EN 14476:2005/FprA2
(Amendment)Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1)
This document specifies test methods and minimum requirements for virucidal activity of chemical disinfectants or antiseptic products for instruments, surfaces, laundry or hands that form a homogeneous physically stable preparation in water.
This document is applicable to a broad spectrum of viruses (see Annex B) and to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
¾ in hospitals, in community medical facilities, and in dental institutions;
¾ clinics of schools, kindergartens, and 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.
It is impossible to determine the virucidal activity of the undiluted product as some dilution is always produced by adding the inoculum. However, a disinfectant or antiseptic which is used in undiluted form is tested in 80% concentration and shall pass this test prior to further assessment.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch Viruzidie für in der Humanmedizin verwendete chemische Desinfektionsmittel und Antiseptika - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Dieses Dokument legt Prüfverfahren und Mindestanforderungen an die viruzide Wirkung von chemischen Desinfektionsmitteln oder Antiseptika für Instrumente, Oberflächen oder Hände fest, die in Wasser als homogenes, physikalisch stabiles Präparat vorliegen.
Dieses Dokument ist auf ein breites Spektrum von Viren (siehe Anhang B) und auf Bereiche und Bedingungen anwendbar, wo eine Desinfektion aus medizinischen Gründen indiziert ist. Solche Indikationen ergeben sich bei der Versorgung von Patienten, beispielsweise
- 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.
Eine Bestimmung der viruziden Wirkung des unverdünnten Produktes ist nicht möglich, da durch Zugabe des Inokulums immer eine bestimmte Verdünnung bewirkt wird. Jedoch wird ein Desinfektionsmittel oder Antiseptikum, das in unverdünnter Form verwendet wird, in 80 %iger Konzentration geprüft und muss vor weiterer Bewertung diese Prüfung bestehen.
Antiseptiques et désinfectants chimiques - Essai virucide quantitatif de suspension pour les antiseptiques et désinfectants chimiques utilisés en médecine humaine - Méthode d'essai et prescriptions (phase 2, étape 1)
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus virucidnega delovanja kemičnih razkužil in antiseptikov v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)
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
- 5098 - Decision to abandon - Formal Approval
- Start Date
- 12-Feb-2010
- Completion Date
- 12-Feb-2010
Relations
- Effective Date
- 08-Jun-2022
Overview
EN 14476:2005/FprA2 is a CEN draft amendment to the European standard for a virucidal quantitative suspension test (Phase 2, Step 1). It specifies test methods and minimum requirements to assess the virucidal activity of chemical disinfectants and antiseptics used in human medicine. The standard applies to homogeneous, water‑based preparations intended for instruments, surfaces, laundry or hands and covers a broad spectrum of viruses (see Annex B).
Key topics and requirements
- Scope and applicability: Products for hospitals, dental institutions, clinics, schools, kindergartens, nursing homes, workplaces, homes, laundries and kitchens supplying patient products.
- Test type: Quantitative suspension test (Phase 2, Step 1) to determine virucidal activity under defined conditions.
- Product form: Applicable to preparations that form a homogeneous, physically stable solution in water.
- Undiluted products: Because adding the inoculum produces dilution, products normally used undiluted are tested at 80% concentration and must pass this test before further assessment.
- Virus panel: Designed to assess activity against a broad spectrum of viruses (Annex B). The amendment updates test virus details:
- Poliovirus type 1 strain replaced by strain Chat (ATCC VR-1562).
- Reference virus suspension and cell lines: Modifications clarify reference virus handling and recommend sensitive cell lines for poliovirus (e.g., ATCC LC-MK2, VERO, HeLa).
- Minimum requirements: The document sets performance thresholds and procedural requirements (test conditions, controls and validation criteria) to demonstrate virucidal efficacy - as required for medical disinfection use.
Practical applications and users
Who uses EN 14476:2005/FprA2:
- Manufacturers and formulators of chemical disinfectants and antiseptics seeking virucidal claims for human medical use.
- Accredited testing laboratories and contract research organizations performing suspension tests.
- Infection control teams, hospitals and public health authorities evaluating product selection for clinical settings.
