oSIST prEN 17915:2022

SLOVENSKI STANDARD
oSIST prEN 17915:2022
01-december-2022
Kemična razkužila in antiseptiki - Kvantitativna preskusna metoda s steklenim
nosilcem za vrednotenje virucidnega delovanja kemičnih razkužil na trdih
neporoznih površinah v živilski in drugih industrijah, gospodinjstvu in javnih
ustanovah - Preskusna metoda in zahteve (faza 2, stopnja 2)
Chemical disinfectants and antiseptics - Quantitative carrier test method for the
evaluation of virucidal activity of chemical disinfectants on hard non-porous surfaces in
food, industrial, domestic and institutional areas - Test method and requirements (phase
2, step 2)
Chemische Desinfektionsmittel und Antiseptika – Quantitative Keimträgerprüfung zur
Bestimmung der viruziden Wirkung chemischer Desinfektionsmittel auf harten nicht-
porösen Oberflächen in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche
Einrichtungen – Prüfverfahren und Anforderungen (Phase2, Stufe2)
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface non poreuse sans
action mécanique pour l’évaluation de l’activité virucide des désinfectants chimiques
utilisés dans l’agroalimentaire, l’industrie, la sphère domestique et les collectivités -
Méthode d’essai et exigences (phase 2, étape 2)
Ta slovenski standard je istoveten z: prEN 17915
ICS:
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
oSIST prEN 17915:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 17915:2022

---------------------- Page: 2 ----------------------
oSIST prEN 17915:2022


DRAFT
EUROPEAN STANDARD
prEN 17915
NORME EUROPÉENNE

EUROPÄISCHE NORM

October 2022
ICS 11.080.20; 71.100.35
English Version

Chemical disinfectants and antiseptics - Quantitative
carrier test method for the evaluation of virucidal activity
of chemical disinfectants on hard non-porous surfaces in
food, industrial, domestic and institutional areas - Test
method and requirements (phase 2, step 2).
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de surface non poreuse sans action Quantitative Keimträgerprüfung zur Bestimmung der
mécanique pour l'évaluation de l'activité virucide des viruziden Wirkung chemischer Desinfektionsmittel auf
désinfectants chimiques utilisés dans l'agroalimentaire, harten nicht-porösen Oberflächen in den Bereichen
l'industrie, la sphère domestique et les collectivités - Lebensmittel, Industrie, Haushalt und öffentliche
Méthode d'essai et exigences (phase 2, étape 2) Einrichtungen - Prüfverfahren und Anforderungen
(Phase2, Stufe2)
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 216.

If this draft becomes a European Standard, 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.

This draft European Standard 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, 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, Türkiye 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17915:2022 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 7
3 Terms and definitions . 8
4 Requirements for virucidal activity on surfaces. 9
5 Test methods . 10
5.1 Principle . 10
5.2 Materials and reagents, including cell cultures . 11
5.2.1 Test organisms . 11
5.2.2 Culture media, reagents and cell cultures . 11
5.3 Apparatus and glassware . 14
5.3.1 General . 14
5.3.2 Usual microbiological laboratory equipment . 15
5.3.3 Test surfaces . 16
5.4 Preparation of test organism suspensions and product test solutions . 16
5.4.1 Test organism suspension (test virus suspension) . 16
5.4.2 Product test solution . 17
5.5 Procedure for assessing the virucidal activity of the product . 17
5.5.1 Experimental conditions . 17
5.5.2 Test procedure . 18
5.5.3 Cytotoxicity caused by product solutions . 20
5.5.4 Control of efficiency for suppression of disinfectant virucidal activity . 21
5.5.5 Reference test for virus inactivation . 21
5.5.6 Titration of the virus control . 21
5.6 Experimental data and calculation . 21
5.6.1 Protocol of the results . 21
5.6.2 Calculation of infectivity titre (TCID PFU) . 21
50 –
5.7 Verification of the methodology . 22
5.8 Expression of results . 23
5.8.1 General . 23
5.8.2 Calculation of the virucidal activity of products used in chemo-thermal processes . 23
5.8.3 Calculation of the virucidal activity of products . 23
5.8.4 Calculation of the virucidal activity against enveloped viruses . 23
5.9 Test report . 24
Annex A (normative) Detoxification of test mixtures by molecular sieving . 26
A.1 Molecular sieving with Sephadex™ LH 20 . 26
A.1.1 Principle . 26
A.1.2 Sephadex suspension . 26
A.1.3 Procedure. 26
A.2 Molecular sieving using MicroSpin™ S 400 HR . 28
A.3 Determination of the residual virus titre by the large-volume-plating (LVP) method . 28
2

