EN 14476:2005+A1:2006
(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 a test method and the minimum requirements for virucidal activity of chemical disinfectants or antiseptic products for instruments, surfaces or hands that form a homogeneous physically stable preparation when diluted with hard water – or in the case of ready-to-use products - with water.
This document is applicable to a broad spectrum of viruses (Annex B) and 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.
It is impossible to determine the virucidal activity of the undiluted product as some dilution is always produced by adding the inoculum and interfering substance. 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.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2, step 1 test (see Annex F).
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 ein Prüfverfahren und die Mindestanforderungen an die viruzide Wirkung von chemischen Desinfektionsmitteln oder Antiseptika für Instrumente, Oberflächen oder Hände fest, die in Wasser standardisierter Härte oder im Falle von gebrauchsfertigen Produkten 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 und der Belastungssubstanz 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.
ANMERKUNG 1 Das beschriebene Verfahren dient zur Bestimmung der Wirksamkeit kommerziell erhältlicher Zuberei¬tungen oder Wirkstoffe unter den Bedingungen, unter denen sie angewendet werden.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 1 (siehe Anhang F).
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)
Le présent document spécifie une méthode d'essai et les prescriptions minimales relatives à l'activité virucide des antiseptiques ou désinfectants chimiques pour instruments, surfaces ou mains qui forment une préparation homogène et physiquement stable lorsque dilués avec de l'eau dure ou dans le cas de produits prêts à l'emploi avec de l'eau.
Le présent document s'applique à un spectre étendu de virus (Annexe B) et aux domaines et situations où la désinfection est indiquée. De telles indications se produisent pour les soins des patients, par exemple :
- dans les hôpitaux, les centres médicaux communautaires, et les institutions dentaires ;
- dans les cliniques d'écoles, de jardins d'enfants et de maison de soins infirmiers ;
et peuvent se produire sur le lieu de travail et à la maison. Elles peuvent également inclure les services tels que les blanchisseries et les cuisines fournissant directement des produits aux patients.
Il est impossible de déterminer l'activité virucide d’un produit non dilué car une dilution est toujours réalisée par addition de l'inoculum et de la substance interférente. Cependant, un désinfectant ou antiseptique utilisé sous forme non diluée est soumis à essai en concentration de 80 % et doit passer cet essai avant toute évaluation supplémentaire.
NOTE 1 La méthode décrite a pour objet de déterminer l'activité de formulations commerciales ou de substances actives dans leurs conditions d'emploi.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 1 (voir Annexe F).
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)
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Standards Content (Sample)
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 14476:2005+A1:2006SIST EN 14476:2005+A1:2007en;fr;de11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:SIST EN 14476:20051DGRPHãþDSLOVENSKI
STANDARDSIST EN 14476:2005+A1:200701-april-2007
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14476:2005+A1
October 2006 ICS 11.080.20 Supersedes EN 14476:2005English 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 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) This European Standard was approved by CEN on 3 March 2005 and includes Amendment 1 approved by CEN on 28 September 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards 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 translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36
B-1050 Brussels © 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14476:2005+A1:2006: E
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 the viral infectivity titre.25 Annex D (informative)
Presentation of test results of one active concentration.27 Annex E (informative)
Quantitative determination of formaldehyde concentrations.30 Annex F (informative)
Information on the application and interpretation of European standards on chemical disinfectants and antiseptics.31 Bibliography.33
3.2 cytotoxicity morphological alteration of cells and/or their destruction or their reduced sensitivity to virus multiplication caused by the product
3.3 dirty conditions conditions representative of surfaces which are known to or may contain organic and/or inorganic substances
3.4 inactivation of viruses reduction of infectivity of a virus by a product NOTE Alteration of antigenic reactivity or of any viral component does not necessarily mean reduction of infectivity of a virus.
