EN 1650:2019

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".

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 Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die bei Verdünnung in Wasser standardisierter Härte oder – im Falle gebrauchsfertiger Produkte – in Wasser eine homogene, physikalisch stabile Zubereitung bilden. Die Produkte können nur bei einer Konzentration von höchstens 80 % geprüft werden, da durch die Zugabe der Prüforganismen und der Belastungssubstanz immer eine bestimmte Verdünnung auftritt.
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 angezeigt ist, und Produkte, die auf lebenden Geweben benutzt werden, hier wiederum außer denen, die zur Handhygiene in den vorstehend genannten Bereichen verwendet werden. Es werden mindestens folgende Bereiche abgedeckt:
a) Verarbeitung, Vertrieb und Verkauf von:
1) Lebensmitteln tierischer Herkunft:
— Milch und Milcherzeugnisse;
— Fleisch und Fleischprodukte;
— Fisch, Meerestiere und zugehörige Erzeugnisse;
— Eier und Eierprodukte;
— Tiernahrung;
— usw.
2) Lebensmitteln pflanzlicher Herkunft:
— Getränke;
— Obst, Gemüse und zugehörige Erzeugnisse (einschließlich Zucker, Destillationsprodukte usw.);
— Mehl, gemahlene und gebackene Produkte;
— Tiernahrung;
— usw.
b) öffentliche Einrichtungen und Haushaltsbereiche:
— Verpflegungseinrichtungen;
— öffentliche Bereiche;
— öffentliche Verkehrsmittel;
— Schulen;
— Kindergärten;
— Geschäfte;
— Sportstätten;
— Abfallbehälter (Mülltonnen usw.);
— Hotels;
— Wohngebäude;
— klinisch nicht relevante Bereiche in Krankenhäusern;
— Büroräume;
— usw.
prEN 1650:2018 (D)
7
c) andere industrielle Bereiche:
— Verpackungsmaterial;
— Biotechnologie (Hefe, Proteine, Enzyme usw.);
— Pharmazeutika;
— Kosmetika und Toilettenartikeln;
— Textilien;
— Luft- und Raumfahrtindustrie, Computerindustrie;
— usw.
EN 14885 legt im Einzelnen den Zusammenhang zwischen den verschiedenen Prüfungen sowie zu den „Anwendungsempfehlungen“ fest.
ANMERKUNG 1 Das beschriebene Verfahren dient zur Bestimmung der Wirkung handelsüblicher Zubereitungen oder Wirkstoffe unter den Bedingungen, unter denen sie angewendet werden.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der 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)

Le présent document spécifie une méthode d’essai et les exigences 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 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 une concentration inférieure ou égale à 80 % car l’addition des microorganismes d’essai et de la substance interférente s’accompagne nécessairement d’une dilution.
Le présent document s’applique aux produits utilisés dans le domaine de l’agroalimentaire, dans l’industrie, dans les domaines domestiques et les collectivités, à l’exclusion des domaines et des situations où la désinfection est médicalement prescrite et à l’exclusion des produits utilisés sur les tissus vivants (excepté ceux destinés à l’hygiène des mains dans les domaines indiqués ci-dessus). Les domaines concernés sont notamment :
a)   la transformation, la distribution et le commerce de détail des :
1)   aliments d’origine animale :   2)   aliments d’origine végétale :
—   lait et produits laitiers ;   —   boissons ;
—   viande et produits carnés ;   —   fruits, légumes et leurs dérivés (y compris le sucre, les produits de distillation, etc.) ;
—   poisson, fruits de mer et leurs dérivés ;   —   farine, minoterie et boulangerie ;
—   œufs et produits dérivés ;   —   alimentation animale ;
—   alimentation animale ;   —   etc. ;
—   etc. ;   
b)   les domaines domestiques et les collectivités :
—   établissements de restauration ;
—   lieux publics ;
—   transports publics ;
—   écoles ;
—   crèches ;
—   magasins ;
—   salles de sport ;
—   conteneurs pour déchets (bennes, etc.) ;
—   hôtels ;
—   locaux d’habitation ;
—   zones cliniquement non sensibles des hôpitaux ;
—   bureaux ;
—   etc. ;
c)   les autres secteurs industriels :
—   matériaux d’emballage ;
—   biotechnologie (levure, protéines, enzymes, etc.) ;
—   industrie pharmaceutique ;
—   cosmétiques et produits d’hygiène corporelle ;
—   textiles ;
—   industrie spatiale, secteur informatique ;
—   etc.
L’EN 14885 spécifie de façon détaillée la relation entre les différents essais et les « recommandations d’utilisation ».

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)

