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)
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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
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 cool the cell maintenance medium and the reaction mixtures during the test (see 6.1, 6.6.3, and 6.6.6.1). 5.1.2.14 Basin as ice bath with ice and water. 5.1.2.15 Container: sterile test tubes, culture bottles or flasks of suitable capacity. 5.1.2.16 Graduated sterile pipettes, of nominal capacities 10 ml and 1 ml and 0,1 ml. NOTE Calibrated automatic pipettes may be used. 5.1.2.17 Volumetric flasks calibrated at 20 °C. 5.1.2.18
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