EN 1276:2019
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - Test method and requirements (phase 2, step 1)
This European Standard specifies a test method and the minimum requirements for bactericidal 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:
milk and milk products;
meat and meat products;
fish, seafood, and related products;
eggs and egg products;
animal feeds;
etc. 2) food of vegetable origin:
beverages;
fruits, vegetables and derivatives (including sugar, distillery, etc.);
flour, milling and baking;
animal feeds;
etc.
b) institutional and domestic areas:
catering establishments;
public areas;
public transports;
schools;
nurseries;
shops;
sports rooms;
waste containers (bins, etc.);
hotels;
dwellings;
clinically non sensitive areas of hospitals;
offices;
etc.
c) other industrial areas:
packaging material;
biotechnology (yeast, proteins, enzymes, etc.);
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 bakteriziden 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 für und die Mindestanforderungen an die bakterizide Wirkung von chemischen Desinfektionsprodukten und antiseptischen Produkten fest, die bei Verdünnung in Wasser standardisierter Härte oder – im Falle gebrauchsfertiger Produkte – in Wasser als homogenes und physikalisch stabiles Präparat vorliegen. 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 genutzt werden; ausgenommen sind Bereiche und Situationen, in denen die Desinfektion medizinisch angezeigt ist, und Produkte, die auf lebenden Geweben verwendet 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 Haushalt:
- Verpflegungseinrichtungen;
- 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:
- Verpackungsmaterial;
- Biotechnologie (Hefe, Proteine, Enzyme usw.);
- Pharmazeutika;
- Kosmetika und Toilettenartikel;
- Textilien;
- Luft- und Raumfahrtindustrie, Computerindustrie;
- usw.
EN 14885 legt im Einzelnen den Zusammenhang zwischen den verschiedenen Prüfungen sowie zu den „Anwendungsempfehlungen“ fest.
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l’évaluation de l’activité bactéricide 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)
La présente Norme européenne spécifie une méthode d’essai et les exigences minimales relatives à
l’activité bactéricide 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 :
lait et produits laitiers ;
viande et produits carnés ;
poisson, fruits de mer et leurs
dérivés ;
oeufs et produits dérivés ;
alimentation animale ;
etc. ;
2) aliments d’origine végétale :
boissons ;
fruits, légumes et leurs dérivés (y
compris le sucre, et les produits de
distillation, etc.) ;
farine, minoterie et boulangerie ;
alimentation animale ;
etc. ;
b) les domaines domestiques et les collectivités :
établissements de restauration ;
lieux publics ;
transports publics ;
écoles ;
crèches ;
magasins ;
salles de sport ;
conteneurs pour déchets (poubelles, etc.) ;
hôtels ;
locaux d’habitation ;
zones cliniquement non sensibles des hôpitaux ;
bureaux ;
etc. ;
prEN1276:2018 (F)
7
c) les autres secteurs industriels :
matériaux d’emballage ;
biotechnologie (levures, protéines, enzymes, etc.) ;
industrie pharmaceutique ;
cosmétiques et produits d’hygiène corporelle ;
textiles ;
industrie spatiale, secteur informatique ;
etc.
L’EN 14885 spécifie de façon détaillée larelation entre les différents essais et les « recommandations
d’utilisation ».
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 Cette méthode correspond à un essai de phase 2, étape 1.
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje baktericidnega delovanja kemičnih razkužil in antiseptikov v živilski in drugih industrijah, gospodinjstvu in javnih ustanovah - Preskusna metoda in zahteve (faza 2, stopnja 1)
Ta evropski standard določa preskusno metodo in minimalne zahteve za baktericidno delovanje kemičnih razkužil in antiseptikov, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo oziroma z vodo pri izdelkih, ki so pripravljeni za uporabo. 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:
– 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 itd.);
– 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 itd.);
– hoteli;
– bivališča;
– klinično neobčutljivi prostori bolnišnic;
– pisarne;
– itn.
