EN 13623:2020

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems - Test method and requirements (phase 2, step 1)

This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products intended to be used for treatment in aqueous systems against Legionella pneumophila that form a homogeneous, physically stable preparation when diluted with buffered ferrous hard water or hard water. Whenever Legionella pneumophila poses a risk to human health, this method is suitable for water used in cooling towers and water for general purposes, like spas, pools, showers and other uses. The method is not suitable for electro-chemical disinfection.
The document applies to products used as a single application shock treatment in order to kill Legionella pneumophila. It is not suitable for the evaluation of those products that are dosed continuously into water systems to control the growth of Legionella pneumophila.
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.
NOTE 3   This method does not take into account the fact that Legionella pneumophila is often found in cells of amoebae and/or biofilms and that thereby a product’s activity against the bacteria may be reduced.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendation".

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung gegen Legionella von chemischen Desinfektionsmitteln für wasserführende Systeme - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)

Dieses Dokument legt ein Prüfverfahren und die Mindestanforderungen an die bakterizide Wirkung von chemischen Desinfektionsmitteln zur Verwendung bei der Aufbereitung in wasserführenden Systemen gegen Legionella pneumophila fest, die bei Verdünnung mit gepuffertem eisenhaltigem Wasser standardisierter Härte oder Wasser standardisierter Härte als homogenes, physikalisch stabiles Präparat vorliegen. Immer wenn Legionella pneumophila ein Risiko für die menschliche Gesundheit darstellt, ist dieses Verfahren für in Kühltürmen genutztes Wasser und Wasser für allgemeine Zwecke, wie z. B. Bäder, Schwimm  und Bade¬becken, Duschen und andere Zwecke, geeignet. Das Verfahren ist nicht für die elektrochemische Desinfektion geeignet.
Das Dokument gilt für Produkte, die als einmalige Schockbehandlung zur Abtötung von Legionella pneumophila verwendet werden. Es ist nicht geeignet für die Bewertung derjenigen Produkte, die kontinuierlich in Wassersysteme dosiert werden, um das Wachstum von Legionella pneumophila zu kontrollieren.
ANMERKUNG 1   Das beschriebene Verfahren dient zur Bestimmung der Wirksamkeit von handelsüblichen Zube-reitungen oder Wirkstoffen unter den Bedingungen, unter denen sie angewendet werden.
ANMERKUNG 2   Das Verfahren entspricht einer Prüfung der Phase 2, Stufe 1.
ANMERKUNG 3   Das vorliegende Verfahren berücksichtigt nicht die Tatsache, dass Legionella pneumophila oft in Zellen von Amöben und/oder Biofilmen zu finden ist und dass dadurch die Wirksamkeit des Produkts gegen die Bakterien möglicherweise verringert ist.
EN 14885 legt im Einzelnen die Beziehungen der verschiedenen Prüfungen untereinander und zu den „Anwendungsempfehlungen“ fest.

Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l’évaluation de l’activité bactéricide contre des légionelles des désinfectants chimiques pour les systèmes aqueux - Méthode d’essai et prescriptions (phase 2, étape 1)

Le présent document décrit une méthode d’essai et les prescriptions minimales relatives à l’activité bactéricide des produits désinfectants chimiques destinés au traitement des systèmes aqueux vis-à-vis de Legionella pneumophila et donnant une préparation homogène, physiquement stable quand ils sont dilués dans de l’eau dure ferreuse tamponnée ou dans de l’eau dure. Lorsque Legionella pneumophila présente un risque pour la santé humaine, la présente méthode est adaptée à l’eau utilisée dans les tours de refroidissement et l’eau à usage général telle que l’eau utilisée dans les jacuzzis, les piscines, les douches et autres. La méthode n’est pas adaptée à la désinfection électrochimique.
Le document s’applique aux produits utilisés en traitement de choc à application unique destinés à tuer Legionella pneumophila. Il n’est pas adapté à l’évaluation des produits dosés en continu dans les réseaux d’approvisionnement en eau afin de contrôler la croissance de Legionella pneumophila.
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   La présente méthode correspond à un essai de phase 2, étape 1.
NOTE 3   La présente méthode ne tient pas compte du fait que Legionella pneumophila se trouve souvent dans des cellules amibiennes et/ou dans des biofilms, ce qui peut réduire l’activité du produit vis-à-vis des bactéries.
L’EN 14885 spécifie de manière détaillée la relation entre les différents essais et les « recommandations d’emploi ».

Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje baktericidnega delovanja kemičnih razkužil za razkuževanje vode na bakterijo Legionella - Preskusna metoda in zahteve (faza 2, stopnja 1)

General Information

• Status: Published
• Publication Date: 27-Oct-2020
• Withdrawal Date: 29-Apr-2021
• 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 1 - Human medicine
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 28-Oct-2020
• Due Date: 18-Nov-2019
• Completion Date: 28-Oct-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 13623:2021 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems - Test method and requirements (phase 2, step 1)

Relations

• Replaces: EN 13623:2010 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems - Test method and requirements (phase 2, step 1)
• Effective Date: 25-May-2016

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2021
Nadomešča:
SIST EN 13623:2010
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za
vrednotenje baktericidnega delovanja kemičnih razkužil za razkuževanje vode na
bakterijo Legionella - Preskusna metoda in zahteve (faza 2, stopnja 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of bactericidal activity against Legionella of chemical disinfectants for aqueous systems -
Test method and requirements (phase 2, step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der bakteriziden Wirkung gegen Legionella von chemischen
Desinfektionsmitteln für wasserführende Systeme - Prüfverfahren und Anforderungen
(Phase 2, Stufe 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour
l'évaluation de l'activité bactéricide contre des légionelles des désinfectants chimiques
pour les systèmes aqueux - Méthode d'essai et prescriptions (phase 2, étape 1)
Ta slovenski standard je istoveten z: EN 13623:2020
ICS:
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 13623
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2020
EUROPÄISCHE NORM
ICS 71.100.35 Supersedes EN 13623:2010
English Version
Chemical disinfectants and antiseptics - Quantitative
suspension test for the evaluation of bactericidal activity
against Legionella of chemical disinfectants for aqueous
systems - 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
bactéricide contre des légionelles des désinfectants bakteriziden Wirkung gegen Legionella von
chimiques pour les systèmes aqueux - Méthode d'essai chemischen Desinfektionsmitteln für wasserführende
et prescriptions (phase 2, étape 1) Systeme - Prüfverfahren und Anforderungen (Phase 2,
Stufe 1)
This European Standard was approved by CEN on 19 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13623:2020 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 . 6
5 Test methods . 6
5.1 Principle . 6
5.2 Materials and reagents . 7
5.2.1 Test organism . 7
5.2.2 Culture media and reagents . 7
5.3 Apparatus and glassware . 11
5.3.1 General . 11
5.3.2 Usual microbiological laboratory equipment . 11
5.4 Preparation of test organism suspensions and test solutions . 12
5.4.1 Test organism suspension (test suspension N and validation suspension N ) . 12
V
5.4.2 Product test solution . 14
5.5 Procedure for assessing the bactericidal activity of the product . 14
5.5.1 General . 14
5.5.2 Dilution-neutralization method . 16
5.5.3 Membrane filtration method . 18
5.6 Experimental data and calculations . 19
5.6.1 Explanation of terms and abbreviations . 19
5.6.2 Calculation . 20
5.7 Verification of methodology . 25
5.7.1 General . 25
5.7.2 Control of weighted mean counts . 25
5.7.3 Basic limits . 25
5.8 Expression of results and precision . 25
5.8.1 Reduction . 25
5.8.2 Control of active and non-active product test solution (5.4.2) . 26
5.8.3 Bactericidal concentration . 26
5.8.4 Precision, repetition . 26
5.9 Interpretation of results – conclusion . 26
5.9.1 General . 26
5.9.2 Bactericidal activity for general purposes . 26
5.9.3 Bactericidal activity for specific purposes . 26
5.10 Test report . 26
Annex A (informative) Referenced strains in national collections . 28
Annex B (informative) Determination of the bactericidal activity against Legionella
pneumophila . 29
Annex C (informative) Neutralizer . 32
Annex D (informative) Graphical representation of test procedures . 34
Bibliography . 38
European foreword
This document (EN 13623:2020) 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 2021, and conflicting national standards shall be
withdrawn at the latest by April 2021.
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 13623:2010.
This document was revised to adapt it to the latest state of CEN/TC 216, to correct errors and
ambiguities. The following is a list of significant changes since the last edition:
— the temperature range for incubation of plates from (36 ± 1) °C or (37 ± 1) °C was changed to the
range (36 ± 2) °C as given in the new ISO 11731 standard for Legionella culture;
— a new paragraph was added to the scope to state that the method is not suitable for continuously
dosed products;
— new Annex A " Referenced strains in national collections" was added;
— the calculation errors in Table A.2 (now Table B.2) were corrected.
The changes mentioned above have no impact on the test results obtained with reference to 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Introduction
This European Standard specifies a suspension test for establishing whether a chemical disinfectant has
a bactericidal activity against Legionella pneumophila in the fields described in the scope. This standard
is specifically prepared for water treatment products, but it may also be possible to use it for other
products.
Proliferation of Legionella only occurs in waters under certain conditions, and predominantly poses a
risk when aerosolised. Many systems containing water do not require treatment. A decision to add
chemical disinfectants to any water should be based on an appropriate assessment according to
national regulations.
If the product complies with the requirements of this standard, it can be considered bactericidal against
Legionella pneumophila, but it should not necessarily be inferred that the product is acceptable for a
specific site of application without consideration of other relevant factors such as the pH, water,
chemistry, temperature and degree of biological fouling at that site of application. It does not take into
account the protective effect conveyed by biofilm on the organisms.
The conditions are intended to cover general purposes and to allow reference between laboratories and
product types. Each concentration of the chemical disinfectant 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.
1 Scope
This document specifies a test method and the minimum requirements for bactericidal activity of
chemical disinfectant products intended to be used for treatment in aqueous systems against Legionella
pneumophila that form a homogeneous, physically stable preparation when diluted with buffered
ferrous hard water or hard water. Whenever Legionella pneumophila poses a risk to human health, this
...