EN 17111:2018
(Main)Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of virucidal 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 virucidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
This document specifies a test method and the minimum requirements for virucidal 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 document applies to products that are used in the medical area for disinfecting instruments by immersion.
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 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 2 test.
EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Keimträgerversuch zur Prüfung der viruziden Wirkung für Instrumente im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Dieses Dokument legt ein Prüfverfahren und die Mindestanforderungen an die viruzide Wirkung von chemischen Desinfektionsmitteln fest, die bei Verdünnung mit Wasser standardisierter Härte als homogene, physikalisch stabile Zubereitung vorliegen bzw. bei gebrauchsfertigen Produkten mit Wasser verdünnt werden.
Dieses Dokument gilt für Produkte, die zur Instrumentendesinfektion im humanmedizinischen Bereich durch Eintauchen verwendet werden.
Dieses Dokument gilt für Bereiche und unter Bedingungen, wo eine Desinfektion aus medizinischen Gründen angezeigt ist. Indikationen dieser Art liegen z. B. vor bei der Patientenbetreuung
- in Krankenhäusern, kommunalen medizinischen Einrichtungen und im Dentalbereich,
- in 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 1 Das beschriebene Verfahren dient zur Bestimmung der Wirkung von kommerziell erhältlichen Zubereitungen oder Wirkstoffen unter den Bedingungen, unter denen sie angewendet werden.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 2.
EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den Anwendungsempfehlungen fest.
Désinfectants chimiques et antiseptiques - Essai quantitatif de porte-germe pour l'évaluation de l'activité virucide pour instruments utilisés en médecine - Méthode d'essai et exigences (phase 2, étape 2)
Le présent document décrit une méthode d’essai et les exigences minimales relatives à l’activité virucide 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.
Le présent document s’applique aux produits utilisés en médecine pour la désinfection des instruments par immersion.
Le présent document s’applique aux domaines et situations où la désinfection est indiquée en médecine. De telles indications se rencontrent dans le cadre des soins apportés aux patients, par exemple :
- dans les hôpitaux, les centres de soins médicaux et les cabinets dentaires ;
- dans les infirmeries d’écoles, de crèches/garderies 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 dans lesquelles elles sont utilisées.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 2.
L’EN 14885 spécifie de façon détaillée la relation entre les différents essais et les « recommandations d’utilisation ».
Kemična razkužila in antiseptiki - Kvantitativni preskus s steklenim nosilcem za vrednotenje virucidnega delovanja kemičnih razkužil in antiseptikov za instrumente, ki se uporabljajo v humani medicini - Preskusna metoda in zahteve (faza 2, stopnja 2)
Ta evropski standard določa preskusno metodo in minimalne zahteve za virucidno delovanje kemičnih razkužil, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčena s trdo vodo ali, pri proizvodih, ki so pripravljeni za uporabo, z vodo. Ta evropski standard se uporablja za izdelke, ki se uporabljajo v humani medicini za dezinfekcijo instrumentov s potopitvijo – tudi če niso zajeti v Direktivi EGS/93/42 o medicinskih pripomočkih. Ta evropski standard se uporablja za področja in primere, ko obstajajo zdravniške indikacije za dezinfekcijo. Te indikacije se pojavljajo pri negi bolnikov, na primer: a) v bolnišnicah, skupnih zdravstvenih in zobozdravstvenih ustanovah; b) v klinikah šol, vrtcev in domov za starejše; c) in lahko nastanejo 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 2 faze 2. Standard EN 14885 podrobno določa razmerje med različnimi preskusi in »priporočili za uporabo«.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2019
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Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of
virucidal activity for instruments used in the medical area - Test method and
requirements (phase 2, step 2)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Keimträgerversuch zur
Prüfung der viruziden 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 virucide pour instruments utilisés en médecine - Méthode d'essai
