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