EN 17387:2021

Chemical disinfectants and antiseptics - Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)

This document specifies a test method and the minimum requirements for bactericidal and yeasticidal and additionally fungicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water.
NOTE   Dilutions are necessary as three concentrations in the active to non-active range are tested.
This document applies to products that are used in the medical area for disinfecting non-porous surfaces without mechanical action.
This document applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example:
-   in hospitals, in community medical facilities and in dental institutions;
-   in clinics of schools, of kindergartens and of nursing homes;
and can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients.
EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations.
Using this document, it is possible to determine the activity of products like commercial formulations or active substances on bacteria and/or fungi in the conditions in which they are used and therefore it corresponds to a phase 2, step 2 test.
This method excludes the evaluation of the activity of products against mycobacteria and bacterial spores.

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Versuch zur Bestimmung der bakteriziden und levuroziden und/oder fungiziden Wirkung chemischer Desinfektionsmittel im humanmedizinischen Bereich auf nicht porösen Oberflächen ohne mechanische Einwirkung - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)

Dieses Dokument legt ein Prüfverfahren und die Mindestanforderungen an die bakterizide und levurozide und zusätzlich auch fungizide Wirkung von chemischen Desinfektionsmitteln fest, die bei Verdünnung mit Wasser standardisierter Härte als homogene, physikalisch stabile Zubereitung vorliegen bzw. bei gebrauchs¬fertigen Produkten mit Wasser verdünnt werden.
ANMERKUNG   Verdünnungen sind erforderlich, da drei Konzentrationen im aktiven bis nichtaktiven Bereich geprüft werden.
Dieses Dokument gilt für Produkte, die ohne mechanische Einwirkung zur Desinfektion nichtporöser Oberflächen im humanmedizinischen Bereich verwendet werden.
Dieses Dokument gilt für Bereiche und unter Bedingungen, wo eine Desinfektion oder Antiseptik aus medizinischen Gründen angezeigt ist. Indikationen dieser Art liegen z. B. bei der Patientenbetreuung in:
-   Krankenhäusern, kommunalen medizinischen Einrichtungen und im Dentalbereich;
-   medizinischen Einrichtungen in Schulen, Kindergärten und Heimen;
vor und können auch am Arbeitsplatz und im häuslichen Bereich gegeben sein. Eingeschlossen sein können auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung der Patienten dienen.
EN 14885 legt im Einzelnen die Beziehungen der verschiedenen Prüfungen untereinander und zu den Anwendungsempfehlungen fest.
Mit diesem Dokument ist es möglich, die Wirkung von Produkten wie handelsüblichen Formulierungen oder Wirkstoffen unter den Bedingungen, unter denen sie verwendet werden, auf Bakterien und/oder Pilze zu bestimmen und entspricht somit einer Prüfung der Phase 2, Schritt 2.
Dieses Verfahren schließt die Bewertung der Wirkung von Produkten gegen Mykobakterien und bakterielle Sporen aus.

Antiseptiques et désinfectants chimiques - Essai quantitatif pour l’évaluation de l’activité bactéricide et levuricide et/ou fongicide des désinfectants chimiques utilisés en médecine sur des surfaces non poreuses sans action mécanique - Méthode d’essai et exigences (phase 2, étape 2)

