EN 13697:2015/FprA1:2019

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 domestiques et en collectivité - Méthode d'essai sans action mécanique et prescriptions (phase 2/étape 2)

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) - Dopolnilo A1

General Information

• Status: Not Published
• ICS: 11.080.20 - Disinfectants and antiseptics
• ICS: 71.100.35 - Chemicals for industrial and domestic disinfection purposes
• Technical Committee: CEN/TC 216 - Chemical disinfectants and antiseptics
• Drafting Committee: CEN/TC 216/WG 3 - Food hygiene and domestic and institutional use
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 09-May-2019
• Due Date: 29-Jul-2019
• Completion Date: 09-May-2019
• Ref Project: SIST EN 13697:2015/kFprA1:2019 - 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)

Relations

• Merged Into: EN 13697:2015+A1:2019 - 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)
• Effective Date: 22-May-2019
• Amends: EN 13697:2015 - 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)
• Effective Date: 17-May-2017

Overview

EN 13697:2015/FprA1:2019 is a European Standard developed by CEN that defines a quantitative test method for evaluating the bactericidal, fungicidal, and/or yeasticidal activities of chemical disinfectants on non-porous surfaces. This test method (Phase 2, Step 2) applies to disinfectants used in food, industrial, domestic, and institutional areas under conditions without mechanical action. The standard excludes areas requiring medical disinfection and products intended for living tissues.

This methodology ensures that chemical disinfectants form a physically stable and homogeneous preparation, tested in hard water or water for ready-to-use products, enabling the assessment of their antimicrobial efficacy. EN 13697 is essential for manufacturers, regulatory bodies, and end-users aiming to verify disinfectant performance in real-world usage conditions.

Key Topics

• Scope and Application Areas
  Covers disinfectants used in diverse sectors such as:

  • Food processing and retail (animal and plant-origin foods including dairy, meat, seafood, fruits, vegetables, animal feed)
  • Institutional and domestic environments (catering, public transport, schools, hotels, offices, and non-sensitive hospital areas)
  • Various industrial areas (packaging, biotechnology, pharmaceuticals, cosmetics, textiles, and even high-tech industries such as space and computer industries)

• Test Methodology

  • Quantitative assessment of antimicrobial activity on non-porous surfaces
  • Testing without mechanical action (e.g., wiping or scrubbing) to simulate realistic conditions
  • Use of three product concentrations to cover active to non-active ranges ensuring product stability in hard water
  • Contact time ranges from 1 to 60 minutes and temperatures from 4±1°C to 40±1°C to mimic specific use scenarios
  • Use of interfering substances such as bovine albumin and skimmed milk to simulate clean and dirty conditions

• Microbial Targets
  Includes a broad spectrum of test organisms such as:

  • Bacteria: Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Enterococcus hirae, Salmonella typhimurium, Lactobacillus brevis, Enterobacter cloacae
  • Yeasts and fungi: Candida albicans, Saccharomyces cerevisiae, Aspergillus brasiliensis
    The log reduction criteria specify at least a 4 log reduction for bacteria and 3 log for yeasts and fungi.

• Test Conditions & Parameters

  • Defined interfering substances under clean (0.3 g/l bovine albumin) and dirty (3.0 g/l bovine albumin or skimmed milk for dairy applications) conditions
  • Temperature controlled chambers for test consistency
  • Detailed preparation steps for suspensions and colony counting to ensure reproducibility

Applications

EN 13697:2015/FprA1:2019 provides vital guidance for:

• Food Industry Hygiene
  Validates disinfectants used on surfaces in food processing, logistics, retail, and packaging to ensure food safety by controlling pathogenic bacteria and fungi.

• Institutional and Public Safety
  Ensures cleaning products used in public spaces, schools, hotels, and offices demonstrate effective antimicrobial activity under practical conditions, reducing infection risks.

• Industrial Manufacturing
  Assists producers of pharmaceuticals, cosmetics, textiles, and biotechnology products in validating disinfectants that maintain aseptic environments without damaging equipment or products.

• Regulatory Compliance and Product Development
  Manufacturers use this standard to fulfill regulatory requirements and optimize disinfectant formulations ensuring efficacy where mechanical action is not feasible.

Related Standards

• EN 14885
  This standard details relationships and cross-references between various chemical disinfectant testing protocols, providing guidance on test selection and result interpretation.

• ISO Standards on Disinfection
  Other ISO norms complement EN 13697, covering different surfaces, microbial spectra, or testing with mechanical action to broaden disinfectant evaluation portfolios.

• CEN/TC 216 Committee Publications
  This Technical Committee continually updates and amends relevant testing standards for chemical disinfectants, including amendments like FprA1:2019 which refine test conditions and requirements.

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Keywords: EN 13697, chemical disinfectants standard, bactericidal test method, fungicidal activity evaluation, yeasticidal activity, quantitative surface test, food industry disinfectants, industrial disinfection standards, institutional hygiene, non-porous surface disinfection, CEN standards, disinfectant efficacy testing.

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 13697:2015/oprA1:2018
01-junij-2018
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]DYUHGQRWHQMHEDNWHULFLGQHJDLQDOLIXQJLFLGQHJDGHORYDQMDNHPLþQLKUD]NXåLOY
åLYLOVNLLQGUXJLKLQGXVWULMDKJRVSRGLQMVWYXLQMDYQLKXVWDQRYDK3UHVNXVQD
PHWRGDLQ]DKWHYHEUH]PHKDQVNHJDGHORYDQMDID]DVWRSQMD'RSROQLOR$
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); Deutsche und Englische Fassung
EN 13697/prA1:2017
Ta slovenski standard je istoveten z: EN 13697:2015/prA1
ICS:
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
SIST EN 13697:2015/oprA1:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN 13697:2015/oprA1:2018
SIST EN 13697:2015/oprA1:2018
DRAFT
EUROPEAN STANDARD
EN 13697:2015
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
May 2018
ICS 11.080.20; 71.100.35
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)
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); Deutsche und Englische Fassung EN
13697/prA1:2017
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 216.