Ta dokument določa preskusno metodo in minimalne zahteve za fungicidno delovanje ali delovanje kemičnih razkužil in antiseptikov na kvasovke, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo oziroma, pri izdelkih, ki so pripravljeni za uporabo, z vodo. Izdelke je mogoče preskušati samo pri 80-odstotni ali nižji koncentraciji, ker dodajanje preskusnih organizmov in moteče snovi vedno povzroči razredčenje.
Ta dokument se uporablja za izdelke, ki se uporabljajo v živilski in drugih industrijah, gospodinjstvu in javnih ustanovah, izključeni pa so področja in primeri, ko obstajajo zdravstvene indikacije za dezinfekcijo ter izdelki, ki se uporabljajo na živih tkivih, razen tistih, ki se uporabljajo za higieno rok v zgoraj navedenih področjih. Naslednja področja so najmanj vključena:
a) predelava, distribucija in prodaja:
1) hrane živalskega izvora:           2) hrane rastlinskega izvora:
– mleko in mlečni izdelki;   – napitki;
– meso in mesni izdelki;   – sadje, zelenjava in derivati (vključno s sladkorjem, destilati ...);
– ribe, morski sadeži in podobno;   – moka, mletje in peka;
– jajca in jajčni izdelki;      – živalska krma;
– živalska krma;                      – itn.
– itn.   
b) javne ustanove in gospodinjstva:
– priprava in dostava hrane;
– javne ustanove;
– javni prevozi;
– šole;
– vrtci;
– trgovine;
– športni objekti;
– zbiralniki odpadkov (koši ...);
– hoteli;
– bivališča;
– klinično neobčutljivi prostori bolnišnic;
– pisarne;
– itn.
c) druga industrijska področja:
– embalaža;
– biotehnologija (kvasovke, proteini, encimi ...);
– farmacevtski izdelki;
– kozmetični in toaletni izdelki;
– tkanine;
– vesoljska in računalniška industrija;
– itn.
Standard EN 14885 podrobno določa razmerje med različnimi preskusi in priporočili za uporabo.
OPOMBA 1:   Opisana metoda je namenjena določevanju dejavnosti komercialnih oblik ali aktivnih snovi pod pogoji, v katerih se uporabljajo.
OPOMBA 2:   Ta metoda ustreza preskusu stopnje 1 faze 2.

General Information

• Status: Published
• Publication Date: 13-Aug-2019
• Withdrawal Date: 28-Feb-2020
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 14-Aug-2019
• Due Date: 18-Nov-2019
• Completion Date: 14-Aug-2019
• Ref Project: SIST EN 1650:2019 - 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 1650:2008+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: 04-May-2016

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2019
Nadomešča:
SIST EN 1650:2008+A1:2013
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)
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 1650:2019
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 1650
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2019
EUROPÄISCHE NORM
ICS 71.100.35 Supersedes EN 1650:2008+A1:2013
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 Chemische Desinfektionsmittel und Antiseptika -
quantitatif de suspension pour l'évaluation de l'activité Quantitativer Suspensionsversuch zur Bestimmung der
fongicide ou levuricide des antiseptiques et des fungiziden oder levuroziden Wirkung chemischer
désinfectants chimiques utilisés dans le domaine de Desinfektionsmittel und Antiseptika in den Bereichen
l'agro-alimentaire, dans l'industrie, dans les domaines Lebensmittel, Industrie, Haushalt und öffentliche
domestiques et en collectivité - Méthode d'essai et Einrichtungen - Prüfverfahren und Anforderungen
prescriptions (phase 2, étape 1) (Phase 2, Stufe 1)
This European Standard was approved by CEN on 10 June 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 1650:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 7
3 Terms and definitions . 7
4 Requirements . 7
5 Test method . 9
5.1 Principle . 9
5.2 Materials and reagents . 10
5.2.1 Test organisms . 10
5.2.2 Culture media and reagents . 10
5.3 Apparatus and glassware . 13
5.4 Preparation of test organism suspensions and product test solutions . 14
5.4.1 Test organism suspensions (test and validation suspension) . 14
5.4.2 Product test solutions . 18
5.5 Procedure for assessing the fungicidal or yeasticidal activity of the product . 19
5.5.1 General . 19
5.5.2 Dilution-neutralization method . 20
5.5.3 Membrane filtration method . 22
5.6 Experimental data and calculation . 24
5.6.1 Explanation of terms and abbreviations . 24
5.6.2 Calculation . 25
5.7 Verification of methodology . 28
5.7.1 General . 28
5.7.2 Control of weighted mean counts . 28
5.7.3 Basic limits . 28
5.7.4 Microscopic observation . 28
5.8 Expression of results and precision . 29
5.8.1 Reduction . 29
5.8.2 Control of active and non-active product test solution (5.4.2) . 29
5.8.3 Limiting test organism and fungicidal/yeasticidal concentration . 29
5.8.4 Precision, replicates . 29
5.9 Interpretation of results - conclusion . 30
5.9.1 General . 30
5.9.2 Fungicidal activity for general purposes . 30
5.9.3 Yeasticidal activity for general purposes . 30
5.9.4 Yeasticidal activity for hand hygiene . 30
5.10 Test report . 30
Annex A (informative) Referenced strains in national collections . 32
Annex B (informative) Examples of neutralizers of the residual antimicrobial activity of
chemical disinfectants and antiseptics and rinsing liquids . 33
Annex C (informative) Graphical representations of dilution-neutralization method and
membrane filtration method . 35
Annex D (informative) Example of a typical test report . 39
Annex E (informative) Precision of the test result . 44
Bibliography . 47

European foreword
This document (EN 1650:2019) 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 February 2020 and conflicting national standards shall
be withdrawn at the latest by February 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 supersedes EN 1650:2008+A1:2013.
Data obtained by using the latest version of EN 1650:2008+A1:2013 are still valid.
The main changes in relation to EN 1650:2008+A1:2013 are:
— inclusion of hand hygiene;
— handrub and handwash test conditions and test requirements have been harmonized with
EN 13624;
— interfering substance for breweries, soft drinks, cosmetics and cleaning in place have been deleted.
A sentence to allow additional interfering substance for specific applications has been added;
— the obligatory conditions (temperature and contact time) have been deleted. The text has been
harmonized with EN 13624 keeping specified time intervals and temperature steps.
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 describes 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
...