c) druga industrijska področja:
– embalaža;
– biotehnologija (kvasovke, proteini, encimi itd.);
– 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2019
Nadomešča:
SIST EN 1276:2010
SIST EN 1276:2010/AC:2010
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za
vrednotenje baktericidnega delovanja kemičnih razkužil in antiseptikov 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 bactericidal 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 bakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika in
den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen -
Prüfverfahren und Anforderungen (Phase 2, Stufe 1); Deutsche und Englische Fassung
prEN 1276:2016
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour
lévaluation de lactivité bactéricide des antiseptiques et des désinfectants chimiques
utilisés dans le domaine de lagro-alimentaire, dans lindustrie, dans les domaines
domestiques et en collectivité - Méthode dessai et prescriptions (phase 2, étape 1)
Ta slovenski standard je istoveten z: EN 1276:2019
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 1276
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2019
EUROPÄISCHE NORM
ICS 71.100.35 Supersedes EN 1276:2009
English Version
Chemical disinfectants and antiseptics - Quantitative
suspension test for the evaluation of bactericidal 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
bactéricide des antiseptiques et des désinfectants bakteriziden Wirkung chemischer Desinfektionsmittel
chimiques utilisés dans le domaine de l'agro- und Antiseptika in den Bereichen Lebensmittel,
alimentaire, dans l'industrie, dans les domaines Industrie, Haushalt und öffentliche Einrichtungen -
domestiques et en collectivité - Méthode d'essai et Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
prescriptions (phase 2, étape 1)
This European Standard was approved by CEN on 17 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 1276:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 7
5 Test method . 8
5.1 Principle . 8
5.2 Materials and reagents . 9
5.3 Apparatus and glassware . 12
5.4 Preparation of test organism suspensions and product test solutions . 13
5.5 Procedure for assessing the bactericidal activity of the product . 15
5.6 Experimental data and calculation . 21
5.7 Verification of methodology . 24
5.8 Expression of results and precision . 25
5.9 Interpretation of results - conclusion . 25
5.10 Test report . 26
Annex A (informative) Referenced strains in national collections . 28
Annex B (informative) Neutralizers and rinsing liquids. 29
Annex C (informative) Graphical representations of dilution neutralization method and
membrane filtration method . 31
Annex D (informative) Example of a typical test report . 35
Annex E (informative) Precision of the test result . 39
European foreword
This document (EN 1276:2019) 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 1276:2009.
Data obtained by using the latest version of EN 1276 are still valid.
The main changes in relation to EN 1276:2009 are:
— handrub and handwash test conditions and test requirements have been harmonized with
EN 13727;
— 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 13727 keeping specified time intervals and temperature steps;
— test conditions for temperatures ≥ 40 °C have been added.
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,
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 document describes a suspension test for establishing whether a chemical disinfectant or
antiseptic has or does not have bactericidal 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 test conditions. However, for some applications, the recommendations of use of
a product can 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 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:
— milk and milk products;
— meat and meat products;
— fish, seafood, and related products;
— eggs and egg products;
— animal feeds;
— etc.
2) food of vegetable origin:
— beverages;
— fruits, vegetables and derivatives (including sugar, distillery, etc.);
— flour, milling and baking;
— animal feeds;
— etc.
b) institutional and domestic areas:
— catering establishments;
— public areas;
— public transports;
— schools;
— nurseries;
— shops;
— sports rooms;
— waste containers (bins, etc.);
— hotels;
— dwellings;
— clinically non sensitive areas of hospitals;
— offices;
— etc.
c) other industrial areas:
— packaging material;
— biotechnology (yeast, proteins, enzymes, etc.);
— 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”.
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 14885:2018, 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 14885:2018 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
4 Requirements
The product shall demonstrate at least a 5 decimal logarithm (lg) reduction (3 lg for handwashes) 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 suitable test conditions as described in 5.5.1.1, Tables 1 and 2 here
below.
Table 1 — Test conditions for general purpose disinfection
Test Conditions Bactericidal activity
Enterococcus hirae
Escherichia coli
Test organism
(see 5.2.1)
Pseudomonas aeruginosa
obligatory
Staphylococcus aureus
E. faecium (for temperatures ≥ 40 °C)
Example of Salmonella Typhimurium
additional test Lactobacillus brevis
microorganisms Enterobacter cloacae
Test temperature
in a range from 4 °C to 60 °C
Contact time
in a range from 1 min to 60 min (from 1 min to 5 min at intervals of 1
min and from 5 min to 6
...
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