prEN 14349
(Main)Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
This European Standard specifies a test method and the minimum requirements for bactericidal 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, 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 This method cannot be used to evaluate the activity of products against mycobacteria.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Bestimmung der bakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich auf nicht-porösen Oberflächen ohne mechanische Wirkung - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Dieses Dokument legt ein Prüfverfahren und die Mindestanforderungen an die bakterizide Wirkung von che
mischen Desinfektionsmitteln und Antiseptika fest, die bei Verdünnung mit Wasser standardisierter Härte oder— im Fall gebrauchsfertiger Produkte— mit Wasser eine homogene, physikalisch stabile Zubereitung bilden.
Das beschriebene Verfahren ist für die Bestimmung der Wirkung von handelsüblichen Zubereitungen oder Wirkstoffen unter den Bedingungen, unter denen sie verwendet werden, bestimmt. Dieses Dokument gilt für Produkte, die im Veterinärbereich zur Desinfektion nicht-poröser Oberflächen ohne mechanische Wirkung angewendet werden, 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 eintreten.
EN14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den „Anwen
dungsempfehlungen“ fest.
ANMERKUNG Dieses Verfahren entspricht einer Prüfung der Phase2, Stufe2.
Dieses Verfahren schließt die Bewertung der Wirkung gegen Hefen, Pilzsporen, Mykobakterien und bakterielle Sporen aus.
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface pour l'évaluation de l'activité bactéricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire sur des surfaces non poreuses sans action mécanique - Méthode d’essai et exigences (phase 2, étape 2)
Le présent document spécifie une méthode d’essai et les exigences minimales relatives à l’activité bactéricide des produits antiseptiques et désinfectants chimiques 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.
La méthode décrite vise à déterminer l’activité des formulations commerciales ou des substances actives dans les conditions d’utilisation. Le présent document s’applique aux produits utilisés dans le domaine vétérinaire pour désinfecter des surfaces non poreuses sans action mécanique, à savoir dans la reproduction, l’élevage, la production, le transport et l’abattage de tous les animaux, à l’exception 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 Cette méthode correspond à un essai de phase 2, étape 2.
Cette méthode exclut l’évaluation de l’activité des produits vis-à-vis des levures, des spores fongiques, des mycobactéries et des spores bactériennes.
Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah brez mehanskega delovanja za vrednotenje baktericidnega delovanja kemičnih razkužil in antiseptikov v veterini - Preskusna metoda in zahteve (faza 2, stopnja 2)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2023
Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah
brez mehanskega delovanja za vrednotenje baktericidnega delovanja kemičnih
razkužil in antiseptikov v veterini - Preskusna metoda in zahteve (faza 2, stopnja 2)
Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of
bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area
on non-porous surfaces without mechanical action - Test method and requirements
(phase 2, step 2)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur
Bestimmung der bakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika
für den Veterinärbereich auf nicht-porösen Oberflächen ohne mechanische Wirkung -
Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface pour l'évaluation
de l'activité bactéricide des antiseptiques et des désinfectants chimiques utilisés dans le
domaine vétérinaire sur des surfaces non poreuses sans action mécanique -
Ta slovenski standard je istoveten z: prEN 14349
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
January 2023
ICS 71.100.35 Will supersede EN 14349:2012
English Version
Chemical disinfectants and antiseptics - Quantitative
surface test for the evaluation of bactericidal activity of
chemical disinfectants and antiseptics used in the
veterinary area on non-porous surfaces without
mechanical action - Test method and requirements (phase
2, step 2)
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de surface pour l'évaluation de l'activité Quantitativer Oberflächenversuch zur Bestimmung der
bactéricide des antiseptiques et des désinfectants bakteriziden Wirkung chemischer Desinfektionsmittel
chimiques utilisés dans le domaine vétérinaire sur des und Antiseptika für den Veterinärbereich auf nicht-
surfaces non poreuses sans action mécanique - porösen Oberflächen ohne mechanische Wirkung -
Prüfverfahren und Anforderungen (Phase 2, Stufe 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14349:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms, definitions and abbreviations . 5
4 Requirements . 6
5 Test method . 7
Annex A (informative) Referenced strains in national collections . 27
Annex B (informative) Examples of neutralizers of the residual antimicrobial activity of
chemical disinfectants and antiseptics . 28
Annex C (informative) Graphical representation of the method . 30
Annex D (informative) Example of a typical test report . 34
Bibliography . 37
European foreword
This document (prEN 14349:2023) 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 14349:2012.
