EN 14476:2013+A1:2015/FprA2:2018
(Amendment)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)
This European Standard 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. Products can only be tested at a concentration of 80 % (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard 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 European Standard 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 may occur in the workplace and in the home. It may 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.
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 Produkte können nur bei einer Konzentration von 80 % (97 % bei einem modifizierten Verfahren für Sonderfälle) geprüft werden, da durch Zugabe der Prüfkeime und der Belastungssubstanz immer eine gewisse Verdünnung bewirkt wird.
Diese Europäische Norm 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.
Diese Europäische Norm 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 Zubereitungen 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)
La présente Norme européenne 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 ne peuvent être soumis à essai qu’à une concentration de 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.
La présente Norme européenne 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.
La présente Norme européenne 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) - Dopolnilo A2
General Information
- Status
- Not Published
- Technical Committee
- CEN/TC 216 - Chemical disinfectants and antiseptics
- Drafting Committee
- CEN/TC 216/WG 1 - Human medicine
- Current Stage
- 5060 - Closure of Vote - Formal Approval
- Start Date
- 13-Sep-2018
- Due Date
- 22-Oct-2018
- Completion Date
- 13-Sep-2018
- Directive
- Not Harmonized93/42/EEC - Medical devices
Relations
- Effective Date
- 15-May-2019
- Effective Date
- 10-Aug-2016
Overview
EN 14476:2013+A1:2015/FprA2:2018 is a crucial European standard developed by CEN for evaluating the effectiveness of chemical disinfectants and antiseptics against viruses in the medical field. This standard prescribes a quantitative suspension test (Phase 2/Step 1) to assess the virucidal activity of products intended for hygienic handrub, handwash, instrument disinfection, surface disinfection, and textile disinfection. EN 14476 covers products that form homogeneous, stable preparations when diluted, as well as ready-to-use solutions. By outlining mandatory test methods and minimum requirements, the standard helps ensure safety and efficacy in medical environments such as hospitals, clinics, schools, nursing homes, and related services like laundries and kitchens.
Key Topics
- Virucidal Activity Testing: Specifies how to test chemical disinfectants and antiseptics for their ability to inactivate viruses under standardized laboratory conditions, ensuring reliable and comparable results.
- Scope of Application: The standard applies to products used for hand hygiene, surface cleaning and disinfection, instrument immersion, textile disinfection, and more within medical, dental, and associated care settings.
- Test Methodology: Products are generally tested at an 80% concentration, with a 97% concentration allowed in special cases, to accommodate dilution during testing.
- Minimal Requirements: Defines the minimum requirements for virucidal efficacy that products must meet to be considered effective.
- Interfering Substances and Conditions: Establishes "clean" and "dirty" scenarios by introducing substances like bovine albumin and erythrocytes, mimicking conditions that disinfectants encounter in real-use settings.
- Test Organisms: Outlines the viruses and cell lines to be used, including references to specific vaccinia virus strains, adenovirus, murine norovirus, and others for different disinfection scenarios.
- Detection and Calculation Methods: Covers methods such as the large-volume-plating (LVP) technique to determine residual virus and ensure accurate assessment of disinfectant performance.
Applications
EN 14476 is widely adopted across the healthcare sector to:
- Evaluate Disinfectant Efficacy: Manufacturers and users rely on this standard to confirm product claims regarding virucidal activity, supporting product registration and regulatory compliance.
- Guide Product Selection: Hospitals, clinics, dental offices, and care institutions use this standard to select appropriate disinfectant and antiseptic products, ensuring effective infection prevention and control.
- Hygiene Protocol Development: Infection control teams use EN 14476 results to build evidence-based cleaning routines for surfaces, medical instruments, and textiles, especially in environments where risk of viral transmission is high.
- Quality Assurance: Laboratories and manufacturers use these protocols for batch testing, product development, and quality assurance programs to maintain high standards in health and safety.
Related Standards
Understanding EN 14476 in context is important for compliance and best practice:
- EN 14885: Details the relationship of various European standards for chemical disinfectants and antiseptics and provides guidance on "use recommendations".
- EN 13727: Focuses on bactericidal activity of chemical disinfectants and antiseptics in the medical area.
- EN 13624: Specifies fungicidal and yeasticidal test methods.
- ISO 18184: Covers methods for determining antiviral activity on textiles.
By integrating EN 14476 with related standards, organizations can ensure a comprehensive approach to infection prevention, workplace safety, and compliance with national and EU guidelines for medical disinfectants and antiseptics.
Keywords: EN 14476, virucidal activity, chemical disinfectants, antiseptics, quantitative suspension test, healthcare hygiene, infection prevention, surface disinfection, medical area, CEN standards.
