EN 13697:2015+A1:2019
(Main + Amendment)Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements without mechanical action (phase 2, step 2)
Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements without mechanical action (phase 2, step 2)
This European Standard specifies a test method (phase 2/step 2) and the minimum requirements for bactericidal and/or fungicidal or yeasticidal activity of chemical disinfectants that form a homogeneous physically stable preparation in hard water or – in the case of ready-to-use products – with water in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues.
The scope of this European Standard applies at least to the following:
a) Processing, distribution and retailing of:
1) Food of animal origin:
i) milk and milk products;
ii) meat and meat products;
iii) fish, seafood and products;
iv) eggs and egg products;
v) animal feeds;
vi) etc.
2) Food of vegetable origin:
i) beverages;
ii) fruits, vegetables and derivatives (including sugar distillery);
iii) flour, milling and backing;
iv) animal feeds;
v) etc.
b) Institutional and domestic areas:
1) catering establishments;
2) public areas;
3) public transports;
4) schools;
5) nurseries;
6) shops;
7) sports rooms;
8) waste container (bins);
9) hotels;
10) dwellings;
11) clinically non sensitive areas of hospitals;
12) offices;
13) etc.
c) Other industrial areas:
1) packaging material;
2) biotechnology (yeast, proteins, enzymes...);
3) pharmaceutical;
4) cosmetics and toiletries;
5) textiles;
6) space industry, computer industry;
7) etc.
Using this European Standard, it is possible to determine the bactericidal or fungicidal or yeasticidal activity of the undiluted product. As three concentrations are tested, in the active to non active range, dilution of the product is required and, therefore, the product forms a homogeneous stable preparation in hard water.
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 on bacteria and/or fungi in the conditions in which they are used.
NOTE 2 This method cannot be used to evaluate the activity of products against mycobacteria.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächen-Versuch zur Bestimmung der bakteriziden und/oder fungiziden Wirkung chemischer Desinfektionsmittel auf nicht porösen Oberflächen in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen - Prüfverfahren und Anforderungen ohne mechanische Behandlung (Phase 2, Stufe 2)
Diese Europäische Norm legt ein Prüfverfahren (Phase 2/Stufe 2) und die Mindestanforderungen an die bakterizide und/oder fungizide oder levurozide Wirkung von chemischen Desinfektionsmitteln in den Bereichen Lebensmittel, Industrie, Haushalt und in öffentlichen Einrichtungen fest, die mit Wasser standardisierter Härte oder – im Fall von gebrauchsfertigen Produkten – mit Wasser eine homogene, physikalisch stabile Lösung ergeben. Ausgenommen davon sind Bereiche und Situationen mit medizinisch indizierter Desinfektion und Produkte, die auf lebenden Geweben benutzt werden.
Diese Europäische Norm gilt mindestens für den folgenden Anwendungsbereich:
a) Verarbeitung, Vertrieb und Verkauf von:
1) Lebensmitteln tierischer Herkunft:
i) Milch und Milchprodukte;
ii) Fleisch und Fleischprodukte;
iii) Fisch, Meerestiere und daraus hergestellte Erzeugnisse;
iv) Eier und Eiprodukte;
v) Tiernahrung;
vi) usw.
2) Lebensmitteln pflanzlicher Herkunft:
i) Getränke;
ii) Früchte, Gemüse und daraus hergestellte Erzeugnisse (einschließlich Zucker, Destillations-produkte);
iii) Mehl, gemahlene und gebackene Produkte;
iv) Tiernahrung;
v) usw.
b) gewerbliche Einrichtungen und Haushaltsbereiche:
1) Verpflegungseinrichtungen;
2) öffentliche Bereiche;
3) öffentliche Verkehrsmittel;
4) Schulen;
5) Kindergärten;
6) Geschäfte;
7) Sportstätten;
8) Abfallbehälter (Mülltonnen);
9) Hotels;
10) Wohngebäude;
11) klinisch nicht relevante Bereiche von Krankenhäusern;
12) Büroräume;
13) usw.
c) andere industrielle Bereiche:
1) Verpackungsmaterial;
2) Biotechnologie (Hefe, Proteine, Enzyme usw.);
3) Hersteller von Pharmazeutika;
4) Hersteller von Kosmetika und Toilettenartikeln;
5) Hersteller von Textilien;
6) Weltraumforschungsindustrie und Computerindustrie;
7) usw.