Le présent document spécifie une méthode d’essai et les exigences minimales relatives à l’activité bactéricide, levuricide ainsi que fongicide des désinfectants chimiques qui forment une préparation homogène, physiquement stable, lorsqu’ils sont dilués dans l’eau dure ou - dans le cas de produits prêts à l’emploi - dans l’eau.
NOTE   Des dilutions sont nécessaires car trois concentrations dont une concentration active et une concentration non active sont soumises à essai.
Le présent document s’applique aux produits utilisés en médecine pour désinfecter les surfaces non poreuses sans action mécanique.
Le présent document s’applique aux zones et aux situations où la désinfection ou l’antisepsie est médicalement préconisée. De telles indications se rencontrent dans le cadre des soins apportés aux patients, par exemple :
-   dans des hôpitaux, centres de soins médicaux et cabinets dentaires ;
-   dans des infirmeries d’écoles, de jardins d’enfants et de maisons de retraite ;
et peuvent aussi se rencontrer sur les lieux de travail ou à domicile. Elles peuvent également concerner des services tels que des blanchisseries et des cuisines qui fournissent des produits directement aux patients.
L’EN 14885 précise de manière détaillée la relation entre les différents essais et les recommandations d’utilisation.
Il est possible, en utilisant le présent document, de déterminer l’activité de produits tels que les formulations ou substances actives commerciales sur les bactéries et/ou champignons dans leurs conditions d’utilisation, ce qui correspond à un essai de phase 2, étape 2.
Cette méthode exclut l’évaluation de l’activité de produits sur les mycobactéries et les spores de bactéries.

Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah brez mehanskega delovanja za vrednotenje baktericidnega in/ali fungicidnega delovanja in delovanja kemičnih razkužil na kvasovke v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 2)

Ta evropski standard določa preskusno metodo in minimalne zahteve za baktericidno in/ali fungicidno delovanje kemičnih razkužil in/ali delovanje kemičnih razkužil na kvasovke, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčena s trdo vodo oziroma, pri proizvodih, ki so pripravljeni za uporabo, z vodo.
Ta evropski standard se uporablja za proizvode, ki se na zdravstvenem področju uporabljajo za razkuževanje neporoznih površin brez mehanskega delovanja.
Ta evropski standard se uporablja za področja in primere, ko obstajajo zdravniške indikacije za dezinfekcijo. Te indikacije se pojavljajo pri negi bolnikov, na primer:
v bolnišnicah, javnih zdravstvenih in zobozdravstvenih ustanovah;
v ambulantah šol, vrtcev in domov za starejše;
in lahko se pojavljajo na delovnem mestu ali doma. Vključujejo lahko tudi storitve, kot so pralnice in kuhinje, ki proizvode dostavljajo neposredno bolnikom.
OPOMBA:   Ta metoda ustreza preskusu stopnje 2 faze 2.
Standard EN 14885 podrobno določa razmerje med različnimi preskusi in »priporočili za uporabo«.

General Information

• Status: Published
• Publication Date: 17-Aug-2021
• Withdrawal Date: 29-Nov-2021
• 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 1 - Human medicine
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 18-Aug-2021
• Due Date: 27-Nov-2020
• Completion Date: 18-Aug-2021
• Ref Project: SIST EN 17387:2022 - Chemical disinfectants and antiseptics - Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2022
Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah
brez mehanskega delovanja za vrednotenje baktericidnega in/ali fungicidnega
delovanja in delovanja kemičnih razkužil na kvasovke v humani medicini -
Preskusna metoda in zahteve (faza 2, stopnja 2)
Chemical disinfectants and antiseptics - Quantitative test for the evaluation of
bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the
medical area on non-porous surfaces without mechanical action - Test method and
requirements (phase 2, step 2)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Versuch zur Bestimmung
der bakteriziden und levuroziden und/oder fungiziden Wirkung chemischer
Desinfektionsmittel im humanmedizinischen Bereich auf nicht porösen Oberflächen ohne
mechanische Einwirkung - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Antiseptiques et désinfectants chimiques - Essai quantitatif pour l’évaluation de l’activité
bactéricide et levuricide et/ou fongicide des désinfectants chimiques utilisés en
médecine sur des surfaces non poreuses sans action mécanique - Méthode d’essai et
exigences (phase 2, étape 2)
Ta slovenski standard je istoveten z: EN 17387:2021
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 17387
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2021
EUROPÄISCHE NORM
ICS 11.080.20; 71.100.35
English Version
Chemical disinfectants and antiseptics - Quantitative test
for the evaluation of bactericidal and yeasticidal and/or
fungicidal activity of chemical disinfectants in the medical
area on non-porous surfaces without mechanical action -
Test method and requirements (phase 2, step 2)
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif pour l'évaluation de l'activité bactéricide et Quantitativer Versuch zur Bestimmung der
levuricide et/ou fongicide des désinfectants chimiques bakteriziden und levuroziden und/oder fungiziden
utilisés en médecine sur des surfaces non poreuses Wirkung chemischer Desinfektionsmittel im
sans action mécanique - Méthode d'essai et exigences humanmedizinischen Bereich auf nicht porösen
(phase 2, étape 2) Oberflächen ohne mechanische Einwirkung -
Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
This European Standard was approved by CEN on 25 January 2021.

