Chemical disinfectants and antiseptics - Methods of airborne room disinfection by automated process - Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities

The test methods described are designed to determine the disinfectant activity of processes used in the 1) medical area, 2) veterinary area, 3) food, industrial, domestic and institutional area using automated processes for distributing chemicals by air diffusion with no operator manually applying the disinfectant. This document covers the disinfection of nonporous surfaces but not that of the air.
The objective of the described processes is to disinfect the surfaces of the overall area including the external surfaces of the equipment contained in such rooms. Air handling and products or processes specifically designed for the disinfection of medical devices are excluded from the scope of this document. The test methods and volumes described provide a defined challenge.
This document is applicable to processes for which activity is claimed against the following groups of microorganisms:
—   vegetative bacteria,
—    mycobacteria,
—   bacterial spores,
—   yeasts,
—   fungal spores,
—   viruses,
—   bacteriophages.
This document does not cover processes for which the mode of action is based on immersing and/or circulation, flooding, spraying, wiping or other processes where the product is directly applied to the surfaces and not via air dispersion.

Chemische Desinfektionsmittel und Antiseptika - Verfahren zur luftübertragenen Raumdesinfektion durch automatisierte Verfahren - Bestimmung der bakteriziden, mykobakteriziden, sporiziden, fungiziden, levuroziden, viruziden, tuberkuloziden, und Phagen-Wirksamkeit

Die beschriebenen Prüfverfahren sind zur Bestimmung der desinfizierenden Wirkung von verwendeten Prozessen 1) im humanmedizinischen Bereich, 2) im Veterinärbereich, 3) in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen ausgelegt, bei denen automatisierte Verfahren zur Verteilung von Chemikalien durch Diffusion in der Luft ohne manuelles Auftragen des Desinfektionsmittel durch einen Anwender genutzt werden. Dieses Dokument umfasst die Desinfektion von porenfreien Oberflächen, aber nicht der Luft.
Das Ziel der beschriebenen Verfahren besteht im Desinfizieren der Oberflächen der gesamten Fläche, einschließlich der Außenflächen der in diesen Räumen befindlichen Ausrüstung. Speziell für die Desinfektion von Medizinprodukten ausgelegte Luftbehandlungen und Produkte oder Prozesse sind vom Anwendungsbereich dieses Dokuments ausgeschlossen. Die beschriebenen Prüfverfahren und Volumina stellen eine festgelegte Herausforderung dar.
Dieses Dokument gilt für Prozesse, für die die Wirkung bei den folgenden Gruppen von Mikroorganismen ausgewiesen wird:
-   vegetative Bakterien;
-   Mykobakterien;
-   bakterielle Sporen;
-   Hefen;
-   Schimmelpilzsporen;
-   Viren;
-   Bakteriophagen.
Dieses Dokument enthält keine Verfahren, bei denen die Wirkungsweise auf Eintauchen und/oder Zirkulieren, Fluten, Besprühen, Wischen oder anderen Vorgehensweisen, bei denen das Produkt direkt auf die Oberflächen aufgetragen und nicht durch die Luft verteilt wird, beruht.

Antiseptiques et désinfectants chimiques - Méthodes de désinfection des pièces par voie aérienne par des procédés automatisés - Détermination de l'activité bactéricide, fongicide, levuricide, sporicide, tuberculocide, mycobactéricide, virucide et phagocide

Les méthodes d’essai décrites sont destinées à déterminer l’activité désinfectante des procédés de désinfection de produits chimiques dans l’air, sans application manuelle du désinfectant par un opérateur, utilisés dans les secteurs 1) médical, 2) vétérinaire, 3) agro-alimentaire, industriel, domestique et collectivités. Le présent document couvre la désinfection de surfaces non poreuses mais pas celle de l’air.
Les procédés décrits ont pour objectif la désinfection des surfaces de l’ensemble de la zone traitée, y compris les surfaces externes des équipements contenus dans ces locaux. Le traitement de l’air et les produits ou procédés spécifiquement destinés à la désinfection des dispositifs médicaux sont exclus du domaine d’application du présent document. Les méthodes et volumes d’essai décrits fournissent un objectif défini.
Le présent document est applicable aux procédés déclarés actifs contre les groupes de micro-organismes suivants :
-   bactéries végétatives,
-   mycobactéries,
-   spores bactériennes,
-   levures,
-   spores fongiques,
-   virus,
-   bactériophages.
Le présent document ne couvre pas les procédés dont le mode d’action repose sur l’immersion et/ou la circulation, l’inondation, la pulvérisation, l’essuyage ou d’autres procédés dans lesquels le produit est directement appliqué sur les surfaces et non par dispersion dans l’air.

Kemična razkužila in antiseptiki - Metode za dezinfekcijo površin v prostorih z delci v zraku z avtomatiziranim postopkom - Določevanje baktericidne, mikobaktericidne, sporocidne, fungicidne, virucidne, tuberkulocidne in fagocidne aktivnosti ter aktivnosti kvasovk

General Information

Status
Published
Publication Date
07-Apr-2020
Withdrawal Date
30-Oct-2020
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
08-Apr-2020
Due Date
26-Nov-2019
Completion Date
08-Apr-2020

