prEN 18000-1

SLOVENSKI STANDARD
01-december-2023
Diagnostične analize zdravja živali - Nadzor diagnostičnih reagentov in vitro - 1.
del: Vloga za začetno kontrolo in kontrolo od serije do serije
Animal health diagnostic analyses - Control of in vitro diagnostic reagents - Part 1:
Application file for the initial and the batch-to-batch control
Tiergesundheitsdiagnostische Analysen - Kontrolle von in-vitro-diagnostischen
Reagenzien - Teil 1: Antragsunterlagen für die Erstkontrolle und die Kontrolle von
Charge zu Charge
Analyses de diagnostic en santé animale - Contrôle des réactifs de diagnostic in vitro -
Partie 1 : Dossier de présentation pour le contrôle initial et le contrôle lot à lot
Ta slovenski standard je istoveten z: prEN 18000-1
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
11.220 Veterinarstvo Veterinary medicine
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2023
ICS
English Version
Animal health diagnostic analyses - Control of in vitro
diagnostic reagents - Part 1: Application file for the initial
and the batch-to-batch control
Analyses de diagnostic en santé animale - Contrôle des Tiergesundheitsdiagnostische Analysen - Kontrolle von
réactifs de diagnostic in vitro - Partie 1 : Dossier de in-vitro-diagnostischen Reagenzien - Teil 1:
présentation pour le contrôle initial et le contrôle lot à Antragsunterlagen für die Erstkontrolle und die
lot Kontrolle von Charge zu Charge
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 469.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 18000-1:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 General control steps and prerequisites . 15
5 Content of the file for the initial control . 15
5.1 General. 15
5.2 Administrative information . 16
5.2.1 General. 16
5.2.2 Presentation . 16
5.3 Technical file of the reagent . 17
5.3.1 Manufacture . 17
5.3.2 Assessment file . 18
5.4 References . 21
6 Content of the file for batch-to-batch control . 21
6.1 Written batch control request. 21
6.2 Results of the applicant’s internal quality control . 21
7 Conformity certificates . 22
8 Modifications of a reagent . 22
8.1 CO and end-user information . 22
8.2 Management of major and minor modifications by the control organization . 22
Annex A (informative) Description form and label of a reference material . 23
Annex B (informative) File to be compiled by the applicant for assessment validation of a
reagent by a control organization. 25
Annex C (normative) Declaration of interest . 28
Annex D (normative) Reagent or batch conformity certificate (issued by the control
organization) . 29
Annex E (informative) Notification of reagent modification . 30
Bibliography . 31

European foreword
This document (prEN 18000-1:2023) has been prepared by Technical Committee CEN/TC 469 “Animal
health diagnostic analyses”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
Introduction
The objective of the EN 18000 series is to facilitate the mutual recognition of the work of the animal health
in vitro diagnostic reagent control organizations at European level (or even more widely) and thus to
eventually allow the use of strategic reagents controlled by a single control organization for a given disease.
The EN 18000 series aims to describe the optimal requirements for in vitro diagnostic reagents in animal
health. It is divided into three parts. The first part concerns the submission of a reagent dossier to a control
organization for control and approval. The second and third parts concern the specific aspects of the control
of an immunological diagnostic reagent and of a polymerase-chain reaction diagnostic reagent for the
detection or quantification of pathogen-specific nucleic acids (PCR), respectively.
Like any standard, it is intended to be voluntary and, if its use is prescribed by a competent authority or any
other animal health stakeholder, it will be up to them to determine for which diseases this standard will be
applied by the control bodies they have designated for this purpose.
1 Scope
The level of requirements presented in the EN 18000 series has been established as a priority for infectious
diseases (bacterial, viral, fungal or parasitic) 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.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular
those for which certain parameters described in this standard cannot be validly evaluated in accordance with
international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly
validated reference materials.
This first part describes the general and specific elements constituting the dossier for the submission of an
animal health in vitro diagnostic reagent, in the above-described framework, to the control and approval by
a control organization. Its purpose 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. It describes the
optimal administrative and technical information regarding the applicant 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.
NOTE This document does not cover the step in which the user verifies a reagent (refer to section 3.1 for
definition).
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE These terms are written in italics throughout the EN 18000 series.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1
analysis method adoption
verification by a laboratory that it can properly perform a method before introducing it by ensuring that it
can achieve the required performance, e.g. in comparison with a second test method
Note 1 to entry: This concept is called “in-house validation” by WOAH.
[SOURCE: EN ISO/IEC 17025:2017]
3.2
analyte
substance to be detected or determined purpose of the analysis method
Note 1 to entry: In this standard, the term analyte may refer to a single analyte or to a given population of analytes
(antibodies, antigens, nucleic acids, live or inactivated organisms, etc.).
3.3
analytical sensitivity
measured through the limit of detection (LOD), i.e. the estimated amount of analyte
in a specified matrix that would produce a positive result at least a specified per cent of the time
[SOURCE: WOAH Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2022 - Glossary of terms]
3.4
analytical sensitivity
measured through the limit of detection (LOD), i.e. the smallest detectable amount
of analyte that can be measured with a defined certainty (i.e. a signal significantly above a matrix without the
analyte)
[SOURCE: WOAH Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2022 - Glossary of terms]
3.5
analytical specificity
degree to which the assay distinguishes between the target analyte and other components in the sample
matrix
Note 1 to entry: The higher the analytical specificity, the lower the level of false positives.
[SOURCE: WOAH Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2022 - Glossary of terms]
3.6
applicant
individual or legal entity that submits the dossier of a reagent for initial control or who submits a batch of
reagent for batch-to-batch control
3.7
assay validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use
or application have been fulfilled
Note 1 to entry: In this standard, for the applicant, this consists in providing assessment results that demonstrate that
the method using the reagent submitted to control is validated according to existing standards, i.e. generic ones (Test
validation according to WOAH) and disease-specific ones (according to the state of art, e.g. disease-specific standards,
scientific literature).
Note 2 to entry: The control organization does not strictly speaking validate the reagent itself, but verifies through the
documentation provided and by the implementation of a limited number of appropriate tests, that the elements of the
application file and the submitted batch comply with the requirem
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