EN 17126:2018
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants in the medical area - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants in the medical area - Test method and requirements (phase 2, step 1)
This document specifies a test method and the minimum requirements for sporicidal activity of chemical disinfectant 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 instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.
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 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 sporiziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Dieses Dokument legt ein Prüfverfahren für und die Mindestanforderungen an die sporizide Wirkung von chemischen Desinfektionsmitteln fest, die bei Verdünnung mit Wasser standardisierter Härte als homogene, physikalisch stabile Zubereitung vorliegen, bzw. bei gebrauchsfertigen Produkten bei der Verdünnung mit Wasser. Die Produkte können nur bei einer Konzentration bis zu 80 % (97 % bei einem modifizierten Verfahren für Sonderfälle) geprüft werden, da durch Zugabe der Prüforganismen und der Belastungssubstanz immer eine gewisse Verdünnung bewirkt wird.
Diese Europäische Norm gilt für Produkte, die im medizinischen Bereich bei der Instrumentendesinfektion durch Eintauchen und bei der Oberflächendesinfektion durch Abwischen, Besprühen, Einschwemmen oder auf sonstige Weise verwendet werden.
Diese Europäische Norm gilt für Bereiche und unter Bedingungen, wo eine Desinfektion aus medizinischen Gründen angezeigt ist. Indikationen dieser Art liegen z. B. bei der Patientenbetreuung in
Krankenhäusern, kommunalen medizinischen Einrichtungen und im Dentalbereich und
medizinischen Einrichtungen in Schulen, Kindergärten und Heimen
vor und können auch am Arbeitsplatz und im häuslichen Bereich gegeben sein. Eingeschlossen sein können auch Einrichtungen wie Wäschereien und Küchen, die der direkten Versorgung von Patienten dienen.
ANMERKUNG 1 Das beschriebene Verfahren dient zur Bestimmung der Wirkung handelsüblicher Zubereitungen oder Wirkstoffe unter den Bedingungen, unter denen sie angewendet werden.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 1.
EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den „Anwendungsempfehlungen“ fest.
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l’évaluation de l’activité sporicide des désinfectants chimiques utilisés dans le domaine médical - Méthodes d’essai et exigences (phase 2, étape 1)
Le présent document décrit une méthode d’essai et les exigences minimales relatives à l’activité sporicide des désinfectants chimiques 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 l’eau. Les produits ne peuvent être soumis à l’essai qu’à la concentration de 80 % (97 % avec une méthode modifiée pour les cas particuliers) ou à des concentrations inférieures, car l’ajout des microorganismes d’essai et de la substance interférente s’accompagne forcément d’une dilution.
La présente Norme européenne s’applique aux produits utilisés en médecine dans la désinfection des instruments par immersion, ainsi que la désinfection des surfaces par essuyage, pulvérisation, rinçage ou d’autres moyens.
La présente Norme européenne s’applique dans les domaines et situations où la désinfection est indiquée en médecine humaine. De telles indications se rencontrent dans le cadre des soins apportés aux patients, par exemple :
- dans des hôpitaux, dans des centres de soins médicaux et des 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 vise à déterminer l’activité des formulations commerciales ou des substances actives dans les conditions d’utilisation.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 1.
L’EN 14885 spécifie de façon détaillée les relations des différents essais entre eux et avec les « recommandations d’emploi ».
