SIST EN 14476:2005/kFprA2:2009

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
• Public Enquiry End Date: 09-Jul-2009
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 27-Aug-2010
• Due Date: 01-Sep-2010
• Completion Date: 27-Aug-2010
• Ref Project: EN 14476:2005/FprA2 - 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)

Relations

• Revised: SIST EN 14476:2005+A1:2007 - 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)
• Effective Date: 01-Jun-2009

Overview

SIST EN 14476:2005/kFprA2:2009 outlines standardized test methods and minimum requirements for assessing the virucidal activity of chemical disinfectants and antiseptics used in human medicine. Developed by the Slovenian Institute for Standardization (SIST) and aligned with European standards, this document is crucial for evaluating products intended for infection prevention in a variety of healthcare, community, and domestic settings. The standard applies to products tested as stable, homogeneous preparations in water and addresses their effectiveness against a broad spectrum of viruses.

Key Topics

• Virucidal Quantitative Suspension Test: The standard details step-by-step laboratory procedures (phase 2, step 1) for testing the efficacy of chemical disinfectants and antiseptics.
• Tested Viruses: The standard applies to many significant viruses relevant to healthcare situations (see referenced Annex B in the complete text).
• Test Product Preparation: Only physically stable, homogeneous products dissolved in water are tested, simulating real-world use.
• Minimum Performance Requirements: Specifies the minimum virucidal effectiveness needed for a disinfectant or antiseptic to be considered compliant.
• Concentration and Dilution: Products specified for undiluted use are tested at 80% concentration due to inevitable dilution during the test inoculum process.

Applications

SIST EN 14476:2005/kFprA2:2009 is relevant in diverse settings where infection prevention is critical, including:

• Hospitals and Clinics: Disinfectant and antiseptic efficacy testing for surfaces, instruments, and hands in medical environments.
• Dental Offices and Nursing Homes: Helps ensure products used in vulnerable populations meet virucidal standards.
• Community Medical Facilities and Schools: Appropriate for clinics in schools, kindergartens, and other community care environments.
• Workplaces and Domestic Use: Serves as a reference for disinfectants used in workplaces, homes, kitchens, and laundries supplying healthcare services.

By following this standard, manufacturers, healthcare administrators, and cleaning service providers can ensure that disinfectants and antiseptics meet recognized European requirements for controlling viral contamination. Compliance supports public health, regulatory approval, and product communication in the market.

Related Standards

For comprehensive chemical disinfectant and antiseptic compliance, consider these connected standards:

• EN 14885: Application of European Standards for chemical disinfectants and antiseptics.
• EN 13727: Bactericidal efficacy testing under medical conditions.
• EN 13624: Fungicidal and yeasticidal efficacy tests.
• EN 1500: Hygienic handrub efficacy testing.
• EN 12791: Surgical hand disinfection procedures.

SIST EN 14476:2005/kFprA2:2009 fits into a broader framework of infection prevention and control standards, enabling consistent evaluation across product types and use cases in healthcare and public environments.

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Keywords: chemical disinfectants, antiseptics, virucidal activity, quantitative suspension test, human medicine, infection control, EU standard, medical disinfection, SIST EN 14476, healthcare hygiene, surface disinfection, instrument hygiene, public health standards.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2009
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GHORYDQMDNHPLþQLKUD]NXåLOLQDQWLVHSWLNRYYKXPDQLPHGLFLQL3UHVNXVQDPHWRGD
LQ]DKWHYHID]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
...