EN 13624:2013
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)
This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic 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 (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms and interfering substance.
This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
This European Standard applies to areas and situations where disinfection or antisepsis 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 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.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Diese Europäische Norm legt ein Prüfverfahren und Mindestanforderungen für die fungizide oder levurozide (Hefen abtötende) Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die bei Verdünnung mit Wasser standardisierter Härte bzw. – im Fall von gebrauchsfertigen Produkten – mit Wasser als homogenes physikalisch stabiles Präparat vorliegen. Die Produkte können nur in einer Konzentration bis zu 80 % (97 % bei einem modifizierten Verfahren in Sonderfällen) geprüft werden, da durch Zu¬gabe der Prüforganismen und der Belastungssubstanz stets eine gewisse Verdünnung bewirkt wird.
Diese Europäische Norm gilt für Produkte, die im humanmedizinischen Bereich für hygienische Hände-desinfektion und Händewaschung, chirurgische Händedesinfektion und Händewaschung, für die Instrumentendesinfektion durch Eintauchen sowie für die Oberflächendesinfektion mittels Wischen, Sprühen, Spülen o. ä. verwendet werden.
Diese Europäische Norm gilt für Bereiche und Bedingungen, wo eine Desinfektion oder Antisepsis aus medizinischen Gründen angezeigt ist. Derartige Gründe treten bei der Patientenbetreuung z. B. in
Krankenhäusern, kommunalen medizinischen Einrichtungen und im Dentalbereich;
medizinischen Einrichtungen in Schulen, Kindergärten und Heimen;
auf und können auch am Arbeitsplatz oder im privaten Bereich gegeben sein. Eingeschlossen sein können auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung der Patienten dienen.
ANMERKUNG 1 Das beschriebene Verfahren dient zur Bestimmung der Wirksamkeit kommerziell erhältlicher Zubereitungen oder Wirkstoffe unter den jeweiligen Anwendungsbedingungen.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 1.
EN 14885 legt detailliert die Beziehungen der unterschiedlichen Prüfungen untereinander und zu „Anwen¬dungs-empfehlungen“ fest.
Désinfectants chimiques et antiseptiques - Essai quantitatif de suspension pour l'évaluation de l'activité fongicide ou levuricide en médecine - Méthode d'essai et prescriptions (phase 2, étape 1)
La présente Norme européenne spécifie une méthode d’essai et les exigences minimales relatives à l’activité fongicide et levuricide des désinfectants chimiques et des produits antiseptiques qui forment une préparation homogène, physiquement stable, lorsqu’ils sont dilués dans de l'eau dure ou — dans le cas de produits prêts à l’emploi — dans de l’eau. Les produits ne peuvent être soumis à l’essai qu’à une concentration inférieure ou égale à 80 % (97 % avec une méthode modifiée dans certains cas particuliers), car l’ajout des souches d’essai et de la substance interférente entraîne toujours une dilution.
La présente Norme européenne s’applique aux produits employés en médecine pour la friction et le lavage hygiéniques des mains, pour la friction et le lavage chirurgicaux des mains, pour la désinfection des instruments par immersion et pour la désinfection de surface par essuyage, pulvérisation, rinçage ou autre.
Le présent document s’applique dans les zones et situations où la désinfection ou l’antisepsie 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 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 La présente méthode correspond à un essai de type phase 2, étape 1.
L’EN 14885 précise de manière détaillée la relation entre les différents essais et les « recommandations d’utilisation.
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje fungicidnega delovanja ali delovanja na kvasovke v medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)
Ta evropski standard določa preskusno metodo in minimalne zahteve za fungicidno delovanje ali delovanje na kvasovke kemičnih razkužil in antiseptikov, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo ali, pri proizvodih, ki so pripravljeni za uporabo, z vodo. Proizvode je mogoče preskušati samo pri 80-odstotni ali nižji koncentraciji (s prilagojeno metodo v posebnih primerih 97-odstotni), ker dodajanje preskusnih organizmov in moteče snovi vedno povzroči razredčenje. Ta evropski standard velja za proizvode, ki se uporabljajo na področju zdravstva pri higienskem drgnjenju rok, higienskem umivanju rok, kirurškem drgnjenju rok, kirurškem umivanju rok, dezinfekciji instrumentov s potapljanjem in površinski dezinfekciji z brisanjem, pršenjem, zalivanjem ali na druge načine. Ta evropski standard se uporablja za področja in primere, ko obstajajo zdravniške indikacije za dezinfekcijo ali antisepso. Te indikacije se pojavljajo pri negi bolnikov, na primer: – v bolnišnicah, skupnih zdravstvenih in zobozdravstvenih ustanovah; – v klinikah šol, vrtcev in domov za starejše; in lahko nastanejo na delovnem mestu ali doma. Vključujejo lahko tudi storitve, kot so pralnice in kuhinje, ki proizvode neposredno dostavljajo bolnikom.