- Regulatory bodies and standards committees assessing compliance and product labeling.
- Service providers such as medical laundries and catering services supplying patient care environments.
Benefits:
- Provides a harmonized, reproducible method to verify virucidal performance.
- Supports product validation for clinical and public health infection‑prevention measures.
Related standards
- EN 14476:2005 and amendment EN 14476:2005+A1:2006 (as referenced in the draft)
- Developed under CEN/TC 216 (Chemical disinfectants and antiseptics)
Keywords: EN 14476:2005/FprA2, virucidal, quantitative suspension test, disinfectants, antiseptics, phase 2 step 1, poliovirus Chat ATCC VR-1562, medical disinfection.
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
EN 14476:2005/FprA2 is a draft published by the European Committee for Standardization (CEN). Its full title is "Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for chemical disinfectants and antiseptics used in human medicine - Test method and requirements (phase 2, step 1)". This standard covers: This document specifies test methods and minimum requirements for virucidal activity of chemical disinfectants or antiseptic products for instruments, surfaces, laundry or hands that form a homogeneous physically stable preparation in water. This document is applicable to a broad spectrum of viruses (see Annex B) and to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: ¾ in hospitals, in community medical facilities, and in dental institutions; ¾ clinics of schools, kindergartens, and 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. It is impossible to determine the virucidal activity of the undiluted product as some dilution is always produced by adding the inoculum. However, a disinfectant or antiseptic which is used in undiluted form is tested in 80% concentration and shall pass this test prior to further assessment.
This document specifies test methods and minimum requirements for virucidal activity of chemical disinfectants or antiseptic products for instruments, surfaces, laundry or hands that form a homogeneous physically stable preparation in water. This document is applicable to a broad spectrum of viruses (see Annex B) and to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: ¾ in hospitals, in community medical facilities, and in dental institutions; ¾ clinics of schools, kindergartens, and 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. It is impossible to determine the virucidal activity of the undiluted product as some dilution is always produced by adding the inoculum. However, a disinfectant or antiseptic which is used in undiluted form is tested in 80% concentration and shall pass this test prior to further assessment.
EN 14476:2005/FprA2 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 14476:2005/FprA2 has the following relationships with other standards: It is inter standard links to EN 14476:2005+A1:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 14476:2005/FprA2 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
01-junij-2009
.HPLþQDUD]NXåLODLQDQWLVHSWLNL.YDQWLWDWLYQLVXVSHQ]LMVNLSUHVNXVYLUXFLGQHJD
GHORYDQMDNHPLþQLKUD]NXåLOLQDQWLVHSWLNRYYKXPDQLPHGLFLQL3UHVNXVQDPHWRGD
LQ]DKWHYH ID]DVWRSQMD
Chemical disinfectants and antiseptics - Virucidal quantitative suspension test for
chemical disinfectants and antiseptics used in human medicine - Test method and
requirements (phase 2, step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch
Viruzidie für in der Humanmedizin verwendete chemische Desinfektionsmittel und
Antiseptika - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Antiseptiques et désinfectants chimiques - Essai virucide quantitatif de suspension pour
les antiseptiques et désinfectants chimiques utilisés en médecine humaine - Méthode
d'essai et prescriptions (phase 2, étape 1)
Ta slovenski standard je istoveten z: EN 14476:2005/FprA2
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 14476:2005+A1:2006
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA2
April 2009
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Virucidal quantitative
suspension test for chemical disinfectants and antiseptics used
in human medicine - Test method and requirements (phase 2,
step 1)
Antiseptiques et désinfectants chimiques - Essai virucide Chemische Desinfektionsmittel und Antiseptika -
quantitatif de suspension pour les antiseptiques et Quantitativer Suspensionsversuch Viruzidie für in der
désinfectants chimiques utilisés en médecine humaine - Humanmedizin verwendete chemische Desinfektionsmittel
Méthode d'essai et prescriptions (phase 2, étape 1) und Antiseptika - 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 A2, if approved, will modify the European Standard EN 14476:2005+A1:2006. 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 mem
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...