EN 13697:2015+A1:2019
(Main)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
- Status
- Withdrawn
- Publication Date
- 30-Jul-2019
- Withdrawal Date
- 13-Apr-2025
- 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
- 01-Nov-2023
- Completion Date
- 14-Apr-2025
Relations
- Effective Date
- 18-Jan-2023
- Effective Date
- 22-May-2019
- Effective Date
- 28-Jul-2021
Frequently Asked Questions
EN 13697:2015+A1:2019 is a standard published by the European Committee for Standardization (CEN). Its full title is "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 standard covers: 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.
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.
EN 13697:2015+A1:2019 is classified under the following ICS (International Classification for Standards) categories: 11.080.20 - Disinfectants and antiseptics; 71.100.35 - Chemicals for industrial and domestic disinfection purposes. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 13697:2015+A1:2019 has the following relationships with other standards: It is inter standard links to EN 13697:2015, EN 13697:2015/FprA1:2019, EN 13697:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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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 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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, 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 at least a 4 decimal log (lg) reduction for bacteria and at least a 3
decimal log (lg) reduction for fungi, when tested in accordance with Table 1 and 5.5.1.
!
Table 1 — Experimental conditions
Yeasticidal activity on Fungicidal activity on
Bactericidal activity on
non-porous surfaces non-porous surfaces
Test conditions non-porous surfaces
without mechanical without mechanical
without mechanical action
action action
Test organisms
Enterococcus hirae
(see 5.2.1)
Escherichia coli Candida albicans
minimum
Candida albicans
spectrum of Pseudomonas aeruginosa Aspergillus brasiliensis
test
Staphylococcus aureus
organisms
Saccharomyces cerevisiae
Salmonella typhimurium
(for breweries)
Test organisms
additional Lactobacillus brevis any relevant test organism
Saccharomyces cerevisiae
(examples)
var. diastaticus (for
Enterobacter cloacae
breweries)
In a range from (4 ± 1) °C In a range from (4 ± 1) °C
In a range from (4 ± 1) °C to
to (40 ± 1) °C to (40 ± 1) °C
(40 ± 1) °C
For tests performed at For tests performed at
Test temperature
For tests performed at room
room temperature, the room temperature, the
temperature, the range shall
range shall be between range shall be between
be between 18 °C and 25 °C
18 °C and 25 °C 18 °C and 25 °C
in a range from 1 min to 60 in a range from 1 min to in a range from 1 min to 60
min (from 1 min to 5 min at 60 min (from 1 min to 5 min (from 1 min to 5 min
Contact time intervals of 1 min and from min at intervals of 1 min at intervals of 1 min and
5 min to 60 min at intervals and from 5 min to 60 min from 5 min to 60 min at
of 5 min) at intervals of 5 min) intervals of 5 min)
0,3 g/l bovine albumin for
Interfering
Staphylococcus aureus, 0,3 g/l bovine albumin for
0,3 g/l bovine albumin for
substance
Enterococcus hirae, C. albicans and A.
C. albicans
Escherichia coli and brasiliensis
clean conditions
Pseudomonas aeruginosa
Yeasticidal activity on Fungicidal activity on
Bactericidal activity on
non-porous surfaces non-porous surfaces
Test conditions non-porous surfaces
without mechanical without mechanical
without mechanical action
action action
3,0 g/l bovine albumin for
Interfering
Staphylococcus aureus, 3,0 g/l bovine albumin for
3,0 g/l bovine albumin for
substance
Enterococcus hirae, C. albicans and A.
C. albicans
Pseudomonas aeruginosa brasiliensis
dirty conditions
and Escherichia coli
Interfering
substance
any relevant substance any relevant substance any relevant substance
additional
Log reduction
from a water
≥ 4 lg ≥ 3 lg ≥ 3 lg
control (decimal
lg)
The referenced test conditions (General purposes) are by no means intended as requirements for the use
of a product, nor as requirements for the evaluation and acceptance of products by regulatory authorities.
The application time for the product is specified by the manufacturer.
If specific applications have to be considered, the bactericidal/yeasticidal/fungicidal activity has to be
determined additionally under relevant conditions concerning application time, temperature, strains and
Interfering Substances.
"
5 Test methods
5.1 Principle
A test suspension of bacteria or fungi in a solution of interfering substances is inoculated onto a test
stainless steel surface and dried. A prepared sample of the product under test is applied in a manner
which covers the dried film. The surface is maintained at a specified temperature for a defined period of
time. The surface is transferred to a previously validated neutralization medium so that the action of
the disinfectant is immediately neutralized. The number of surviving organisms which can be recovered
from the surface is determined quantitatively.
The number of bacteria or fungi on a surface treated with hard water in place of the disinfectant is also
determined and the reduction in viable counts attributed to the product is calculated by difference.
