EN 14348:2005

Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)

This document 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. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.
This document applies to products that are used in the medical area including those that are covered by the EEC/93/42 Directive on Medical Devices.
This document 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 1   The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2   This method corresponds to a phase 2, step 1 test (see Annex E).

Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der mykobakteriziden Wirkung chemischer Desinfektionsmittel im humanmedizinischen Bereich einschließlich der Instrumentendesinfektionsmittel - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)

Dieses Dokument legt ein Prüfverfahren und die Mindestanforderungen an die mykobakterizide (oder tuberkulozide) Wirkung chemischer Desinfektionsmittel fest, die bei Verdünnung in Wasser standardisierter Härte als homogenes, physikalisch stabiles Präparat vorliegen (oder bei gebrauchsfertigen Produkten bei Verdünnung in Wasser). Die Produkte können nur bei einer Konzentration von 80 % oder weniger geprüft werden, weil durch Zugabe der Prüfkeime und Belastungssubstanzen immer eine gewisse Verdünnung erfolgt.
Dieses Dokument gilt für im humanmedizinischen Bereich verwendete Produkte einschließlich derer, die in der Richtlinie 93/42/EWG über Medizinprodukte behandelt werden.
Dieses Dokument gilt für Bereiche und Bedingungen, wo eine Desinfektion aus medizinischen Gründen indiziert ist. Solche Indikationen ergeben sich bei der Versorgung von Patienten, beispielsweise
-   in Krankenhäusern, kommunalen medizinischen Einrichtungen und zahnärztlichen Einrichtungen,
-   in medizinischen Bereichen in Schulen, Kindergärten und Pflegeeinrichtungen,
und können auch am Arbeitsplatz oder im häuslichen Bereich vorliegen. Es kann sich auch um Einrichtungen handeln wie Wäschereien und Küchen, die direkt Produkte für die Patienten liefern.
ANMERKUNG 1   Das beschriebene Verfahren dient zur Bestimmung der Wirksamkeit kommerziell erhältlicher Zubereitungen oder Wirkstoffe unter den Bedingungen, unter denen sie angewendet werden.
ANMERKUNG 2   Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 1 (siehe Anhang E).

Antiseptiques et désinfectants chimiques - Essai quantitatif en suspension pour l'evaluation de l'activité mycobactéricide des désinfectants chimiques utilisés en médecine humaine et incluant les désinfectants pour dispositifs médicaux - Méthode d'essai et prescriptions (phase 2, étape 1)

Le présent document 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. Les produits ne peuvent être soumis à l’essai qu’à une concentration inférieure ou égale à 80 %, car l’ajout des micro-organismes d’essai et de la substance interférente entraîne toujours une dilution.
Le présent document s’applique aux produits utilisés dans le domaine médical, y compris ceux qui sont couverts par la Directive européenne 93/42/CEE sur les 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 1   La méthode décrite est destinée à déterminer l’activité des formulations commerciales ou des substances actives dans leurs conditions d’utilisation.
NOTE 2   Cette méthode correspond à la phase 2, étape 1 (voir Annexe E).

Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za ocenjevanje mikobaktericidnega delovanja kemičnih razkužil, ki se uporabljajo v humani medicini, vključno razkužil za instrumente - Preskusne metode in zahteve (faza 2, stopnja 1)

General Information

• Status: Published
• Publication Date: 18-Jan-2005
• Withdrawal Date: 30-Jul-2005
• 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: 9093 - Decision to confirm - Review Enquiry
• Start Date: 06-Nov-2009
• Completion Date: 06-Nov-2009
• 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 14348:2005 - Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)

Standards Content (Sample)

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 im humanmedizinischen Bereich einschließlich der Instrumentendesinfektionsmittel - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)Antiseptiques et désinfectants chimiques - Essai quantitatif en suspension pour l'evaluation de l'activité mycobactéricide des désinfectants chimiques utilisés en médecine humaine et incluant les désinfectants pour dispositifs médicaux - 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 in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:Ta slovenski standard je istoveten z:EN 14348:2005SIST EN 14348:2005en,fr,de01-junij-2005SIST EN 14348:2005SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14348January 2005ICS 11.080.20English versionChemical disinfectants and antiseptics - Quantitative suspensiontest for the evaluation of mycobactericidal activity of chemicaldisinfectants in the medical area including instrumentdisinfectants - Test methods and requirements (phase 2, step 1)Désinfectants chimiques - Essai quantitatif de suspensionpour l'evaluation de l'activité mycobactéricide desdésinfectants chimiques utilisés en médecine y compris lesdésinfectants pour instruments - Méthode d'essai etprescriptions (phase 2, étape 1)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Suspensionsversuch zur Bestimmung dermykobakteriziden Wirkung chemischer Desinfektionsmittelim humanmedizinischen Bereich einschließlich derInstrumentendesinfektionsmittel - Prüfverfahren undAnforderungen (Phase 2, Stufe 1)This European Standard was approved by CEN on 22 November 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© 2005 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14348:2005: ESIST EN 14348:2005

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.33 Annex ZA (informative)
Clauses of this document addressing essential requirements or other provisions of EU Directives.35 Bibliography.36
This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Medical Devices Directive 93/42. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. A collaborative trial has been undertaken and will be evaluated to provide a precision annex to this document. Other methods to evaluate the efficacy of chemical disinfectants and antiseptics for different applications in the medical area are in preparation. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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. SIST EN 14348:2005

The conditions are intended to cover general purposes and to allow reference between laboratories and product types. Each concentration of the chemical disinfectant found by this test corresponds to the chosen experimental conditions. However, for some applications the instructions of use of a product may differ and therefore additional test conditions need to be used. SIST EN 14348:2005

in hospitals, in community medical facilities and in dental institutions;
in clinics of schools, of kindergartens 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 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a phase 2, step 1 test (see Annex E). 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 microbial strains used for the determination of bactericidal and fungicidal activity. EN 14820, Single-use containers for human venous blood specimen collection. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 product chemical agent or formulation used as a chemical disinfectant or antiseptic 3.2 mycobactericide product which 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 test organisms under defined conditions SIST EN 14348:2005

Mycobacterium terrae. Where indicated, additional specific mycobactericidal or tuberculocidal activity shall be determined applying other contact times, temperatures and interfering substances (5.5.1.1) in order to take into account intended specific use conditions.
NOTE For these additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions. SIST EN 14348:2005

Mycobacterium avium ATCC
Mycobacterium terrae ATCC
15755 The tuberculocidal activity shall be evaluated using only
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