EN 14204:2012
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal 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 mycobactericidal 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 mycobactericidal 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.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
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.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der mykobakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Diese Europäische Norm legt ein Prüfverfahren und die Mindestanforderungen an die mykobakterizide Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die bei der Verdünnung mit Wasser standardisierter Härte oder - im Fall von gebrauchsfertigen Produkten - mit Wasser als homogene, physikalisch stabile Zubereitung vorliegen.
Produkte können nur bei einer Konzentration von 80 % oder weniger geprüft werden, da immer eine bestimmte Verdünnung durch Zugabe des Prüfkeims und der Belastungssubstanz erfolgt.
Diese Europäische Norm gilt für Produkte für den Veterinärbereich, d. h. bei deren Verwendung bei der Aufzucht, Haltung, Produktion und beim Transport von Tieren sowie bei der Tierkörperbeseitigung, außer wenn die Tiere nach der Tötung durch Zuführung in die weiterverarbeitende Industrie in die Nahrungsmittel¬kette eintreten.
EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den "Anwendungsempfehlungen" fest.
ANMERKUNG 1 Das beschriebene Verfahren ist für die Bestimmung der Wirkung von handelsüblichen Zubereitungen oder Wirkstoffen unter den Bedingungen, unter denen sie verwendet werden, bestimmt.
ANMERKUNG 2 Das Verfahren entspricht einer Prüfung der Phase 2, Stufe 1.
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité mycobactéricide 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 mycobactéricide des produits antiseptiques et désinfectants chimiques qui forment une préparation homogène, physiquement stable, lorsqu’ils sont dilués dans de l'eau dure ou - dans le cas de produits prêts à l’emploi - dans l’eau.
Les produits ne peuvent être soumis à l’essai qu’à la concentration de 80 % ou à des concentrations inférieures, car l’ajout des microorganismes d’essai et de la substance interférente s’accompagne forcément d’une dilution.
La présente Norme européenne s'applique aux produits utilisés dans le domaine vétérinaire, à savoir la reproduction, l'élevage, la production, le transport et l’abattage de tous les animaux, hors de la chaîne alimentaire qui suit l’abattage et l’entrée dans l’industrie de transformation.
L'EN 14885 spécifie de façon détaillée les relations des différents essais entre eux et avec les « recommandations d’emploi ».
NOTE 1 La méthode décrite vise à déterminer l’activité des formulations commerciales ou des substances actives dans les conditions dans lesquelles elles sont utilisées.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 1.
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje mikobaktericidnega delovanja kemičnih razkužil in antiseptikov v veterini - Preskusna metoda in zahteve (faza 2, stopnja 1)
Ta evropski standard določa preskusno metodo in minimalne zahteve za mikobaktericidno delovanje kemičnih razkužil in antiseptikov, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo oziroma z vodo pri proizvodih, ki so pripravljeni za uporabo. Proizvode je mogoče preskušati samo pri 80-odstotni ali nižji koncentraciji, ker dodajanje preskusnih organizmov in moteče snovi vedno povzroči razredčenje. Ta evropski standard se uporablja za izdelke v veterini, tj. pri vzreji, živinoreji, proizvodnji, prevozu in odstranjevanju vseh živali, razen če so v prehrambeni verigi po smrti in so del predelovalne industrije. Standard EN 14885 podrobno določa razmerje med različnimi preskusi in priporočili za uporabo. OPOMBA 1 Opisana metoda je namenjena določevanju dejavnosti komercialnih oblik ali aktivnih snovi pod pogoji, v katerih se uporabljajo. OPOMBA 2 Ta metoda ustreza preskusu faze 2, stopnje 1.
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der mykobakteriziden 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 mycobactéricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions (Phase 2, étape 1)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)11.220VeterinarstvoVeterinary medicine11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:Ta slovenski standard je istoveten z:EN 14204:2012SIST EN 14204:2013en,fr,de01-januar-2013SIST EN 14204:2013SLOVENSKI
STANDARDSIST EN 14204:20041DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14204
November 2012 ICS 71.100.35 Supersedes EN 14204:2004English Version
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal 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 de suspension pour l'évaluation de l'activité mycobactéricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions (Phase 2, étape 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der mykobakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1) This European Standard was approved by CEN on 22 September 2012.
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 CEN-CENELEC Management Centre 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 CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14204:2012: ESIST EN 14204:2013
Page Foreword .3Introduction .41Scope .52Normative references .53Terms and definitions .54Requirements .55Test method .65.1Principle .65.2Materials and reagents .75.2.1Test organisms .75.2.2Culture media and reagents .75.3Apparatus and glassware . 105.3.1General . 105.3.2Usual microbiological laboratory equipment and, in particular, the following: . 105.4Preparation of mycobacterial test suspension and product test solutions . 115.4.1Mycobacterial test suspensions (test and validation suspension) . 115.4.2Product test solutions . 135.5Procedure for assessing the mycobactericidal activity of the product . 145.5.1General . 145.5.2Test procedure - Dilution-neutralization method . 155.5.3Test procedure - Membrane filtration method . 175.6Experimental data and calculation. 195.6.1Explanation of terms and abbreviations . 195.6.2Calculation . 195.7Verification of methodology . 235.7.1General . 235.7.2Control of weighted mean counts . 235.7.3Basic limits . 235.8Expression of results . 245.8.1Reduction . 245.8.2Control of active and non-active product test solution (5.4.2) . 245.8.3Mycobactericidal concentration . 245.9Interpretation of results - conclusion . 245.9.1General . 245.9.2Mycobactericidal activity for general purposes . 245.9.3Qualification for certain fields of application . 245.10Test report . 25Annex A (informative)
Referenced strain in national collections . 27Annex B (informative)
Examples of neutralizers of the residual antimicrobial activity of chemical disinfectants and antiseptics and rinsing liquids . 28Annex C (informative)
Graphical representations of dilution-neutralization method . 30Annex D (informative)
Example of a typical test report . 32Bibliography . 36 SIST EN 14204:2013
Introduction This European Standard specifies a suspension test for establishing whether a chemical disinfectant or antiseptic has mycobactericidal activity in the area and fields described in the scope. This laboratory test takes into account practical conditions of application of the product including contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence its action in practical situations. 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 the chosen experimental conditions. However, for some applications the instructions of use of a product may differ and therefore additional test conditions need to be used. SIST EN 14204:2013
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. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. 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. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 12353, Chemical disinfectants and antiseptics — Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity EN 14885, Chemical disinfectants and antiseptics — Application of European Standards for chemical disinfectants and antiseptics 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 14885 apply. 4 Requirements The product shall demonstrate at least a 4 decimal log (lg) reduction when tested in accordance with Table 1 and Clause 5 under simulated low level (3,0 g/l bovine albumin) or high level soiling (10 g/l yeast extract and 10 g/l bovine albumin). SIST EN 14204:2013
Mycobacterium avium b) additional any relevant test organism Test temperature a) obligatory
10°C ± 1°C b) additional 4°C ± 1°C; 20°C ± 1°C; 40°C ± 1°C Contact time a) obligatory
60 min ± 10 sa b) additional 1 min ± 5 s; 5 min ± 10 s; 10 min ± 10 s, 15 min ± 10 s, 30 min ± 10 s, 120 min ± 10 s Interfering substance a) obligatory low level soiling high level soiling
3,0 g/l bovine albumin
10 g/l yeast extract plus 10 g/l bovine albumin b) additional any relevant substance NOTE For the additional
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