EN 14476:2013+A1:2015/FprA2:2018

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
• ICS: 11.080.20 - Disinfectants and antiseptics
• 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: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 14476:2013+A1:2015/kFprA2:2018 - 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)

Relations

• Merged Into: EN 14476:2013+A2:2019 - 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)
• Effective Date: 15-May-2019
• Amends: EN 14476:2013+A1:2015 - 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)
• Effective Date: 10-Aug-2016

Overview

EN 14476:2013+A1:2015/FprA2:2018 is a critical European Standard developed by CEN for assessing the virucidal efficacy of chemical disinfectants and antiseptics in the medical field. This standard defines a quantitative suspension test (Phase 2/Step 1), including test methods and minimum requirements to validate the virucidal activity of products. It covers products that remain physically stable when diluted with hard water or are applied ready-to-use without dilution.

The standard is applicable to a wide variety of disinfection processes-hygienic handrub, handwash, instrument immersion, surface disinfection (wiping, spraying, flooding), and textile treatment. It focuses on environments where disinfection is medically indicated, such as hospitals, dental clinics, nursing homes, schools, workplaces, and even domestic settings.

Key Topics

• Scope and Application
  EN 14476 targets disinfectants and antiseptics designed for the medical area, ensuring their efficacy against viruses under real-use conditions. It covers various disinfection modes including hand hygiene, instrument sterilization, surface, and textile disinfection.

• Virucidal Activity Testing
  The standard specifies procedures to test products against a range of viruses including:

  • Poliovirus, Adenovirus, Murine Norovirus (limited spectrum virucidal activity)
  • Enveloped viruses such as Vaccinia Virus (virucidal activity against enveloped viruses) The use of the Modified Vaccinia Virus Ankara (MVA) and Vaccinia Virus Elstree strain are included as test organisms.

• Test Conditions
  Testing must be performed at a product concentration of 80%, or 97% for ready-to-use products, considering the unavoidable dilution during testing. Both clean and dirty conditions are simulated using bovine albumin solutions with or without erythrocytes to replicate realistic contamination scenarios.

• Large-Volume-Plating (LVP) Method
  This advanced method improves detection sensitivity for residual virus titers, enabling precise calculation of virucidal efficacy based on viral infectivity reduction using Poisson distribution and Taylor series formulas.

• Requirements and Contact Times
  The standard outlines contact times that vary according to product use (e.g., surface disinfectants frequently touching patients require a maximum contact time of 5 minutes). The minimum contact times and temperatures depend on the specific product application and the manufacturer’s recommendations.

Applications

• Medical Facility Hygiene
  EN 14476 supports the evaluation of disinfectants for hospitals, community healthcare centers, dental offices, nursing homes, and clinics, ensuring the safe elimination of viral pathogens from hands, instruments, surfaces, and textiles.

• Hand Hygiene Products
  Products intended for hygienic handrubs and handwashes undergo rigorous testing to verify rapid and effective viral inactivation, essential for infection control.

• Instrument and Surface Disinfection
  The standard ensures that disinfectants used for medical instruments and surfaces meet virucidal efficacy requirements under defined contact times and conditions, safeguarding patient and staff safety.

• Domestic and Workplace Use
  Disinfectants for use in homes, workplaces, laundries, and kitchens supplying products for patients also benefit from validation under EN 14476, ensuring reliable virucidal performance.

Related Standards

• EN 14885
  Provides comprehensive guidance on the interrelationship of multiple chemical disinfectant and antiseptic testing methods and their respective “use recommendations.” EN 14476 is referenced within EN 14885 as a Phase 2, Step 1 test.

• EN 13727 and EN 13624
  These standards cover bactericidal and fungicidal testing methods of chemical disinfectants, complementing EN 14476’s focus on virucidal activity.

• ISO 21702
  Addresses antiviral testing on surfaces and can be used alongside EN 14476 to evaluate virucidal performance in different contexts.

Summary

EN 14476:2013+A1:2015/FprA2:2018 is an essential benchmark for the development, testing, and validation of chemical disinfectants and antiseptics with proven virucidal activity for medical applications. Its rigorous quantitative suspension test method supports infection control by ensuring products effectively inactivate viruses in real-world healthcare and community settings. Compliance with EN 14476 not only enhances patient safety but also aligns with European healthcare regulations and hygiene standards.

Keywords: EN 14476 standard, virucidal activity test, chemical disinfectants, antiseptics, medical disinfection, suspension test, Vaccinia Virus, Modified Vaccinia Virus Ankara, instrument disinfection, surface disinfection, hygienic handrub, textile disinfection, European Standard CEN, Phase 2 Step 1 test.

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 14476:2013+A1:2015/oprA2:2017
01-januar-2017
.HPLþQDUD]NXåLODLQDQWLVHSWLNL.YDQWLWDWLYQLVXVSHQ]LMVNLSUHVNXV]D
YUHGQRWHQMHYLUXFLGQHJDGHORYDQMDYPHGLFLQL3UHVNXVQDPHWRGDLQ]DKWHYHID]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
...