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; German version FprEN 18000-1:2024
Abstract
The purpose of this document is to provide the applicant submitting an animal disease in-vitro diagnostic reagent to control with the general input for the preparation of the control application file. This document first lists the terms and definitions that are relevant to its reading and understanding and, where appropriate, used in other parts of the standard. It describes the minimal administrative and technical information regarding the applicant, the manufacturer and the reagent required for the application file for initial control and for a batch to batch control respectively. It specifies, in particular, the validation parameters of the method using the reagent (objectives, methodology, criteria and results) according to international standards.
Begin
2023-01-13
WI
00469001
Planned document number
DIN EN 18000-1
Project number
05702602
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; German and English version prEN 18000-1:2023
2023-10
Order from DIN Media
