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CEN

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
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
5098 - Decision to abandon - Formal Approval
Start Date
12-Feb-2010
Completion Date
12-Feb-2010
Ref Project
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)

Relations

Amends
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
08-Jun-2022

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EN 14476:2005/kFprA2:2009 - osnova: EN 14476:2005+A1:2006/FprA2:2009EN 14476:2005/kFprA2:2009 - osnova: EN 14476:2005+A1:2006/FprA2:2009
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EN 14476:2005/kFprA2:2009 - osnova: EN 14476:2005+A1:2006/FprA2:2009
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Standards Content (Sample)


SLOVENSKI STANDARD
01-junij-2009
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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
...

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