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CEN

EN 14476:2005

(Main)

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 virucidnosti kemičnih razkužil in antiseptikov, ki se uporabljajo v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)

General Information

Status
Withdrawn
Publication Date
19-Apr-2005
Withdrawal Date
24-Oct-2006
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
9960 - Withdrawal effective - Withdrawal
Start Date
25-Oct-2006
Completion Date
25-Oct-2006
Ref Project
SIST EN 14476:2005 - 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

Merged Into
EN 14476:2005+A1:2006 - 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
18-Jan-2023
Amended By
EN 14476:2005/prA1 - 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
22-Dec-2008

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.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 quantitatif de suspension pour les antiseptiques et désinfectants chimiques utilisés en médecine humaine - Méthode d'essai et prescriptions (phase 2, étape 1)Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch Viruzidie für in der Humanmedizin verwendete chemische Desinfektionsmittel und Antiseptika - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)Ta slovenski standard je istoveten z:EN 14476:2005SIST EN 14476:2005English
or
French or German
language11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:SLOVENSKI
STANDARDSIST EN 14476:200501-junij-2005







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14476April 2005ICS 11.080.20English versionChemical disinfectants and antiseptics - Virucidal quantitativesuspension test for chemical disinfectants and antiseptics usedin human medicine - Test method and requirements (phase 2,step 1)Antiseptiques et désinfectans chimique - Essai quantitatifde suspension virucide pour les antiseptiques etdésinfectants chimiques utilisés en médecine humaine -Méthode d'essai et exigences (phase 2, étape 1)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Suspensionsversuch Viruzidie für in derHumanmedizin verwendete chemische Desinfektionsmittelund Antiseptika - Prüfverfahren und Anforderungen (Phase2, Stufe 1)This European Standard was approved by CEN on 3 March 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2005 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14476:2005: E



EN 14476:2005 (E) 2 Contents Page Foreword.3 1 Scope.4 2 Normative references.4 3 Terms and definitions.4 4 Requirements.6 5 Materials and reagents.6 6 Test method (general).11 7 Test protocols with specific test viruses for specified intended use.15 8 Calculation and expression of results.18 9 Expression of results.19 Annex A (normative)
Detoxification of test mixtures by molecular sieving.21 Annex B (informative)
Examples of viruses which may contaminate human medical instruments, hands, surfaces.23 Annex C (informative)
Calculation of th
...

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