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SLOVENSKI STANDARD
SIST EN 17272:2020
01-julij-2020
Kemična razkužila in antiseptiki - Metode za dezinfekcijo površin v prostorih z
delci v zraku z avtomatiziranim postopkom - Določevanje baktericidne,
mikobaktericidne, sporocidne, fungicidne, virucidne, tuberkulocidne in fagocidne
aktivnosti ter aktivnosti kvasovk
Chemical disinfectants and antiseptics - Methods of airborne room disinfection by
automated process - Determination of bactericidal, mycobactericidal, sporicidal,
fungicidal, yeasticidal, virucidal and phagocidal activities
Chemische Desinfektionsmittel und Antiseptika - Verfahren zur luftübertragenen
Raumdesinfektion durch automatisierte Verfahren - Bestimmung der bakteriziden,
mykobakteriziden, sporiziden, fungiziden, levuroziden, viruziden, tuberkuloziden, und
Phagen-Wirksamkeit
Antiseptiques et désinfectants chimiques - Méthodes de désinfection des pièces par voie
aérienne par des procédés automatisés - Détermination de l'activité bactéricide,
fongicide, levuricide, sporicide, tuberculocide, mycobactéricide, virucide et phagocide
Ta slovenski standard je istoveten z: EN 17272:2020
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
SIST EN 17272:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 17272:2020

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SIST EN 17272:2020


EN 17272
EUROPEAN STANDARD

NORME EUROPÉENNE

April 2020
EUROPÄISCHE NORM
ICS 11.080.20; 71.100.35
English Version

Chemical disinfectants and antiseptics - Methods of
airborne room disinfection by automated process -
Determination of bactericidal, mycobactericidal,
sporicidal, fungicidal, yeasticidal, virucidal and phagocidal
activities
Antiseptiques et désinfectants chimiques - Méthodes Chemische Desinfektionsmittel und Antiseptika -
de désinfection des pièces par voie aérienne par des Verfahren zur luftübertragenen Raumdesinfektion
procédés automatisés - Détermination de l'activité durch automatisierte Verfahren - Bestimmung der
bactéricide, fongicide, levuricide, sporicide, bakteriziden, mykobakteriziden, sporiziden,
tuberculocide, mycobactéricide, virucide et phagocide fungiziden, levuroziden, viruziden, tuberkuloziden, und
Phagen-Wirksamkeit
This European Standard was approved by CEN on 13 October 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17272:2020 E
worldwide for CEN national Members.

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SIST EN 17272:2020
EN 17272:2020 (E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Requirements . 7
4.1 Efficacy tests . 7
4.2 Distribution tests . 8
5 Test method . 8
5.1 Principle . 8
5.2 Materials and reagents . 9
5.3 Apparatus and glassware . 15
5.4 Preparation and counting of test suspensions . 18
5.5 Procedure for evaluating the automated airborne disinfection process activity . 29
5.6 Experimental data and calculations (bacteria, yeasts, fungal spores, bacterial spores,
bacteriophages and mycobacteria) . 40
5.7 Interpretation of results . 44
5.8 Test report . 45
Annex A (normative) Summary of test requirements . 49
Annex B (normative)  Distance between diffusion device and test-carriers . 52
Annex C (normative)  Interfering substance . 53
Annex D (normative)  Preparation of spore stock suspensions of Bacillus subtilis . 56
Annex E (normative) Graphical representation of the test procedure . 58
Bibliography . 64

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SIST EN 17272:2020
EN 17272:2020 (E)
European foreword
This document (EN 17272:2020) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document shall be given the status of a national standard, either by publication of an identical text
or by endorsement, at the latest by October 2020, and conflicting national standards shall be withdrawn
at the latest by October 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 describes a Phase 2 step 2 method designed:
— to check, under standardized laboratory conditions close to real-world practice, that the proposed
airborne surface disinfection processes meet the objective for which they were devised;
— to cross-compare different processes under reproducible conditions;
— to provide an experimental design within specified limits when real-world-practice conditions
depart from the conditions given in the text below.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
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SIST EN 17272:2020
EN 17272:2020 (E)
Introduction
The purpose of this document is to describe a test method for assessing the disinfectant activity of
airborne surface disinfection processes under a specific experimental condition.
The proposed test method consists of 2 parts:
— Part 1 - Efficacy test: intended to ensure that minimum efficacy requirements are fulfilled for each
type of activity claimed and for the targeted application area(s) (CEN/TC 216 WG 1 and/or WG 2
and/or WG 3).
— Part 2 - Distribution test: intended to ensure efficacy of the process throughout the enclosure. It is
performed with a reference test organism at 4 sampling positions.
The processes concerned include those involving chemical disinfectants in dispersed gaseous, vapour
and/or aerosolised form.
Every automated airborne disinfection cycle/application is unique and the purpose of this document is
to provide a defined challenge for the automated airborne disinfection system to successfully meet in
order to be considered an efficacious process. This standard method should therefore be regarded as a
useful starting point and not as a validation for all intended treatments with a particular automated
airborne disinfection system.
The method is used to qualify the process, i.e. the device(s) and product(s) needed for implementation.
For such chemical processes, the combination of device and product cannot be separated.
For the defined test conditions the number of carriers and their test positions can be increased
according to specific needs of a given application or local requirements.
The manufacturer:
— specifies the limitations and precautions for use of the process;
— ensures that the specified test conditions are representative for the recommended application(s).
The aim of this document is to simulate practical conditions of airborne disinfection in a laboratory
situation; obligatory conditions are defined according to the test method defined below. Additional
conditions are also proposed.
The test report specifies and summarizes the conditions under which the tests are carried out.
Generally, the processes are implemented after a cleaning procedure and then tested, according to the
application areas, under clean or low-level soiling conditions. For specified applications and/or
according to the manufacturer recommendations, test methods with other interfering substance can
also be envisaged as additional conditions.
The tests described in this document are based on measuring the reduction (expressed as decimal
logarithm lg) in terms of numbers of surviving test organisms of different strains of bacteria,
mycobacteria, bacterial spores, fungal spores, yeasts, viruses or bacteriophages and under specified
conditions. Test organisms may be supplemented by other test organisms. The experimental design
described in this document is expected to be followed, but the conditions can be varied according to the
needs of the practical application(s).
This method can be used as a basis for biosecurity applications in laboratories.
CEN/TC 216 phase 2, step 1 suspension tests for evaluating the irreversible inactivation by the product
cannot be performed as the product is changed by the diffusion through the air (e.g. liquid state vs
vapour state).
4

