EN 14204:2004

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)Désinfectants et antiseptiques 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 14204:2004SIST EN 14204:2004en,fr,de01-december-2004SIST EN 14204:2004SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14204June 2004ICS 11.080.20English versionChemical disinfectants and antiseptics - Quantitative suspensiontest for the evaluation of mycobactericidal activity of chemicaldisinfectants and antiseptics used in the veterinary area - Testmethod and requirements (phase 2, step 1)Antiseptiques et désinfectants chimiques - Essai quantitatifde suspension pour l'évaluation de l'activitémycobactéricide des antiseptiques et des désinfectantschimiques utilisés dans le domaine vétérinaire - Méthoded'essai et prescriptions (Phase 2, étape 1)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Suspensionsversuch zur Bestimmung dermykobakteriziden Wirkung chemischer Desinfektionsmittelund Antiseptika für den Veterinärbereich - Prüfverfahrenund Anforderungen (Phase 2, Stufe 1)This European Standard was approved by CEN on 20 February 2004.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© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14204:2004: ESIST EN 14204:2004

Test for validation of dilution-neutralization method.18 Annex B (informative)
Homogenization of mycobacterial test suspensions.20 Annex C (informative)
Neutralizers.21 Annex D (informative)
Example of a typical test report.22 Annex E (informative)
Corresponding referenced strains.24 Annex F (informative)
Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics.25 Bibliography.27
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
EN 1656, Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary field - Test method and requirements (phase 2/step 1). EN 12353, Chemical disinfectants and antiseptics – Preservation of microbial strains used for the determination of bactericidal and fungicidal activity. 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 a chemical disinfectant or antiseptic [EN 1040] 3.2 mycobactericide product that kills mycobacteria under defined conditions NOTE The adjective derived from "mycobactericide" is "mycobactericidal". 3.3 mycobactericidal activity capability of a product to produce a reduction in the number of viable mycobacterial cells of relevant organisms under defined conditions SIST EN 14204:2004

1) ATCC 15769 is the collection number of strain supplied by the American Type Culture Collections. This information is given for the convenience of users of this standard and does not constitute an endorsement by CEN of the product named.
Corresponding strains supplied by other culture collections may be used if they can be shown to lead to the same results. SIST EN 14204:2004

2) Analytical quality, non-hydrolized in accordance with European Pharmacopaeia volume 1. TWEEN 80  is an example of a suitable product available commercially. This information is given for the convenience of users of this standard and does not constitute an endorsement by CEN of this product. SIST EN 14204:2004

30°+for a minimum holding time of 15 min ; b) for dry heat sterilization, a hot air oven capable of being maintained at 180 0+ 5°C for a minimum holding time of 30 min, at 170 0+ 5°C for a minimum holding time of 1 h or at 160 0+ 5°C for a minimum holding time of 2 h ; c) membrane filtration apparatus suitable for use with filters of diameter 47 mm to 50 mm of 0.22 µm pore size for media sterilization. 5.3.2.2 Water baths, capable of being controlled at 4 °C ± 1 °C, 10 °C ± 1 °C, 20 °C ± 1 °C and 40 °C ± 1 °C and 45 °C ± 1 °C. 5.3.2.3 CO2 Incubator, capable of being controlled at either 36 °C ± 1 °C or 37 °C ± 1 °C. An incubator at 36 °C ± 1 °C or 37 °C ± 1 °C may be used if a CO2 incubator is not available. 5.3.2.4 pH-meter, having an accuracy of calibration of 0,1 pH units at 25 °C. 5.3.2.5 Stopwatch. 5.3.2.6 Electromechanical agitator, e.g. Vortex  mixer3). 5.3.2.7 Containers, test tubes, flasks or bottles of suitable capacity. 5.3.2.8 Graduated pipettes, of nominal capacities 10 ml and 1 ml and 0.1 ml. Calibrated automatic pipettes may be used. 5.3.2.9 Petri dishes of size 90 mm to 100 mm. 5.3.2.10 Glass beads (Diameter : 3 mm to 4 mm). 5.3.2.11 Volumetric flasks (calibrated at 20 °C). 5.3.2.12 Mechanical shaker. 5.3.2.13 Plastic screw cap tubes (50 ml).
2) Disposable Sterile Equipment is an acceptable alternative to reusable glassware. 3) Vortex  is an example of a suitable product available commercially. This information is given for the convenience of users of this standard and does not constitute an endorsement by CEN of this product. SIST EN 14204:2004

4) Potter  Apparatus is an example of a suitable product available commercially. This information is given for the convenience of users of this standard and does not constitute an endorsement by CEN of this product. SIST EN 14204:2004

5) cfu/ml = colony forming units per ml. SIST EN 14204:2004
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