EN 14561:2006

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Quantitativer Keimträgerversuch zur Prüfung der bakteriziden Wirkung für Instrumente im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)Désinfectants chimiques et antiseptiques - Essai quantitatif de porte germe pour l'évaluation de l'activité bactéricide pour instruments utilisés en médecine humaine - Méthode d'essai et prescriptions (phase 2, étape 2)Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:Ta slovenski standard je istoveten z:EN 14561:2006SIST EN 14561:2006en,fr,de01-september-2006SIST EN 14561:2006SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14561May 2006ICS 11.080.20 English VersionChemical disinfectants and antiseptics - Quantitative carrier testfor the evaluation of bactericidal activity for instruments used inthe medical area - Test method and requirements (phase 2, step2)Désinfectants et antiseptiques chimiques - Essai quantitatifde porte germe pour l'évaluation de l'activité bactéricidepour instruments utilisés en médecine humaine - Méthoded'essai et prescriptions (phase 2, étape 2)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Keimträgerversuch zur Prüfung derbakteriziden Wirkung für Instrumente imhumanmedizinischen Bereich - Prüfverfahren undAnforderungen (Phase 2, Stufe 2)This European Standard was approved by CEN on 29 August 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, Romania,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© 2006 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14561:2006: ESIST EN 14561:2006

Referenced strains in national collections.26 Annex B (informative)
Suitable neutralizers.27 Annex C (informative)
Graphical representations of the test method.29 Annex D (informative)
Example of a typical test report.31 Annex E (informative)
Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics.34 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC.36 Bibliography.37
Introduction This European Standard specifies a carrier test for establishing whether a chemical disinfectant for use on instruments (surgical instruments, anaesthesia material, endoscopes etc.) has a bactericidal activity in the fields described in the scope. The laboratory test closely simulates practical conditions of application including pre-drying bacteria on a carrier, contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence the action of chemical disinfectants in practical situations.
The obligatory conditions are intended to cover general purposes and to allow reference between laboratories and product types. Each utilization concentration of the chemical disinfectant 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. SIST EN 14561:2006

1 Scope This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water.
This European Standard applies to products that are used in the medical area for disinfecting instruments by immersion – even if they are not covered by the EEC/93/42 Directive on Medical Devices. This European Standard applies 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 kindergardens 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. NOTE This method corresponds to a phase 2, step 2 test (see Annex E). 2 Normative references The following referenced documents are indispensable for the application of this European Standard. 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, sporicidal 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 3.2 bactericide product that kills vegetative bacteria under defined conditions NOTE The adjective derived from "bactericide" is "bactericidal". 3.3 bactericidal activity capability of a product to produce a reduction in the number of viable bacterial cells of relevant test organisms under defined conditions 3.4 clean conditions conditions representative of surfaces which have been cleaned satisfactorily and/or are known to contain minimal levels of organic and/or inorganic substances SIST EN 14561:2006

NOTE For these additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions.
5 Test method 5.1 Principle 5.1.1 A test suspension of bacteria in a solution of interfering substances is spread on a glass carrier. After drying the carrier is immersed into a sample of the product as delivered and/or diluted with hard water (for ready to use products: water). The carrier is maintained at 20 °C ± 1 °C for 60 min ± 10 s (obligatory test conditions). At the end of this contact time, the carrier is transferred into a neutralizer containing glass beads. The bacteria are to be severed from the surface by shaking. The numbers of surviving bacteria in each sample are determined and the reduction is calculated. 5.1.2 The test is performed using Pseudomonas aeruginosa, Staphylococcus aureus and Enterococcus hirae as test-organisms (obligatory test conditions). 5.1.3 Additional and optional contact times and temperatures are specified. Additional interfering substances can be used. 5.2 Materials and reagents 5.2.1 Test organisms The bactericidal activity shall be evaluated using the following strains as test organisms1):  Pseudomonas aeruginosa ATCC
15442  Staphylococcus aureus ATCC
6538  Enterococcus hirae ATCC
1) The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collections (ATCC). This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of the product named. SIST EN 14561:2006

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1 ° (5.3.2.3). The same temperature (either 36 °C or 37 °) shall be used for all incubations performed during a test and its control and validation. If additional test organisms are used, they shall be incubated under optimum growth conditions (temperature, time, atmosphere, media) noted in the test report. If the additional test organisms selected do not correspond to the specified strains, their suitability for supplying the required inocula shall be verified. If these additional test organisms are not classified at a reference centre, their identification characteristics shall be stated. In addition, they shall be held by the testing laboratory or national culture collection under a reference for five years.
5.2.2 Culture media and reagents 5.2.2.1 General All weights of chemical substances given in this European Standard refer to the anhydrous salts. Hydrate
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