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SIST EN 17272:2020
EN 17272:2020 (E)
1 Scope
The test methods described are designed to determine the disinfectant activity of processes used in the
1) medical area, 2) veterinary area, 3) food, industrial, domestic and institutional area using automated
processes for distributing chemicals by air diffusion with no operator manually applying the
disinfectant. This document covers the disinfection of nonporous surfaces but not that of the air.
The objective of the described processes is to disinfect the surfaces of the overall area including the
external surfaces of the equipment contained in such rooms. Air handling and products or processes
specifically designed for the disinfection of medical devices are excluded from the scope of this
document. The test methods and volumes described provide a defined challenge.
This document is applicable to processes for which activity is claimed against the following groups of
microorganisms:
— vegetative bacteria,
— mycobacteria,
— bacterial spores,
— yeasts,
— fungal spores,
— viruses,
— bacteriophages.
This document does not cover processes for which the mode of action is based on immersing and/or
circulation, flooding, spraying, wiping or other processes where the product is directly applied to the
surfaces and not via air dispersion.
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 10088-2, Stainless steels —Part 2: Technical delivery conditions for sheet/plate and strip of corrosion
resisting steels for general purposes
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
5

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SIST EN 17272:2020
EN 17272:2020 (E)
3 Terms and definitions
For the purposes of this document, the terms of EN 14885 and the following definitions apply:
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
3.1
chemical process
process in which the active substance is a chemical agent (product) diffused in gas, liquid and/or solid
form
Note 1 to entry: The product and the diffusion system (device) cannot be evaluated separately.
3.2
automated airborne disinfection process
process diffusing a product in the form of a gas, vapour and/or an aerosol (excluding aqueous steam)
from a device, without the need for human intervention, targeting surfaces and not the air
3.3
airborne disinfection contact time
ADC time
time from the first release of the product (disinfectant) to the point where carriers are recovered or to
the point where aeration starts, if an aeration time is considered necessary
Note 1 to entry: The carriers can be recovered at the end of ADC time, or during the aeration time, with suitable
personal protective equipment (PPE) where necessary.
3.4
aeration time
period of time during which an air exchange of the enclosure achieves an appropriate concentration of
the product in the enclosure based on the manufacturer’s use instructions and risk assessment, to
enable the recovery of the carriers
Note 1 to entry: The duration of this aeration time is dependent of the air treatment system characteristics.
3.5
distribution test
placement of test-carriers loaded with test organisms in such a way that the distribution of a product by
the combination of a device (machine) and the product achieves its claimed activity throughout the
enclosure
Note 1 to entry: This test is performed after or in parallel with the efficacy test.
3.6
supplementary obligatory conditions
test conditions used instead of the obligatory conditions where the practical use of the process and the
manufacturers claims are clearly and unambiguously excluding the obligatory test conditions
3.7
sensitive test organism
test organism where the drying causes a lg reduction of more than 1,5 by the end of the aeration time
6

