EN 14675:2006
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
This European Standard specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use-products - with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the veterinary field i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
NOTE 1 The method described is intended to determine the virucidal 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 (Annex E).
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der viruziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Die vorliegende Europäische Norm legt ein Prüfverfahren und die Mindestanforderungen an die viruzide Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die, bei Verdünnung mit hartem Wasser oder - bei der Verwendung von gebrauchsfertigen Produkten - mit Wasser, eine homogene, physikalisch stabile Zubereitung bilden. Die Produkte können nur bei einer Konzentrationen von 80 % oder darunter geprüft werden, da durch die Zugabe der Prüforganismen und der Belastungssubstanz immer eine Verdünnung hervorgerufen wird.
Diese Europäische Norm gilt für Produkte, die im Veterinärbereich eingesetzt werden, d. h. bei der Aufzucht, Haltung, Produktion, beim Transport und bei der Tierkörperbeseitigung aller Tierarten mit Ausnahme der Bereiche, in denen Tiere direkt nach der Tötung als Nahrungsmittel verwendet oder der weiterverarbeitenden Industrie zugeführt werden.
ANMERKUNG 1 Das beschriebene Verfahren ist zur Bestimmung der viruziden Wirksamkeit von im Handel erhältlichen Zubereitungen oder aktiven Substanzen unter Anwendungsbedingungen vorgesehen.
ANMERKUNG 2 Das Verfahren entspricht einem Versuch der Phase 2/Stufe 1 (siehe Anhang D).
Die vorliegende Norm beschreibt Prüfverfahren für den Rinderenterovirus vom Typ 1 (Enteric Cytopathegenic Orphan [ECBO]-Virus ) als Modellvirus für alle Anwendungen, nämlich zur Desinfektion von Instrumenten und Oberflächen sowie zur Behandlung der Postkontamination von Leichenräumen, Rinnsteinen und Nutzviehställen. Die Auswahl dieses Modellvirus beruht auf:
der Durchführbarkeit der Aufstellung eines Verfahrens zum Prüfen auf Viren;
der Repräsentation einer Gruppe klinisch bedeutender Viren;
der gleichhohen Resistenz gegenüber chemischen und physikalischen Wirkstoffen wie andere klinisch bedeutende Viren im Veterinärbereich.
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité virucide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions (phase 2, étape 1)
La présente Norme européenne spécifie une méthode d'essai et les prescriptions minimales relatives à l'activité virucide des produits antiseptiques et désinfectants chimiques qui forment une préparation homogène et physiquement stable lorsqu’ils sont dilués avec de l'eau dure ou – dans le cas de produits prêts à l'emploi – avec de l'eau. Les produits ne peuvent être soumis à essai qu'à une concentration inférieure ou égale à 80 % car il se produit toujours une certaine dilution du fait de l’addition des organismes d'essai et de la substance interférente.
La présente Norme européenne s'applique aux produits utilisés dans le domaine vétérinaire c'est-à-dire dans la sélection, l'élevage, la production, le transport et l'élimination de tous les animaux, sauf au cours de la chaîne alimentaire à la suite de leur mort et de leur entrée dans l’industrie de transformation.
NOTE 1 La méthode décrite a pour objet de déterminer l'activité virucide 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 E).
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje virucidnega delovanja kemičnih razkužil in antiseptikov v veterini - Preskusna metoda in zahteve (faza 2, stopnja 1)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2006
.HPLþQDUD]NXåLODLQDQWLVHSWLNL.YDQWLWDWLYQLVXVSHQ]LMVNLSUHVNXV]D
YUHGQRWHQMHYLUXFLGQHJDGHORYDQMDNHPLþQLKUD]NXåLOLQDQWLVHSWLNRYYYHWHULQL
3UHVNXVQDPHWRGDLQ]DKWHYH ID]DVWRSQMD
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of virucidal activity of chemical disinfectants and antiseptics used in the veterinary area -
Test method and requirements (phase 2, step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der viruziden Wirkung chemischer Desinfektionsmittel und Antiseptika für
den Veterinärbereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour
l'évaluation de l'activité virucide des antiseptiques et des désinfectants chimiques utilisés
dans le domaine vétérinaire - Méthode d'essai et prescriptions (phase 2, étape 1)
Ta slovenski standard je istoveten z: EN 14675:2006
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
11.220 Veterinarstvo Veterinary medicine
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 14675
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2006
ICS 11.080.20; 11.220
English Version
Chemical disinfectants and antiseptics - Quantitative suspension
test for the evaluation of virucidal activity of chemical
disinfectants and antiseptics used in the veterinary area - Test
method and requirements (phase 2, step 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif Chemische Desinfektionsmittel und Antiseptika -
de suspension pour l'évaluation de l'activité virucide des Quantitativer Suspensionsversuch zur Bestimmung der
antiseptiques et des désinfectants chimiques utilisés dans viruziden Wirkung chemischer Desinfektionsmittel und
le domaine vétérinaire - Méthode d'essai et prescriptions Antiseptika für den Veterinärbereich - Prüfverfahren und
(phase 2, étape 1) Anforderungen (Phase 2, Stufe 1)
This European Standard was approved by CEN on 26 September 2005.
