EN 17422:2022
(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 procedure 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 in the veterinary area on teat skin without mechanical action as pre-milking and/or post-milking teat disinfectants.
NOTE 1 The method described is intended to determine the activity of commercial formulations under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 2 test.
NOTE 3 Two types of synthetic skin were assessed in a ring trial with no significant difference in performance. Other synthetic skins may become available and may be used if it can be shown that they give comparable results to the two referenced in this standard.
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 als homogenes und physikalisch stabiles Präparat vorliegen.
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, d. h. 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 soll der Bestimmung der Wirkung handelsüblicher Zubereitungen unter den Bedingungen dienen, unter denen sie in der Praxis angewendet werden.
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, 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.
NOTE 1 La méthode décrite a pour objet de déterminer l’activité de formulations commerciales 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)
Ta postopek določa preskusno metodo in minimalne zahteve za baktericidno delovanje kemičnih razkužil za seske, ki tvorijo homogen, fizikalno stabilen pripravek, razredčen s trdo vodo oziroma ga razredčimo z vodo pri proizvodih, ki so pripravljeni za uporabo.
Ta metoda se uporablja za kemična razkužila za seske, ki se uporabljajo v veterinarski medicini kot razkužila za seske pred in/ali po molži brez mehanskega delovanja.
OPOMBA 1: Opisana metoda je namenjena določevanju dejavnosti komercialnih mešanic pod pogoji, v katerih se uporabljajo.
OPOMBA 2: Ta metoda ustreza 2. stopnji preskusa faze 2.
OPOMBA 3: Pri krožnem preskušanju sta bili ocenjeni dve vrsti sintetične kože brez pomembne razlike v učinkovitosti. Ob odstopanju od tega standarda se lahko uporabljajo druge sintetične kože, če je mogoče dokazati, da dajejo rezultate, primerljive z obema, navedenima v tem standardu.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2022
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: EN 17422:2022
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 17422
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2022
EUROPÄISCHE NORM
ICS 71.100.35
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 European Standard was approved by CEN on 8 May 2022.
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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17422:2022 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 . 5
5 Test method . 6
5.1 Principle . 6
5.2 Materials and reagents . 6
5.3 Apparatus and glassware . 9
5.4 Preparation of test organism suspension and product test solutions . 10
5.5 Procedure for assessing the bactericidal activity of the product . 12
5.6 Experimental data and calculation . 15
5.7 Verification of methodology . 18
5.8 Expression of results and precision. 18
5.9 Interpretation of results – conclusion . 19
5.10 Test report . 20
Annex A (informative) Referenced strains in national collections . 22
Annex B (informative) Examples of neutralizers of the residual antimicrobial activity of
chemical disinfectants and antiseptics and rinsing liquids . 23
Annex C (informative) Example of a typical test report . 24
Bibliography . 27
European foreword
This document (EN 17422:2022) 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 December 2022, and conflicting national standards shall
be withdrawn at the latest by December 2022.
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.
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 specifies a surface test for establishing whether a teat disinfectant, for use on teat skin
without mechanical action, in the veterinary area, has or does not have bactericidal activity under the
laboratory conditions defined by this document, which influence the action of disinfectants in practical
use.
The laboratory test takes into account practical conditions of application of the product including
applying test organisms and interfering substances on a synthetic skin test surface, contact time and
temperature, i.e. conditions that may influence its action in practical situations.
In this document, synthetic human skin is used as the test surface.
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 - 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 into processing industry.
NOTE 1 The method described is intended to determine the activity of commercial formulations 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 1656, Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of
bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area — Test method
and requirements (phase 2, step 1)
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 terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obpuirements
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 milk powder for post-milking teat disinfectants, 3,0 g / l
bovine albumin for pre-milking teat disinfectants).
Table 1 — Requirements
Bactericidal activity on synthetic skin
Test Conditions
without mechanical action
Escherichia coli
Test organism
Staphylococcus aureus
Test temperature 30 °C ± 1 °C
Pre-milking teat Post-milking teat
disinfectants disinfectants
Minimum contact time
30 s ± 5 s 1 min ± 5 s
Pre-milking teat Post-milking teat
disinfectants disinfectants
Maximum contact time
3 min ± 10 s 5 min ± 10 s
Other contact times may be selected at intervals of 30 s for contact times up to
1 min and at intervals of 1 min for contact times > 1 min
Interfering substance
10,0 g/l milk powder
Post-milking teat disinfectants
3,0 g/l bovine albumin
Pre-milking teat disinfectants
5 Test method
5.1 Principle
A test suspension of bacteria mixed with interfering substance is inoculated onto a synthetic skin test
surface and maintained at 30 °C for a period of conditioning.
After this conditioning time, the test surface is immersed in the product or dilutions of the product at
30 °C for a defined period of time specified in Table 1. At the end of that contact time, neutralizer is added
so that the action of the disinfectant is immediately neutralized.
The bacteria are removed from the surface by ultrasound treatment. The numbers of surviving bacteria
which can be recovered from the surface are determined quantitatively.
The number of bacteria on a surface treated with water in place of the disinfectant is also determined and
the reduction is calculated.
5.2 Materials and reagents
5.2.1 Test organisms
The bactericidal activity shall be evaluated using the following strains as test organisms:
- Escherichia coli
- Staphylococcus aureus
NOTE Refer to Annex A for strain references in other culture collections.
The required incubation temperature for these test organisms is 36 °C ± 1 °C or 37 °C ± 1 °C (5.3.2.3).
5.2.2 Culture media and reagents
5.2.2.1 General
All weights of chemical substances given in this method refer to the anhydrous salts. Hydrated forms may
be used as an alternative, but the weights required shall be adjusted to allow for consequent molecular
weight differences.
The reagents shall be of analytical grade and/or appropriate for microbiological purposes. They shall be
free from substances that are toxic or inhibitory to the test organisms.
To improve reproducibility, it is recommended that commercially available dehydrated material is used
for the preparation of culture media. The manufacturer's instructions relating to the preparation of these
products should be rigorously followed.
A ready-to-use medium may be used if it complies with the required specification.
For each culture medium and reagent, a time limitation for use should be fixed.
5.2.2.2 Water
The water shall be freshly glass-distilled water and not demineralized water. If distilled water of adequate
quality is not available, water for injections (see bibliographic reference [2]) may be used.
Sterilize in the autocla
...
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