EN 14476:2013/FprA1

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.

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)

Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje virucidnega delovanja v medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)

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: 26-Jun-2015
• Due Date: 08-Jun-2016
• Completion Date: 26-Jun-2015
• 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/kFprA1:2015 - 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)

Relations

• Merged Into: 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: 19-Jan-2023
• Amends: EN 14476:2013 - 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: 05-Dec-2014

EN 14476:2013/FprA1 - Virucidal Activity Test for Chemical Disinfectants and Antiseptics

Overview

EN 14476:2013/FprA1 is a European Standard developed by CEN Technical Committee 216, specifying a quantitative suspension test for assessing virucidal activity of chemical disinfectants and antiseptic products in medical settings. This standard outlines the test method and minimum efficacy requirements (Phase 2/Step 1). It applies to products intended for use in hygienic handrub, handwash, instrument disinfection, surface and textile disinfection within health care environments.

The standard targets disinfectants and antiseptics that either form stable homogeneous solutions when diluted or are ready-to-use products. Testing is typically performed at concentrations around 80%, considering dilution effects from test organisms and interfering substances.

Key Topics

• Scope of Application: Covers chemical disinfectants used in hospitals, clinics, dental care, nursing homes, schools, workplaces, and home environments where medical disinfection is necessary. This includes surface wiping, immersion, spraying, and textile treatments.

• Virucidal Spectrum: The test evaluates activity against enveloped and non-enveloped viruses. A significant update is the inclusion of testing against enveloped viruses using Vacciniavirus (strain Ankara, MVA) to ensure efficacy against all enveloped viruses.

• Test Conditions: Defined minimum and additional test conditions include:

  • Test organisms such as poliovirus, adenovirus, murine norovirus, parvovirus, and Vacciniavirus.
  • Test temperatures ranging between 4°C and 70°C depending on application.
  • Contact times varying from 30 seconds up to 60 minutes based on product type and use scenario.
  • Interfering substances to simulate clean or dirty environments using bovine albumin and erythrocytes to reflect real-world conditions.

• Methodology Amendments:

  • Multiplication of viruses in specific cell lines for sensitivity, including BHK-21 for Vacciniavirus.
  • Adjusted calculation parameters for viral titre reduction to ensure methodological accuracy.
  • Clear guidelines on acceptable variation ranges in virus titre reduction after exposure to disinfectants.

• Regulatory Alignment: Supports conformity with EU Directive 93/42/EEC (Medical Device Directive), helping manufacturers demonstrate virucidal efficacy as part of medical device compliance.

Applications

EN 14476:2013/FprA1 is essential for manufacturers and regulators to establish the virucidal efficacy of chemical disinfectants and antiseptic products. Typical applications include:

• Hygienic Hand Disinfection: Validation of handrub and handwash formulations ensuring virus inactivation under hygienic conditions.

• Instrument Disinfection: Ensuring effective viral decontamination of reusable medical instruments through immersion processes.

• Surface and Textile Disinfection: Verification of efficacy against medically relevant viruses on surfaces frequently contacted by patients and staff, as well as textiles used in medical facilities.

• Healthcare Settings: Applicable in hospitals, clinics, dental practices, nursing homes, and community healthcare facilities.

• Supporting Infection Control: Critical in preventing virus transmission in health care and other environments requiring stringent disinfection protocols.

Related Standards

• Phase 2, Step 2 European Standards: Often used in conjunction with EN 14476 to confirm performance evaluation in practical use conditions.

• Other CEN Chemical Disinfectant Standards: Complementary standards specifying requirements for bactericidal, fungicidal, and sporicidal activity.

• EU Directives: EN 14476 harmonizes product testing with Medical Device Directive 93/42/EEC essential requirements, facilitating regulatory acceptance.

Keywords

Chemical disinfectants, antiseptics, virucidal activity, quantitative suspension test, medical disinfection, EN 14476, Vacciniavirus, enveloped viruses, medical device compliance, hygiene handrub, instrumental disinfection, surface disinfection, textile disinfection, CEN standards, EU Directive 93/42/EEC.

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By adhering to EN 14476:2013/FprA1, manufacturers and healthcare providers can ensure their disinfectant products effectively inactivate viruses in medical environments, supporting infection prevention and patient safety. This standard provides a robust, scientifically validated framework for virucidal efficacy testing demanded by European regulations and best practices.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2015
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YUHGQRWHQMHYLUXFLGQHJDGHORYDQMDYPHGLFLQL3UHVNXVQDPHWRGDLQ]DKWHYHID]D
VWRSQMD
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/FprA1
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 14476:2013
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
March 2015
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 quantitatif Chemische Desinfektionsmittel und Antiseptika -
de suspension pour l'évaluation de l'activité virucide dans le Quantitativer Suspensionsversuch zur Bestimmung der
domaine médical - Méthode d'essai et prescriptions (Phase viruziden Wirkung im humanmedizinischen Bereich -
2/Étape 1) Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 216.
This draft amendment A1, if approved, will modify the European Standard EN 14476:2013. 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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14476:2013/FprA:2015 E
worldwide for CEN national Members.

Contents
Page
Foreword .3
1 Modifications to Foreword .4
2 Modifications to Clause 4, Table 1 .4
3 Modifications to 5.2.1 .5
4 Modification to 5.5.1.1 .5
5 Modification to 5.5.4.1 .6
6 Modification to 5.7 .6
7 Modification to C.1 .6
8 Addition of an Annex ZA .6

Foreword
This document (EN 14476:2013/FprA1:2015) 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 Unique Acceptance Procedure.
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).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
NOTE Due to fact that the EC has not yet been able to confirm the financial commitment for the New Approach
Consultants’ work in 2015, there are currently no New Approach Consultants in place for 2015. Therefore the provisions of
CEN-CENELEC Guide 15 cannot be met.
This shall not prevent the processing of draft standards nor the offering of harmonized standards to the European
Commission. In particular, draft standards can be sent to vote without Consultant assessment.
This note will be removed from the Foreword of the finalized publication.

1 Modifications to Foreword
Add the following new paragraphs:
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).
For relationship with EU Directive(s), see informative Annex ZA, whichwhich is an integral part of this
document.
Add the following to the existing list of modifications :
"• For the hygienic handrub and handwash method a test for virucidal activity against enveloped viruses
with Vacciniavirus was added.
• The relationship between this Europaen Standard and the MDD was added (For
...