5.2 Materials and reagents
5.2.1 Test organisms
The bactericidal activity shall be evaluated using the following four strains:
— Pseudomonas aeruginosa 1
)
ATCC 15 442 ;
— Staphylococcus aureus ATCC 6 538;
— Enterococcus hirae ATCC 10 541;
— Escherichia coli ATCC 10 536.
The fungicidal or yeasticidal activity shall be evaluated using the following two strains:
— Candida albicans ATCC 10 231;
— Aspergillus brasiliensis (ex A. niger) ATCC 16 404.
If required for specific applications, additional strains may be chosen from, for example:
— Salmonella typhimurium ATCC 13 311;
— Lactobacillus brevis DSM 6 235;
— Enterobacter cloacae DSM 6 234;
— Saccharomyces cerevisiae (for breweries) or ATCC 9 763 or DSM 1 333;
— Saccharomyces cerevisiae var. diastaticus (for DSM 70 487.
breweries)
NOTE See Annex A for corresponding strain numbers in some other culture collections.
If additional strains are used, they shall be incubated under optimum growth conditions (temperature,
time, atmosphere) and noted in the test report.
If the additional strains selected do not correspond to the specified strains, their suitability for
supplying inocula of sufficient concentration shall be verified. If the additional strains tested are not
classified at a reference centre, their identification characteristics shall be stated. In addition, they shall
be held by the testing laboratory or national culture under a reference for 5 years.
5.2.2 Culture media and reagents
5.2.2.1 General
The reagents shall be of analytical grade and/or appropriate for microbiological purposes.
5.2.2.2 Water
The water shall be free from substances that are toxic or inhibiting to bacteria and fungi. It shall be
freshly glass distilled and not demineralized water.
1)
ATCC 15 442, ATCC 6 538, ATCC 10 541, ATCC 10 536, ATCC 10 231, ATCC 16 404 and ATCC 13311 are the collection
numbers of strains supplied by the American Type Culture Collections. This information is given for the convenience of users of
this standard and does not constitute an endorsement by CEN of the product named. Equivalent products can be used if they
can be shown to lead to the same results.
Sterilize in the autoclave (see 5.3.2.1).
NOTE 1 If the water is sterilized during sterilization of the reagents, this is not necessary.
NOTE 2 If distilled water of adequate quality is not available, water for injectable preparation (see European
Pharmacopoeia) can be used.
5.2.2.3 Tryptone Soya Agar (TSA)
For maintenance of bacterial strains and performance of viable counts.
Tryptone, pancreatic digest of casein 15,0 g
Soya peptone, papaic digest of Soybean meal 5,0 g
NaCl 5,0 g
Agar 15,0 g
Water (see 5.2.2.2) 1 000,0 ml
Sterilize in the autoclave (see 5.3.2.1). After sterilization, the pH of the medium shall be equivalent to
7,2 ± 0,2 when measured at 20 ° C.
5.2.2.4 Malt extract agar (MEA)
For maintenance of fungal strains, sporulation and performance of viable counts.
Malt extract (food grade, e.g. Cristomalt powder from 30,0 g
Difal)
Agar 15,0 g
Water (see 5.2.2.2) 1 000,0 ml
The malt extract should be food grade (e.g. Cristomalt powder from Difal) or equivalent that is not
2)
highly purified and not only based on maltose (e.g. Malt extract from OXOID) . However, if there are
problems producing at least 75 % spiny spores see 5.4.1.4.2.
Sterilize in the autoclave [5.3.2.1a)]. After sterilization, the pH of the medium shall be equivalent to
5,6 ± 0,2 when measured at (20 ± 1) °C.
In case of encountering problems with neutralization (5.5.2.3 and 5.5.2.4), it may be necessary to add
neutralizer to the MEA. Annex B gives guidance on the neutralizers that may be used.
2)
This information is given for the convenience of users of this European Standard and does not constitute an endorsement by
CEN of the product named. Equivalent products may be used if they can be shown to lead to the same results.
5.2.2.5 Diluent
Tryptone sodium chloride solution:
Tryptone, pancreatic digest of casein 1,0 g
NaCl 8,5 g
Water (see 5.2.2.2) 1 000,0 ml
Sterilize in the autoclave (see 5.3.2.1). After sterilization the pH shall be equivalent to 7,0 ± 0,2 when
measured at 20 °C.
5.2.2.6 Neutralizer
The neutralizer shall be validated for the product under test in accordance with 5.5.2.3 and 5.5.2.4. The
neutralizer shall be sterile.
NOTE Information on neutralizers that have been found to be suitable for some categories of products is
given in Annex B.
