SIST EN 1657:2025
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal 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. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the veterinary area - i.e. in the breeding, husbandry, production, 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 1 test (Annex F).
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Dieses Dokument legt ein Prüfverfahren und die Mindestanforderungen an die fungizide oder levurozide Wir
kung von chemischen Desinfektionsmitteln und Antiseptika fest, die in Wasser standardisierter Härte oder– im Fall gebrauchsfertiger Produkte– in Wasser eine homogene, physikalisch stabile Zubereitung bilden. Die
dukte können nur bis zu einer Konzentration von 80% geprüft werden, da immer eine bestimmte Verdünnung durch Zugabe der Prüforganismen oder der Belastungssubstanz erfolgt.
Dieses Dokument gilt für Produkte für die Anwendung im Veterinärbereich, d.h. bei der Aufzucht, Haltung, Produktion und beim Transport von Tieren sowie bei der Tierkörperbeseitigung, außer wenn die Tiere nach der Tötung durch Zuführung in die weiterverarbeitende Industrie in die Nahrungsmittelkette gelangen.
EN14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den „Anwen
dungsempfehlungen“ fest.
ANMERKUNG1 Das beschriebene Verfahren ist zur Bestimmung der Wirkung von handelsüblichen Zubereitungen oder Wirkstoffen unter deren Anwendungsbedingungen vorgesehen.
ANMERKUNG2 Dieses Verfahren entspricht einer Prüfung der Phase2, Stufe1.
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité fongicide ou levuricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions (ph
Le présent document spécifie une méthode d’essai et les exigences minimales relatives à l’activité fongicide et levuricide des désinfectants chimiques et des produits antiseptiques 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 de l’eau. Les produits ne peuvent être soumis à l’essai qu’à la concentration de 80 % ou à des concentrations inférieures, car l’ajout des micro-organismes d’essai et de la substance interférente s’accompagne forcément d’une dilution.
Le présent document s’applique aux produits utilisés dans le domaine vétérinaire, à savoir la reproduction, l’élevage, la production, les services de soins vétérinaires, le transport et l’abattage de tous les animaux, hors de la chaîne alimentaire qui suit l’abattage et l’entrée dans l’industrie de transformation. Le présent document s’applique également aux produits utilisés pour la désinfection des trayons.
L’EN 14885 spécifie en détail la relation entre les différents essais et les « recommandations d’usage ».
NOTE 1 La méthode décrite vise à déterminer l’activité des formulations commerciales ou des substances actives dans leurs conditions d’utilisation.
NOTE 2 Cette méthode correspond à un essai de type phase 2, étape 1.
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje fungicidnega delovanja ali delovanja kemičnih razkužil in antiseptikov na kvasovke v veterini - Preskusna metoda in zahteve (faza 2, stopnja 1)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2025
Nadomešča:
SIST EN 1657:2016
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za
vrednotenje fungicidnega delovanja ali delovanja kemičnih razkužil in antiseptikov
na kvasovke v veterini - Preskusna metoda in zahteve (faza 2, stopnja 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the
veterinary area - Test method and requirements (phase 2, step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel
und Antiseptika für den Veterinärbereich - Prüfverfahren und Anforderungen (Phase 2,
Stufe 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour
l'évaluation de l'activité fongicide ou levuricide des antiseptiques et des désinfectants
chimiques utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions (ph
Ta slovenski standard je istoveten z: EN 1657:2024
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 1657
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2024
EUROPÄISCHE NORM
ICS 71.100.35 Supersedes EN 1657:2016
English Version
Chemical disinfectants and antiseptics - Quantitative
suspension test for the evaluation of fungicidal or
yeasticidal activity of chemical disinfectants and
antiseptics used in the veterinary area - Test method and
requirements (phase 2, step 1)
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de suspension pour l'évaluation de l'activité Quantitativer Suspensionsversuch zur Bestimmung der
fongicide ou levuricide des antiseptiques et des fungiziden oder levuroziden Wirkung chemischer
désinfectants chimiques utilisés dans le domaine Desinfektionsmittel und Antiseptika für den
vétérinaire - Méthode d'essai et exigences (phase 2, Veterinärbereich - Prüfverfahren und Anforderungen
étape 1) (Phase 2, Stufe 1)
This European Standard was approved by CEN on 18 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 1657:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms, definitions and abbreviated terms . 6
3.1 Terms and definitions . 6
3.2 Symbols and abbreviated terms . 7
4 Requirements . 7
5 Test method . 8
5.1 Principle . 8
5.2 Materials and reagents . 9
5.2.1 Test organisms . 9
5.2.2 Culture media and reagents . 9
5.3 Apparatus and glassware . 12
5.3.1 General . 12
5.3.2 Usual microbiological laboratory equipment and, in particular, the following . 12
5.4 Preparation of test organism suspensions and product test solutions . 13
5.4.1 Test organism suspensions (test and validation suspension) . 13
5.4.2 Product test solutions . 18
5.5 Procedure for assessing the fungicidal or yeasticidal activity of the product . 18
5.5.1 General . 18
5.5.2 Dilution-neutralization method . 19
5.5.3 Membrane filtration method . 22
5.6 Experimental data and calculation . 24
5.6.1 Explanation of terms and abbreviations . 24
5.6.2 Calculation . 24
5.7 Verification of methodology . 27
5.7.1 General . 27
5.7.2 Control of weighted mean counts . 27
5.7.3 Basic limits . 28
5.7.4 Additional limits for Aspergillus brasiliensis . 28
5.8 Expression of results and precision . 28
5.8.1 Reduction . 28
5.8.2 Control of active and non-active product test solution (5.4.2) . 28
5.8.3 Limiting test organism and fungicidal/yeasticidal concentration . 28
5.8.4 Precision, replicates . 29
5.9 Interpretation of results – conclusion . 29
5.9.1 General . 29
5.9.2 Fungicidal activity for general purposes . 29
5.9.3 Fungicidal activity for specific purposes . 29
5.9.4 Yeasticidal activity for general purposes . 29
5.9.5 Yeasticidal activity for specific purposes . 29
5.9.6 Yeasticidal activity for teat disinfectants . 30
5.10 Test report . 30
Annex A (informative) Referenced strains in national collections . 32
Annex B (informative) Neutralizers and rinsing liquids . 33
Annex C (informative) Graphical representation of test procedures . 35
C.1 Dilution-neutralization method . 35
C.2 Membrane filtration method . 37
Annex D (informative) Example of a typical test report . 40
Annex E (informative) Precision of the test result. 45
Bibliography . 48
European foreword
This document (EN 1657:2024) 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 supersedes EN 1657:2016.
This document was revised to correct obvious errors and ambiguities, to harmonize the structure and
wording with other tests of CEN/TC 216 (existing or in preparation), and to improve the readability of
the standard and thereby make it more understandable.
The obligatory conditions have been removed and the preparation of the milk interfering substance has
been amended.
The data obtained using the 2016 version of EN 1657 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 specifies a suspension test method for establishing whether a chemical disinfectant or
antiseptic has a fungicidal or yeasticidal activity in the areas 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.
...
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