prEN 17422
(Main)Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of teat disinfectants used in the veterinary area - Test method and requirements (phase 2 step 2)
Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of teat disinfectants used in the veterinary area - Test method and requirements (phase 2 step 2)
This document specifies a test method and the minimum requirements for bactericidal activity of teat 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 method applies to teat disinfectants that are used on teat skin without mechanical action as pre-milking and/or post-milking teat disinfectants in the veterinary area, e.g. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry.
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.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Beurteilung von Zitzendesinfektionsmittel für den Veterinärbereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Dieses Dokument legt ein Prüfverfahren für und die Mindestanforderungen an die bakterizide Wirkung von Zitzendesinfektionsmitteln fest, die bei Verdünnung in Wasser standardisierter Härte - oder im Falle gebrauchsfertiger Produkte - in Wasser eine homogene, physikalisch stabile Zubereitung bilden.
Dieses Verfahren ist anzuwenden für Zitzendesinfektionsmittel, die auf der Zitzenhaut ohne mechanische Einwirkung als Desinfektionsmittel vor und/oder nach dem Melken im Veterinärbereich zum Einsatz kommen, z. B. bei der Aufzucht, Haltung, Produktion, in veterinärischen Pflegeeinrichtungen, beim Transport von Tieren sowie bei der Tierkörperbeseitigung aller Tiere mit Ausnahme der Tiere, die nach der Tötung direkt als Nahrungsmittel verwendet oder der weiterverarbeitenden Industrie zugeführt werden.
ANMERKUNG 1 Das beschriebene Verfahren ist dafür vorgesehen, die Wirksamkeit gewerblich hergestellter Zubereitungen oder anderer Wirkstoffe unter Anwendungsbedingungen zu bestimmen.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 2.
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface pour l’évaluation des désinfectants de trayons 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 bactéricide des désinfectants de trayons qui forment une préparation homogène, physiquement stable, lorsqu’ils sont dilués dans de l’eau dure ou - dans le cas de produits prêts à l’emploi - dans l’eau.
Cette méthode s’applique aux désinfectants de trayons utilisés sur la peau des trayons sans action mécanique comme désinfectants pré-traite et/ou post-traite dans le domaine vétérinaire, par exemple 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.
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.
Kemična razkužila in antiseptiki - Kvantitativni površinski preskus brez mehanskega delovanja za vrednotenje razkužil za seske v veterini - Preskusna metoda in zahteve (faza 2, stopnja 2)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2024
Kemična razkužila in antiseptiki - Kvantitativni površinski preskus brez
mehanskega delovanja za vrednotenje razkužil za seske v veterini - Preskusna
metoda in zahteve (faza 2, stopnja 2)
Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of
teat disinfectants used in the veterinary area - Test method and requirements (phase 2
step 2)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur
Beurteilung von Zitzendesinfektionsmittel für den Veterinärbereich - Prüfverfahren und
Anforderungen (Phase 2, Stufe 2)
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface pour l’évaluation
des désinfectants de trayons utilisés dans le domaine vétérinaire - Méthode d’essai et
prescriptions (phase 2, étape 2)
Ta slovenski standard je istoveten z: prEN 17422
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.
DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2024
ICS 71.100.35 Will supersede EN 17422:2022
English Version
Chemical disinfectants and antiseptics - Quantitative
surface test for the evaluation of teat disinfectants used in
the veterinary area - Test method and requirements
(phase 2 step 2)
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de surface pour l'évaluation des Quantitativer Oberflächenversuch zur Beurteilung von
désinfectants de trayons utilisés dans le domaine Zitzendesinfektionsmittel für den Veterinärbereich -
vétérinaire - Méthode d'essai et prescriptions (phase 2, Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
étape 2)
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 216.
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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17422:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction. 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions. 6
3.1 Symbols and abbreviated terms . 6
4 Requirements . 7
5 Test method . 7
5.1 Principle . 7
5.2 Materials and reagents . 7
5.2.1 Test organisms . 7
5.2.2 Culture media and reagents . 8
5.2.3 Test surface . 10
5.3 Apparatus and glassware . 10
5.3.1 General . 10
5.3.2 Usual microbiological equipment,and in particular, the following . 10
5.4 Preparation of test organism suspension and product test solutions . 11
5.4.1 Test organism suspension (test and validation suspension) . 11
5.4.2 Product test solution . 12
5.5 Procedure for assessing the bactericidal activity of the product . 13
5.5.1 General . 13
5.5.2 Test procedure . 14
5.6 Experimental data and calculation . 16
5.6.1 Explanation of terms and abbreviations . 16
5.6.2 Calculation . 16
5.7 Verification of methodology . 19
5.7.1 General . 19
5.7.2 Control of weighted mean “WM” counts . 19
5.7.3 Basic limits . 19
5.8 Expression of results and precision. 19
5.8.1 Reduction. 19
5.8.2 Control of active and non-active product test solution (5.4.2) . 20
5.8.3 Limiting test organism and bactericidal concentration . 20
5.8.4 Precision, repetitions . 20
5.9 Interpretation of results – conclusion . 20
5.9.1 General . 20
5.9.2 Bactericidal activity for teat disinfection . 20
5.10 Test report . 21
Annex A (informative) Referenced strains in national collections . 23
Annex B (informative) Examples of neutralizers of the residual antimicrobial activity of
chemical disinfectants and antiseptics and rinsing liquids . 24
Annex C (informative) Example of a typical test report . 25
Bibliography . 28
European foreword
This document (prEN 17422:2024) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document will supersede EN 17422:2022.
This document was revised to harmonize the milk soiling levels, clarify terms and abbreviations and
provide clearer definitions around the calculations.
Introduction
This document specifies a surface test for establishing whether a chemical disinfectant or antiseptic has
a bactericidal activity in the fields described in the scope.
This laboratory test takes into account practical conditions of application of the product, including
contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence
its action in practical situations.
The conditions are intended to cover general purposes and to allow reference between laboratories and
product types. Each utilization concentration of the chemical disinfectant or antiseptic found by this test
corresponds to defined experimental conditions. However, for some applications the recommendations
of use of a product may differ and therefore additional test conditions need to be used.
1 Scope
This document specifies a test method and the minimum requirements for bactericidal activity of teat
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 method applies to teat disinfectants that are used on teat skin without mechanical action as pre-
milking and/or post-milking teat disinfectants in the veterinary area, e.g. in the breeding, husbandry,
production, veterinary care facilities, transport and disposal of all animals except when in the food chain
following death and entry into processing industry.
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.
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 14885, Chemical disinfectants and antiseptics — Application of European Standards for chemical
disinfectants and antiseptics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 14885 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
• IEC Electromedical: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp/
3.1 Symbols and abbreviated terms
N Test suspension
Na Test suspension + Interference substance
Nv Validation suspension
Nw Water control
B Control B
C Control C
Vc Viable count
NUw Used water
NUd Used disinfectant
Nws Water control surface
Nts Test surface
4 Requirements
The product shall demonstrate at least a 4 decimal log (lg) (post-milking disinfectant) or 3 decimal log
(lg) (pre-milking disinfectant) reduction from a water control, when tested in accordance with Table 1
and Clause 5 under simulated soiling (10,0 g/l skimmed milk for post-milking teat disinfectants, 3,0 g/l
bovine albumin for pre-milking teat disinfectants).
Table 1 — Test Conditions
Bactericidal activity on sy
...
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