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Frequently Asked Questions
EN 14476:2013+A1:2015/FprA2:2018 is a draft published by the European Committee for Standardization (CEN). Its full title is "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)". This standard covers: This European Standard 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. Products can only be tested at a concentration of 80 % (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This European Standard 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 European Standard 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 may occur in the workplace and in the home. It may 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. NOTE 3 EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
This European Standard 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. Products can only be tested at a concentration of 80 % (97 %, with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance. This European Standard 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 European Standard 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 may occur in the workplace and in the home. It may 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. NOTE 3 EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
EN 14476:2013+A1:2015/FprA2:2018 is classified under the following ICS (International Classification for Standards) categories: 11.080.20 - Disinfectants and antiseptics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 14476:2013+A1:2015/FprA2:2018 has the following relationships with other standards: It is inter standard links to EN 14476:2013+A2:2019, EN 14476:2013+A1:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 14476:2013+A1:2015/FprA2:2018 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 14476:2013+A1:2015/FprA2:2018 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 14476:2013+A1:2015/oprA2:2017
01-januar-2017
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YUHGQRWHQMHYLUXFLGQHJDGHORYDQMDYPHGLFLQL3UHVNXVQDPHWRGDLQ]DKWHYH ID]D
VWRSQMD 'RSROQLOR$
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: EN 14476:2013+A1:2015/prA2
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
SIST EN en,fr,de
14476:2013+A1:2015/oprA2:2017
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN 14476:2013+A1:2015/oprA2:2017
SIST EN 14476:2013+A1:2015/oprA2:2017
DRAFT
EUROPEAN STANDARD
EN 14476:2013+A1:2015
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA2
November 2016
ICS 11.080.20
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 amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 216.
This draft amendment A2, if approved, will modify the European Standard EN 14476:2013+A1:2015. If this draft becomes an
amendment, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration.
This draft amendment 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14476:2013+A1:2015/prA2:2016 E
worldwide for CEN national Members.
SIST EN 14476:2013+A1:2015/oprA2:2017
EN 14476:2013+A1:2015/prA2:2016 (E)
Contents Page
European foreword . 3
1 Modifications to the Foreword . 4
2 Modifications to Clause 4, Table 1 . 4
3 Modification to 5.2.1 c) 1) . 5
4 Modification to 5.2.2.8.3 . 5
5 Modification to 5.5.1.1 e) . 5
6 Modification of 5.5.4.3 . 6
7 Modification to 5.5.5.1 . 6
8 Modification of Annex B . 6
B.3 Determination of the residual virus titre by the large-volume-plating (LVP) method . 6
B.3.1 General . 6
B.3.2 Example for the calculation of titres and the reduction according to the large-
volume-plating method . 7
SIST EN 14476:2013+A1:2015/oprA2:2017
EN 14476:2013+A1:2015/prA2:2016 (E)
European foreword
This document (EN 14476:2013+A1:2015/prA2:2016) 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+A1:2015.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
SIST EN 14476:2013+A1:2015/oprA2:2017
EN 14476:2013+A1:2015/prA2:2016 (E)
1 Modifications to the Foreword
Add the following to the existing list of modifications: “
• For the surface disinfection a test for virucidal activity against enveloped viruses with Vaccinia Virus
was added.
• The spelling of Vaccinavirus is corrected to Vaccinia Virus (Table 1).
• The Vaccinia Virus Elstree was added as alternative strain (5.2.1 c) 1)), (5.5.1.1 e)).
• For dirty conditions (5.2.2.8.3) the resuspension shall be done in PBS and not in water.
• The dilution in ice-cold medium for the control of efficiency of suppression of products activity
(5.5.5.1) was clarified.
• Addition of the large-volume-platting method (5.5.4.3, B.3).”.
2 Modifications to Clause 4, Table 1
a
In Table 1, 4th column, add “Limited spectrum virucidal activity ”, “Adenovirus, Murine Norovirus”,
b
“Virucidal activity against enveloped viruses ” and “Vaccinia Virus” to read as follows:
“Table 1 — Minimum and additional test conditions
Test Hygienic handrub Instrument Surface Textile
Conditions and handwash disinfection disinfection
disinfection
Minimum Poliovirus Poliovirus Poliovirus Parvovirus
spectrum of
Adenovirus Adenovirus Adenovirus
test organisms
Murine Norovirus Murine Norovirus Murine Norovirus
Limited spectrum when temperature is Limited spectrum
a a
virucidal activity 40 °C or higher: only virucidal activity
Adenovirus Parvovirus Adenovirus
Murine Norovirus Murine Norovirus
!Virucidal Virucidal activity
activity against against enveloped
b b
enveloped viruses viruses
Vaccinia Virus" Vaccinia Virus
additional Any relevant test organism
Test
according to the manufacturer’s recommendation, but at / between
temperature
20 °C 20 °C and 70 °C 4 °C and 30 °C 30 °C and 70 °C
Contact time according to the manufacturer’s recommendation
but between but no longer than but no longer than but no longer than
30 s and 120 s 60 min 5 min or 20 min
c
60 min
Interfering substance
SIST EN 14476:2013+A1:2015/oprA2:2017
EN 14476:2013+A1:2015/prA2:2016 (E)
Test Hygienic handrub Instrument Surface Textile
Conditions and handwash disinfection disinfection
disinfection
clean 0,3 g/l bovine 0,3 g/l bovine 0,3 g/l bovine
conditions albumin solution albumin solution albumin solution
d
(hygienic handrub)
and/or and/or
dirty 3,0 g/l bovine 3,0 g/l bovine 3,0 g/l bovine 3,0 g/l bovine
conditions albumin solution albumin solution album
...
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