5.2.2.7 Hard water for dilution of the products
Hard water for dilution of products shall be prepared as follows:
— solution A: Dissolve 19,84 g anhydrous MgCl and 46,24 g anhydrous CaCl in water (see 5.2.2.2)
2 2
and dilute to 1 000 ml. Sterilize by membrane filtration (5.3.2.19) or in the autoclave (5.3.2.1 a).
Autoclaving – if used - may cause a loss of liquid. In this case, make up to 1 000 ml with water
(5.2.2.2) under aseptic conditions. Store the solution in the refrigerator (5.3.2.15) for no longer
than one month;
— solution B: Dissolve 35,02 g NaHC0 in water (see 5.2.2.2) and dilute to 1 000 ml. !deleted text"
Sterilize by membrane filtration (5.3.2.19). Store the solution in the refrigerator (5.3.2.15) for no
longer than one week.
Add at least 600 ml water (see 5.2.2.2) to 6,0 ml of solution A in a 1 000 ml volumetric flask, then add
8,0 ml solution B. Mix and dilute to 1 000 ml with water (see 5.2.2.2).
Sterilize by passing through a filter with a maximum effective pore size of 0,45 µm.
The pH of the hard water shall be 7,0 ± 0,2, when measured at (20 ± 1) °C (5.3.2.6). If necessary, adjust
the pH by using a solution of approximately 40 g/l (about 1 mol/l) of sodium hydroxide (NaOH) or
approximately 36,5 g/l (about 1 mol/l) of hydrochloric acid (HCl).
The hard water shall be freshly prepared under aseptic conditions and used within 12 h.
NOTE When preparing the test product solutions (5.4.2), the addition of the product to the hard water
produces a different final water hardness expressed as calcium carbonate (CaCO3) in each test tube. In any case,
the final hardness is lower than 375 mg/l of calcium carbonate.
5.2.2.8 Interfering substances
5.2.2.8.1 General
The interfering substance shall be chosen according to the conditions of use laid down for the product.
The interfering substance shall be sterile and prepared at 2 times its final concentration in the test.
For the additional interfering substances, the ionic composition (e.g. pH, calcium and/or magnesium
hardness) and chemical composition (e.g. mineral substances, protein, carbohydrates, lipids,
detergents) shall be fully defined.
NOTE The term “interfering substance” is used even if it contains more than one substance.
The method of preparation and sterilization together with the composition shall be noted in the test
report (see 5.7).
5.2.2.8.2 !Bovine albumin solutions"
!Bovine albumin solutions for the test conditions shall be prepared as follows:
— Preparation for clean conditions:
— dissolve 0,06 g of bovine albumin (Cohn fraction V for Dubos medium) in 100 ml of water (see
5.2.2.2);
— sterilize by 0,45 µm membrane filtration (see 5.3.2.19), keep in the refrigerator and use within
one month.
The final concentration of bovine albumin in the test procedure (see 5.5.2) is 0,3 g/l.
— Preparation for dirty conditions:
— dissolve 0,6 g of bovine albumin (Cohn fraction V for Dubos medium) in 100 ml of water (see
5.2.2.2);
— sterilize by 0,45 µm membrane filtration (see 5.3.2.19), keep in the refrigerator and use within
one month.
The final concentration of bovine albumin in the test procedure (see 5.5.2) is 3,0 g/l."
5.2.2.8.3 Milk (dairies)
Skimmed milk, guaranteed free of antibiotics or additives, shall be reconstituted at a rate of 100 g
powder per litre of water (see 5.2.2.2). The working solution shall be prepared as follows:
— prepare a solution of 2,0 % (V/V) in water (see 5.2.2.2) by adding 2 parts of reconstituted milk to
98 parts of water;
— sterilize for 30 min at 105 °C ± 3 °C (or 5 min at 121 °C ± 3 °C).
!The final concentration of the reconstituted milk should be 1,0 % (v / v) in the test (see 5.5.2) or
1 g/l of milk powder during the test."
!Deleted text"
!Deleted text"
!Deleted text"
!Deleted text"
5.2.3 Test surface
Stainless steel discs (2 cm diameter discs) 304 with grade 2b finish on both sides. The surfaces should
be flat.
The surfaces should be used only once.
Prior to use the surfaces should be placed in a beaker (minimum size: 50 ml) containing not less than
® 3)
20 ml of 5 % (V/V) Decon for 60 min. Immediately rinse the discs with running freshly distilled
water for 10 s.
The surface shall not be allowed to dry to any extent. The discs shall only be handled with forceps. Rinse
the discs with water (see 5.2.2.2) for a further 10 s to ensure complete removal of the surfactant. To
supply a satisfactory flow of water, a sterilized fluid dispensing pressure vessel with suitable hose and
connectors or other suitable method can be used and regulated to supply approximately 2 000 ml per
min. To sterilize, place the clean disc in a bath containing 70 % (V/V) iso-propanol for 15 min. Remove
the disc and dry by evaporation under laminar air flow.