---------------------- Page: 4 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
A.3.1 General . 28
A.3.2 Example for the calculation of titres and the reduction according to the large-
volume-plating Method . 29
Annex B (informative) Calculation of the viral infectivity titre . 31
B.1 Quantal tests — Example of TCID determination by the Spearman-Kärber method . 31
50
B.2 Plaque test . 32
B.3 Biometrical evaluation of experimental approaches and assessment of the
disinfecting effect on the virus (reduction [R]) . 32
B.3.1 General . 32
B.3.2 Calculating the virus titre . 32
B.3.3 Calculating the reduction . 33
B.3.4 Practical example . 33
B.3.4.1 Introduction. 33
B.3.4.2 Calculating the virus titre w: . 34
B.3.4.3 Calculating the reduction: . 34
Bibliography . 35
3

---------------------- Page: 5 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
European foreword
This document (prEN 17915:2022) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.

4

---------------------- Page: 6 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
Introduction
This document 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 virucidal activity on non-porous
surfaces.
The laboratory test closely simulates practical conditions of application. Chosen conditions (contact time,
temperature, organisms on surfaces etc.) 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. Each utilization concentration of the chemical disinfectant or antiseptic found by this test
corresponds to defined experimental conditions.
However for special applications the recommendations of use of a product can differ and therefore
additional test conditions might be needed, which cannot be covered by this European Standard.
5

---------------------- Page: 7 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
1 Scope
This document specifies a test method and the minimum requirements for virucidal activity of chemical
disinfectants that form a homogeneous physically stable preparation when diluted with hard water – or
in the case of ready-to-use products - with water.
This document applies to products that are used in the food, industrial, domestic and institutional area
for disinfecting non-porous surfaces without mechanical action, excluding areas and situations where
disinfection is medically indicated and excluding products used on living tissues.
This document applies at least to the following:
a) processing, distribution and retailing of:
1)  food of animal origin:
— milk and milk products;
— meat and meat products;
— fish, seafood, and related products;
— eggs and egg products;
— animal feeds;
— etc.;
2) food of vegetable origin:
— beverages;
— fruits, vegetables and derivatives (including sugar, distillery, etc.);
— flour, milling and baking;
— animal feeds;
— etc.;
b) institutional and domestic areas:
— catering establishments;
— public areas;
— public transports;
— schools;
— nurseries;
— shops;
— sports rooms;
6

---------------------- Page: 8 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
— waste containers (bins, etc.);
— hotels;
— dwellings;
— clinically non sensitive areas of hospitals;
— offices;
— etc.;
c) industries other than food:
— packaging material;
— biotechnology (yeast, proteins, enzymes, etc.);
— pharmaceutical;
— cosmetics and toiletries;
— textiles;
— space industry, computer industry;
— etc.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use
recommendations”.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 12353, Chemical disinfectants and antiseptics - Preservation of test organisms used for the
determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal
(including bacteriophages) activity
EN 14885, Chemical disinfectants and antiseptics - Application of European Standards for chemical
disinfectants and antiseptics
EN 10088-1, Stainless steels - Part 1: List of stainless steels
EN 10088-2, Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion
resisting steels for general purposes
7

---------------------- Page: 9 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 14885 and the following apply.
3.1
cytotoxicity
morphological alteration of cells and/or their destruction or their reduced sensitivity to virus
multiplication caused by the product
3.2
plaque forming units
PFU
number of infectious virus particles per unit volume (ml)
3.3
reference test for virus inactivation
test with a defined product (e.g. glutaraldehyde) in parallel with a product under test for the internal
control of the test
3.4
TCID
50
50 % infecting dose of a virus suspension or that dilution of the virus suspension that induce a CPE (3.5)
in 50 % of cell culture units
3.5
viral cytopathic effect
CPE
morphological alteration of cells and/or their destruction as a consequence of virus multiplication
3.6
viral plaque
area of lysis formed in a cell monolayer under semisolid medium due to infection by and multiplication
of a single infectious virus particle
3.7
virus titre
amount of infectious virus per unit volume present in a cell culture lysate or in a solution
3.8
virucidal activity
capability of a product to reduce the number of infectious virus particles of adenovirus and murine
norovirus for surfaces disinfection in applications other than food processing, distribution and retailing,
and murine norovirus for food processing, distribution and retailing areas
3.9
high level virucidal activity
capability of a product used in healthcare areas and other professional areas where disinfection is
medically indicated to reduce the number of infectious virus particles of murine parvovirus for surfaces
disinfection in industries other than institutional, domestic, food processing distribution and retailing
areas
8

