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
Order from DIN Media