FprEN 14204
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal 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 mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
This document specifies a test method and the minimum requirements for mycobactericidal 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.
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 is applicable to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying or flooding or other means and teat disinfection 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 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 1 test.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der mykobakteriziden 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 mykobakterizide Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die bei der Verdünnung mit Wasser standardisierter Härte oder — im Fall von gebrauchsfertigen Produkten — mit Wasser als homogene, physikalisch stabile Zubereitung vorliegen.
Produkte können nur bei einer Konzentration von 80 % oder weniger geprüft werden, da immer eine bestimmte Verdünnung durch Zugabe der Prüforganismen und der Belastungssubstanz erfolgt.
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 zur Instrumentendesinfektion durch Eintauchen, zur Oberflächendesinfektion durch Abwischen, Besprühen, Überfluten oder auf sonstige Weise sowie zur Zitzendesinfektion im Veterinärbereich verwendet werden, d. h. bei der Aufzucht, Haltung, Produktion, in veterinärmedizinischen Versorgungseinrichtungen 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 Das Verfahren entspricht einer Prüfung der Phase 2, Stufe 1.
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité mycobactéricide des antiseptiques et des désinfectants chimiques utilisés dans la domaine vétérinaire - (phase 2, étape 1)
Le présent document spécifie une méthode d'essai et les exigences minimales relatives à l'activité mycobactéricide 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.
Les produits ne peuvent être soumis à l'essai qu'à la concentration de 80 % ou à des concentrations inférieures, car l'ajout des microorganismes d'essai et de la substance interférente s'accompagne d'une dilution.
La méthode décrite vise à déterminer l'activité des formulations commerciales ou des substances actives dans les conditions dans lesquelles elles sont utilisées.
Le présent document s'applique aux produits utilisés pour la désinfection des appareils par immersion, la désinfection des surfaces par essuyage, pulvérisation ou inondation ou par d'autres moyens et la désinfection des trayons dans le domaine vétérinaire, à savoir pour la reproduction, l'élevage, la production, les installations 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.
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 1.
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje mikobaktericidnega delovanja kemičnih razkužil in antiseptikov v veterini - Preskusna metoda in zahteve (faza 2, stopnja 1)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2024
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za
vrednotenje mikobaktericidnega delovanja kemičnih razkužil in antiseptikov v
veterini - Preskusna metoda in zahteve (faza 2, stopnja 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of mycobactericidal 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 mykobakteriziden 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 mycobactéricide des antiseptiques et des désinfectants
chimiques utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions (phase
2, é
Ta slovenski standard je istoveten z: prEN 14204
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
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.
DRAFT
EUROPEAN STANDARD
prEN 14204
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2024
ICS 71.100.35 Will supersede EN 14204:2012
English Version
Chemical disinfectants and antiseptics - Quantitative
suspension test for the evaluation of mycobactericidal
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
mycobactéricide des antiseptiques et des désinfectants mykobakteriziden Wirkung chemischer
chimiques utilisés dans le domaine vétérinaire - Desinfektionsmittel und Antiseptika für den
Méthode d'essai et prescriptions (phase 2, é 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14204:2024 E
worldwide for CEN national Members.
prEN 14204:2024 (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 . 6
5.1 Principle . 6
5.2 Materials and reagents . 6
5.2.1 Test organisms . 6
5.2.2 Culture media and reagents . 7
5.3 Apparatus and glassware . 9
5.3.1 General. 9
5.3.2 Usual microbiological laboratory equipment and, in particular, the following . 9
5.4 Preparation of mycobacterial test suspension and product test solutions . 11
5.4.1 Test organism suspensions (test and validation suspension) . 11
5.4.2 Product test solutions . 13
5.5 Procedure for assessing the mycobactericidal activity of the product . 13
5.5.1 General. 13
5.5.2 Test procedure - Dilution-neutralization method . 14
5.5.3 Test procedure - Membrane filtration method . 17
5.6 Experimental data and calculation . 19
5.6.1 Explanation of terms and abbreviations . 19
5.6.2 Calculation . 19
5.7 Verification of methodology . 23
5.7.1 General. 23
5.7.2 Control of weighted mean counts . 24
5.7.3 Basic limits . 24
5.8 Expression of results . 24
5.8.1 Reduction . 24
5.8.2 Control of active and non-active product test solution (5.4.2) . 25
5.8.3 Mycobactericidal concentration . 25
5.9 Interpretation of results - conclusion. 25
5.9.1 General. 25
5.9.2 Mycobactericidal activity for general purposes . 25
5.9.3 Qualification for certain fields of application . 25
5.10 Test report . 25
Annex A (informative) Referenced strain in national collections . 27
Annex B (informative) Examples of neutralizers of the residual antimicrobial activity of
chemical disinfectants and antiseptics and rinsing liquids . 28
Annex C (informative) Graphical representations of dilution-neutralization method . 30
Annex D (informative) Example of a typical test report . 32
Bibliography . 35
prEN 14204:2024 (E)
European foreword
This document (prEN 14204:2024) 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 supersedes EN 14204:2012 and was revised to harmonize the structure and wording
with other quantitative suspension tests of CEN/TC 216 (existing or in preparation).
Results obtained using the previous version of this standard are still valid.
prEN 14204:2024 (E)
Introduction
This document specifies a suspension test for establishing whether a chemical disinfectant or antiseptic
has mycobactericidal activity in the area 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 chosen experimental conditions. However, for some applications the
recommendations of use of a product may differ and therefore additional test conditions need to be
used.
prEN 14204:2024 (E)
1 Scope
This document specifies a test method and the minimum requirements for mycobactericidal 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.
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 for equipment disinfection by immersion, surface
disinfection by wiping, spraying or flooding or other means and teat disinfection 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 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 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, 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 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
...
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