Bei Anwendung dieser Europäischen Norm ist die Bestimmung der bakteriziden oder fungiziden oder levuroziden Wirkung des unverdünnten Produkts möglich. Da vom aktiven bis zum nicht aktiven Bereich drei Konzentrationen geprüft werden, ist eine Verdünnung des Produkts erforderlich, deshalb bildet das Produkt eine homogene stabile Lösung mit Wasser standardisierter Härte.
In EN 14885 ist die Beziehung zwischen den einzelnen Prüfungen untereinander und zu den Anwen-dungsempfehlungen detailliert festgelegt.
ANMERKUNG 1 Das beschriebene Verfahren bestimmt die Wirksamkeit gewerblich hergestellter Zubereitungen oder anderer aktiver Substanzen auf Bakterien und/oder Pilzen unter Anwendungsbedingungen.
ANMERKUNG 2 Dieses Verfahren kann nicht zur Bestimmung der Wirkung der Produkte gegenüber Mykobakterien angewendet werden.
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface non-poreuse pour l'évaluation de l'activité bactéricide et/ou fongicide des désinfectants chimiques utilisés dans le domaine de l'agro-alimentaire, dans l'industrie, dans les domaines
La présente Norme européenne décrit une méthode d’essai (phase 2, étape 2) et les prescriptions minimales relatives à l’activité bactéricide et/ou fongicide ou levuricide des désinfectants chimiques qui forment une préparation homogène, physiquement stable dans l’eau dure ou – dans le cas des produits prêts à l'emploi, avec de l'eau – et qui sont utilisés dans le domaine de l’agro-alimentaire, dans l’industrie, dans le domaine domestique et en collectivités, à l’exception des domaines et des situations où la désinfection est médicalement prescrite et à l’exclusion des produits utilisés sur les tissus vivants.
Le domaine d’application de la présente Norme européenne couvre au moins les secteurs suivants :
a) la fabrication, distribution et vente au détail de :
1) les produits alimentaires d’origine animale :
i) lait et produits laitiers ;
ii) viande et produits carnés ;
iii) poisson, fruits de mer et leurs produits dérivés;
iv) œufs et produits dérivés ;
v) alimentation animale ;
vi) etc.
2) les produits alimentaires d’origine végétale :
i) boissons ;
ii) fruits, légumes et leurs dérivés (y compris le sucre, les produits de distillation) ;
iii) farine, minoterie et boulangerie ;
iv) alimentation animale
v) etc.
b) les domaines domestiques et en collectivité :
1) établissements de restauration ;
2) lieux publics ;
3) transports publics ;
4) écoles ;
5) crèches ;
6) magasins ;
7) salles de sport ;
8) conteneurs pour déchets (poubelles) ;
9) hôtels ;
10) locaux d’habitation ;
11) zones cliniquement non sensibles des hôpitaux ;
12) bureaux ;
13) etc.
c) autres secteurs industriels :
1) les matériaux d'emballage ;
2) la biotechnologie (levure, protéines, enzymes...) ;
3) l'industrie pharmaceutique ;
4) les cosmétiques et les produits d'hygiène corporelle ;
5) les textiles ;
6) l’industrie spatiale, le secteur informatique ;
7) etc.
Il est possible d’utiliser la présente Norme européenne pour déterminer l’activité bactéricide ou fongicide ou levuricide des produits prêts à l’emploi. Trois concentrations, dont une active et l’autre non active, sont soumises à essai, une dilution du produit est nécessaire et ce dernier forme donc une préparation homogène et stable dans l’eau dure.
L'EN 14885 spécifie en détail la relation entre les différents essais et les « recommandations d'emploi ».
NOTE 1 La méthode décrite est destinée à déterminer l’efficacité des formulations commerciales ou des substances actives sur les bactéries et/ou les champignons et les levures dans les conditions dans lesquelles elles doivent être utilisées.
NOTE 2 Cette méthode ne peut pas être utilisée pour évaluer l'activité des produits vis-à-vis des mycobactéries.
Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah za vrednotenje baktericidnega in/ali fungicidnega delovanja kemičnih razkužil v živilski in drugih industrijah, gospodinjstvu in javnih ustanovah - Preskusna metoda in zahteve brez mehanskega delovanja (faza 2, stopnja 2) (vključno z dopolnilom A1)
Ta evropski standard določa preskusno metodo (faza 2/stopnja 2) in minimalne zahteve za baktericidno in/ali fungicidno delovanje ali delovanje kemičnih razkužil na kvasovke, ki tvorijo homogen, fizikalno stabilen pripravek v trdi vodi ali – pri izdelkih, ki so pripravljeni za uporabo – in se z vodo 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.
Obseg tega evropskega standarda se uporablja vsaj za naslednje:
a) predelava, distribucija in prodaja:
1) hrane živalskega izvora:
i) mleko in mlečni izdelki;
ii) meso in mesni izdelki;
iii) ribe, morski sadeži in izdelki;
iv) jajca in jajčni izdelki;
v) živalska krma;
vi) itd.
2) hrane rastlinskega izvora:
i) pijače;
ii) sadje, zelenjava in derivati (vključno z destilati sladkorja);
iii) moka, mletje in peka;
iv) živalska krma;
v) itd.
b) javne ustanove in gospodinjstva:
1) priprava in dostava hrane;
2) javne ustanove;
3) javni prevozi;
4) šole;
5) vrtci;
6) trgovine;
7) športne dvorane;
8) zbiralniki odpadkov (koši);
9) hoteli;
10) bivališča;
11) klinično neobčutljivi prostori bolnišnic;
12) pisarne;
13) itd.
c) druga industrijska področja:
1) embalaža;
2) biotehnologija (kvasovke, proteini, encimi ipd.);
3) farmacevtski izdelki;
4) kozmetični in toaletni izdelki;
5) tkanine;
6) vesoljska in računalniška industrija;
7) itd.
S tem evropskim standardom je mogoče določiti baktericidno ali fungicidno delovanje ali delovanje kemičnih razkužil na kvasovke pri nerazredčenem izdelku. Ker so preskušene tri koncentracije od aktivnega do neaktivnega razpona, je potrebno razredčevanje izdelka in zato tvorijo homogen in stabilen pripravek v trdi vodi.
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 na bakterijah in/ali glivah pod pogoji, v katerih se uporabljajo.
OPOMBA 2: Te metode ni mogoče uporabiti za vrednotenje delovanja izdelkov proti mikobakterijam.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2019
Nadomešča:
SIST EN 13697:2015
Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah
za vrednotenje baktericidnega in/ali fungicidnega delovanja kemičnih razkužil v
živilski in drugih industrijah, gospodinjstvu in javnih ustanovah - Preskusna
metoda in zahteve brez mehanskega delovanja (faza 2, stopnja 2) (vključno z
dopolnilom A1)
Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the
evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food,
industrial, domestic and institutional areas - Test method and requirements without
mechanical action (phase 2, step 2)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächen-Versuch zur
Bestimmung der bakteriziden und/oder fungiziden Wirkung chemischer
Desinfektionsmittel auf nicht porösen Oberflächen in den Bereichen Lebensmittel,
Industrie, Haushalt und öffentliche Einrichtungen - Prüfverfahren und Anforderungen
ohne mechanische Behandlung (Phase 2, Stufe 2)
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface non-poreuse pour
l'évaluation de l'activité bactéricide et/ou fongicide des désinfectants chimiques utilisés
dans le domaine de l'agro-alimentaire, dans l'industrie, dans les domaines
Ta slovenski standard je istoveten z: EN 13697:2015+A1:2019
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 13697:2015+A1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 11.080.20; 71.100.35 Supersedes EN 13697:2015
English Version
Chemical disinfectants and antiseptics - Quantitative non-
porous surface test for the evaluation of bactericidal
and/or fungicidal activity of chemical disinfectants used in
food, industrial, domestic and institutional areas - Test
method and requirements without mechanical action
(phase 2, step 2)
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de surface non-poreuse pour l'évaluation de Quantitativer Oberflächen-Versuch zur Bestimmung
l'activité bactéricide et/ou fongicide des désinfectants der bakteriziden und/oder fungiziden Wirkung
chimiques utilisés dans le domaine de l'agro- chemischer Desinfektionsmittel auf nicht porösen
alimentaire, dans l'industrie, dans les domaines Oberflächen in den Bereichen Lebensmittel, Industrie,
domestiques et en collectivité - Méthode d'essai sans Haushalt und öffentliche Einrichtungen - Prüfverfahren
action mécanique et prescriptions (phase 2/étape 2) und Anforderungen ohne mechanische Behandlung
(Phase 2, Stufe 2)
This European Standard was approved by CEN on 20 January 2015 and includes Amendment 1 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 13697:2015+A1:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 7
