EN 13624:2021
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water, or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.
This document applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
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.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 1 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Dieses Dokument legt ein Prüfverfahren und Mindestanforderungen für die fungizide oder levurozide (Hefen abtötende) Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die bei Verdünnung mit Wasser standardisierter Härte bzw. – im Fall von gebrauchsfertigen Produkten – mit Wasser als homogenes physikalisch stabiles Präparat vorliegen. Die Produkte können nur in einer Konzentration bis zu 80 % (97 % bei einem modifizierten Verfahren in Sonderfällen) geprüft werden, da durch Zugabe der Prüforganismen und der Belastungssubstanz stets eine gewisse Verdünnung bewirkt wird.
Dieses Dokument ist anzuwenden für Produkte, die im humanmedizinischen Bereich für hygienische Händedesinfektion, hygienische Händewaschung, chirurgische Händedesinfektion, chirurgische Händewaschung, für die Instrumentendesinfektion durch Eintauchen sowie für die Oberflächendesinfektion mittels Wischen, Sprühen, Spülen o. Ä. verwendet werden.
Dieses Dokument ist anzuwenden für Bereiche und Bedingungen, wo eine Desinfektion oder Antisepsis 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 oder im häuslichen Bereich gegeben sein. Eingeschlossen sein können auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung der Patienten dienen.
ANMERKUNG 1 Das beschriebene Verfahren dient zur Bestimmung der Wirksamkeit kommerziell erhältlicher Zubereitungen oder Wirkstoffe unter den jeweiligen Anwendungsbedingungen.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 1.
EN 14885 legt detailliert die Beziehungen der unterschiedlichen Prüfungen untereinander und zu „Anwendungsempfehlungen“ fest.
Désinfectants chimiques et antiseptiques - Essai quantitatif de suspension pour l’évaluation de l’activité fongicide ou levuricide en médecine - Méthode d'essai et exigences (phase 2, étape 1)
Le présent document spécifie une méthode d’essai et les exigences minimales relatives à l’activité fongicide et levuricide des désinfectants chimiques et des produits antiseptiques qui forment une préparation homogène, physiquement stable, lorsqu’ils sont dilués dans de l’eau dure ou, dans le cas de produits prêts à l’emploi, dans de l’eau. Les produits ne peuvent être soumis à l’essai qu’à une concentration inférieure ou égale à 80 % (97 % avec une méthode modifiée dans certains cas particuliers), car l’ajout des souches d’essai et de la substance interférente entraîne toujours une dilution.
Le présent document s’applique aux produits employés en médecine pour la friction et le lavage hygiéniques des mains, pour la friction et le lavage chirurgicaux des mains, pour la désinfection des instruments par immersion et pour la désinfection de surface par essuyage, pulvérisation, rinçage ou autre.
Le présent document s’applique dans les zones et 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, dans des centres de soins médicaux et des 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 cuisines qui fournissent des produits directement aux patients.
NOTE 1 La méthode décrite vise à déterminer l’activité des formulations commerciales ou des substances actives dans leurs conditions d’utilisation.
NOTE 2 Cette méthode correspond à un essai de type phase 2, étape 1.
L’EN 14885 précise de manière détaillée la relation entre les différents essais et les « recommandations d’utilisation ».
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje fungicidnega delovanja ali delovanja na kvasovke v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)
Ta dokument določa preskusno metodo in minimalne zahteve za fungicidno delovanje ali delovanje kemičnih razkužil in antiseptikov na kvasovke, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo oziroma, pri proizvodih, ki so pripravljeni za uporabo, z vodo. Proizvode je mogoče preskušati samo pri 80-odstotni ali nižji koncentraciji (s prilagojeno metodo v posebnih primerih 97-odstotni), ker dodajanje preskusnih organizmov in moteče snovi vedno povzroči razredčenje.
Ta dokument se uporablja za proizvode, ki se uporabljajo na področju zdravstva pri higienskem drgnjenju rok, higienskem umivanju rok, kirurškem drgnjenju rok, kirurškem umivanju rok, dezinfekciji instrumentov s potapljanjem in površinski dezinfekciji z brisanjem, pršenjem, zalivanjem ali na druge načine.
Ta dokument se uporablja za področja in primere, ko obstajajo zdravniške indikacije za razkuževanje ali antisepso. 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 1: Opisana metoda je namenjena določevanju dejavnosti komercialnih oblik ali aktivnih snovi pod pogoji, v katerih se uporabljajo.
OPOMBA 2: Ta metoda ustreza preskusu stopnje 1 faze 2.
