EN 1650:2008

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)

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 food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. The following areas are at least included:
a)   processing, distribution and retailing of:
1)   food of animal origin:   2)   food of vegetable origin:
-   milk and milk products;      beverages;
-   meat and meat products;      fruits, vegetables and derivatives (including sugar, distillery ...);
-   fish, seafood, and related products;   flour, milling and baking;
-   eggs and egg products;      animal feeds;
-   animal feeds;                   etc.
-   etc.   
b)   institutional and domestic areas:
-   catering establishments;
-   public areas;
-   public transports;
-   schools;
-   nurseries;
-   shops;
-   sports rooms;
-   waste containers (bins ...);
-   hotels;
-   dwellings;
-   clinically non-sensitive areas of hospitals;
-   offices;
-   etc.
c)   other industrial areas:
-   packaging material;
-   biotechnology (yeast, proteins, enzymes, ...);
-   pharmaceutical;
-   cosmetics and toiletries;
-   textiles;
-   space industry, computer industry;
-   etc.
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.

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen - 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 hartem Wasser oder im Fall gebrauchs¬fertiger Lösungen in Wasser eine homogene, physikalisch stabile Zubereitung bilden. Produkte können nur bis zu einer Konzentration von 80 % geprüft werden, da immer eine bestimmte Verdünnung durch Zugabe der Impfkultur oder der Belastungssubstanz erfolgt.
Dieses Dokument gilt für Produkte, die im Lebensmittelbereich, in der Industrie, im Haushalt und in öffentlichen Einrichtungen benutzt werden. Ausgenommen sind Bereiche und Situationen, in denen die Desinfektion medizinisch indiziert ist und Produkte, die auf lebenden Geweben benutzt werden, außer solchen, die zur Handhygiene in den oben genannten Bereichen verwendet werden. Die folgenden Bereiche sind mindestens eingeschlossen:
a)   Verarbeitung, Vertrieb und Verkauf von:
1)   Lebensmitteln tierischer Herkunft:
   Milch und Milchprodukte;
   Fleisch und Fleischprodukte;
   Fisch, Meerestiere und daraus hergestellte Zubereitungen;
   Eier und Eiprodukte;
   Tiernahrung;
   usw.
2)   Lebensmitteln pflanzlicher Herkunft:
   Getränke;
   Früchte, Gemüse und daraus hergestellte Zubereitungen (einschließlich Zucker, Destillations¬produkte usw.);
   Mehl, gemahlene und gebackene Produkte;
   Tiernahrung;
   usw.
b)   öffentliche Einrichtungen und Haushaltsbereiche:
   Verpflegungsbetriebe;
   Öffentliche Bereiche;
   Öffentliche Verkehrsmittel;
   Schulen;
   Kindergärten;
   Geschäfte;
   Sportstätten;
   Abfallbehälter (Mülltonnen usw.);
   Hotels;
   Wohngebäude;
   klinisch nicht relevante Bereiche in Krankenhäusern;
   Büroräume;
   usw.
c)   andere industrielle Bereiche:
   Packmaterial;
   Biotechnologie (Hefe, Proteine, Enzyme usw.);
   Hersteller von Pharmazeutika;
   Hersteller von Kosmetika und Toilettenartikel;
   Hersteller von Textilien;
   Weltraumforschungsindustrie, Computerindustrie;
   usw.

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 de l'agro-alimentaire, dans l'industrie, dans les domaines domestiques et en collectivité - Méthode d'essai et prescriptions (phase 2, étape 1)