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SIST EN 17272:2020
EN 17272:2020 (E)
4 Requirements
4.1 Efficacy tests
The automated airborne disinfection process to be tested under the obligatory experimental conditions
defined in 5.5 shall lead to the following reductions in terms of numbers, expressed in decimal log (lg):
Bactericidal activity:
— 5 lg or greater reduction on test-carriers compared to control-carriers not exposed to the process,
for each of the four specified bacterial test organisms.
For medical area, refer to 5.2.1.2, 5.2.1.3, 5.2.1.4, 5.2.1.5.
For veterinary area, refer to 5.2.1.1, 5.2.1.2, 5.2.1.3, 5.2.1.6.
For food, industrial, domestic and institutional area, refer to 5.2.1.1, 5.2.1.2, 5.2.1.3, 5.2.1.4.
Mycobactericidal activity:
— 4 lg or greater reduction for medical area and food industry and laboratory area on test-carriers
comparative to control-carriers not exposed to the process for the two test organisms
implemented, refer to 5.2.1.15, 5.2.1.16.
— 4 lg or greater reduction for veterinary area on test-carriers comparative to control-carriers not
exposed to the process for the specified test organism, refer to 5.2.1.15.
Sporicidal activity:
— 4 lg or greater reduction for medical area, 3 lg for veterinary area and food, industrial, domestic and
institutional area on test-carriers compared to control-carriers not exposed to the process for the
specified bacterial spore test organism, refer to 5.2.1.7.
Fungicidal activity:
— 4 lg or greater for medical area, veterinary area and food, industrial, domestic and institutional area
on test-carriers compared to control-carriers not exposed to the process for the two specified
fungal test organisms (yeast and fungal spore), refer to 5.2.1.8 and 5.2.1.9.
Yeasticidal activity:
— 4 lg or greater reduction for medical area, veterinary area and food industry and laboratory area on
test-carriers comparative to control-carriers not exposed to the process for the specified yeast test
organism, refer to 5.2.1.8.
Virucidal activity:
— 4 lg or greater reduction for medical area and food industry and laboratory area on test-carriers
comparative to control-carriers not exposed to the process, for the two specified test organisms,
refer to 5.2.1.10 and 5.2.1.11.
— 4 lg or greater reduction for veterinary area on test-carriers comparative to control-carriers not
exposed to the process, for the specified test organism, refer to 5.2.1.12.
Phagocidal activity:
— 4 lg or greater reduction for food industry and laboratory area on test-carriers comparative to
control-carriers not exposed to the process for the specified two test organisms, refer to 5.2.1.13
and 5.2.1.14.
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SIST EN 17272:2020
EN 17272:2020 (E)
The requirements and test methods are summarized in Annex A.
The reductions are expressed as decimal logarithmic values (lg).
The reductions indicated in the table of Annex A are the minimum reductions to be obtained on test-
carriers in comparison to control-carriers not exposed to the process.
These activities may be determined independently, i.e. by separate testing of the different
microbiological groups, e.g. mycobacteria, and do not all shall be undertaken simultaneously. Each
activity can be claimed independently but passing both bactericidal and yeasticidal activity as described
in Annex A is the minimum requirement to claim compliance with this document.
These seven activities shall be determined under the standard-reference experimental conditions
defined in 5.5.
Additional specific bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal, and
phagocidal activity can, as appropriate, be determined under other conditions (e.g. other ADC times,
type of carriers, test organisms, volume of the enclosure, temperature, humidity), for specific intended
uses. These additional conditions shall be described, recorded and reported in the test report.
Even if an automated airborne disinfection system has passed all or part of the test method described
here, the system and its delivered cycles shall then be validated in the individual enclosure (e.g. hospital
room, or animal house) in practice to be disinfected using appropriate biological or validated chemical
indicators.
4.2 Distribution tests
The reduction in the number of viable bacterial cells throughout the enclosure shall be determined with
Staphylococcus aureus ATCC 6538 = CIP 4,83 (refer to 5.2.1.2) to achieve 5 lg or greater reduction on
each test–carrier. Test-carriers shall be located in accordance with Annex A, part 2. Test conditions shall
replicate those used in the efficacy tests.
5 Test method
5.1 Principle
5.1.1 Preliminary test to validate absence of residual effect
The aim of the preliminary test is to identify whether there is any residual activity due to residual
product transferred via the carriers into the subculture media (agar plates and/or membranes) and to
find a method for eliminating this effect. This procedure should ensure that the results of the efficacy
test are based only on the irreversible inactivation of the test organisms and not on an inhibitory
(static) effect.
Non-contaminated carriers are exposed to the process after deposition and drying of the interfering
substance used in the assay.
Recovery into 100 ml (20 ml for virucidal activity) of sterile liquid medium, and testing for
microbiostatic (e.g. bacteriostatic) effects due to traces of the product residing on the carriers, which
could generate an inhibitory effect in agar medium and/or on the filter membranes or a decrease in the
residual viral titre.
5.1.2 Efficacy test
Using test organism suspensions containing interfering substance, deposit 50 µl per carrier prepared as
described in 5.2.3.
Spread and air-dry the inoculum as described in 5.5.1.2.2, then expose the prepared test-carriers to the
product diffused by the tested automated airborne disinfection process, under defined conditions.
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Recover the surviving bacteria, mycobacteria, bacterial spores, yeasts, fungal spores, viruses or
bacteriophages by mechanical action, such as scraping (e.g. with a glass pipette or scalpel), or if
required sonicate, from the carriers, into the recovery liquid:
For bacteria, mycobacteria, bacterial spores, fungal spores and yeasts, dilute and inoculate the agar with
a fraction of the recovery liquid. Incubate and count the colonies. Filtrate the remaining recovery liquid
using membrane filtration, then rinse to eliminate as much product as possible. Transfer onto agar
medium. Place the carrier into agar medium to capture any remaining surviving test organisms.
Incubate and count the number of colonies.
For viruses and bacteriophages, dilute a fraction of the recovery liquid, incubate on a cell line and
determine the viral titre.
5.1.3 Distribution test
The distribution test is a replication of the efficacy test except that only Staphylococcus aureus is used as
the test organism and the test carriers are located in other defined positions and orientations.
5.2 Materials and reagents
5.2.1 Test organisms
Depending on the type of activity targeted, tests shall use all or some of the following test organisms.
These test organisms can be obtained from culture collections. The test organisms are:
For bactericidal activity tests:
— 5.2.1.1 Pseudomonas aeruginosa ATCC 15442 = CIP 103-467 (DSM 937)
— 5.2.1.2 Staphylococcus aureus ATCC 6538 = CIP 4.83 (DSM 799)
— 5.2.1.3 Enterococcus hirae ATCC 10541 = CIP 5855 (DSM 3320)
— 5.2.1.4 Escherichia coli ATCC 10536 = CIP 54127 (DSM 682)
— 5.2.1.5 Acinetobacter baumanii ATCC 19606 = CIP 70.34 (DSM 30007)
— 5.2.1.6 Proteus hauseri ATCC 13315 = CIP 58.60(DSM 30118)
For sporicidal activity tests:
— 5.2.1.7 Bacillus subtilis spores ATCC 6633 = CIP 52 62
For yeasticidal activity tests:
— 5.2.1.8 Candida albicans ATCC 10231 = IP 4872 (DSM 1386)
For fungicidal activity tests:
— 5.2.1.8 Candida albicans ATCC 10231 = IP 4872 (DSM 1386)
— 5.2.1.9 Aspergillus brasiliensis ATCC 16404 = IP 1431-83 (DSM 1988)
For virucidal activity tests:
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EN 17272:2020 (E)
— 5.2.1.10 Murine Norovirus souche S99, Friedrich Loefler Institut, Berlin. MNV cultured on
RAW 264.7 (ATCC TIB-71) cells line
— 5.2.1.11 Adenovirus type 5, adenoid strain, ATCC VR-5. Adenovirus cultured on HeLa cells or other
lines of suitable susceptibility.
— 5.2.1.12 Porcine Parvovirus NADL2 strain cultured on ST cells or other appropriate cells line
For phagocidal activity:
— 5.2.1.13 Bacteriophage for Lactococcus lactis subspecies lactis P001 (DSM 4262)
— 5.2.1.14. Bacteriophage for Lactococcus lactis subspecies lactis P008 (DSM 10567)
The multiplication of these two bacteriophages shall be obtained from the following host strain:
Lactococcus lactis subspecies lactis F7/2 (DSM 4366).
For mycobactericidal activity:
— 5.2.1.15. Mycobacterium avium ATCC 15769 = CIP 105415
— 5.2.1.16 Mycobacterium terrae ATCC 15755 (tuberculocidal activity)
Both test organisms shall be tested, except for the veterinary area where only Mycobacterium avium is
required.
These strains can be obtained from biological collection resource centres.
The use of other test organisms
If additional test organisms are used, they shall be incubated under optimum growth conditions
(temperature, time, atmosphere, media) and noted in the test report. If the additional test organisms
selected do not correspond to the specified strains, their suitability for supplying the required inocula
shall be verified. 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 and reagents
5.2.2.1 General
All weights of chemical substances given in this document 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.
NOTE Commercial information (e.g. product name…) are provided by CEN as a convenience to users of this
document and does not represent an endorsement by CEN of this product. Equivalent products can be used if it is
demonstrated that they lead to the same results.
5.2.2.2 Culture media for bacteria, mycobacteria, spores, fungal spores and yeasts
5.2.2.2.1 Water
The water shall be freshly glass-distilled water and not demineralized water.
Sterilize in the autoclave (5.3.2.1a).
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Sterile distilled water is necessary for the preparation of suspensions for tests. Sterilization is not
necessary if the water is used for e.g. preparation of culture media and subsequently sterilized.
NOTE If distilled water of adequate quality is not available, water for injection can be used.
5.2.2.2.2 Agar for bacterial counts (Tryptone Soya Agar: TSA)
For counts of viable bacterial cells (5.2.1.1 to 5.2.1.6)
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) to 1 000 ml
Sterilize in the autoclave. After sterilization, pH of the medium shall be equivalent to (7,2 ± 0,2) when
measured at (20 ± 1) °C.
If necessary, add a neutralizer to the medium (and record the addition in the test report).
Agar for the preservation of test organisms 5.2.1.1 to 5.2.1.6 (refer to 5.2.2.2.2) without neutralizer.
5.2.2.2.3 Reconstituted milk for use with sensitive test organisms
Prepare the reconstituted skimmed milk (15 g/l fat) as follows:
Skimmed powdered milk, guaranteed antibiotic-free and additive-free, reconstituted at 100 g powder
per 1 l distilled water.
Sterilize 30 min at (105 ± 3) °C or 5 min at (121 ± 3) °C.
5.2.2.2.4 Malt extract agar (MEA)
For counts on the number of viable yeast and fungal spore cells (5.2.1.8 and 5.2.1.9).
Malt extract (technical grade) 30,0 g
Agar 15,0 g
Water
...

