prEN 14476
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
TThis document specifies a test method and the minimum requirements for virucidal 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, i.e, products that are not diluted when applied, - with water. Ready-to-use-products can only be tested at a concentration up to 80 % (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, instrument disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and textile disinfection.
This document applies to areas and situations where disinfection 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 patient.
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.
NOTE 3 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 viruziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Dieses Dokument legt ein Prüfverfahren für und die Mindestanforderungen an die viruzide Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die bei Verdünnung mit Wasser standardisierter Härte als homogene, physikalisch stabile Zubereitung vorliegen, bzw. bei gebrauchsfertigen Produkten, z. B. Produkte, die bei der Anwendung nicht mit Wasser verdünnt werden. Die gebrauchsfertigen Produkte können nur bei einer Konzentration von bis zu 80 % (97 % bei einem modifizierten Verfahren für Sonderfälle) geprüft werden, da durch Zugabe der Prüfkeime und der Belastungssubstanz immer eine gewisse Verdünnung bewirkt wird.
Dieses Dokument gilt für Produkte, die im medizinischen Bereich auf den Gebieten der hygienischen Händedesinfektion, hygienischen Händewaschung, Instrumentendesinfektion durch Eintauchen und Oberflächendesinfektion durch Abwischen, Besprühen, Überfluten oder auf sonstige Weise sowie für die Wäschedesinfektion verwendet werden.
Dieses Dokument gilt für Bereiche und unter Bedingungen, wo eine Desinfektion aus medizinischen Gründen angezeigt ist. Indikationen dieser Art liegen z. B. vor bei der Patientenbetreuung:
- in Krankenhäusern, kommunalen medizinischen Einrichtungen und im Dentalbereich;
- in medizinischen Bereichen in Schulen, Kindergärten und Heimen
und können auch am Arbeitsplatz oder im privaten Bereich gegeben sein. Eingeschlossen sein können auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung von Patienten dienen.
ANMERKUNG 1 Das beschriebene Verfahren dient zur Bestimmung der Wirksamkeit kommerziell erhältlicher Zuberei¬tungen oder Wirkstoffe unter den Bedingungen, unter denen sie angewendet werden.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 1.
ANMERKUNG 3 EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den "Anwendungsempfehlungen" fest.
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité virucide dans le domaine médical - Méthode d'essai et prescriptions (Phase 2/Étape 1)
Le présent document spécifie une méthode d’essai et les prescriptions minimales relatives à l’activité virucide des produits antiseptiques et 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, c’est-à-dire de produits qui ne sont pas dilués lors de leur utilisation - dans l’eau. Les produits prêts à l’emploi ne peuvent être soumis à essai qu’à une concentration allant jusqu’à 80 % (97 % avec une méthode modifiée dans certains cas particuliers), car l’ajout des microorganismes d’essai et de la substance interférente s’accompagne forcément d’une dilution.
Le présent document s’applique aux produits utilisés dans le domaine médical pour le traitement hygiénique des mains par frictions, le lavage hygiénique des mains, la désinfection des instruments par immersion, la désinfection des surfaces par essuyage, pulvérisation, inondation ou d’autres moyens, et la désinfection des textiles.
Le présent document s’applique aux domaines et situations où la désinfection est indiquée en médecine humaine. De telles indications se produisent pour les soins des patients, par exemple :
- dans les hôpitaux, les centres médicaux communautaires et les institutions dentaires ;
- dans les cliniques d’écoles, de jardins d’enfants et de maisons de soins infirmiers ;
et peuvent se produire sur le lieu de travail et à la maison. Elles peuvent également inclure les services tels que les blanchisseries et les cuisines fournissant directement des produits aux patients.
NOTE 1 La méthode décrite a pour objet de déterminer l’activité de formulations commerciales ou de substances actives dans leurs conditions d’emploi.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 1.
NOTE 3 L’EN 14885 spécifie de façon détaillée les relations des différents essais entre eux et avec les « recommandations d’emploi ».