Le présent document spécifie une méthode d'essai et les prescriptions minimales relatives à l'activité fongicide ou levuricide des produits antiseptiques et désinfectants chimiques qui forment une préparation homogène, physiquement stable, lorsqu'ils sont dilués dans 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 forcément d'une dilution.
Le présent document s'applique aux produits qui sont utilisés dans les domaines alimentaire, industriel, domestique et en collectivités à l'exclusion des domaines et des situations où la désinfection est médicalement indiquée et à l'exclusion des produits utilisés sur les tissus vivants à l'exception de ceux utilisés pour l'hygiène des mains dans les domaines considérés ci-dessus. Sont inclus au moins les domaines suivants :
a)   la transformation, la distribution et le commerce de détail des :
1)   aliments d'origine animale :   2)   aliments d'origine végétale :
   le lait et les produits laitiers ;      les boissons ;
   la viande et les produits carnés ;      les fruits, les légumes et leurs dérivés (y compris le sucre, et les produits de la distillation...) ;
   le poisson, les fruits de mer, et leurs dérivés ;      la farine, la minoterie et la boulangerie ;
   les oeufs et les produits dérivés ;      l'alimentation animale ;
   l'alimentation animale ;      etc.
   etc.   
b)   les domaines domestique et la collectivité :
   les établissements de restauration ;
   les domaines publics ;
   les transports publics ;
                les écoles ;
   les crèches ;
   les magasins ;
   les salles de sport ;
   les conteneurs pour déchets (bennes...) ;
   les hôtels ;
   les locaux d'habitation ;
   les zones cliniquement non sensibles des hôpitaux ;
   les bureaux ;
   etc.

Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje fungicidnega delovanja ali delovanja kemičnih razkužil in antiseptikov na kvasovke v živilski in drugih industrijah, gospodinjstvu in javnih ustanovah - Preskusna metoda in zahteve (faza 2, stopnja 1)

General Information

• Status: Withdrawn
• Publication Date: 06-May-2008
• Withdrawal Date: 21-May-2013
• ICS: 07.100.01 - Microbiology in general
• ICS: 11.080 - Sterilization and disinfection
• 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 3 - Food hygiene and domestic and institutional use
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 22-May-2013
• Completion Date: 22-May-2013
• Ref Project: SIST EN 1650:2008 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)

Relations

• Replaces: EN 1650:1997 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas - Test method and requirements (phase 2, step 1)
• Effective Date: 22-Dec-2008
• Merged Into: EN 1650:2008+A1:2013 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
• Effective Date: 20-Mar-2013
• Amended By: EN 1650:2008/FprA1 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
• Effective Date: 16-Jul-2011

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2008
1DGRPHãþD
SIST EN 1650:2001
.HPLþQDUD]NXåLODLQDQWLVHSWLNL.YDQWLWDWLYQLVXVSHQ]LMVNLSUHVNXV]D
YUHGQRWHQMHIXQJLFLGQHJDGHORYDQMDDOLGHORYDQMDNHPLþQLKUD]NXåLOLQDQWLVHSWLNRY
QDNYDVRYNHYåLYLOVNLLQGUXJLKLQGXVWULMDKJRVSRGLQMVWYXLQMDYQLKXVWDQRYDK
3UHVNXVQDPHWRGDLQ]DKWHYHID]DVWRSQMD
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food,
industrial, domestic and institutional areas - 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 in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche
Einrichtungen - 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 de l'agro-alimentaire, dans l'industrie, dans les
domaines domestiques et en collectivité - Méthode d'essai et prescriptions (phase 2,
étape 1)
Ta slovenski standard je istoveten z: EN 1650:2008
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.

EUROPEAN STANDARD
EN 1650
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2008
ICS 71.100.35 Supersedes EN 1650:1997
English Version
Chemical disinfectants and antiseptics - Quantitative suspension
test for the evaluation of fungicidal or yeasticidal activity of
chemical disinfectants and antiseptics used in food, industrial,
domestic and institutional areas - Test method and requirements
(phase 2, step 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif Chemische Desinfektionsmittel und Antiseptika -
de suspension pour l'évaluation de l'activité fongicide ou Quantitativer Suspensionsversuch zur Bestimmung der
levuricide des antiseptiques et des désinfectants chimiques fungiziden oder levuroziden Wirkung chemischer
utilisés dans le domaine de l'agro-alimentaire, dans Desinfektionsmittel und Antiseptika in den Bereichen
l'industrie, dans les domaines domestiques et en Lebensmittel, Industrie, Haushalt und öffentliche
collectivité - Méthode d'essai et prescriptions (phase 2, Einrichtungen - Prüfverfahren und Anforderungen (Phase 2,
étape 1) Stufe 1)
This European Standard was approved by CEN on 5 April 2008.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1650:2008: E
worldwide for CEN national Members.