et prescriptions (phase 2, étape 2)
Ta slovenski standard je istoveten z: EN 17111:2018
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 17111
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2018
EUROPÄISCHE NORM
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Quantitative
carrier test for the evaluation of virucidal activity for
instruments used in the medical area - Test method and
requirements (phase 2, step 2)
Désinfectants chimiques et antiseptiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de porte-germe pour l'évaluation de Quantitativer Keimträgerversuch zur Prüfung der
l'activité virucide pour instruments utilisés en viruziden Wirkung für Instrumente im
médecine - Méthode d'essai et exigences (phase 2, humanmedizinischen Bereich - Prüfverfahren und
étape 2) Anforderungen (Phase 2, Stufe 2)
This European Standard was approved by CEN on 18 June 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 17111:2018 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 . 8
5.1 Principle . 8
5.2 Materials and reagents . 8
5.2.1 Test organisms . 8
5.2.2 Culture media, reagents and cell cultures . 9
5.3 Apparatus and glassware . 12
5.3.1 General . 12
5.3.2 Usual microbiological laboratory equipment . 12
5.4 Preparation of test organism suspensions and product test solutions . 14
5.4.1 Test organism suspensions (test suspension) . 14
5.4.2 Product test solution . 14
5.5 Procedure for assessing the virucidal activity of the product . 15
5.5.1 General . 15
5.5.2 Method . 16
5.5.3 Cytotoxicity caused by product solutions . 18
5.5.4 Control of efficiency for suppression of disinfectant activity . 19
5.5.5 Reference test for virus inactivation . 19
5.5.6 Titration of the virus control . 19
5.5.7 Titration of test samples . 19
5.6 Experimental data and calculation . 20
5.6.1 Protocol of the results . 20
5.6.2 Calculation of infectivity titre (TCID PFU) . 20
50 –
5.7 Verification of the methodology . 20
5.8 Explanation of terms and abbreviations . 21
5.9 Expression of results . 21
5.9.1 General . 21
5.9.2 Calculation of the virucidal activity of products . 21
5.10 Calculation . 21
5.10.1 Virucidal activity . 21
5.10.2 Claims . 22
5.11 Test report . 22
Annex A (informative) Example of a typical test report . 24
Annex B (informative) Examples of viruses sorted according to their presence in the
human body in case of virus infection . 26
Annex C (normative) Detoxification of test mixtures by molecular sieving . 28
C.1 Molecular sieving with Sephadex™ LH 20 . 28
C.1.1 Principle . 28
C.1.2 Sephadex suspension . 28
C.1.3 Procedure . 28
C.2 Molecular sieving using MicroSpin™ S 400 HR. 30
C.3 Determination of the residual virus titre by the large-volume-plating (LVP) method . 30
C.3.1 General . 30
C.3.2 Example for the calculation of titres and the reduction according to the large-
volume-plating Method . 31
Annex D (informative) Calculation of the viral infectivity titre . 33
D.1 Quantal tests - Example of TCID determination by the Spaerman-Kärber method . 33
D.2 Plaque test . 34
D.3 Biometrical evaluation of experimental approaches and assessment of the
disinfecting effect on the virus (reduction [R]): . 34
D.3.1 General . 34
D.3.2 Calculating the virus titre with 95 % confidence interval . 35
D.3.3 Calculating the reduction and its 95 % confidence interval . 35
D.3.4 Calculating the average reduction (R ) and its 95 % confidence interval . 36
(mi)
D.3.5 Practical example . 37
Bibliography . 40
European foreword
This document (EN 17111:2018) has been prepared by Technical Committee CEN/TC 216 “Chemical
desinfectants 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 April 2019, and conflicting national standards shall be
withdrawn at the latest by April 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 carrier test for establishing whether a chemical disinfectant for use
on instruments (surgical instruments, anaesthesia material, endoscopes etc.) has a virucidal activity in
the fields described in the scope.
The laboratory test closely simulates practical conditions of application including pre-drying viruses on
a carrier, contact time, temperature, test organisms and interfering substances, i.e. conditions which
may influence the action of chemical disinfectants in practical situations. Each utilization concentration
of the chemical disinfectant found by this test corresponds to defined experimental conditions.
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