Standard EN 14885 podrobno določa razmerje med različnimi preskusi in »priporočili za uporabo«.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2022
Nadomešča:
SIST EN 13624:2013
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za
vrednotenje fungicidnega delovanja ali delovanja na kvasovke v humani medicini -
Preskusna metoda in zahteve (faza 2, stopnja 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of fungicidal or yeasticidal activity in the medical area - Test method and requirements
(phase 2, step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der fungiziden oder levuroziden Wirkung im humanmedizinischen Bereich -
Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Désinfectants chimiques et antiseptiques - Essai quantitatif de suspension pour
l’évaluation de l’activité fongicide ou levuricide en médecine - Méthode d'essai et
prescriptions (phase 2, étape 1)
Ta slovenski standard je istoveten z: EN 13624:2021
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 13624
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2021
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN 13624:2013
English Version
Chemical disinfectants and antiseptics - Quantitative
suspension test for the evaluation of fungicidal or
yeasticidal activity in the medical area - Test method and
requirements (phase 2, step 1)
Désinfectants chimiques et antiseptiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de suspension pour l'évaluation de l'activité Quantitativer Suspensionsversuch zur Bestimmung der
fongicide ou levuricide en médecine - Méthode d'essai fungiziden oder levuroziden Wirkung im
et exigences (phase 2, étape 1) humanmedizinischen Bereich - Prüfverfahren und
Anforderungen (Phase 2, Stufe 1)
This European Standard was approved by CEN on 3 October 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 13624:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Requirements . 6
5 Test method . 7
5.1 Principle . 7
5.2 Materials and reagents . 8
5.3 Apparatus and glassware . 11
5.4 Preparation of test organism suspensions and product test solutions . 13
5.5 Procedure for assessing the fungicidal and yeasticidal activity of the product . 18
5.6 Experimental data and calculation . 26
5.7 Verification of methodology . 32
5.8 Expression of results and precision . 33
5.9 Interpretation of results – conclusion . 34
5.10 Test report . 36
Annex A (informative) Referenced strains in national collections . 38
Annex B (informative) Neutralizers and rinsing liquids. 39
Annex C (informative) Graphical representation of test procedures. 41
C.1 Dilution-neutralization method . 41
C.2 Membrane filtration method . 43
C.3 Dilution-neutralization method (modified method for ready-to-use products) . 45
C.4 Membrane filtration method (modified method for ready-to-use products) . 47
Annex D (informative) Example of a typical test report . 49
Annex E (informative) Precision of the test result . 54
Bibliography . 57
European foreword
This document (EN 13624:2021) 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 May 2022, and conflicting national standards shall be
withdrawn at the latest by May 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.
This document supersedes EN 13624:2013.
The document was revised to adapt it to the latest state of science, to correct errors and ambiguities, to
harmonize the structure and wording with other tests of CEN/TC 216 existing or in preparation and to
improve the readability of the standard and thereby make it more understandable. The following is a
list of significant technical changes since the last edition:
— De-harmonization of the standard (Annex ZA and references to MDR/MDD deleted);
— Textile disinfection was added (see Table 1, 5.5.1.3);
— The amounts for the dirty conditions for the modified method for ready-to-use products were
reduced (5.2.2.8.4 b));
— Clarification that a neutralization time of 10 s shall be used for all products with contact times of
10 min or shorter (5.5.2.2. c) and 5.5.2.5 b));
— Explanation for alternative controls for chemo-thermal disinfection (5.5.2.3);
— The reference to CIP numbers for the fungi strains were deleted and the UMIP numbers were added
(Annex A);
— Harmonization of the text with EN 13727;
— Correction of editorial mistakes.
The changes of this revision have no impact on the test results obtained with reference to the version
EN 13624:2013. Those results are still valid.
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 specifies a suspension test for establishing whether a chemical disinfectant or an
antiseptic has a fungicidal or yeasticidal activity in the area and fields described in the scope.
This laboratory test takes into account practical conditions of application of the product including
contact time, temperature, test organisms and interfering substances, i.e. conditions which can
influence its action in practical situations. Each utilization concentration of the chemical disinfectant or
antiseptic found by this test corresponds to the chosen experimental conditions.
1 Scope
This document specifies a test method and the minimum requirements for fungicidal or yeasticidal
activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable
preparation when diluted with hard water, or – in the case of ready-to-use products – with water.
Products can only be tested at a concentration of 80 % or less (97 % with a modified method for special
cases) as some dilution is always produced by adding the test organisms and interfering substance.
This document applies to products that are used in the medical area in the fields of hygienic handrub,
hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and
surface disinfection by wiping, spraying, flooding or other means.
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.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active
substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2 step 1 test.
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
ISO 4793:1980, Laboratory sintered (fritted) filters — Porosity grading, classification and designation
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 14885 apply.
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
4 Requirements
The product shall demonstrate at least a 4 decimal logarithms (lg) reduction (for hygienic handwash at
least a 2 lg reduction), when tested in accordance with Table 1 and Clause 5.
Table 1 — Minimum and additional test conditions
Hygienic
Textile
Test Surgical handrub Instrument Surface
handrub and
d
conditions and handwash disinfection disinfection disinfection
handwash
Minimum Candida albicans Candida albicans a) fungicidal a) fungicidal a) fungicidal
spectrum of (vegetative cells) (vegetative cells) activity: activity: activity:
test Aspergillus Aspergillus Aspergillus
organisms brasiliensis brasiliensis brasiliensis
(conidiospores) (conidiospores) (conidiospores)
Candida albicans Candida albicans Candida albicans
(veg. cells) (veg. cells) (veg. cells)
b) yeasticidal b) yeasticidal b) yeasticidal
activity: activity: activity:
Candida albicans Candida albicans Candida albicans
(veg. cells) (veg. cells) (veg. cells)
additional Any relevant test organi
...
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