This draft amendment A1, if approved, will modify the European Standard EN 13697:2015. If this draft becomes an amendment,
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration.

This draft amendment was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13697:2015/prA1:2018 E
worldwide for CEN national Members.

SIST EN 13697:2015/oprA1:2018
EN 13697:2015/prA1:2018 (E)
Contents Page
European foreword . 3
1 Modification to Clause 4. 4
2 Modification to Clause 5.2.2.8.2 . 5
3 Modification to Clause 5.2.2.8.3 . 6
4 Modification to Clause 5.2.2.8.4 . 6
5 Modification to Clause 5.2.2.8.5 . 6
6 Modification to Clause 5.2.2.8.6 . 6
7 Modification to Clause 5.2.2.9 . 6
8 Modification to Clause 5.3.2.2 . 6
9 Addition of new Clause 5.3.2.20 . 6
10 Modification to Clause 5.4.1.3 . 6
11 Modification to Clause 5.4.1.4 . 7
12 Modification to Clause 5.4.1.5 . 8
13 Modification to Clause 5.5.1 . 8
14 Modification to Clause 5.5.2.1 . 8
15 Modification to Clause 5.5.2.2 . 9
16 Modification to Clause 5.5.2.3 . 9
17 Modification to Clause 5.5.2.4 . 10
18 Modification to Clause 5.5.3 . 10
19 Modification to Clause 5.6.2 . 10
20 Modification to Clause 5.6.4.1 . 11

SIST EN 13697:2015/oprA1:2018
EN 13697:2015/prA1:2018 (E)
European foreword
This document (EN 13697:2015/prA1:2018) has been prepared by Technical Committee CEN/TC 216
“Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document is submitted to the CEN Enquiry.
Option 1
Data from the latest EN 13697 are still valid with the exception of:
— Pseudomonas aeruginosa and Candida albicans under clean conditions
or
Option 2
Data from the latest EN 13697 are still valid
(to be discussed during CEN Enquiry).
SIST EN 13697:2015/oprA1:2018
EN 13697:2015/prA1:2018 (E)
1 Modification to Clause 4
Replace Table 1 by the following:
Table 1 — Experimental conditions
Bactericidal activity on Yeasticidal activity on Fungicidal activity on
non-porous surfaces non-porous surfaces non-porous surfaces
Test Conditions
without mechanical without mechanical without mechanical
action action action
Test organism
Enterococcus hirae
(see 5.2.1)
Candida albicans
Escherichia coli
minimum
Candida albicans
Aspergillus brasiliensis (ex
spectrum of Pseudomonas aeruginosa
A. niger)
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 to In a range from 4 ± 1°C to In a range from 4 ± 1°C to
40 ± 1°C 40 ± 1°C 40 ± 1°C
For tests performed at For tests performed at For tests performed at
Test temperature
room temperature, the room temperature, the room temperature, the
range shall be between range shall be between range shall be between
18°C and 25°C°C 18°C and 25°C°C 18°C°C and 25°C°C
in a range from 1 min and in a range from 1 min and in a range from 1 min and
between 5 and 60 min between 5 and 60 min between 5 and 60 min
(from 1 min to 5 min at (from 1 min to 5 min at (from 1 min to 5 min at
intervals of 1 min and intervals of 1 min and from intervals of 1 min and from
Contact time
from 5 min to 60 min at 5 min to 60 min at intervals 5 min to 60 min at intervals
intervals of 5 min) of 5 min) 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
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
SIST EN 13697:2015/oprA1:2018
EN 13697:2015/prA1:2018 (E)
Bactericidal activity on Yeasticidal activity on Fungicidal activity on
non-porous surfaces non-porous surfaces non-porous surfaces
Test Conditions
without mechanical without mechanical without mechanical
action action action
Interfering
substance
any relevant substance any relevant substance any relevant substance
additional
Log reduction
from a water
≥ 4Lg ≥ 3Lg ≥ 3Lg
control (decimal
log)
The referenced test conditions 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 recommended contact time for the use of the product is within the responsibility of the manufacturer.
Where appropriate (specific purposes), additional specific bactericidal/yeasticidal/fungicidal activity shall be
determined under other conditions of time, temperature, additional strains and interfering substances in order to take
into account intended specific use conditions.

2 Modification to Clause 5.2.2.8.2
Replace the title of Clause 5.2.2.8.2. as follows
Bovine albumin solutions
Replace the whole text of Clause 5.2.2.8.2 by the following:
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 0,60 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.
In addition, other interfering substances for chemical disinfectants with detergent properties (therefore
simulating additional dirty conditions for specific uses) can be chosen:
SIST EN 13697:2015/oprA1:2018
EN 13697:2015/prA1:2018 (E)
3 Modification to Clause 5.2.2.8.3
At the end of Clause 5.2.2.8.3, replace
The final concentration of milk in the test procedure (see 5.5.2) shall be 1,0 % (V/V) of reconstituted
milk.
with
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.
4 Modification to Clause 5.2.2.8.4
Delete the whole clause.
5 Modification to Clause 5.2.2.8.5
Delete the whole clause.
6 Modification to Clause 5.2.2.8.6
Delete the whole clause.
7 Modification to Clause 5.2.2.9
Delete the whole clause.
8 Modification to Clause 5.3.2.2
Replace the title of clause 5.3.2.2 by the following
Temperature controlled cabinet capable of being controll
...