chemical agent or formulation used as a chemical disinfectant or antiseptic 3.8 reference virus inactivation test test with a defined product (e.g. formaldehyde) in parallel with a product under test for the internal control of the test 3.9 TCID50 50 % infecting dose of a virus suspension or that dilution of the virus suspension that induce a CPE (see 3.10) in 50 % of cell culture units 3.10 viral cytopathic effect (CPE)
morphological alteration of cells and/or their destruction as a consequence of virus multiplication 3.11 viral infectivity ability of a virus to produce infectious progeny in a sensitive cell strain NOTE Viral infectivity may also include the expression of at least part of the virus’ genetic information in cells 3.12 viral plaque
area of lysis formed in a cell monolayer under semisolid medium due to infection by and multiplication of a single infectious virus particle
3.13 virucide product that inactivates viruses under defined conditions NOTE The adjective derived from "virucide" is "virucidal". 3.14 virucidal activity capability of a product to produce a reduction in the number of infectious virus particles of relevant test organisms under defined conditions
3.15 virus titre amount of infectious virus per unit volume present in a cell culture lysate
Requirements A product, when tested in accordance with Clause 6 and Clause 7, shall demonstrate at least a decimal log (lg) reduction of 4 in virus titre of the test strains when tested under the test conditions described in Table 1. Table 1 — Required test conditions Test conditions Instrument and surface disinfectantsHygienic handrub and handwash Chemothermal disinfection procedureTest virus Poliovirus and Adenovirus Poliovirus and Adenovirus Parvovirus Test temperature
20 °C ± 1 °C (except for chemothermal disinfection) 20 °C ± 1 °C (except for chemothermal disinfection) according to the recommendation of the manufacturer, but not higher than 60°C Contact time a) obligatory
b) additional
60 min
5 min, 15 min, 30 min 1 min or 30 s, if manufacturer recommends < 1 min 3 min according to the contact time recommended by the manufacturer, but not longer than 60 min - Interfering substances a) clean
and/or b) dirty
0,3 g/l bovine serum albumin and/or 3,0 g/l bovine serum albumin plus 3,0 ml erythrocytes
PBSa)
-
0,3 g/l bovine serum albumin and/or 3,0 g/l bovine serum albumin plus 3,0 ml erythrocytes
a) Phosphate Buffered Saline NOTE The human immunodeficiency virus (HIV) is not considered a virus which requires testing, because it is a highly fragile virus. Therefore testing of the virucidal activity of chemical disinfectants against HIV is not necessary within the framework of this European Standard, if the product is active against poliovirus. In fact, poliovirus is selected as test virus because it has a high resistance to chemicals, is acid-stable and is unaffected by lipid solvents such as ether, and most detergents or quaternary products. 5 Materials and reagents 5.1 Apparatus and glassware 5.1.1 General Sterilise all glassware and parts of the apparatus that will come into contact with the culture media and reagents or the sample, except those that are supplied sterile, by one of the methods described in 5.1.2.2.
a minimum holding time of 1 h or at (16050+) °C for
a minimum holding time of 2 h. 5.1.2.3 Water bath capable of being controlled at 20 °C ± 1 °C. 5.1.2.4 Refrigerator, capable of being controlled at 2 °C to 8 °C. 5.1.2.5 pH-meter, having an accuracy of calibration of 0,1 pH units at 25 °C. 5.1.2.6 Inverted microscope for reading cell cultures microscopically 5.1.2.7 Stopwatch 5.1.2.8 Electromechanical agitator , e.g. Vortex ® mixer2). 5.1.2.9 Membrane filtration apparatus for filtration of media (0,22 µm pore size). 5.1.2.10 Microtitre plates or tubes, petri dishes and flasks for cell culture use. 5.1.2.11 Magnetic stirrer for keeping cells in suspension before seeding. 5.1.2.12 CO2 incubator (95% air, 5% CO2), capable of being controlled at 36 °C ± 1 °C, for incubation of cell cultures. An incubator at 37 °C ± 1 °C may be used if an incubator at 36 °C ± 1 °C is not available. 5.1.2.13
Ice producing machine or commercially available ice to
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