5.3 Apparatus and glassware
5.3.1 General
Sterilize all glassware and parts of apparatus that will come into contact with the culture media and
reagents or the sample, except those which are supplied sterile, by one of the following methods:
+3
a) in the autoclave (see 5.3.2.1) by maintaining it at 121 °C for a minimum holding time of 15 min;
b) in the dry heat sterilizer (see 5.3.2.1) by maintaining it at 180 °C for a minimum holding time of
30 min, at 170 °C for a minimum holding time of 1 h or at 160 °C for a minimum holding time of 2 h.
4)
5.3.2 Usual microbiological laboratory equipment and in particular, the following:
5.3.2.1 Apparatus for sterilization:
+3
a) For moist heat sterilization, an autoclave capable of being maintained at 121 °C for 15 min;
b) for dry heat treatment, a hot air oven capable of being maintained at 180 °C for a minimum holding
time of 30 min, at 170 °C for a minimum holding time of 1 h or at 160 °C for a minimum holding
time of 2 h.
5.3.2.2 !Temperature controlled cabinet capable of being controlled at test temperatures,
(θ ± 1) °C."
5.3.2.3 Water baths capable of being controlled at 20 °C ± 1 °C, at 45 °C ± 1 °C and at additional test
temperatures θ ± 1 °C (see 5.5.1).
5.3.2.4 Incubator (for bactericidal activity), capable of being controlled at either 36 °C ± 1 °C or
37 °C ± 1 °C. An incubator at 37 °C ± 1 °C may be used if an incubator at 36 °C ± 1 °C is not available.
5.3.2.5 Incubator (for fungicidal or yeasticidal activity), capable of being controlled at 30 °C ± 1 °C.
5.3.2.6 pH meter, having an accuracy of calibration of 0,1 pH units at 20 °C ± 1 °C.
5.3.2.7 Stopwatch.
® 5)
5.3.2.8 Vortex mixer (mechanical shaker or electromechanical agitator, i.e. Vortex mixer ).
3)
Decon is an example of a suitable product available commercially. This information is given for the convenience of users
of this standard and does not constitute an endorsement by CEN of this product.
4)
Disposable equipment is an acceptable alternative to reusable glassware.
5.3.2.9 Containers: Test tubes, culture bottles or flasks of suitable capacity.
5.3.2.10 Graduated pipettes of nominal capacities 10 ml, 1 ml, 0,1 ml and 0,05 ml, or calibrated
automatic pipettes.
5.3.2.11 Petri dishes of size 90 mm to 100 mm.
5.3.2.12 Glass beads (Diameter: ≤ 5 mm).
5.3.2.13 Volumetric flasks.
5.3.2.14 Mechanical shaker.
5.3.2.15 Refrigerator capable of being controlled at 2 °C to 8 °C.
5.3.2.16 Forceps.
5.3.2.17 Microbiological filtered laminar air flow cabinet.
5.3.2.18 Fritted filter: Porosity of 40 µm to 100 µm (see ISO 4793).
5.3.2.19 Membrane filtration apparatus, constructed of a material compatible with the substances
to be filtered.
The apparatus shall have a filter holder of at least 50 ml volume. It shall be suitable for use with filters
of diameter 47 mm to 50 mm and 0,45 μm pore size for sterilization of hard water (5.2.2.7).
!
5.3.2.20 Vacuum desiccator, Desiccator with an active desiccant. Vacuum source may be a pump or
central supply and should achieve a vacuum of 20 mmHg to 25 mmHg (508-635 torr; 677-847 mbar;
68000-85000 Pascal; conversion tables are readily available on the Internet for other units)."
5.4 Preparation of test organism suspensions and product test solutions
5.4.1 Test organism suspensions
5.4.1.1 Stock cultures of test organisms
Stocks cultures shall be kept in accordance with the requirements of EN 12353.
5.4.1.2 Working culture of test organisms
a) Bacteria:
In order to prepare the working culture of the test organism, subculture from the stock culture (see
5.4.1.1) by streaking on TSA slopes (see 5.2.2.3) and incubate (see 5.3.2.4). After 18 h to 24 h,
prepare a second subculture from the first subculture in the same way and incubate for 18 h to 24
h. From this second subculture, a third subculture may be produced in the same way.
NOTE 1 The second and/or third subculture are the working culture(s).
5)
Vortex® in an example of a suitable product available commercially. This information is given for the convenience of users
of this standard and does not constitute an endorsement by CEN of this product.
If it is not possible to prepare the second subculture on a particular day, a 48 h subculture may be
used for subsequent subculturing, provided that the subculture has been kept in the incubator
during the 48 h period. In these circumstances, prepare a further 24 h subculture after proceeding.
