EN 14562:2006
(Main)Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant products for instruments 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).
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Keimträgerversuch zur Prüfung der fungiziden oder levuroziden Wirkung für Instrumente im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Diese Europäische Norm legt ein Prüfverfahren und die Mindestanforderungen an die fungizide oder levurozide 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.
ANMERKUNG Das Verfahren entspricht einer Prüfung der Phase 2, Stufe 2 (Anhang E).
Désinfectants et antiseptiques chimiques - Essai quantitatif de porte germe pour l'évaluation de l'activité fongicide ou levuricide pour instruments utilisés en médecine humaine - Méthode d'essai et prescriptions (phase 2, étape 2)
Le présent document spécifie une méthode d'essai et les prescriptions minimales relatives à l'activité fongicide ou levuricide des désinfectants chimiques pour instruments 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.
Le présent document s’applique aux produits utilisés en médecine humaine pour désinfecter des instruments par immersion, y compris ceux qui sont couverts par la Directive européenne 93/42/CEE relative aux dispositifs médicaux.
Le présent document 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, de jardins d’enfants et de 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.
NOTE Cette méthode correspond à la phase 2, étape 2 (voir Annexe E).
Kemična razkužila in antiseptiki - Kvantitativni preskus s steklenim nosilcem za vrednotenje fungicidnega delovanja ali delovanja kemičnih razkužil in antiseptikov na kvasovke 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 fungiziden oder levuroziden Wirkung für Instrumente im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)Désinfectants et antiseptiques chimiques - Essai quantitatif de porte germe pour l'évaluation de l'activité fongicide ou levuricide 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 fungicidal or yeasticidal 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 14562:2006SIST EN 14562:2006en,fr,de01-september-2006SIST EN 14562:2006SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14562May 2006ICS 11.080.20 English VersionChemical disinfectants and antiseptics - Quantitative carrier testfor the evaluation of fungicidal or yeasticidal activity forinstruments used in the medical area - Test method andrequirements (phase 2, step 2)Désinfectants et antiseptiques chimiques - Essai quantitatifde porte germe pour l'évaluation de l'activité fongicide oulevuricide pour instruments utilisés en médecine humaine -Méthode d'essai et prescriptions (phase 2, étape 2)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Keimträgerversuch zur Prüfung der fungizidenoder levuroziden 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 14562:2006: ESIST EN 14562:2006
Referenced strains in national collections.28 Annex B (informative)
Suitable neutralizers.29 Annex C (informative)
Graphical representations of the test method.31 Annex D (informative)
Example of a typical test report.33 Annex E (informative)
Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics.37 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC.39 Bibliography.40
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 and/or instructions of use of a product may differ and therefore additional test conditions need to be used. SIST EN 14562:2006
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 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 3.2 fungicide product that kills fungi (moulds and yeasts) and their spores under defined conditions NOTE The adjective derived from "fungicide" is "fungicidal". 3.3 fungicidal activity capability of a product to produce a reduction in the number of viable vegetative yeast cells and mould spores of relevant test organisms under defined conditions 3.4 yeasticide product that kills yeasts under defined conditions NOTE The adjective derived from "yeasticide" is "yeasticidal". SIST EN 14562:2006
ATCC
Aspergillus niger
ATCC
16404 The yeasticidal activity shall be evaluated using only Candida albicans ATCC 10231. NOTE See Annex A for strain references in some other culture collections. The required incubation temperature for these test organisms is 30 °C ± 1 °C (5.3.2.3) 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 year
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