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje virucidnega delovanja v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za
vrednotenje virucidnega delovanja v humani medicini - Preskusna metoda in
zahteve (faza 2, stopnja 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der viruziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und
Anforderungen (Phase 2, Stufe 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour
l'évaluation de l'activité virucide dans le domaine médical - Méthode d'essai et
prescriptions (Phase 2/Étape 1)
Ta slovenski standard je istoveten z: prEN 14476
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2024
ICS 11.080.20 Will supersede EN 14476:2013+A2:2019
English Version
Chemical disinfectants and antiseptics - Quantitative
suspension test for the evaluation of virucidal activity in
the medical area - Test method and requirements (Phase
2/Step 1)
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de suspension pour l'évaluation de l'activité Quantitativer Suspensionsversuch zur Bestimmung der
virucide dans le domaine médical - Méthode d'essai et viruziden Wirkung im humanmedizinischen Bereich -
prescriptions (Phase 2/Étape 1) Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 216.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14476:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 7
5 Test methods . 9
5.1 Principle . 9
5.2 Materials and reagents, including cell cultures . 10
5.2.1 Test viruses . 10
5.2.2 Culture media, reagents and cell cultures . 11
5.3 Apparatus and glassware . 14
5.4 Preparation of test organism suspensions and product test solutions . 15
5.4.1 Test organisms suspensions (test virus suspension) . 15
5.4.2 Product test solutions . 16
5.5 Procedure for assessing the virucidal activity of the product . 17
5.5.1 General . 17
5.5.2 Test procedure . 18
5.5.3 Modified method for ready-to-use products . 19
5.5.4 Cytotoxicity caused by product test solutions . 19
5.5.5 Interference control – control of cell susceptibility . 20
5.5.6 Control of efficiency of suppression of product’s activity . 20
5.5.7 Reference test for virus inactivation . 21
5.5.8 Titration of the virus control . 22
5.5.9 Titration of test samples . 22
5.6 Experimental data and calculation . 23
5.6.1 Protocol of results. 23
5.6.2 Calculation of infectivity titre (TCID or PFU) . 23
5.6.3 Calculating the reduction and its 95 % confidence interval . 29
5.6.4 Calculating the average reduction [R ] and its 95 % confidence interval. . 30
(mi)
5.7 Verification of the methodology . 31
5.8 Expression of results . 31
5.8.1 General . 31
5.8.2 Calculation of the virucidal activity of products . 32
5.9 Test report . 32
Annex A (informative) Examples of viruses sorted according to their presence in the human
body in case of virus infection . 34
Annex B (informative) Detoxification of test mixtures by molecular sieving . 36
TM
B.1 Molecular sieving with Sephadex LH 20 . 36
B.1.1 Principle . 36
B.1.2 Sephadex suspension . 36
B.1.3 Procedure . 36
B.2 Molecular sieving using MicroSpinTM S 400 HR . 38
Annex C (informative) Presentation of data results of one active concentration. 39
Annex D (informative) Quantitative determination of formaldehyde and PAA concentrations . 41
D.1 Quantitative determination of formaldehyde . 41
D.2 Determination of PAA concentration . 42
Bibliography. 44
European foreword
This document (prEN 14476:2024) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN-Enquiry.
This document will supersede EN 14476:2013+A2:2019.
This 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 existing tests of CEN/TC 216 or in preparation and to
improve its readability and thereby make it more understandable.
EN 14476:2013+A2:2019:
— the scope was expanded for the following fields of application within the medical area, i.e. products
for textile disinfection (including Peracetic Acid as reference);
— for the hygienic handrub and handwash claims, a test for virucidal activity against enveloped viruses
with vaccinia virus was added with specific log reduction requirement for handwash products;
— the calculation was shifted to the main text (harmonized with EN 13727);
— the LVP method was shifted to the main text;
— it was clarified that given cell line numbers are only examples;
— spelling errors and incorrect references were corrected.
The changes of this revision have no impact on the test results obtained with reference to the version
EN 14476:2013+A2:2019. Those results are still valid with the exception of test reports using gel
filtration detoxification, which do not provide a parallel titration of the non-detoxified test mixture.
Other methods to evaluate the efficacy of chemical disinfectants and antiseptics for different applications
in the medical area are in preparation.
Introduction
This document specifies a suspension test for establishing whether a chemical disinfectant or an
antiseptic has a virucidal 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 virucidal 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, i.e, products that are not diluted when applied,
– with water. Ready-to-use-products can only be tested at a concentration up to 80 % (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, instrument disinfection by immersion, surface disinfection by wiping, spraying,
flooding or other means and textile disinfection.
This document applies to areas and situations where disinfection 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 th
...
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