Do not take a fourth subculture.
For additional strains (see 5.2.1), any departure from this method of culturing the bacteria or
preparing the suspensions shall be noted, giving the reasons in the test report.
b) fungi:
In order to prepare the working culture of Candida albicans, subculture from the stock culture (see
5.4.1.1) by streaking onto MEA slopes (see 5.2.2.4) and incubate (see 5.3.2.5). After 42 h to 48 h,
prepare a second subculture from the first subculture in the same way and incubate for 42 h to
48 h. From this second subculture, a third subculture may be produced in the same way.
NOTE 2 The second and/or third subculture are the working culture(s).
For Aspergillus brasiliensis (previously A. niger) (5.2.1), use only the first subculture grown on MEA
(5.2.2.4) in Petri dishes or flasks with ventilated caps (5.3.2.17) and incubate at 30 °C ± 1 °C for 7 d
to 9 d. No further subculturing is needed. Do not stack the Petri dishes during the incubation to
improve the temperature homogenization.
At the end of incubation, all the cultures shall show a dark brown or black surface. Cultures with
appearance of rare and small white or grey areas might be kept.
5.4.1.3 Test suspensions
!a) Bacterial test suspension:
Take 10 ml of diluent (see 5.2.2.5) and place in a 100 ml flask with 5 g of glass beads (see 5.3.2.12).
Take the working culture (see 5.4.1.2) and transfer loopfuls of the cells into the diluent. The cells
should be suspended in the diluent by immersing the loop in the diluent and rubbing it against the
side of the flask to dislodge the cells. Shake the flask for 3 min using a mechanical shaker (see
5.3.2.14). Aspirate the suspension from the glass beads and transfer to another flask. Adjust the
8 8
number of cells in the suspension to 1,5 × 10 cfu/ml to 5,0 × 10 cfu/ml using the diluent for E.
coli, E. hirae and S. aureus. For Pseudomonas aeruginosa adjust the number of cells in the suspension
8 8
to 1,5 × 10 cfu/ml to 5,0 × 10 cfu/ml using the diluent for tests under dirty conditions and adjust
9 9
to1,5 × 10 cfu/ml to 5,0 × 10 cfu/ml using the diluent for tests under clean conditions.
The numbers of units shall be estimated by means of spectrophotometer or any other suitable
means. Maintain this suspension in the water bath at 20 °C ± 1 °C and use within 2 h."
b) fungal test suspension:
!1) Candida albicans:
Take 10 ml of diluent (see 5.2.2.5) and place in a 100 ml flask with 5 g of glass beads. Take the
working culture (see 5.4.1.2) and transfer loopfuls of the cells into the diluent. The cells should
be suspended in the diluent by immersing the loop in the diluent and rubbing it against the side
of the flask to dislodge the cells. Shake the flask for 3 min using a mechanical shaker (5.3.2.14).
Aspirate the suspension from the glass beads and transfer to another flask. Adjust the number
7 7
of cells in the suspension to 1,5 × 10 cfu/ml to 5,0 × 10 cfu/ml using the diluent for tests to
be performed under dirty conditions, estimating the numbers of units by means of a
spectrophotometer or other suitable technique. Maintain this suspension in the water bath at
20 °C ± 1 °C and use within 2 h. Adjust the number of cells in the suspension to
8 8
1,5 × 10 cfu/ml to 5,0 × 10 cfu/ml using the diluent for tests to be performed under clean
conditions, estimating the numbers of units by means of a spectrophotometer or other suitable
technique. Maintain this suspension in the water bath at 20 °C ± 1 °C and use within 2 h."
2) Aspergillus brasiliensis (ex A. niger):
Take the working culture (see 5.4.1.2) and suspend the cells in 10 ml of sterile 0,05 % w/v
6)
polysorbate 80 solution in water (see 5.2.2.2). Using a sterile glass rod or spatula detach the
conidiospores from the culture surface. Transfer the suspension into a flask and gently shake
by hand for one minute together with glass beads (see 5.3.2.12). The suspension is filtered
through a fritted filter (see 5.3.2.18).
Carry out a microscopic examination under x 400 magnification immediately after the preparation to
show:
— the presence of a high concentration (at least 75 % of spiny spores) of characteristic mature spores,
i.e. spiny spores (versus smooth spores);
— the absence of spore germination (check at least 10 fields of view);
— the absence of mycelia fragments (check at least 10 fields of view).
If germinated spores are present, discard the suspension.
nd
If mycelia are present, proceed to a 2 fritted filtration.
If mycelia are still present, discard the suspension.