---------------------- Page: 10 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
3.10
virucidal activity against enveloped viruses
capability of a product to reduce the number of infectious virus particles of Vaccinia virus, covering
activity against all enveloped viruses
4 Requirements for virucidal activity on surfaces
The product shall demonstrate at least a decimal log (lg) reduction of 4 in virus titre, when tested in
accordance with Table 1 and Clause 5.
Table 1 — Minimum and additional test conditions
Minimum conditions Surfaces disinfection in industries, food Surfaces disinfection in institutional
processing, distribution and retailing and domestic areas
areas
Minimum spectrum of Virucidal activity for biopharmaceutical Virucidal activity for institutional
test organisms industry and domestic use
Murine Parvovirus Adenovirus
Virucidal activity for industries other Murine Norovirus
than biopharmaceutical and food
Virucidal activity against enveloped
industry
viruses
Adenovirus
Vaccinia virus
Murine Norovirus

Virucidal activity for food industry
Murine Norovirus
Virucidal activity against enveloped
viruses
Vaccinia virus
Virucidal activity (chemo-thermal)
Murine Parvovirus for temperatures >40°C
Test temperature between 18 °C and 25 °C but for chemo- between 18°C and 25 °C
thermal activity


Additional temperature between 4 °C and ≤ 40 °C between 4 °C and and ≤ 40 °C
Contact time according to the manufacturer’s according to the manufacturer’s
recommendation, but not longer than 60 recommendation, but not longer than
c c
min 60 min
9

---------------------- Page: 11 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
Minimum conditions Surfaces disinfection in industries, food Surfaces disinfection in institutional
processing, distribution and retailing and domestic areas
areas
Interfering substances 0,3 g/l bovine serum albumin 0,3 g/l bovine serum albumin
a) clean and/or and/or
b) dirty 3,0 g/l bovine serum albumin 3,0 g/l bovine serum albumin
a Further contact time(s), interfering Further contact time(s), interfering
Additional conditions
substance(s) or virus(es) substance(s) or virus(es)
a
Where appropriate (specific purposes), additional specific virucidal activity shall be determined under other
conditions of time, temperature, and interfering substances (see 5.2.2.8) in accordance with 5.5, in order to take
into account intended specific use conditions. Additional virus(es) can be tested, if relevant. For the additional
conditions, the concentration defined as a result can be lower than the one obtained under the minimum test
conditions.
b
The test for “virucidal activity against enveloped viruses” will cover all enveloped viruses only
c
The contact times for surface disinfectants stated in this table are chosen on the basis of the practical conditions
of the product. The recommended contact time for the use of the product is within the responsibility of the
manufacturer.
d
Adenovirus to be tested only for surface disinfection in applications other than food processing, distribution
and retailing
The determined virucidal concentration of the test product is suggested as being suitable for practical
situations of use.
5 Test methods
5.1 Principle
5.1.1 A test suspension of viruses in a solution of interfering substances is inoculated onto a test surface
and dried. A prepared sample of the product under test is applied in a manner which covers the dried
film.
The test surface is maintained at a specified temperature for a defined period of time. The test surface is
transferred to cell maintenance medium so that the action of the disinfectant is immediately neutralized.
The titre of the virus recovered from the test surface is determined.
The titre of the inoculum on a test surface treated with hard water in place of the disinfectant is also
determined and the reduction in virus titre attributed to the product is calculated by difference.
5.1.2 The test is performed using the test organisms as specified in Clause 4, Table 1.
5.1.3 Other contact times and temperatures within the limits specified in Clause 4, Table 1 may be used.
Additional interfering substances and test organisms may be used.
10

