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)

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 Wirkung 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, Destillationsprodukte 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.
EN 14885 legt im Einzelnen die Beziehungen der verschiedenen Prüfungen untereinander und zu den „Anwendungsempfehlungen“ fest.
ANMERKUNG 1   Das beschriebene Verfahren dient dazu, die Aktivität handelsüblicher Zubereitungen oder Wirksubstanzen unter deren Anwendungsbedingungen zu bestimmen.
ANMERKUNG 2   Diese Methode entspricht einem Phase 2/Stufe 1-Verfahren.

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 :

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) (vključno z dopolnilom A1)

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 proizvodih, ki so pripravljeni za uporabo, z vodo. Proizvode je mogoče preskušati samo pri 80-odstotni ali nižji koncentraciji, ker dodajanje preskusnih organizmov in moteče snovi vedno povzroči razredčenje. Ta dokument velja 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:
– mleko in mlečni izdelki;– meso in mesni izdelki;
– ribe, morski sadeži in podobno;
– jajca in jajčni izdelki;
– živalska krma;
– itn.
2) hrane rastlinskega izvora:
– napitki;
– sadje, zelenjava in derivati (vključno s sladkorjem, destilati ...);
– moka, mletje in peka;
– živalska krma;
– 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.
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: Withdrawn
• Publication Date: 21-May-2013
• Withdrawal Date: 13-Aug-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 3 - Food hygiene and domestic and institutional use
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 14-Aug-2019
• Ref Project: SIST 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)

Relations

• Merged From: 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)
• Effective Date: 20-Mar-2013
• Merged From: 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: 20-Mar-2013
• Replaced By: 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)
• Effective Date: 04-May-2016

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.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)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)71.100.35Kemikalije za dezinfekcijo v industriji in domaChemicals for industrial and domestic disinfection purposesICS:Ta slovenski standard je istoveten z:EN 1650:2008+A1:2013SIST EN 1650:2008+A1:2013en,fr,de01-julij-2013SIST EN 1650:2008+A1:2013SLOVENSKI
STANDARDSIST EN 1650:20081DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1650:2008+A1
May 2013 ICS 71.100.35 Supersedes EN 1650:2008
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 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)
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) This European Standard was approved by CEN on 5 April 2008 and includes Amendment 1 approved by CEN on 28 March 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1650:2008+A1:2013: E SIST EN 1650:2008+A1:2013

Referenced strains in national collections . 31 Annex B (informative)
Examples of neutralizers of the residual antimicrobial activity of chemical disinfectants and antiseptics and rinsing liquids . 32 Annex C (informative)
Graphical representations of dilution-neutralization method and membrane filtration method . 34 Annex D (informative)
Example of a typical test report . 38 Annex E (informative)
Precision of the test result . 44 Bibliography . 47
!". 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 organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
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. SIST EN 1650:2008+A1:2013

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. SIST EN 1650:2008+A1:2013

The fungicidal activity shall be evaluated using the following two test organisms:
 Candida albicans (vegetative cells); SIST EN 1650:2008+A1:2013

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, an aliquot is taken, and the fungicidal and/or the fungistatic activity in this portion is immediately neutralized or suppressed by a validated method. The method of choice is dilution-neutralization. If a suitable neutralizer cann
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