Data obtained using the former version of EN 14349 may still be used.
It 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.
Introduction
This document specifies a surface test for establishing whether a chemical disinfectant or antiseptic has
bactericidal activity in the area and 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 the 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
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.
The method described is intended to determine the activity of commercial formulations or active
substances under the conditions in which they are used. This document applies to products that are used
in the veterinary area for disinfecting non-porous surfaces without mechanical action 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 This method corresponds to a Phase 2 Step 2 test.
This method excludes the evaluation of the activity of products against yeasts, fungal spores,
mycobacteria and bacterial spores.
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, definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 14885 apply.
3.2 Symbols and abbreviations
c is the sum of V -values taken into account
C
cfu colony forming units
d is the dilution taken into account, lower dilution factor
n is the number of V -values taken into account
C
N number of cells per ml in the test suspension
N number of cfu recovered from the test surface in the water control
w
B counting of the cfu in the neutralizer control
Na number of cfu recovered from the test surface in the test
C counting of the cfu in the method validation
N number of colony forming units remaining on the test surface
ts
R reduction
V is the volume of the inoculated into the plate expressed in ml
Nv is the validation suspension
4 Requirements
The product shall demonstrate at least a 4 decimal log (lg) reduction when diluted with hard water
(5.2.2.6) 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 g/l bovine albumin) or high level soiling (10 g/l
yeast extract and 10 g/l bovine albumin) on a surface.
Table 1 - Test conditions
Test conditions Bactericidal activity on non-porous surfaces
without mechanical action in the veterinary
area
Minimum spectrum of test
Enterococcus hirae
organisms
Pseudomonas aeruginosa
Staphylococcus aureus
additional any relevant test organism
Test temperature According to the manufacturer’s recommendation
but between
Minimum 4 °C ± 1 °C
Maximum 40 °C ± 1 °C
At intervals of 5°C
Contact time
Minimum 1 min ± 5 s
Maximum 120 min ± 10 s
At intervals of 30 s from 30 s to 5 min and at
intervals of 5 min from 5 min to 120 min
Interfering substance
low level soiling 3,0 g/l bovine albumin
high level soiling 10 g/l yeast extract plus 10 g/l bovine albumin
additional any relevant substance
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.
NOTE For the additional conditions, the concentration defined as a result can be lower
than the one obtained under the minimum test conditions.
Any additional specific bactericidal 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.
5 Test method
5.1 Principle
A test suspension of bacteria in a solution of interfering substances (5.2.2.7) is inoculated onto a test
stainless steel surface and dried. A sample of the product under test is applied in a manner that
completely covers the dried test organisms. The surface is maintained at the test temperature and contact
time exemplified in Clause 4 and (5.5.2). At the end of the contact time the surface is transferred to a
previously validated neutralization medium to suppress any product activity immediately. The number
of surviving test organisms which can be recovered from the surface is determined quantitatively.
The number of bacteria on a test surface treated with hard water (or water in the case of ready to use
products) in place of the product under test is also determined and the reduction in viable counts
attributed to the product is calculated as the difference between the two test surfaces’ results.
5.2 Materials and reagents
5.2.1 Test organisms
The bactericidal activity shall be evaluated using the following strains:
— Enterococcus hirae
— Pseudomonas aeruginosa
— Staphylococcus aureus
NOTE See Annex A for strain references in some culture collections.
The required incubation temperature for these test organisms is 36 °C ± 1 °C or 37 °C ± 1 °C (5.3.2.3). The
same temperature (either 36 °C or 37 °C) shall be used for all incubations performed during a test and its
control and validation.
If additional test organisms are used, they shall be incubated under optimum growth conditions
(temperature, time, atmosphere, media) noted in the test report. If the additional test organisms selected
do not correspond to the specified strains, their suitability for supplying the required inocula shall be
verified. If these additional test organisms are not classified at a reference centre, their identification
characteristics shall be stated. In addition, they shall be held by the testing laboratory or national culture
collection under a reference for five years.
5.2.2 Culture media and reagents
5.2.2.1 General
All weights of chemical substances given in this Standard refer to the anhydrous salts. Hydrated forms
may be used as an alterna
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