EN 16437:2014+A1:2019

Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on 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 disinfectants 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 porous surfaces without mechanical action 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 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 or bacterial spores.

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Bestimmung der bakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich auf porösen Oberflächen ohne mechanische Wirkung - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)

Diese Europäische Norm legt ein Prüfverfahren und die Mindestanforderungen an die bakterizide Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die bei Verdünnung mit Wasser standardisierter Härte oder – im Fall gebrauchsfertiger Produkte – mit Wasser eine homogene, physikalisch stabile Zubereitung bilden.
Diese Europäische Norm gilt für Produkte, die im Veterinärbereich auf porösen Oberflächen ohne mechanische Wirkung angewendet werden, d. h. bei der Aufzucht, Haltung, Produktion !in veterinärmedizinischen Gesundheitseinrichtungen," 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.
EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den „Anwendungsempfehlungen“ fest.
ANMERKUNG 1 Das beschriebene Verfahren ist für die Bestimmung der Wirkung von handelsüblichen Zubereitungen oder Wirkstoffen unter den Bedingungen, unter denen sie verwendet werden, bestimmt.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 2.
ANMERKUNG 3 Dieses Verfahren kann nicht angewendet werden, um die Wirkung von Produkten gegen Mykobakterien oder bakterielle Sporen zu bewerten.

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 poreuses sans action mécanique - Méthode d'essai et prescriptions (phase 2, étape 2)

La présente Norme européenne spécifie une méthode d’essai et les prescriptions 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 présente Norme européenne s'applique aux produits utilisés dans le domaine vétérinaire sur des surfaces poreuses sans action mécanique, à savoir 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.
L'EN 14885 spécifie en détail la relation entre les différents essais et les « recommandations d'emploi ».
NOTE 1 La méthode décrite vise à déterminer l’activité des formulations commerciales ou des substances actives dans les conditions dans lesquelles elles sont utilisées.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 2.
NOTE 3 Cette méthode ne peut pas être utilisée pour évaluer l'activité des produits vis-à-vis des mycobactéries ou des spores bactériennes.

Kemična razkužila in antiseptiki - Kvantitativni preskus na poroznih površinah brez mehanskega delovanja za vrednotenje baktericidnega delovanja kemičnih razkužil in antiseptikov v veterini - Preskusna metoda in zahteve (faza 2, stopnja 2) (vključno z dopolnilom A1)

Standard EN 16437:2014+A1 določa preskusno metodo ter minimalne zahteve za baktericidno delovanje kemičnih razkužil in antiseptikov, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo ali, pri proizvodih, ki so pripravljeni za uporabo, z vodo. Ta evropski standard se uporablja za izdelke v veterini na poroznih površinah brez mehanskega delovanja, tj. pri vzreji, živinoreji, proizvodnji, v veterinarskih ambulantah, pri prevozu in odstranjevanju vseh živali, razen če so v prehrambeni verigi po smrti in so del predelovalne industrije. EN 14885 podrobno določa razmerje med različnimi preskusi in priporočili za uporabo.

General Information

• Status: Published
• Publication Date: 15-Oct-2019
• ICS: 71.100.35 - Chemicals for industrial and domestic disinfection purposes
• Technical Committee: CEN/TC 216 - Chemical disinfectants and antiseptics
• Drafting Committee: CEN/TC 216/WG 2 - Veterinary use
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 30-Jan-2020
• Ref Project: SIST EN 16437:2014+A1:2019 - Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)

