EN 17122:2019
(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 gilt 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
Le présent document spécifie une méthode d’essai et les prescriptions minimales relatives à l’activité virucide des désinfectants chimiques qui forment une préparation homogène et physiquement stable lorsqu’ils sont dilués dans de l’eau dure ou – dans le cas de produits prêts à l’emploi – dans l’eau.
Le présent document s’applique aux produits utilisés pour désinfecter sans action mécanique des surfaces non poreuses dans le domaine vétérinaire, à savoir pour la reproduction, l’élevage, la production, les établissements de soins vétérinaires, le transport et l’abattage de tous les animaux, sauf au cours de la chaîne alimentaire qui suit l’abattage et l’entrée dans l’industrie de transformation.
L’EN 14885 spécifie de façon détaillée les relations des différents essais entre eux et avec les « recommandations d’emploi ».
NOTE 1 La méthode décrite a pour objet de déterminer l’activité de formulations commerciales ou de substances actives dans leurs conditions d’emploi.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 2.
NOTE 3 L’utilisation du présent document permet de déterminer l’activité virucide d’un produit non dilué.
NOTE 4 Le présent document utilise le parvovirus porcin, car l’entérovirus bovin E [anciennement entérovirus bovin de type 1 (ECBO)] utilisé dans l’essai de suspension de l’EN 14675 ne peut pas être employé pour les essais de surface en raison de sa perte de titre pendant le séchage. Le parvovirus porcin présente une résistance comparable au virus ECBO.
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)
Ta evropski standard določa preskusno metodo in minimalne zahteve za virucidno delovanje kemičnih razkužil in antiseptikov, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo oziroma z vodo pri proizvodih, ki so pripravljeni za uporabo.
Ta evropski standard se uporablja za izdelke v veterini na neporoznih površinah brez mehanskega delovanja, tj. pri vzreji, živinoreji, proizvodnji, v veterinarskih ambulantah, pri prevozu in odstranjevanju vseh živali, razen če so v prehrambeni verigi po smrti in so del predelovalne industrije.
Standard EN 14885 podrobno določa razmerje med različnimi preskusi in »priporočili za uporabo«.
OPOMBA 1: Opisana metoda je namenjena določevanju dejavnosti komercialnih oblik ali aktivnih snovi pod pogoji, v katerih se uporabljajo.
OPOMBA 2 Ta metoda ustreza preskusu faze 2, stopnje 2.
OPOMBA 3: S tem evropskim standardom je mogoče določiti virucidno delovanje kemičnih razkužil pri nerazredčenem izdelku.
OPOMBA 4: V tem standardu je uporabljen prašičji parvovirus, saj govejega enterovirusa tipa 1 (ECBO), ki je uporabljen v preskusu suspenzije EN 14675, ni mogoče uporabiti za površinsko preskušanje zaradi izgube titra med sušenjem. Prašičji parvovirus ima primerljivo odpornost na virus ECBO.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-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)
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 (phase 2, step 2)
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 chimiques utilisés dans le
domaine vétérinaire - Méthode d'essai et prescriptions - Phase 2, étape 2
Ta slovenski standard je istoveten z: EN 17122:2019
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
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2019
EUROPÄISCHE NORM
ICS 11.080.20
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.
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, Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17122:2019 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 . 6
5.1 Principle . 6
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) . 21
Annex C (informative) Calculation of virus infectivity titre . 24
Annex D (informative) Example of a typical test report . 31
Annex E (informative) Full virucidal activity and activity against enveloped viruses only . 33
Bibliography . 34
European Foreword
This document (EN 17122:2019) 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 May 2020, and conflicting national standards shall be
withdrawn at the latest by May 2020.
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.
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, Turkey 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 10088-2, 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 full 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 full virucidal activity
Table 1 — Minimum and additional test conditions
Minimum spectrum of test Full 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 ± 10 s, 15 min ± 10 s, 30 min ± 10 s, 60 min ± 10 s
Maximum contact time 120 min ± 10 s
Interfering substances - low 3,0 g/l bovine albumin
level soiling
Interfering substances - high 10 g/l yeast extract and 10 g/l bovine albumin
level soiling
b Further contact time(s), interfering substance(s) or virus(es)
Additional conditions
a
The contact times for surface disinfectants stated in this table are chosen on the basis of the practical
conditions of the product. The recommended contact time for the use of the product is within the responsibility
of the manufacturer.
b
Where appropriate (specific purposes), additional specific virucidal activity shall be determined under other
conditions of time, temperature, and interfering substances (see 5.2.2.8) in accordance with 5.5, in order to take
into account intended specific use conditions. Additional virus(es) can be tested, if relevant. For the additional
conditions, the concentration defined as a result can be lower than the one obtained under the minimum test
conditions.
The determined virucidal concentration of the test product is suggested as being s
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