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CEN

EN 14561:2006

(Main)

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)

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)

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).

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Keimträgerversuch zur Prüfung der bakteriziden Wirkung für Instrumente im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)

Diese Europäische Norm legt ein Prüfverfahren und die Mindestanforderungen an die bakterizide 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 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)

Kemična razkužila in antiseptiki - Kvantitativni preskus s steklenim nosilcem za vrednotenje baktericidnega delovanja kemičnih razkužil in antiseptikov za instrumente, ki se uporabljajo v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 2)

General Information

Status
Published
Publication Date
09-May-2006
Withdrawal Date
29-Nov-2006
ICS
11.080.20 - Disinfectants and antiseptics
Technical Committee
CEN/TC 216 - Chemical disinfectants and antiseptics
Drafting Committee
CEN/TC 216/WG 1 - Human medicine
Current Stage
9060 - Closure of 2 Year Review Enquiry - Review Enquiry
Start Date
02-Sep-2021
Completion Date
02-Sep-2021
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
Ref Project
SIST EN 14561:2006 - 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)

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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



SIST EN 14561:2006



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



EN 14561:2006 (E) 2 Contents page Foreword.3 Introduction.4 1 Scope.5 2 Normative references.5 3 Terms and definitions.5 4 Requirements.6 5 Test method.6 5.1 Principle.6 5.2 Materials and reagents.6 5.3 Apparatus and glassware.9 5.4 Preparation of test organism suspensions and product test solutions.11 5.5 Procedure for assessing the bactericidal activity of the product.13 5.6 Experimental data and calculation.16 5.7 Verification of methodology.
...

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