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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17387:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms, definitions and abbreviations . 5
3.1 Terms and definitions . 5
3.2 Symbols and abbreviations . 6
4 Requirements . 6
5 Test methods . 7
5.1 Principle . 7
5.2 Materials and reagents . 8
5.2.1 Test organisms . 8
5.2.2 Culture media and reagents . 8
5.2.3 Test surface . 11
5.3 Apparatus and glassware . 12
5.3.1 General . 12
5.3.2 Usual microbiological laboratory equipment and, in particular, the following: . 12
5.4 Preparation of test organism suspensions and product test solutions . 13
5.4.1 Test organism suspensions . 13
5.4.2 Product test solutions . 19
5.5 Procedure for assessing the bactericidal, yeasticidal and fungicidal activity of the
product . 19
5.5.1 Choice of experimental conditions . 19
5.5.2 Test procedure . 20
5.5.3 Counting of the test mixtures . 23
5.6 Calculation and expression of results . 24
5.6.1 Calculation of data . 24
5.6.2 Verification of methodology . 25
5.6.3 Expression of results . 25
5.6.4 Conclusion. 26
5.7 Test report . 26
Annex A (informative) Corresponding referenced strains . 28
Annex B (informative) Neutralizers . 29
Annex C (informative) Expression of results with the dilution-neutralization method . 31
Annex D (informative) Bactericidal activity on surfaces under clean conditions . 33
Annex E (informative) Vacuum drying by desiccator - Instruction of use . 35
Annex F (informative) Precision of the test result . 37
Bibliography . 38

European foreword
This document (EN 17387:2021) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2022, and conflicting national standards
shall be withdrawn at the latest by February 2022.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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.
Introduction
This document describes a surface test method for establishing whether a chemical disinfectant in the
area and fields described in the scope (Clause 1) has or does not have bactericidal and/or fungicidal or
yeasticidal activity on non-porous surfaces without mechanical action.
The laboratory test closely simulates practical conditions of application. Chosen conditions (contact
time, temperature, and microorganisms on surfaces.) reflect parameters which are found in practical
situations including conditions which can influence the action of disinfectants.
However, for some applications the recommendations of use of a product can differ and therefore
additional test conditions need to be used.
This document is not intended to be used when product is applied via an automatic airborne
disinfection method; in such cases, see EN 17272.
1 Scope
This document specifies a test method and the minimum requirements for bactericidal and yeasticidal
and additionally fungicidal activity of chemical disinfectant products that form a homogeneous,
physically stable preparation when diluted with hard water – or in the case of ready-to-use products –
with water.
NOTE Dilutions are necessary as three concentrations in the active to non-active range are tested.
This document applies to products that are used in the medical area for disinfecting non-porous
surfaces without mechanical action.
This document applies to areas and situations where disinfection or antisepsis is medically indicated.
Such indications occur in patient care, for example:
— in hospitals, in community medical facilities and in dental institutions;
— in clinics of schools, of kindergartens and of nursing homes; and can occur in the workplace and in
the home. It can also include services such as laundries and kitchens supplying products directly for
the patients.
EN 14885 specifies in detail the relationship of the various tests to one another and to use
recommendations.
Using this document, it is possible to determine the activity of products like commercial formulations or
active substances on bacteria and/or fungi in the conditions in which they are used and therefore it
corresponds to a phase 2, step 2 test.
This method excludes the evaluation of the activity of products against mycobacteria and bacterial
spores.
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
3 Terms, definitions and abbreviations
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 14885 apply.
ISO and IEC maintain terminological databases for
...