---------------------- Page: 12 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
5.2 Materials and reagents, including cell cultures
5.2.1 Test organisms
The virucidal activity shall be evaluated using the following strain as test organism selected according to
1)
Clause 4, Table 1 :
2)
a) Non-enveloped RNA virus
Murine norovirus, strain S99 Berlin
b) Non-enveloped DNA virus
1) Adenovirus type 5, strain Adenoid 75, ATCC VR-5
2) Murine Parvovirus, minute virus of mice, strain Crawford, ATCC VR-1346
c) Enveloped DNA virus
Modified Vaccinia virus, strain Ankara (MVA), ATCC VR-1508
The required incubation temperature for the test organism is 36 °C ± 1 °C or 37 °C ± 1 °C (5.3.2.12). The
same temperature (either 36 °C or 37 °C) shall be used for all incubations performed during a test and its
control and validation.
If additional test organisms are used, they shall be kept and used under optimum growth conditions
(temperature, time, atmosphere, media) noted in the test report. If these additional test organisms 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 collection under a reference for five years.
5.2.2 Culture media, reagents and cell cultures
5.2.2.1 General
All weights of chemical substances given in this European Standard refer to the anhydrous salts. Hydrated
forms may be used as an alternative, but the weights required shall be adjusted to allow for consequent
molecular weight differences.
The reagents shall be of analytical grade and/or appropriate for microbiological purposes. They shall be
free from substances that are toxic or inhibitory to the test organisms.
To improve reproducibility, it is recommended that commercially available material – if appropriate- is
used for the preparation of culture media. The manufacturer's instructions relating to the preparation of
these products should be rigorously followed.
For each culture medium and reagent, a time limitation for use should be fixed.
All specified pH values are measured at 20 °C ± 1 °C.

1)
The ATCC numbers are the collection numbers of strains supplied by these culture collections. 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.
2)
Murine Norovirus may be obtained from Friedrich-Loeffler-Insitut „Bundesforschungsinstitut" für Tiergesundheit, Hauptsitz
Insel Riems Südufer 10, 17493, Greifswald-Insel Riems; phone: +49 38351 7-0, fax: +49 038351 7-121. http://www.fli.bund.de.
11

---------------------- Page: 13 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
5.2.2.2 Water
The water shall be freshly glass-distilled water and not demineralized water. If distilled water of adequate
quality is not available, water for injections (see bibliographic reference [1]) may be used.
Sterilize in the autoclave [5.3.2.1a)]. Sterilization is not necessary if the water is used e.g. for preparation
of culture media and subsequently sterilized.
See 5.2.2.7 for the procedure to prepare hard water.
5.2.2.3 Phosphate buffered saline (PBS)
Sodium chloride (NaCl) 8,00 g
Potassium chloride (KCl) 0,20 g
Disodium hydrogen phosphate, 12-hydrate (Na HPO x 12H O) 2,89 g
2 4 2
Potassium phosphate, monobasic (KH PO ) 0,20 g
2 4
Water (5.2.2.2) to 1000,0 ml
5.2.2.4 Neutral Red (1:1000 solution)
3)
Prepare neutral red (Sigma N7005 ) stock solution at 0,1 mg/ml in water (5.2.2.2). Filter through a
0,44 µm pore size filter and store at 4 °C in the dark.
5.2.2.5 Foetal calf serum (FCS)
FCS has to be certified free of viruses and mycoplasma. Extraneous viruses and mycoplasma may
interfere with cell and virus growth resulting in false results.
For RAW 264.7 cells, special FCS has to be used due to the cells’ high sensitivity to endotoxins.
5.2.2.6 Trichloroacetic acid (10 % solution) (TCA)
Dissolve 10 g of TCA crystals in 80 ml of water (5.2.2.2), and then adjust the volume to 100 ml with water.
Stir to complete solution.
5.2.2.7 Hard water for dilution of products
For the preparation of 1 l of hard water, the procedure is as follows:
— prepare solution A: dissolve 19,84 g magnesium chloride (MgCl ) and 46,24 g calcium chloride
2
(CaCl ) in water (5.2.2.2) and dilute to 1 000 ml. Sterilize by membrane filtration (5.3.2.11) or in the
2
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 (5.3.2.6)
for no longer than one month;
— prepare solution B: dissolve 35,02 g sodium bicarbonate (NaHCO ) in water (5.2.2.2) and dilute to
3
1000 ml. Sterilize by membrane filtration (5.3.2.11). Store the solution in the refrigerator (5.3.2.6)
for no longer than one week;

3)
Sigma N 7005 is an example of a suitable product available commercially. This information is given for the convenience of
users of this document and does not constitute an endorsement by CEN of this product.
12

---------------------- Page: 14 ----------------------
oSIST prEN 17915:2022
prEN 17915 :2022 (E)
— place 600 ml to 700 ml of water (5.2.2.2) in a 1000 ml volumetric flask (5.3.2.9) and add 6,0 ml of
solution A, then 8,0 ml of solution B. Mix and dilute to 1000 ml with water (5.2.2.2). The pH (5.3.2.4)
of the hard water shall be 7,0 ± 0,2. (5.3.2.4). 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 product test solutions (5.4.2), the addition of the product to the hard water
produces different final
...