EN 17122:2019+A1:2024
(Main)Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements - Phase2, step2
Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements - Phase2, step2
This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when diluted with hard water, or - in the case of ready-to-use-products - with water.
This European Standard applies to products that are used in the veterinary area on non-porous surfaces without mechanical action i.e. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a Phase 2 Step 2 test.
NOTE 3 Using this European Standard, it is possible to determine the virucidal activity of the undiluted product.
NOTE 4 This standard uses Porcine Parvovirus because Bovine Enterovirus Type 1 (ECBO) virus used in the suspension test EN 14675 cannot be used for surface testing because of its loss of titre during drying. Porcine
Parvovirus has comparable resistance to ECBO virus.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Bestimmung der viruziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich auf nicht-porösen Oberflächen - Prüfverfahren und Anforderungen - Phase 2, Stufe 2
Dieses Dokument legt ein Prüfverfahren für und die Mindestanforderungen an die viruzide Wirkung von chemischen Desinfektionsmitteln fest, die bei Verdünnung mit Wasser standardisierter Härte oder – im Falle gebrauchsfertiger Produkte – mit Wasser als homogene und physikalisch stabile Zubereitung vorliegen.
Dieses Dokument ist anwendbar für Produkte, die ohne mechanische Einwirkung zur Desinfektion von nicht porösen Oberflächen im Veterinärbereich verwendet werden, d. h. bei der Aufzucht, Haltung, Produktion, in veterinärmedizinischen Gesundheitseinrichtungen und beim Transport von Tieren sowie bei der Tierkörperbeseitigung, außer wenn die Tiere nach der Tötung durch Zuführung in die weiterverarbeitende Industrie in die Lebensmittelkette gelangen.
EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den „Anwendungsempfehlungen“ fest.
ANMERKUNG 1 Das beschriebene Verfahren ist zur Bestimmung der Wirkung von handelsüblichen Zubereitungen oder Wirkstoffen unter deren Anwendungsbedingungen vorgesehen.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 2.
ANMERKUNG 3 Bei Anwendung dieses Dokuments ist es möglich, die viruzide Wirkung des unverdünnten Produkts zu bestimmen.
ANMERKUNG 4 Für dieses Dokument wird das Porzine Parvovirus verwendet, da das für den Suspensionsversuch EN 14675 eingesetzte Bovine Enterovirus E [(früher Bovine Enterovirus Typ 1 (ECBO)] aufgrund der Abnahme des Virentiters beim Trocknen nicht für Oberflächenprüfungen verwendet werden kann. Das Porzine Parvovirus und das ECBO-Virus weisen eine vergleichbare Resistenz auf.
Antiseptiques et désinfectants chimiques - Essai quantitatif de surfaces non poreuses pour l'évaluation de l'activité virucide des désinfectants et antiseptiques chimiques utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions - Phase 2, étape 2
Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah za vrednotenje virucidnega delovanja kemičnih razkužil in antiseptikov v veterini - Preskusna metoda in zahteve (faza 2, stopnja 2) (vključno z dopolnilom A1)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2025
Nadomešča:
SIST EN 17122:2020
Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah
za vrednotenje virucidnega delovanja kemičnih razkužil in antiseptikov v veterini -
Preskusna metoda in zahteve (faza 2, stopnja 2) (vključno z dopolnilom A1)
Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the
evaluation of virucidal activity of chemical disinfectants and antiseptics used in the
veterinary area - Test method and requirements - Phase2, step2
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur
Bestimmung der viruziden Wirkung chemischer Desinfektionsmittel und Antiseptika für
den Veterinärbereich auf nicht-porösen Oberflächen - Prüfverfahren und Anforderungen
- Phase 2, Stufe 2
Antiseptiques et désinfectants chimiques - Essai quantitatif de surfaces non poreuses
pour l'évaluation de l'activité virucide des désinfectants et antiseptiques chimiques
utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions - Phase 2, étape 2
Ta slovenski standard je istoveten z: EN 17122:2019+A1:2024
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
11.220 Veterinarstvo Veterinary medicine
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 17122:2019+A1
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2024
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN 17122:2019
English Version
Chemical disinfectants and antiseptics - Quantitative non-
porous surface test for the evaluation of virucidal activity
of chemical disinfectants and antiseptics used in the
veterinary area - Test method and requirements - Phase2,
step2
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de surfaces non poreuses pour l'évaluation Quantitativer Oberflächenversuch zur Bestimmung der
de l'activité virucide des désinfectants et antiseptiques viruziden Wirkung chemischer Desinfektionsmittel
chimiques utilisés dans le domaine vétérinaire - und Antiseptika für den Veterinärbereich auf nicht-
Méthode d'essai et prescriptions - Phase 2, étape 2 porösen Oberflächen - Prüfverfahren und
Anforderungen - Phase 2, Stufe 2
This European Standard was approved by CEN on 23 September 2019 and includes Amendment 1 approved by CEN on 25
November 2024.