SLOVENSKI STANDARD
oSIST prEN 17272:2018
01-september-2018
[Not translated]
Chemical Disinfectants and Antiseptics - Quantitative Carrier test for Airborne Room
Disinfection by Automated Processes - Determination of Bactericidal, Fungicidal,
Yeasticidal, Sporicidal, Tuberculocidal, Mycobactericidal, Virucidal and Phagocidal
Activities in the Medical Area, Veterinary Area and Food, Industrial, Domestic and
Institutional Areas - Test Methods and Requirements (phase 2, step 2)
Chemische Desinfektionsmittel und Antiseptika - Quantitative Keimträgerprüfung zur
luftübertragenen Raumdesinfektion durch automatisierte Verfahren - Bestimmung der
bakteriziden, fungiziden, levuroziden, sporiziden, tuberkuloziden, mykobakteriziden,
viruziden und Phagen-Wirksamkeit im humanmedizinischen Bereich, Veterinärbereich, in
den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen -
Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
$QWLVHSWLTXHVHWGpVLQIHFWDQWVFKLPLTXHV(VVDLTXDQWLWDWLIGHSRUWHXUSRXUOD
GpVLQIHFWLRQGHODLUGHVSLqFHVSDUGHVSURFHVVXVDXWRPDWLVpV'pWHUPLQDWLRQGH
ODFWLYLWpEDFWpULFLGHIRQJLFLGHOHYXULFLGHVSRULFLGHWXEHUFXORFLGHP\FREDFWpULFLGH
YLUXFLGHHWSKDJRFLGH
Ta slovenski standard je istoveten z: prEN 17272
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
oSIST prEN 17272:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 17272:2018

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oSIST prEN 17272:2018
CEN/TC 216
Date: 2018 −02
prEN XXXXX: XXXX
Secretariat: AFNOR
Methods of airborne room disinfection by automated process - determination of
bactericidal, yeasticidal, fungicidal, sporicidal, mycobactericidal and virucidal
activities
Einführendes Element — Haupt-Element — Ergänzendes Element
Élément introductif — Élément central — Élément complémentaire
ICS:

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prEN 17272:2018 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 7
3 Terms and definitions . 8
4 Requirements . 9
4.1 Efficacy tests . 9
4.2 Distribution tests . 10
5 Test method . 10
5.1 Principle . 10
5.1.1 Preliminary test to validate absence of residual effect . 10
5.1.2 The test itself . 11
5.2 Materials and reagents . 11
5.2.1 Test microorganisms . 11
5.2.2 Culture media and reagents . 12
5.2.3 Microbial carriers used. 17
5.3 Apparatus and glassware . 17
5.3.1 General. 17
5.3.2 Usual microbiological laboratory equipment, and in particular . 18
5.4 Preparation and counting of test suspensions . 20
5.4.1 Preparation of test suspensions (bacteria, yeasts, moulds, spores and
mycobacteria) . 20
5.4.2 Preparation of suspensions in interfering substances . 21
5.4.3 Counting of suspensions prepared in interfering substance . 25
5.4.4 Preparation and counting of viral suspensions . 27
5.4.5 Preparation and counting of test suspensions (host bacterial and bacteriophage
suspensions) . 28
5.5 Procedure for evaluating the process activity . 31
5.5.1 Procedure for evaluating the process activity according to conditions of use furnished
by the manufacturer (bacteria, yeasts, moulds, spores, viruses, bacteriophages and
mycobacteria) . 31
5.5.2 Virucidal activity tests . 40
5.5.3 Procedure for evaluating the mycobactericidal activity of the process . 42
5.6 Experimental data and calculations (bacteria, yeasts, moulds, bacterial spores and
bacteriophages and mycobacteria) . 43
5.6.1 General. 43
5.6.2 Colony counting and limit thresholds . 43
5.6.3 Determining number of microorganisms N in bacterial, yeasts, moulds, bacterial
spores, mycobacterial and phage suspensions (5.4) . 44
5.6.4 Determining number of microorganisms T on control-carriers (5.5.1.2) . 44
5.6.5 Determining values obtained in the preliminary test (5.5.1.3) . 45
5.6.6 Determining the number of microorganisms and plaques on test-carriers post-
contact exposure and the log base-10 reduction d (5.5.1.4.3) . 45
5.7 Interpretation of results . 47
5.8 Test report . 48
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Table 2 — RESULTS: example for an automatic process . 49
Annex A (normative) Summary of tests objectives and conditions . 51
A.1 Efficacy tests . 51
A.2 Distribution tests . 53
Annex B (normative)  Disinfection apparatus–to–carrier distances . 54
Annex C (normative)  Interfering substances . 55
Annex D (normative)  Preparation of spore stock suspensions of Bacillus subtilis . 58
D.1 Material and reagents . 58
D.1.1 Tryptone Glucose Broth (TGB): . 58
D.1.2 Yeast extract Agar (MYA): . 58
D.1.3 Centrifuge, capable of 10 000 g acceleration . 58
D.2 Preparation of Bacillus spore stock suspensions . 58
Annex E (normative) Schematic diagrams of the test procedure . 60
Bibliography . 64