3 Terms and definitions . 8
4 Requirements . 8
5 Test methods . 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
5.2.3 Test surface . 13
5.3 Apparatus and glassware . 14
5.4 Preparation of test organism suspensions and product test solutions . 15
5.4.1 Test organism suspensions . 15
5.4.2 Product test solutions . 19
5.5 Procedure. 19
5.5.1 Choice of experimental conditions . 19
5.5.2 Test procedure . 20
5.5.3 Counting of the test mixtures . 24
5.6 Calculation and expression of results . 25
5.6.1 Elaboration of data: counting of weighed average values . 25
5.6.2 Verification of methodology . 26
5.6.3 Expression of results . 27
5.6.4 Conclusion. 27
5.7 Test report . 28
Annex A (informative) Corresponding referenced strains . 30
Annex B (informative) Neutralizers . 32
Annex C (informative) Expression of results with the dilution-neutralization method. 34
Annex D (informative) Bactericidal activity in surfaces in general use conditions (for clean
conditions) . 36
Annex E (informative) Precision of the test result . 38
Bibliography . 39
European foreword
This document (EN 13697:2015+A1:2019) 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 January 2020, and conflicting national standards shall
be withdrawn at the latest by January 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 includes Amendment 1 approved by CEN on 10 June 2019.
This document supersedes !EN 13697:2015".
The start and finish of text introduced or altered by amendment is indicated in the text by tags ! ".
!The changes between EN 13697:2015+A1:2019 and EN 13697:2001 are the following:
— interfering substance has been changed from 0,03 % bovine albumin to 0,85 % skimmed milk (see
Clause 4, Table 1) for Pseudomonas aeruginosa under clean conditions only;
— A. brasiliensis (ex A. niger) spore preparation has been updated in order to harmonize this step with
the QST fungicidal test method amendment issued in 2012 (see 5.4.1.3 b));
— calculations of the weighed means and of the results have been modified in order to be harmonized
with new CEN TC 216 standards (see 5.4.1.5, 5.5.2, 5.5.3 and 5.6);
— other paragraphs have been harmonized to new CEN TC 216 standards (e.g. preparation of hard
water, 5.2.2.7);
— deletion of obligatory and additional conditions (see Table 1 and 5.5.1);
— update of Bovine albumin and skimmed solutions preparations (see 5.2.2.8.2);
— add of instruction for using vacuum desiccator;
— update on bacteria working culture preparation (see 5.4.1.2) and counting of bacterial and fungal
test suspensions (see 5.4.1.4);
— clarification to the determination of microbicidal concentrations by updating 5.5.2.1 b) and adding
pictures of carriers;
— updates on dilution preparation for fungal and bacterial strains (see 5.5.2.2, 5.5.2.3, 5.5.2.4) and
counting of test mixtures (5.5.3).
Data from EN 13697:2015 are still valid with the exception of:
— Pseudomonas aeruginosa and Candida albicans under clean conditions."
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, Republic of North Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
the United Kingdom.
Introduction
This European Standard describes a surface test method for establishing whether a product proposed
as a disinfectant in the fields described in Clause 1 has or does not have bactericidal and/or fungicidal
or yeasticidal activity on non-porous surfaces.
This European Standard has been revised in order to modify the interfering substance under “clean
conditions” adopted for P. aeruginosa; in order to modify the calculation of N, NC, NT, Nc, Na and
consequently the final results and to harmonize the standard with the other recent CEN TC 216
standards.
The laboratory test closely simulates practical conditions of application. Chosen conditions (contact
time, temperature, organisms on surfaces .) reflect parameters which are found in practical situations
including conditions which may influence the action of disinfectants. Each use concentration found from
this test corresponds to defined experimental conditions.
The conditions are intended to cover general purposes and to allow reference between laboratories and
product types.
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 European Standard specifies a test method (phase 2/step 2) and the minimum requirements for
bactericidal and/or fungicidal or yeasticidal activity of chemical disinfectants that form a homogeneous
physically stable preparation in hard water or – in the case of ready-to-use products – with water in
food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is
medically indicated and excluding products used on living tissues.
The scope of this European Standard applies at least to the following:
a) Processing, distribution
...
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