If 75 % spiny spores are not achieved it may be due to the Aspergillus brasiliensis (ex A. niger) culture or
the media used to produce these spores. In this situation, it will be necessary to obtain the culture from
another culture collection and/or use a MEA from a different supplier.
7 7
Adjust the number of spores in the suspension to 1,5 × 10 cfu/ml to 5,0 × 10 cfu/ml using the diluent
(5.2.2.5), estimating the number of cfu by any suitable means. Use the suspension within 4 h in a water
bath controlled at 20 °C ± 1 °C (5.3.2.3). In any case, adjust the temperature according to 5.5.1 only
immediately before the start of the test (5.5.2).
The use of a cell counting device for adjusting the number of cells is highly recommended. When using a
suitable counting chamber, follow the instructions explicitly.
−5 −6
For counting, prepare 10 and 10 dilutions of the test suspension using diluent (5.2.2.5). Mix (5.3.2.8).
Take a sample of 1,0 ml of each dilution in duplicate and inoculate using the pour plate or the spread
plate technique.
a) When using the pour plate technique, transfer about half of each 1,0 ml sample into separate Petri
dishes (i.e. in duplicate = four plates) and add 15 ml to 20 ml of melted MEA (5.2.2.4),cooled to
(45 ± 1) °C.
6)
Analytical quality, non hydrolysed in accordance with European Pharmacopoeia, Volume 1. TWEEN 80 is an example of a
suitable product available commercially. This information is given for the convenience of users of this standard and does not
constitute an endorsement by CEN of this product.
b) When using the spread plate technique, spread about one quarter of each 1,0 ml sample on an
appropriate number (at least four) of surface dried plates containing MEA (5.2.2.4) (i.e. in duplicate
– at least eight plates).
This test suspension shall not be stored more than 2 d at 2 °C to 8 °C.
The test suspension shall be mixed (see 5.3.2.8) immediately before use to re-suspend the spores.
5.4.1.4 Counting of bacterial and fungal test suspensions
−6 −7
!Dilute the adjusted bacterial and yeast suspensions (see 5.4.1.3) by 10 (serial dilutions) and 10
for:
— S. aureus, E. coli, E. hirae;
— for P. aeruginosa under dirty conditions;
— C. albicans under clean conditions.
−7 −8
Dilute the adjusted bacterial suspension (see 5.4.1.3) by 10 (serial dilutions) and 10 for:
— P. aeruginosa under clean conditions.
−5 −6
Dilute the adjusted yeast suspension (see 5.4.1.3) by 10 (serial dilutions) and 10 for:
— C. albicans under dirty conditions.
−5 −6
Dilute the adjusted mould spore suspension by 10 and 10 (see 5.4.1.3) using diluent (see 5.2.2.5).
Mix the suspension (see 5.3.2.8).
Take a sample of 1,0 ml of each dilution in duplicate and inoculate pour plates. Pipette each 1,0 ml
sample into separate Petri dishes (see 5.3.2.11) and add 15 ml to 20 ml melted TSA (see 5.2.2.2) for the
bacteria and 15 ml to 20 ml melted MEA (see 5.2.2.3) for the fungi, cooled to 45 °C ± 1 °C. When using
the spread plate technique, spread each 1,0 ml sample – divided into portions of approximately equal
size – on an appropriate number (at least two) of surface dried plates containing TSA or MEA.
a) Counting of bacterial test suspensions