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European foreword
This document (prEN 17272:2018) has been prepared by Technical Committee CEN/TC 216 “Chemical
antiseptics and disinfectants”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
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Introduction
The purpose of this document is to describe a method for assessing the disinfectant activity of airborne
surface disinfection processes under a specific set of experimental conditions.
The processes concerned include those involving chemical disinfectants in dispersed gaseous, vapour
and/or aerosolised form.
This document does not cover processes for which the mode of action is based on submerging and/or
contact optionally associated with a mechanical wiping action. The above effects result in the
displacement of all or part of the microorganisms away from the carrier surface as defined in the
document, without inactivating these microorganisms.
It must be understood that every automated airborne disinfection cycle / application is unique and the
purpose of this standard is to provide a defined challenge that must be met for the automated airborne
disinfection system to be considered an efficacious process. This standard method should therefore be
regarded as a useful starting point and not as a validation for all intended treatments with a particular
automated airborne disinfection system.
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1 Scope
The method described is designed to determine the disinfectant activity of processes used in the 1)
human health, 2) veterinary, 3) food, industrial and institutional sectors using chemical processes.
The objective of the described processes is to disinfect the surfaces of the overall area including the
external surfaces of the equipment contained in such rooms. Air handling and products or processes
specifically designed for the disinfection of medical devices are excluded from the scope of this document.
The test methods and volumes described provide the defined challenge. Even if an automated airborne
disinfection system has passed all or part of the test described here, the system and its delivered cycles
should then be validated in the individual enclosure to be disinfected using appropriate biological or
chemical indicators.
This document describes a Phase 2 step 2 methods designed:
— to check, under standardized laboratory conditions approaching real-world practice, that the
proposed airborne surface disinfection processes meet the objective for which they were devised;
— to cross-compare the different processes under reproducible conditions;
— to provide an experimental design within specified boundaries when real-world-practice conditions
depart from the conditions given in the text below.
The method is applicable to processes to be used in the area of human medicine, the veterinary area and
in food, industrial, domestic and institutional areas (WG1, WG2 and WG3).
It applies to the process of whole enclosure / room disinfection achieved by automated processes (i.e.
with no operator manually applying the disinfectant). This document covers the disinfection of
nonporous surfaces but not that of air;
This method can be used as a basis for biosecurity applications in laboratories.
The method is used to qualify the process, i.e. the set of components and consumables needed for
implementation. By way of example, for chemical processes, the device product combination cannot be
separated.
This document is applicable to processes for which activity is claimed against the following categories of
microorganisms:
— vegetative bacteria including mycobacteria,
— bacterial spores,
— yeasts,
— fungal spores and,
— viruses.
Each activity can be claimed independently but passing both bactericidal and yeasticidal activity as per
text in Annex A tests is the minimum requirement to claim compliance.
An activity tested for each domain of application may only be claimed if the criteria are achieved against
all of the specified organisms associated with that activity.
The proposed method includes 2 parts:
— Part 1 - Efficacy test: intended to ensure that minimal efficacy requirements are obtained for each
type of activity claimed and for the targeted application(s) (WG1 and/or WG2 and/or WG3).
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— Part 2 - Distribution test: intended to ensure efficacy of the process throughout the enclosure. It is
performed with a reference microorganism at 4 sampling positions.
The tests described in this document are based on measuring the logarithmic reduction of different
species of bacteria, yeasts, moulds, bacterial spores, bacteriophages or viruses and mycobacteria under
a specified set of conditions. As the panel of microorganisms selected may prove to be too narrow for
certain applications, it may be supplemented by other strains based on the experimental design described
in this document, by varying the conditions according to the needs of the practical application(s)
envisaged.
For the defined test conditions the number of test position of the carriers can be increased according to
specific needs of a given application or local requirements.
The manufacturer:
— specifies the limitations for use and precautions for use of the process;
— ensures that the documented test conditions are representative of the recommended practice(s).
The aim of this document is to simulate practical conditions of airborne disinfection in a laboratory
situation; obligatory conditions are defined according to the method defined below. Additional conditions
are also proposed.
The test report specifies and summarizes the conditions under which the tests are carried out.
The processes are generally implemented after a cleaning procedure and are then tested, according to
the application sectors, under clean or low-level soiling conditions. For some specific applications, and
according to the manufacturer's recommendations, evaluation methods in the presence of other
interfering substances can also be envisaged under additional conditions.
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
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3 Terms and definitions
For the purposes of this document, the following terms and definitions apply
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
chemical process
process in which the active substance is a chemical agent diffused in gas, liquid or solid form, the process
includes the chemical product and the diffusion system which cannot be evaluated separately
3.2
automatic airborne disinfection process
process diffusing a gas, vapour and/or an aerosol from a release source (i.e. an airborne disinfection
process) without the need for human intervention, with the airborne disinfection process employed on
surfaces and not for disinfection of the air itself
3.3
disinfectant activity of an airborne disinfection process
biocidal process with the ability to reduce the number of viable microorganisms that can be recovered
and counted under conditions described in this document, with the data obtained from specified strains
belonging to the following seven groups of microorganisms: bacteria, bacteria spores, yeasts, moulds,
viruses, bacteriophages and mycobacteria, under defined conditions
Note 1 to entry: Activities should be specified from the following list: bactericidal activity, sporicidal activity,
fungicidal activity, yeasticidal activity, virucidal activity, virucidal activity against bacteriophages, tuberculocidal
activity and mycobactericidal activity
3.4
distribution test
placement of microbiological challenge carriers in such a way as to ensure the device product
combination achieves the claimed disinfectant activity throughout the enclosure and performed after or
in parallel to the efficacy test
3.5
supplementary obligatory conditions
test conditions used instead of the obligatory conditions where the practical use of the process and the
manufacturers claims are clearly and unambiguously outside of the obligatory test conditions
3.6
sensitive strain
loss at drying greater than 1,5 lg after the drying phase, outside the exposure period
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4 Requirements
4.1 Efficacy tests
The process being submitted for testing under the obligatory experimental conditions defined in 5.5.4.2
shall lead to the following reduction rates, expressed in log base-10:
Bactericidal activity:
— 5-lg or greater reduction for human health area on test -carriers comparative to control-carriers non-
exposed to the process, for the 4 bacterial strains implemented (see 5.2.1.2 - 5.2.1.3 - 5.2.1.4 - 5.2.1.5)
— 5-lg or greater reduction for veterinary area on test -carriers comparative to control-carriers non-
exposed to the process, for the 5 bacterial strains implemented (see 5.2.1.1 - 5.2.1.2 - 5.2.1.3 - 5.2.1.4
