kSIST FprEN 1657:2024
(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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN 1657:2023
01-april-2023
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: prEN 1657
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
11.220 Veterinarstvo Veterinary medicine
oSIST prEN 1657:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN 1657:2023
oSIST prEN 1657:2023
DRAFT
EUROPEAN STANDARD
prEN 1657
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2023
ICS Will supersede 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 prescriptions (ph Veterinärbereich - Prüfverfahren und Anforderungen
(Phase 2, Stufe 1)
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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1657:2023 E
worldwide for CEN national Members.
oSIST prEN 1657:2023
prEN 1657:2023(E)
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 . 7
5.1 Principle . 7
5.2 Materials and reagents . 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 fungicidal or yeasticidal activity of the product . 17
5.6 Experimental data and calculation . 22
5.7 Verification of methodology . 26
5.8 Expression of results and precision . 27
5.9 Interpretation of results – conclusion . 27
5.10 Test report . 28
Annex A (informative) Referenced strains in national collections . 30
Annex B (informative) Suitable neutralizers and rinsing liquids . 31
Annex C (informative) Graphical representation of test procedures . 33
Annex D (informative) Example of a typical test report . 37
Annex E (informative) Precision of the test result . 41
Bibliography . 44
oSIST prEN 1657:2023
prEN 1657:2023 (E)
European foreword
This document (prEN 1657:2023) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 1657:2016.
This document was revised to harmonize the preparation of the fungal spore suspension with other
fungicidal tests of CEN/TC 216 and to incorporate amendments applicable to all European Standards.
An additional requirement has been added for the Aspergillus spore suspension and therefore results
obtained using EN 1657:2005 and not fulfilling this additional requirement will need to be confirmed
by repeating the tests using EN 1657:2015.
The test conditions for teat disinfectants have been added.
oSIST prEN 1657:2023
prEN 1657:2023(E)
Introduction
This European Standard specifies a suspension test for establishing whether a chemical disinfectant or
antiseptic has a fungicidal or yeasticidal 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.
oSIST prEN 1657:2023
prEN 1657:2023 (E)
1 Scope
This document 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 document 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.
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 14885:2022, Chemical disinfectants and antiseptics - Application of European Standards for chemical
disinfectants and antiseptics
ISO 4793, Laboratory sintered (fritted) filters — Porosity grading, classification and designation
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 14885:2022 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
4 Requirements
The product shall demonstrate at least a 4 decimal log (lg) reduction when diluted with hard water
(5.2.2.7) or – in the case of ready-to-use products – with water (5.2.2.2) and tested in accordance with
Table 1 and Clause 5 under simulated low level soiling (3,0 g/l bovine albumin) or high level soiling
(10 g/l yeast extract and 10 g/l bovine albumin) or 10 g/l skimmed milk for teat disinfectants or in
additional test conditions.
oSIST prEN 1657:2023
prEN 1657:2023(E)
Table 1 — Obligatory and additional test conditions
Yeasticidal activity for teat
Test conditions Fungicidal activity Yeasticidal activity
disinfectants
Test organisms Aspergillus brasiliensis
Candida albicans Candida albicans
obligatory Candida albicans
additional any relevant test organism any relevant test organism any relevant test organism
At intervals of 5°C
Test temperature
Minimum 5°C ± 1°C 5°C ± 1°C 20°C ± 1°C
Maximum
40°C ± 1°C 40°C ± 1°C 30°C ± 1°C
At intervals of 30 s from 30 s to 5 min and at intervals
of 5 min from 5 min to 120 min
1 min ± 5 s for post-milking
teat disinfectants
Contact time
1 min ± 5 s 1 min ± 5 s
30 s ± 5 s for pre-milking teat
Minimum
disinfectants
Maximum
30 min ± 10 s for post-milking
teat disinfectants
a a
120 min ± 10 s 120 min ± 10 s
3 min ± 10 s for pre-milking
teat disinfectants
Interfering
substance
Post milking: 10,0 g/l of milk
3,0 g/l bovine albumin 3,0 g/l bovine albumin
low level soiling powder
10 g/l yeast extract plus 10 g/l yeast extract plus
high level soiling Pre-milking: 3,0 g/l bovine
10 g/l bovine albumin 10 g/l bovine albumin
albumin
additional any relevant substance any relevant substance any relevant substance
The obligatory contact times for disinfectants stated in Table 1 were chosen to enable comparison of standard
conditions.
NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtained
under the obligatory test conditions.
a
The recommended contact time for the use of the product is within the responsibility of the manufacturer.
Any additional specific fungicidal activity shall be determined in accordance with 5.2.1 and 5.5.1.1 in
order to take into account intended specific use conditions.
oSIST prEN 1657:2023
prEN 1657:2023 (E)
5 Test method
5.1 Principle
5.1.1 A sample of the product as delivered and/or diluted with hard water (or water for ready-to-use
products) is added to a test suspension of fungi (yeast cells or mould spores) in a solution of an
interfering substance. The mixture is maintained at temperatures in accordance with Table 1. At the
end of this contact time, an aliquot is taken, and the fungicidal/yeasticidal and/or the
fungistatic/yeastistatic activity in this portion is immediately neutralized or suppressed by a validated
method.
...
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