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. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17122:2019+A1:2024 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 Requirements for virucidal activity on surfaces. 6
5 Test method . 7
5.1 Principle . 7
5.2 Materials and reagents, including cell cultures . 7
5.3 Apparatus and glassware . 10
5.4 Preparation of test organism suspensions and product test solutions . 12
5.5 Procedure for assessing the virucidal activity of the product . 13
5.6 Experimental data and calculation . 17
5.7 Verification of the methodology . 17
5.8 Expression of results . 18
5.9 Test report . 18
Annex A (informative) Referenced strains of national collections . 20
Annex B (informative) !Detoxification of test mixtures" . 21
Annex C (informative) Calculation of virus infectivity titre . 26
Annex D (informative) Example of a typical test report . 33
Annex E (informative) !Virucidal activity and activity against enveloped viruses" . 35
Bibliography . 36
European foreword
This document (EN 17122:2019+A1:2024) has been prepared by Technical Committee CEN/TC 216
“Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2025, and conflicting national standards shall be
withdrawn at the latest by June 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document includes Amendment 1 approved by CEN on 25 November 2024.
This document supersedes !EN 17122:2019".
The start and finish of text introduced or altered by amendment is indicated in the text by tags !".
!This document has been amended to harmonise the terminology and methods with those adopted
recently for other similar European standards and to make minor editorial changes to improve clarity. A
minor technical error has also been corrected. The changes detailed above have no impact on the test
results obtained using the previous version. Those results are still valid."
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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 the United
Kingdom.
Introduction
This document describes a surface test method for establishing whether a product proposed as a
disinfectant in the fields described in Clause 1 has or does not have virucidal activity on non-porous
surfaces.
The laboratory test closely simulates practical conditions of application. Chosen conditions (contact time,
temperature, organisms on surfaces etc.) reflect parameters which are found in practical situations
including conditions which may influence the action of disinfectants. Each use concentration found from
this test corresponds to defined experimental conditions.
The conditions are intended to cover general purposes and to allow reference between laboratories and
product types. Each utilization concentration of the chemical disinfectant found by this test corresponds
to defined experimental conditions.
However, for special applications the recommendations for use of a product can differ and therefore
additional test conditions might be needed, which cannot be covered by this document.
1 Scope
This document specifies a test method and the minimum requirements for virucidal activity of chemical
disinfectants that form a homogeneous physically stable preparation when diluted with hard water, or –
in the case of ready-to-use-products – with water.
This document applies to products that are used for disinfecting without mechanical action non-porous
surfaces in the veterinary area - i.e. in the breeding, husbandry, production, veterinary care facilities,
transport and disposal of all animals except when in the food chain following death and entry to the
processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use
recommendations”.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active
substances under the conditions in which they are used.
NOTE 2 This method corresponds to a Phase 2 Step 2 test.
NOTE 3 Using this document, it is possible to determine the virucidal activity of the undiluted product.
NOTE 4 This document uses Porcine Parvovirus because Bovine Enterovirus E (former Bovine Enterovirus Type
1 (ECBO)) virus used in the suspension test EN 14675 cannot be used for surface testing because of its loss of titre
during drying. Porcine Parvovirus has comparable resistance to ECBO virus.
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.
EN 12353, Chemical disinfectants and antiseptics — Preservation of test organisms used for the
determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal
(including bacteriophages) activity
EN 14675, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of
virucidal activity of chemical disinfectants and antiseptics used in the veterinary area – Test method and
requirements (Phase 2, step 1)
EN 14885, Chemical disinfectants and antiseptics — Application of European Standards for chemical
disinfectants and antiseptics
!EN 10088-1, Stainless steels — Part 1: List of stainless steels"
EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip of corrosion
resisting steels for general purposes
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 14675 and EN 14885 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
4 Requirements for virucidal activity on surfaces
The product shall demonstrate at least a decimal log (lg) reduction of 3 in virus titre of the parvovirus
and coronavirus test strains when tested in accordance with Table 1 and Clause 5. To claim virucidal
activity against enveloped viruses the product shall pass this standard with the coronavirus test strain
and to claim !deleted word" virucidal activity the product shall pass both EN 14675 with the bovine
enterovirus test strain and this standard with the porcine parvovirus test strain.
NOTE See Annex E for further information on the appropriateness of claims of virucidal activity against
enveloped viruses and !deleted word" virucidal activity
Table 1 — Minimum and additional test conditions
Minimum spectrum of test !deleted word" Virucidal activity
organisms
Porcine Parvovirus, Strain NADL2
Virucidal activity against enveloped viruses
Feline Coronavirus, Strain Munich
Test temperature 10 °C ± 1 °C
Additional temperatures 4 °C ± 1 °C; 20 °C ± 1 °C; 40 °C ± 1 °C
a
Contact time The contact time(s) shall be selected from the values given below
Minimum contact time 1min ± 5 s
Other contact times 5min ± 1
...
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