- 5.2.1.6.) As above
— 5-lg or greater reduction for food industry laboratory area on test -carriers comparative to control-
carriers non-exposed to the process for the 4 bacterial strains implemented (see 5.2.1.1 - 5.2.1.2 -
5.2.1.3 - 5.2.1.4.) As above
Sporicidal activity:
— 4-lg or greater reduction for human health area, veterinary area and food industry laboratory area
on test -carriers comparative to control-carriers non-exposed to the process for the spore-forming
bacterial strain implemented (see 5.2.1.7)
Fungicidal activity:
— 4-lg or greater reduction for human health area, veterinary area and food industry laboratory on test
-carriers comparative to control-carriers non-exposed to the process for the two fungal strains (yeast
and mould) implemented (see 5.2.1.8 - 5.2.1.9)
Yeasticidal activity:
— 4-lg or greater reduction for human health area, veterinary area and food industry laboratory on test
-carriers comparative to control-carriers non-exposed to the process for the yeast strain
implemented (see 5.2.1.8).
Virucidal activity:
— 4-log or greater reduction for human health area and food industry laboratory on test -carriers
comparative to control-carriers non-exposed to the process, for the 2 strains implemented (see
5.2.1.10 – 5.2.1.11)
— 4-lg or greater reduction for veterinary area on test -carriers comparative to control-carriers non-
exposed to the process, for the strain implemented (see 5.2.1.12)
virucidal activity against bacteriophages:
— 4-lg or greater reduction for human health area, veterinary area and food industry laboratory on test
-carriers comparative to control-carriers non-exposed to the process for the 2 strains implemented
(see 5.2.1.13 - 5.2.1.14).
Mycobactericidal activity:
— 4-lg or greater reduction for human health area and food industry laboratory on test -carriers
comparative to control-carriers non-exposed to the process for the 2 strains implemented
(see 5.2.1.15 - 5.2.1.16).
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The requirements and test method are summarized in Annex A.
The reduction rates sought are expressed as log base-10 values and are dependent on the application.
The reduction rates indicated in the table in Annex A are the minimal reduction rates to be obtained on
test-carriers in comparison to control-carriers non-exposed to the process
These activities may be determined independently, i.e. by separate testing of the different microbiological
groups, and do not all have to be undertaken simultaneously.
These seven activities shall be determined under the standard-reference experimental conditions defined
in 5.5.
Additional specific bactericidal, sporicidal, fungicidal, yeasticidal, virucidal (human viruses),
bacteriophagicidal and mycobactericidal activity can, as appropriate, be determined under other
condition variables, from contact time to type of carriers, microorganisms, volume of the test room or
temperature and humidity, in order to account for conditions governing the specific usages the processes
are intended to provide.
These additional conditions shall be described, recorded and reported in the test report.
4.2 Distribution tests
The reduction in the number of viable bacterial cells throughout the enclosure shall be determined with-
Staphylococcus aureus ATCC 6538 = CIP 4.83 (5.2.1.2) to achieve 5-log or greater reduction on each test
–carrier. Carriers shall be located in accordance with Annex A, part 2. Test conditions shall replicate those
used in the efficacy tests.
5 Test method
5.1 Principle
5.1.1 Preliminary test to validate absence of residual effect
The aim of the preliminary test is to identify whether there is any residual activity due to residual
disinfectant transferred via the carriers into the subculture media (in agar plates and on membranes)
and to find a method for eliminating this effect. As such, it is the test itself that determines whether there
is any real bactericidal, fungicidal, yeasticidal, sporicidal, virucidal, including against bacteriophages, and
mycobactericidal activity rather than a simple localized growth-inhibitory effect.
Non-contaminated carriers are exposed to a gas, vapour and/or aerosol.
Recovery into 100 ml (20 ml for virucidal activity) of sterile liquid medium, and testing for bacteriostatic
(or fungistatic or spore germination inhibition or cell susceptibility reduction) effects due to disinfectant
adhering to the carriers, which could generate an inhibitory effect in agar medium and on the filter
membranes or a decrease in the residual viral titration.
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5.1.2 The test itself
Using microorganism suspensions, deposition of 50 µl on an inert carrier prepared as described in 5.2.3.
Spread and air-dry the inoculum as described in 5.5.1.2.1, then hold the carrier set in contact exposure
with the product diffused by the tested process, under defined conditions.
Recover bacteria, mycobacteria, yeasts, moulds, spores or viruses or bacteriophages by scraping, shaking
and sonicate if required, using the carriers, in the recovery liquid:
— for bacteria, mycobacteria, yeasts, moulds and spores, dilution and agar-plating of a fraction of the
recovery liquid. Incubation followed by colony counting. Membrane-filtration of the remaining
recovery liquid, then rinsing to eliminate as much disinfectant as possible. Membrane transferred on
agar medium. Carrier placed in agar medium. Incubation followed by final colony counting.
— for viruses, dilution of fraction of the recovery liquid and testing for viable virus by incubation and
determination of viral titre.
5.2 Materials and reagents
5.2.1 Test microorganisms
Depending on the type of activity targeted, tests shall use all or some of the following strains.
These strains can be obtained from biological collection resource centres. The test strains are:
For bactericidal activity tests:
— 5.2.1.1 Pseudomonas aeruginosa ATCC 15442 = CIP 103-467 (DSM937)
— 5.2.1.2 Staphylococcus aureus ATCC 6538 = CIP 4.83 (DSM 799)
— 5.2.1.3 Enterococcus hirae ATCC 10541 = CIP 5855 (DSM3320)
— 5.2.1.4 Escherichia coli ATCC 10536 = CIP 54127 (DSM682)
— 5.2.1.5 Acinetobacter baumanii ATCC 19606 = CIP 70.34 (DSM30007)
— 5.2.1.6 Proteus vulgaris….ATCC 13315 = CIP 58.60(DSM30118)
For sporicidal activity tests:
— 5.2.1.7 Bacillus subtilis spores ATCC 6633 = CIP 52 62;
For yeasticidal activity tests:
— 5.2.1.8 Candida albicans ATCC 10231 = IP 4872 (DSM 1386)
For fungicidal activity tests:
— 5.2.1.8 Candida albicans ATCC 10231 = IP 4872 (DSM 1386)
— 5.2.1.9 Aspergillus brasiliensis ATCC 16404 = IP 1431-83 (DSM1988)
For virucidal activity tests:
— 5.2.1.10 Murine Parvovirus Crawford strain ATCC VR-1346 cultured on A9 cells line
— 5.2.1.11 Adenovirus type 5, adenoid strain, ATCC VR-5. Adenovirus cultured on HeLa cells or other
lines of suitable susceptibility.
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— 5.2.1.12 Porcine Parvovirus NADL2 strain cultured on ST cells or other appropriate cells line
For virucidal activity against bacteriophage tests:
— 5.2.1.13 Bacteriophage for Lactococcus lactis subspecies lactis P001 (DSM 4262);
— 5.2.1.14. Bacteriophage for Lactococcus lactis subspecies lactis P008 (DSM 10567);
The multiplication of these two phages shall be obtained from the following host strain: Lactococcus lactis
subspecies lactis F7/2 (DSM 4366).
For mycobactericidal activity:
— 5.2.1.15. Mycobacterium avium ATCC 15769 = CIP 105415
— 5.2.1.16 Mycobacterium terrae ATCC 15755 (tuberculocidal activity)
Both organisms shall be tested, except for veterinary area where only Mycobacterium avium is required
These strains can be obtained from biological collection resource centres.
The use of other microorganisms
If additional test microorganisms are used, they shall be incubated under optimum growth conditions
(temperature, time, atmosphere, media) which shall be recorded in the test report. If the additional test
microorganisms chosen do not correspond to the specified species, their suitability for supplying the
required inocula shall be verified. 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 a five-year period.
5.2.2 Culture media and reagents
5.2.2.1 General
All weights of chemical substances given in this document 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 microorganisms.
5.2.2.2 Culture media for bacteria, yeasts, moulds, spores and mycobacteria
5.2.2.2.1 Water
The water shall be freshly glass-distilled water and not demineralized water.
Sterilize in the autoclave (5.3.2.1a).
NOTE 1 Sterile distilled water is necessary for preparation of suspensions tests. Sterilization is not necessary if
the water is used for e.g. preparation of culture media and subsequently sterilized
NOTE
...

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