Contents Page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .6
3 Terms and definitions .6
4 Requirements.6
5 Test method.7
5.1 Principle.7
5.2 Materials and reagents.7
5.3 Apparatus and glassware .11
5.4 Preparation of test organism suspensions and product test solutions .13
5.5 Procedure for assessing the fungicidal or yeasticidal activity of the product .16
5.6 Experimental data and calculation.22
5.7 Verification of methodology .25
5.8 Expression of results and precision.26
5.9 Interpretation of results - conclusion .26
5.10 Test report .27
Annex A (informative) Referenced strains in national collections.29
Annex B (informative) Examples of neutralizers of the residual antimicrobial activity of chemical
disinfectants and antiseptics and rinsing liquids .30
Annex C (informative) Graphical representations of dilution-neutralization method and
membrane filtration method .32
Annex D (informative) Example of a typical test report.36
Annex E (informative) Precision of the test result .42
Bibliography .45

Foreword
This document (EN 1650:2008) 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 November 2008, and conflicting national standards shall be withdrawn
at the latest by November 2008.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1650:1997.
This European Standard was revised to include the results of a collaborative trial (ANDISTAND), to correct
obvious errors and ambiguities, to harmonize the structure and wording with other quantitative suspension
tests of CEN/TC 216 (existing or in preparation), and to improve the readability of the standard and thereby
make it more understandable.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

Introduction
This European Standard specifies a suspension test for establishing whether a chemical disinfectant or
antiseptic has or does not have 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 substance, 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 should be used.
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 food, industrial, domestic and institutional areas excluding
areas and situations where disinfection is medically indicated and excluding products used on living tissues
except those for hand hygiene in the above considered areas. The following areas are at least included:
a) processing, distribution and retailing of:
1) food of animal origin: 2) food of vegetable origin:
 milk and milk products;  beverages;
 meat and meat products;  fruits, vegetables and derivatives
(including sugar, distillery .);
 fish, seafood, and related products;  flour, milling and baking;
 eggs and egg products;  animal feeds;
 animal feeds;  etc.
 etc.
b) institutional and domestic areas:
 catering establishments;
 public areas;
 public transports;
 schools;
 nurseries;
 shops;
 sports rooms;
 waste containers (bins .);
 hotels;
 dwellings;
 clinically non-sensitive areas of hospitals;
 offices;
 etc.
c) other industrial areas:
 packaging material;
 biotechnology (yeast, proteins, enzymes, .);
 pharmaceutical;
 cosmetics and toiletries;
 textiles;
 space industry, computer industry;
 etc.
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 referenced documents are indispensable for the application 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, mycobactericidal, sporicidal and fungicidal activity
EN 14885, 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 apply.
4 Requirements
The product shall demonstrate a reduction of at least a 4 decimal log (lg) 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 Clause
5 under simulated clean conditions (0,3 g/l bovine albumin solution - 5.2.2.8.2) or simulated dirty conditions
(3 g/l bovine albumin solution - 5.2.2.8.3) according to its practical applications and under the other obligatory
test conditions (one or two selected test organisms, 20 °C, 15 min).
The fungicidal activity shall be evaluated using the following two test organisms:
 Candida albicans (vegetative cells);
 Aspergillus niger (spores).
The yeasticidal activity shall be evaluated using the following test organism:
 Candida albicans (vegetative cells);
Where indicated, additional specific fungicidal or yeasticidal activity shall be determined applying other contact
times, temperatures, interfering substances and test organisms (in accordance with 5.2.1, 5.2.2.8 and 5.5.1.1)
in order to take into account intended specific use conditions.
NOTE For these additional conditions, the concentration defined as a result can be lower than the one obtained
under the obligatory test conditions.
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 (20 ± 1) °C for 15 min ± 10 s (obligatory test conditions). At the end of
this contact time,
...