EN 14563:2008
(Main)Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)
This European Standard specifies a test method and the minimum requirements for mycobactericidal or tuberculocidal 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, 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.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE This method corresponds to a phase 2, step 2 test.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Keimträgerversuch zur Prüfung der mykobakteriziden oder tuberkuloziden Wirkung chemischer Desinfektionsmittel für Instrumente im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Diese Europäische Norm legt ein Prüfverfahren und die Mindestanforderungen an die mykobakterizide oder tuberkulozide Wirkung von chemischen Desinfektionsmitteln fest, die in Wasser standardisierter Härte als homogenes physikalisch stabiles Präparat vorliegen bzw. bei gebrauchsfertigen Produkten in Wasser.
Diese Europäische Norm gilt für Produkte, die zur Instrumentendesinfektion im humanmedizinischen Bereich durch Untertauchen verwendet werden, selbst wenn diese nicht durch die Richtlinie 93/42/EWG über Medizinprodukte erfasst sind.
Diese Europäische Norm gilt für Bereiche und unter Bedingungen, wo eine Desinfektion aus medizinischen Gründen angezeigt ist, z. B. bei der Patientenbetreuung in
Krankenhäusern, kommunalen medizinischen Einrichtungen und im Dentalbereich;
medizinischen Einrichtungen in Schulen, Kindergärten und Heimen;
und können auch am Arbeitsplatz oder im häuslichen Bereich gegeben sein. Eingeschlossen sein können auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung von Patienten dienen.
EN 14885 legt im Einzelnen die Beziehungen der verschiedenen Prüfungen untereinander und zu den „Anwendungsempfehlungen“ fest.
ANMERKUNG Das Verfahren entspricht einer Prüfung der Phase 2, Stufe 2.
Désinfectants et antiseptiques chimiques - Essai quantitatif de porte-germe pour l'évaluation de l'activité mycobactéricide ou tuberculocide des désinfectants chimiques utilisés pour instruments en médecine humaine - Méthode d'essai et prescriptions (phase 2, étape 2)
La présente Norme européenne spécifie une méthode d'essai et les prescriptions minimales relatives à
l'activité mycobactéricide ou tuberculocide des désinfectants chimiques qui forment une préparation
homogène, physiquement stable, lorsqu'ils sont dilués dans l'eau dure ou, dans le cas de produits prêts à
l'emploi, dans l'eau.
La présente Norme européenne s'applique aux produits utilisés en médecine humaine pour la désinfection
d'instruments par immersion — y compris ceux qui ne sont pas couverts par la Directive européenne
93/42/CEE relative aux dispositifs médicaux.
La présente Norme européenne s'applique dans les zones et les situations où la désinfection est
médicalement préconisée. De telles indications se rencontrent dans le cadre des soins apportés aux patients,
par exemple :
⎯ dans des hôpitaux, centres de soins médicaux et cabinets dentaires ;
⎯ dans des infirmeries d’écoles, des jardins d’enfants et des maisons de retraite ;
et peuvent aussi se rencontrer sur les lieux de travail ou à domicile. Elles peuvent également concerner des
services tels que des blanchisseries et des cuisines qui fournissent des produits directement aux patients.
L’EN 14885 spécifie en détail la relation entre les différentes méthodes d’essais ainsi que les
« recommandations d'emploi ».
NOTE La présente méthode correspond à un essai de phase 2, étape 2.
Kemična razkužila in antiseptiki - Kvantitativni preskus s steklenim nosilcem za vrednotenje mikobaktericidnega ali tuberkulocidnega delovanja kemičnih razkužil za instrumente, ki se uporabljajo v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 2)
General Information
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Quantitativer Keimträgerversuch zur Prüfung der mykobakteriziden oder tuberkuloziden Wirkung chemischer Desinfektionsmittel 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 mycobactéricide ou tuberculocide des désinfectants chimiques utilisés pour instruments en médecine humaine - Méthode d'essai et prescriptions (phase 2, étape 2)Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments 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 14563:2008SIST EN 14563:2009en,fr,de01-marec-2009SIST EN 14563:2009SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14563November 2008ICS 11.080.20 English VersionChemical disinfectants and antiseptics - Quantitative carrier testfor the evaluation of mycobactericidal or tuberculocidal activity ofchemical disinfectants used for instruments in the medical area -Test method and requirements (phase 2, step 2)Désinfectants et antiseptiques chimiques - Essai quantitatifde porte-germe pour l'évaluation de l'activitémycobactéricide ou tuberculocide des désinfectantschimiques utilisés pour instruments en médecine humaine -Méthode d'essai et prescriptions (phase 2, étape 2)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Keimträgerversuch zur Prüfung dermykobakteriziden oder tuberkuloziden Wirkung chemischerDesinfektionsmittel für Instrumente imhumanmedizinischen Bereich - Prüfverfahren undAnforderungen (Phase 2, Stufe 2)This European Standard was approved by CEN on 18 October 2008.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 CEN 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14563:2008: ESIST EN 14563:2009
Referenced strains in national collections.26 Annex B (informative)
Examples of neutralizers of the residual antimicrobial activity of chemical disinfectants and antiseptics and rinsing liquids.27 Annex C (informative)
Graphical representations of the test method.29 Annex D (informative)
Example of a typical test report.32 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC.35 Bibliography.36
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.
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, 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. EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations". NOTE This method corresponds to a phase 2, step 2 test. 2 Normative references 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 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 European Standard, the terms and definitions given in EN 14885 apply. 4 Requirements The product, when tested in accordance with Clause 5 under simulated clean conditions (0,3 g/l bovine albumin solution) or simulated dirty conditions (3,0 g/l bovine albumin solution, plus 3,0 ml/l washed sheep erythrocytes) according to its practical applications and under the obligatory test conditions, (one or two selected test organisms, 20 °C, 60 min), shall demonstrate at least a decimal log (lg) reduction in counts of 4.
The mycobactericidal activity shall be evaluated using the following two test organisms: Mycobacterium avium and Mycobacterium terrae. The tuberculocidal activity shall be evaluated using the following test organism: Mycobacterium terrae. SIST EN 14563:2009
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 mycobacteria 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 mycobacteria are to be severed from the surface by shaking. The numbers of surviving mycobacteria in each sample are determined and the reduction is calculated. 5.1.2 The test is performed using Mycobacterium avium and Mycobacterium terrae or only Mycobacterium terrae as test organisms (obligatory test conditions). 5.1.3 Additional and optional contact times and temperatures are specified. Additional interfering substances may be used. 5.2 Materials and reagents 5.2.1 Test organisms The mycobactericidal activity shall be evaluated using the following two test-organisms1):
Mycobacterium avium
ATCC
Mycobacterium terrae
ATCC
15755 The tuberculocidal activity shall be evaluated using only Mycobacterium terrae. NOTE See Annex A for strain reference in some other culture collections. 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. Hydrated forms may be used as an alternative, but the weights required shall be adjusted to allow for consequent molecular weight differences. The reagents shall be of analytical grade and/or appropriate for microbiological purposes. They shall be free from substances that are toxic or inhibitory to the test organisms.
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 14563:2009
NOTE 2 For each culture medium and reagent a time limitation for use should be fixed. 5.2.2.2 Water The water shall be freshly glass distilled
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