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje sporocidnega delovanja kemičnih razkužil v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)
Ta evropski standard določa preskusno metodo in minimalne zahteve za sporocidno delovanje kemičnih razkužil in antiseptikov, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo oziroma z vodo pri proizvodih, ki so pripravljeni za uporabo. 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 se uporablja za proizvode, ki se uporabljajo na področju zdravstva pri razkuževanju instrumentov s potapljanjem, površinskem razkuževanju z brisanjem, pršenjem, zalivanjem ali na druge načine. Ta evropski standard se uporablja za področja in primere, ko obstajajo zdravniške indikacije za razkuževanje ali antisepso. Te indikacije se pojavljajo pri negi bolnikov, na primer: – v bolnišnicah, javnih zdravstvenih in zobozdravstvenih ustanovah;
– v ambulantah šol, vrtcev in domov za starejše;
ter se lahko pojavijo na delovnem mestu ali doma. Vključujejo lahko tudi storitve, kot so pralnice in kuhinje, ki proizvode dostavljajo neposredno bolnikom. OPOMBA 1: Opisana metoda je namenjena določevanju dejavnosti komercialnih oblik ali aktivnih snovi pod pogoji, v katerih se uporabljajo. OPOMBA 2: Ta metoda ustreza preskusu stopnje 1 faze 2. EN 14885 podrobno določa razmerje med različnimi preskusi in priporočili za uporabo.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2019
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Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of sporicidal activity of chemical disinfectants in the medical area - Test method and
requirements (phase 2, step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der sporiziden Wirkung im humanmedizinischen Bereich - Prüfverfahren
und Anforderungen (Phase 2, Stufe 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour
l’évaluation de l’activité sporicide des désinfectants chimiques utilisés dans le domaine
médical - Méthodes d’essai et exigences (phase 2, étape 1)
Ta slovenski standard je istoveten z: EN 17126:2018
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 17126
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Quantitative
suspension test for the evaluation of sporicidal activity of
chemical disinfectants in the medical area - Test method
and requirements (phase 2, step 1)
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de suspension pour l'évaluation de l'activité Quantitativer Suspensionsversuch zur Bestimmung der
sporicide des désinfectants chimiques utilisés dans le sporiziden Wirkung im humanmedizinischen Bereich -
domaine médical - Méthodes d'essai et exigences Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
(phase 2, étape 1)
This European Standard was approved by CEN on 28 August 2018.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 17126:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 6
5 Test method . 7
5.1 Principle . 7
5.2 Materials and reagents . 8
5.2.1 Test organisms . 8
5.2.2 Culture media and reagents . 8
5.3 Apparatus and glassware . 14
5.3.1 General . 14
5.3.2 Usual microbiological laboratory equipment . 14
5.4 Preparation of test organism suspensions and product test solutions . 16
5.4.1 Test organism suspensions (test and validation suspension) . 16
5.4.2 Product test solutions . 21
5.5 Procedure for assessing the sporicidal activity of the product . 21
5.5.1 General . 21
5.5.2 Dilution-neutralization method . 23
5.5.3 Membrane filtration method . 25
5.5.4 Modified method for ready-to-use products . 27
5.6 Experimental data and calculation . 29
5.6.1 Explanation of terms and abbreviations . 29
5.6.2 Calculation . 30
5.7 Verification of methodology . 34
5.7.1 General . 34
5.7.2 Control of weighted mean counts . 34
5.7.3 Basic limits . 34
5.8 Expression of results and precision . 35
5.8.1 Reduction . 35
5.8.2 Control of active and non-active product test solution (5.4.2) . 35
5.8.3 Limiting test organism and sporicidal concentration . 35
5.8.4 Precision, repetitions . 36
5.9 Interpretation of results - conclusion . 36
5.9.1 General . 36
5.9.2 Sporicidal activity for surface disinfection products . 36
5.9.3 Sporicidal activity for instrument disinfection products . 36
5.9.4 Sporicidal activity for textile disinfection products . 36
5.9.5 Qualification for certain fields of application . 36
5.10 Test report . 36
Annex A (informative) Referenced strains in national collections . 39
Annex B (informative) Neutralizers and Rinsing Liquids . 40
Annex C (informative) Graphical representation of test procedures . 42
C.1 Dilution-neutralization method . 42
C.2 Membrane filtration method . 44
C.3 Dilution-neutralization method (modified method for ready-to-use products) . 46
C.4 Membrane filtration method (modified method for ready-to-use products) . 48
Annex D (informative) Example of a typical test report . 50
Annex E (informative) Precision of the test result. 54
Annex F (informative) Graphical representation of spore preparation . 55
Annex G (informative) Guide for preparation of reference test solution . 56
Annex H (informative) Example for a titration Peracetic acids and hydrogen peroxide . 57
H.1 General . 57
H.2 Equipment . 57
H.3 Procedure . 57
Bibliography . 59
European foreword
This document (EN 17126:2018) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2019, and conflicting national standards shall be
withdrawn at the latest by June 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Introduction
This European Standard specifies a suspension test for establishing whether a chemical disinfectant has
a sporicidal 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 utilization concentration of the chemical disinfectant found by this test corresponds to the chosen
experimental conditions.
1 Scope
This document specifies a test method and the minimum requirements for sporicidal activity of
chemical disinfectant 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 subst
...
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