prEN 18000-2

SLOVENSKI STANDARD
01-december-2023
Diagnostične analize zdravja živali - Nadzor diagnostičnih reagentov in vitro - 2.
del: Reagenti za imunološke tehnike
Animal health diagnostic analyses - Control of in-vitro diagnostic reagents - Part 2:
Reagents for immunological techniques
Tiergesundheitsdiagnostische Analysen - Kontrolle von in-vitro-diagnostischen
Reagenzien - Teil 2: Reagenzien für immunologische Verfahren
Analyses de diagnostic en santé animale - Contrôle des réactifs de diagnostic in vitro -
Partie 2 : Réactifs pour les techniques immunologiques
Ta slovenski standard je istoveten z: prEN 18000-2
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 2: Reagents for immunological
techniques
Analyses de diagnostic en santé animale - Contrôle des Tiergesundheitsdiagnostische Analysen - Kontrolle von
réactifs de diagnostic in vitro - Partie 2 : Réactifs pour in-vitro-diagnostischen Reagenzien - Teil 2:
les techniques immunologiques Reagenzien für immunologische Verfahren
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 18000-2:2023 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 . 6
5 Prerequisites of the reagent control for the control organization . 6
5.1 General. 6
5.2 Reference materials . 6
5.3 Definition of the objectives of the reagents . 6
5.4 Additional useful information . 7
6 Initial conformity control . 7
6.1 General. 7
6.2 Characterization of the reagents by the applicant and control by the control organization
............................................................................................................................................................................... 7
6.3 Initial control of the reagents by the control organization . 11
7 Batch-to-batch control . 12
7.1 Control at the start of the batch . 12
7.2 Control during the batch validity period . 13
8 Special cases . 13
8.1 Multiple protocols . 13
8.2 Multiple matrices . 13
8.3 Pooling of samples . 13
8.4 Derogations to systematic batch-to-batch control . 13
Bibliography . 14

European foreword
This document (prEN 18000-2:2023) 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 terms and definitions and 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 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 needed, 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 standard and/or
accessible and duly validated reference materials.
This second part describes the control, in the above-described framework, of in vitro reagents for
immunological analyses with a qualitative expression of results used in animal health. It involves control
organizations (CO) and applicants (including their subcontractors, when relevant).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
prEN 18000-1:2023, Animal health diagnostic analyses — Control of in vitro diagnostic reagents —
Part 1: Application file for the initial and the batch-to-batch control
3 Terms and definitions
For the purposes of this document, the terms and definitions given in prEN 18000-1 and the following 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
immunological analysis with qualitative interpretation
analysis involving an antigen-antibody reaction or, more broadly, a ligand-protein reaction, the result of
which is expressed in qualitative terms (positive, negative, inconclusive)
Note 1 to entry: This qualitative result may be the result of the interpretation of numerical data.
EXAMPLES Enzyme Linked Immuno-Sorbent Assay (ELISA), Agar Gel Immunodiffusion (AGID) assay,
Immunofluorescence Assay (IFA).
3.2
reaction support
material (device, object, medium) in or on which the reaction is carried out
EXAMPLES Plate for a rapid agglutination, gel for an agar-based immunodiffusion, microplate for an ELISA, tube
for a tube agglutination.
4 General control steps
The reagents are controlled according to this standard when the regulations or authorities so require.
Depending on the context (e.g. regulation, disease control programme) of the implementation of analyses
with such reagents, the control may include an initial conformity control and several batch-to-batch controls.
Certain steps of the reagent control may be subcontracted by the CO, provided that it ensures that the
subcontractors possess the necessary skills (e.g. accreditation) and are independent.
Here are described the optimal requirements for each of the steps of the control, without defining the criteria
of conformity, which shall be specified beforehand by the CO according to the state of art (e.g. existing disease
test-specific standards, consensus conference recommendations, scientific literature). If necessary, or based
on a particular risk or epidemiological context, additional control tests may be performed that are not
described in detail in this standard.
5 Prerequisites of the reagent control for the control organization
5.1 General
The prerequisites of the control of reagents include:
— the availability of reference materials (RMs);
— the definition of the minimum performance requirements of the reagents (e.g. regulations, standards,
guidelines);
— additional useful information (e.g. templates) provided by the CO, when relevant to harmonize as far as
possible the implementation of control between the CO and the applicant.
5.2 Reference materials
The CO shall possess characterized positive RMs and negative RMs. The RMs may exist in the form of different
matrices in different levels of concentration.
The CO shall provide the applicant with RMs, so that the applicant can prepare its internal RMs in order to
conduct the control described in this standard (refer to ISO Guide 30; ISO/DIS 33403;). With these RMs, it
may provide the characteristics listed in Annex A of prEN 18000-1:2023. For certified RMs, the
characteristics appearing on the certificate to be provided are listed in ISO/DIS 33401.
The RMs may also be prepared and/or supplied by third parties, provided that they meet the criteria defined
by the CO and have been approved by the latter.
Certain RMs are defined by regulations or standards.
For certain matrices (e.g. wet blots), the RMs shall be produced under conditions as close to reality as
possible. If possible, the CO shall provide the user and the applicant with the production protocol.
The CO is not required to provide the field samples or the samples produced by experimental infection that
are necessary for the assessment of the diagnostic sensitivity and specificity.
5.3 Definition of the objectives of the reagents
The CO shall specify in writing the objectives of the reagents for the applicant (regulatory an
...