If necessary, or based on a particular risk or epidemiological context, additional controls may be performed that are not described in detail in this standard. NOTE This document does not cover the step in which the user verifies a reagent.(refer to section 3.1 for definition).
Begin
2023-01-13
WI
00469003
Planned document number
DIN EN 18000-2
Project number
05702651
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 2: Reagents for immunological techniques; German and English version prEN 18000-2:2023
2023-10
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