1) For the bacterial strains, incubate the plates at (36 ± 1) °C or at (37 ± 1) °C for 18 h to
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기사 제목: EN 13697:2015+A1:2019 - 화학 소독제 및 항균제 - 식품, 산업, 가정 및 기관 지역에서 사용되는 화학 소독제의 비균 소독 및/또는 균 소독 효과를 평가하기 위한 비다공성 표면 테스트 방법과 요구 사항 (단계2, 단계2) 기사 내용: 이 유럽 표준은 혼합 물 또는 레디 투 유 제품의 경우 식품, 산업, 가정 및 기관 지역에서 하드 워터와 물로 물리적으로 안정된 준비물 형태를 만드는 화학 소독제의 비균 소독 및/또는 균 소독 또는 효모 살균 작용의 최소 요구 사항과 테스트 방법을 지정한다. 단, 의료적으로 소독이 필요한 지역과 상황, 그리고 생체 조직에 사용되는 제품은 제외된다. 이 유럽 표준의 범위는 적어도 다음과 같은 경우에 적용된다: 가공, 유통 및 소매: 1) 동물 유래 식품: i) 우유 및 우유 제품; ii) 고기 및 육류 제품; iii) 어류, 해산물 및 제품; iv) 계란 및 계란 제품; v) 동물 사료; vi) 등. 2) 식물 유래 식품: i) 음료; ii) 과일, 채소 및 유도체 (당공장 포함); iii) 밀가루, 밀링 및 베이킹; iv) 동물 사료; v) 등. b) 기관 및 가정 지역: 1) 외식업소; 2) 공공 장소; 3) 대중 교통; 4) 학교; 5) 어린이집; 6) 상점; 7) 운동 시설; 8) 쓰레기통; 9) 호텔; 10) 주택; 11) 병원의 비민감한 영역; 12) 사무실; 13) 등. c) 기타 산업 지역: 1) 포장 재료; 2) 생물 공학 (효모, 단백질, 효소 등); 3) 약물; 4) 화장품 및 화장품; 5) 섬유; 6) 우주 산업, 컴퓨터 산업; 7) 등. 이 유럽 표준을 사용하면 희석되지 않은 제품의 비균 소독 또는 균 소독 또는 효모 살균 작용을 결정할 수 있다. 효과적인 범위 내의 세 가지 농도가 테스트되므로 제품의 희석이 필요하며, 따라서 제품은 하드 워터에서 물리적으로 안정한 준비물 형태를 형성한다. EN 14885는 서로 다른 테스트 및 사용 권장 사항과의 관계에 대해 자세히 설명한다. 참고 1: 여기서 설명된 방법은 상업적 조성물이나 활성 물질의 활동을 사용된 조건에서 세균 및/또는 곰팡이에 대한 활동을 결정하기 위한 것이다. 참고 2: 이 방법은 화학제품이 결핵균에 대한 효능을 평가하기 위해 사용될 수 없다.
이 기사는 유럽 표준 EN 13697:2015+A1:2019에 대해 다루고 있는데, 이 표준은 식품, 산업, 가정, 기관 등 다양한 영역에서 사용되는 화학 소독제의 세균 살균 및/또는 곰팡이 살균 또는 악연초 살균 활동을 평가하기 위한 검사 방법과 최소 요구 사항을 명시하고 있습니다. 이 표준은 의료적으로 필요한 소독이 필요한 상황과 생체 조직에 사용되는 제품은 포함하지 않습니다. 이 표준의 적용 범위는 적어도 다음과 같습니다: a) 동물성 식품의 가공, 유통 및 소매 판매: 1) 우유 및 유제품; 2) 고기 및 육류 제품; 3) 생선, 해산물 및 제품; 4) 달걀 및 달걀 제품; 5) 동물 사료; 6) 기타 등. b) 기관 및 가정 영역: 1) 외식업소; 2) 공공 장소; 3) 대중 교통; 4) 학교; 5) 어린이집; 6) 상점; 7) 체육실; 8) 쓰레기통; 9) 호텔; 10) 주택; 11) 병원의 임상적으로 민감하지 않은 지역; 12) 사무실; 13) 기타 등. c) 기타 산업 영역: 1) 포장재; 2) 생물공학 (효모, 단백질, 효소 등); 3) 제약; 4) 화장품과 화장품용품; 5) 섬유; 6) 우주 산업 및 컴퓨터 산업; 7) 기타 등. 이 유럽 표준을 사용하면 농도별로 제품의 세균 살균, 곰팡이 살균 또는 악연초 살균 활동을 결정할 수 있습니다. 활성 도 비활성 도 범위에서 세 가지 농도를 테스트하므로 제품을 희석해야 하며, 따라서 제품은 경수에 동질적인 안정한 혼합물을 형성합니다. EN 14885은 다양한 테스트 간 및 사용 권장 사항과의 상세한 관계를 설명하고 있습니다. 참고: 여기에 기술된 방법은 제품이 사용되는 조건에서 세균과/또는 곰팡이에 대한 상업적으로 판매되는 제형 또는 활성 물질의 활동을 결정하기 위한 것입니다. 참고 2: 본 방법은 제품의 항결핵균 효능을 평가하기 위해 사용될 수 없습니다.
The article discusses the European standard EN 13697:2015+A1:2019, which outlines a test method and minimum requirements for the bactericidal and/or fungicidal activity of chemical disinfectants used in various areas such as food, industrial, domestic, and institutional settings. The standard does not apply to disinfection in medical situations or products used on living tissues. The article also lists specific areas to which the standard applies, such as food processing, retail, institutional and domestic areas like catering establishments, schools, and offices, as well as other industrial areas like pharmaceuticals, cosmetics, and textiles. The standard allows for the determination of the disinfectant's activity in its undiluted form and requires dilution for testing at different concentrations. It is important to note that the method described in the standard is not suitable for evaluating the activity of products against mycobacteria.