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 Ref. No. EN 14675:2006: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Introduction.4
1 Scope .5
2 Normative references .5
3 Terms and definitions.5
4 Requirements .7
5 Test methods.7
5.1 Principle.7
5.2 Materials and reagents .7
5.3 Apparatus and glassware.14
5.4 Product test solutions .15
5.5 Procedure for assessing the virucidal activity of the product .16
5.6 Infectivity assay .17
5.7 Virucidal test – preparation.17
6 Calculation and expression of results.18
6.1 Protocol of the CPE result.18
6.2 Calculation of infectivity titre (TCID ) .18
6.3 Calculation of PFU .18
6.4 Verification of the methodology .18
6.5 Calculation of the virucidal activity of products.19
6.6 Expression of results.19
7 Conclusion .19
7.1 General .19
7.2 Test report .19
Annex A (informative) Referenced strains of national collections .21
Annex B (normative) Cytotoxicity, reference inactivation tests and test virus titration .22
Annex C (informative) Calculation of the viral infectivity titre and plaque-forming units.23
Annex D (informative) Example of a typical test report.25
Annex E (informative) Information on the application and interpretation of European Standards
on chemical disinfectants and antiseptics.26
Bibliography.28
Foreword
This European Standard (EN 14675:2006) has been prepared by Technical Committee CEN/TC 216
“Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by August 2006, and conflicting national standards shall be withdrawn at
the latest by August 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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.
Introduction
This European Standard specifies a suspension test for establishing whether a chemical disinfectant or
antiseptic has or does not have a virucidal activity in the fields described in the scope.
The laboratory test closely simulates practical conditions of application. Chosen conditions e.g. contact time,
temperature, test organisms, interfering substances, reflect parameters which are found in practical situations
including conditions which may influence the action of antiseptics or chemical disinfectants.
The conditions are intended to cover general purposes and to allow reference between laboratories and
product types. Each utilization concentration of the chemical disinfectant or antiseptic found by this test
corresponds to defined experimental conditions. However, for some applications the recommendations of use
of a product may differ and therefore additional test conditions need to be used.
1 Scope
This European Standard specifies a test method and the minimum requirements for virucidal activity of
chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when
diluted with hard water or – in the case of ready-to-use-products – with water. Products can only be tested at a
concentration of 80 % or less as some dilution is always produced by adding the test organisms and
interfering substance.
This European Standard applies to products that are used in the veterinary area i.e. in the breeding,
husbandry, production, transport and disposal of all animals except when in the food chain following death
and entry to the processing industry.
NOTE 1 The method described is intended to determine the virucidal 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 (Annex E).
2 Normative references
Not applicable.
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
product
chemical agent or formulation used as chemical disinfectant or antiseptic
3.2
virucide
product which inactivates viruses under defined conditions
NOTE The adjective derived from ‘virucide' is ‘'virucidal’'.
3.3
virucidal activity
capability of a product to produce a reduction in the number of infectious virus particles of relevant test
organisms under defined conditions
3.4
viral infectivity
ability of a virus to express in cells its genetic information and/or multiply in them to infectious progeny
3.5
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.
3.6
reference virus suspension
virus suspension of a defined virus strain which is not passaged more than 10 times, is maintained in national
culture collection centres and kept in small volumes (less than 1 ml) at a temperature of −196 °C over liquid
nitrogen
NOTE Stock virus suspensions are prepared from reference virus suspensions.
3.7
stock virus suspension
virus suspension of a defined strain that is multiplied on a large scale to obtain a virus suspension of the same
characteristics as the reference virus suspension and kept in a small volume at a temperature of below −70 °C
or preferably at −196 °C over liquid nitrogen
3.8
test virus suspension
virus suspension that is used in the virucidal testing of the disinfectant
3.9
virus Titre
amount of infectious virus per unit volume present in a cell culture lysate
3.10
reference virus inactivation test
test with a defined reagent (e.g. formalin) instead of a product for the internal control of the test
Results of reference virus inactivation test shall be within limits for validating the method.
3.11
cytotoxicity
morphological alteration of cells and/or their destruction or their reduced sensitivity to virus multiplication
caused by the product
3.12
viral cytopathic effect (CPE)
morphological alteration of cells and/or their destruction as a consequence of virus multiplication
3.13
tissue culture infecting dose (TCID )
virus dose that gives rise to cytopathic change (CPE) in 50 % of the inoculated cell cultures
3.14
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
3.15
plaque forming units (PFU)
number of infectious virus particles per unit volume (ml)
4 Requirements
The product when diluted with hard water (5.2.2.3) or – in the case of ready-to-use products – with water
(5.2.2.2) and tested in accordance with Clause 5 under simulated low level soiling (3 g/l bovine albumin
solution) (5.2.2.4.2) or simulated high level soiling (10 g/l bovine albumin solution plus 10 g/l yeast extract)
(5.2.2.4.3) according to its practical applications and under the other obligatory test conditions: 1 selected test
organism, 10 °C, 30 min shall demonstrate at least a lg reduction in virus titre of 4. It is possible to test also
the product as delivered
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.