Relations

• Merged From: EN 16437:2014 - Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
• Effective Date: 19-Jan-2023
• Merged From: EN 16437:2014/FprA1 - Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2019
Nadomešča:
SIST EN 16437:2014
Kemična razkužila in antiseptiki - Kvantitativni preskus na poroznih površinah
brez mehanskega delovanja za vrednotenje baktericidnega delovanja kemičnih
razkužil in antiseptikov v veterini - Preskusna metoda in zahteve (faza 2, stopnja 2)
(vključno z dopolnilom A1)
Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of
bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on
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 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 poreuses sans action mécanique - Mét
Ta slovenski standard je istoveten z: EN 16437:2014+A1:2019
ICS:
11.220 Veterinarstvo Veterinary medicine
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 16437:2014+A1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 71.100.35 Supersedes EN 16437:2014
English Version
Chemical disinfectants and antiseptics - Quantitative
surface test for the evaluation of bactericidal activity of
chemical disinfectants and antiseptics used in veterinary
area on 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 porösen
surfaces poreuses sans action mécanique - Mét Oberflächen ohne mechanische Wirkung -
Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
This European Standard was approved by CEN on 30 November 2013 and includes Amendment 1 approved by CEN on 9 August
2019.
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, Turkey 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 16437:2014+A1:2019 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 . 7
5.3 Apparatus and glassware . 10
5.4 Preparation of test organism suspension and product test solutions . 11
5.5 Procedure for assessing the bactericidal activity of the product . 13
5.6 Experimental data and calculation . 17
5.7 Verification of methodology . 21
5.8 Expression of results and precision . 22
5.9 Interpretation of results – conclusion . 22
5.10 Test report . 23
Annex A (informative) Referenced strains in national collections . 25
Annex B (informative) Neutralisers - Examples of neutralisers of the residual antimicrobial
activity of chemical disinfectants and antiseptics . 26
Annex C (informative) Graphical representations of dilution-neutralization method . 28
Annex D (informative) Example of a typical test report . 32
Bibliography . 37

!European foreword"
This document (EN 16437:2014+A1:2019) 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 April 2020 and conflicting national standards shall be
withdrawn at the latest by April 2020.
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 includes Amendment 1 approved by CEN on 9 August 2019.
The start and finish of text introduced or altered by amendment is indicated in the text by tags ! ".
This document supersedes !EN 6437:2014".
!This document has been amended to update the scope and to correct a mistake in Tryptone Soya
Agar and Broth formulations. The maximum contact time has also been extended and an obligatory
contact time removed. The changes detailed above have no impact on the test results obtained using the
previous version. Those results are still valid."
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
Introduction
This document specifies a surface test for establishing whether a chemical disinfectant or antiseptic, for
use on porous surfaces 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 pre-
drying test organisms and interfering substances on a surface, contact time and temperature, 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 chosen experimental conditions. However, for some applications, the
instructions of use of a product can differ and therefore additional test conditions need to be used.
1 Scope
This European Standard specifies a test method and the minimum requirements for bactericidal activity
of chemical disinfectants 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 porous surfaces
without mechanical action 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 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 or bacterial
spores.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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.
4 Requirements
The product shall demonstrate at least a 4 decimal log (lg) reduction from a water control, when tested
in accordance with Table 1 and Clause 5 under simulated soiling (3,0 g/l bovine albumin).
Table 1 — Obligatory and additional test conditions
Test Conditions Bactericidal activity on porous surfaces
without mechanical action in the

veterinary area
Test organism Enterococcus hirae
a) obligatory Proteus vulgaris
Pseudomonas aeruginosa
Staphylococcus aureus
b) additional any relevant test organism
Test temperature 10 °C ± 1 °C
a) obligatory
b) additional 4 °C ± 1 °C; 20 °C ± 1 °C; 40 °C ± 1 °C
!Contact time The contact time(s) shall be selected from
the values given below"
!minimum 1 min ± 5 s"
!range 5 min ± 10 s, 15 min + 10 s, 30 min ± 10 s;
60 min ± 10 s and then up to 330
min ± 10 s at 30 min intervals"
!maximum 360 min ± 10 s "
Interfering substance 3,0 g/l bovine albumin
a) obligatory
b) additional any relevant substance
!Deleted text"
NOTE For the additional conditions, the concentration defined as a result can be
lower than the one obtained under the obligatory 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 mixed with interfering substance is inoculated onto the test surface and
dried. After the drying time the test surface is immersed into a sample of the product as delivered
and/or diluted with hard water (for ready to use products: water) ensuring that the test surface is
totally covered for one minute. The test surface is removed from the product solution and maintained at
a specified temperature for a defined period of time specified in Clause 4 and 5.5.1.1. At the end of that
contact time, the test surface is transferred to a neutralizer so that the action of the disinfectant is
immediately neutralized. The bacteria are removed from the surface by ultrasound treatment. T
...