この記事では、ヨーロッパ規格EN 13697:2015+A1:2019について説明されています。この規格は食品、産業、家庭、施設などで使用される化学消毒剤の細菌殺菌および/またはカビ殺菌または酵母殺菌能力の評価のための試験方法と最小要件を定めています。ただし、医療的な証拠が必要な消毒や生体組織に使用される製品は対象外です。この規格の適用範囲には、少なくとも以下が含まれます： a) 動物性食品の加工、流通、小売： 1) 乳製品； 2) 肉および肉製品； 3) 魚介類とその製品； 4) 卵および卵製品； 5) 動物飼料； 6) その他。 b) 施設および家庭の領域： 1) 飲食店； 2) 公共の場所； 3) 公共交通機関； 4) 学校； 5) 保育所； 6) 店舗； 7) スポーツ施設； 8) ゴミ箱； 9) ホテル； 10) 住宅； 11) 病院の非感染部位； 12) オフィス； 13) その他。 c) その他の産業領域： 1) 包装資材； 2) バイオテクノロジー（酵母、タンパク質、酵素など）； 3) 製薬； 4) 化粧品およびトイレタリー用品； 5) 繊維； 6) 宇宙産業、コンピュータ産業； 7) その他。 このヨーロッパ規格により、希釈水または試験対象の製品が硬水で均質で物理的に安定した調製物を形成する場合、希釈されていない製品の殺菌性、カビ殺菌性、または酵母殺菌性を確認することができます。三つの濃度がテストされるため、活性と非活性の範囲で製品を希釈する必要があります。 EN 14885では、試験方法と使用推奨事項との関係について詳細に記載されています。 注意1：本手法は、製品が使用される条件で商業的な製剤または有効成分の細菌および/またはカビに対する活性を評価することを意図しています。 注意2：この手法は、製品のマイコバクテリウムに対する活性を評価するために使用することはできません。
記事タイトル：EN 13697:2015+A1:2019-化学消毒剤および抗菌剤-食品、産業、家庭、施設で使用される化学消毒剤の非多孔質表面試験による細菌殺菌および/または真菌殺菌活性の定量評価のための試験方法と要件（フェーズ2、ステップ2） 記事内容：この欧州標準は、硬水または使用される場合は水と均一で物理的に安定した調製形態を形成する化学消毒剤の細菌殺菌および/または真菌殺菌または酵母殺菌活性の試験方法（フェーズ2/ステップ2）およびその最小要件を指定しています。ただし、医学的に必要な消毒や生体組織に使用される製品は除外されます。 この欧州標準の範囲は、少なくとも以下の場合に適用されます： a) 処理、流通、小売りの食品： 1) 動物由来の食品： i) 乳および乳製品； ii) 肉および肉製品； iii) 魚、シーフード、および製品； iv) 卵および卵製品； v) 動物の飼料； vi) など。 2) 植物由来の食品： i) 飲み物； ii) 果物、野菜、および派生物（糖蒸留所を含む）； iii) 小麦粉、粉砕、および焼成； iv) 動物の飼料； v) など。 b) 施設および家庭の領域： 1) 飲食店； 2) 公共の場所； 3) 公共交通機関； 4) 学校； 5) 託児所； 6) 店舗； 7) スポーツ施設； 8) ゴミ容器（ゴミ箱）； 9) ホテル； 10) 住宅； 11) 病院の非感度がある領域； 12) オフィス； 13) など。 c) その他の産業領域： 1) 包装材料； 2) バイオテクノロジー（酵母、タンパク質、酵素など）； 3) 製薬； 4) 化粧品とトイレタリー； 5) 繊維； 6) 宇宙産業、コンピュータ産業； 7) など。 この欧州標準では、希釈されていない製品の細菌殺菌または真菌殺菌または酵母殺菌活性を決定することが可能です。3つの濃度がテストされるため、希釈が必要であり、したがって、製品は硬水中で均一かつ安定した調製形態を形成します。 EN 14885では、各テストと使用推奨事項との関係が詳細に説明されています。 注1：記載されている方法は、商業的製剤または活性物質の細菌および/または真菌に対する活性を使用条件で決定するために使用することを意図しています。 注2：この方法は、製品の結核菌に対する活性を評価するためには使用できません。
The article discusses European Standard EN 13697:2015+A1:2019, which outlines a test method and requirements for evaluating the bactericidal and/or fungicidal activity of chemical disinfectants used in various areas such as food, industrial, domestic, and institutional settings. The standard does not cover disinfectants used on living tissues or in medical situations. The scope of the standard encompasses food processing, distribution, and retailing; institutional and domestic areas like catering establishments, schools, and hotels; and various industrial areas such as packaging, biotechnology, pharmaceuticals, cosmetics, and textiles. The standard allows for the determination of the activity of the disinfectant at various concentrations, both undiluted and diluted in hard water. However, it does not evaluate the activity of products against mycobacteria. The standard also refers to EN 14885 for detailed information on the relationship between various tests and use recommendations.
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