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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 fungiziden oder levuroziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)Désinfectants chimiques et antiseptiques - Essai quantitatif de suspension pour l'évaluation de l'activité fongicide ou levuricide en médecine - Méthode d'essai et prescriptions (phase 2, étape 1)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)11.080.20Dezinfektanti in antiseptikiDisinfectants and antisepticsICS:Ta slovenski standard je istoveten z:EN 13624:2013SIST EN 13624:2013en,fr,de01-november-2013SIST EN 13624:2013SLOVENSKI
STANDARDSIST EN 13624:20041DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13624
September 2013 ICS 11.080.20 Supersedes EN 13624:2003English Version
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1) Désinfectants chimiques et antiseptiques - Essai quantitatif de suspension pour l'évaluation de l'activité fongicide ou levuricide en médecine - Méthode d'essai et prescriptions (phase 2, étape 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1) This European Standard was approved by CEN on 3 August 2013.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13624:2013: ESIST EN 13624:2013
Referenced strains in national collections . 35 Annex B (informative)
Neutralizers and rinsing liquids . 36 Annex C (informative)
Graphical representation of test procedures . 38 C.1 Dilution-neutralization method . 38 C.2 Membrane filtration method . 40 C.3 Dilution-neutralization method (modified method for ready-to-use products) . 42 C.4 Membrane filtration method (modified method for ready-to-use products) . 44 Annex D (informative)
Example of a typical test report . 46 Annex E (informative)
Precision of the test result . 50 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 53 Bibliography . 54
Introduction This European Standard specifies a suspension test for establishing whether a chemical disinfectant or an antiseptic has a fungicidal or yeasticidal activity in the area and fields described in the scope. This laboratory test takes into account practical conditions of application of the product including contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence its action in practical situations. Each utilisation concentration of the chemical disinfectant or antiseptic found by this test corresponds to the chosen experimental conditions. SIST EN 13624:2013
This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means. This European Standard applies to areas and situations where disinfection or antisepsis 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 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. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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 (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity EN 14885, Chemical disinfectants and antiseptics — Application of European Standards for chemical disinfectants and antiseptics ISO 4793:1980, Laboratory sintered (fritted) filters — Porosity grading, classification and designation 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 14885 apply. 4 Requirements The product shall demonstrate at least a 4 decimal log (lg) reduction (for hygienic handwash at least a 2 lg reduction), when tested in accordance with Table 1 and Clause 5. SIST EN 13624:2013
Candida albicans (vegetative cells) Candida albicans (vegetative cells) a) fungicidal activity: Aspergillus brasiliensis (conidiospores) Candida albicans (veg. cells) b) yeasticidal activity: Candida albicans (veg. cells) a) fungicidal activity: Aspergillus brasiliensis (conidiospores) Candida albicans (veg. cells) b) yeasticidal activity: Candida albicans (veg. cells)
additional Any relevant test organism Test temperature according to the manufacturer's recommendation, but at/ between 20 °C 20 °C 20 °C and 70 °C 4 °C and 30 °C Contact time according to the manufacturer's recommendation,
but between
but no longer than 30 s and 60 s 1 min and 5 min 60 min 5 min or 60 mina Interfering substance clean conditions 0,3 g/l bovine albumin solution (hygienic handrub)b 0,3 g/l bovine albumin solution (surgical handrub)b 0,3 g/l bovine albumin solution 0,3 g/l bovine albumin solution dirty conditions 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (hygienic handwash)c 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (surgical and handwash)c and/or 3,0 g
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