FprEN 17915
(Main)Chemical disinfectants and antiseptics - Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the food, industrial, domestic ad institutional area - Test method and requirements (phase 2, step 2).
Chemical disinfectants and antiseptics - Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the food, industrial, domestic ad institutional area - Test method and requirements (phase 2, step 2).
This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectants 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 food, industrial, domestic and institutional area for disinfecting non-porous surfaces without mechanical action, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues.
This document applies at least to the following:
a) processing, distribution and retailing of:
1) food of animal origin:
— milk and milk products;
— meat and meat products;
— fish, seafood, and related products;
— eggs and egg products;
— animal feeds;
— etc.;
2) food of vegetable origin:
— beverages;
— fruits, vegetables and derivatives (including sugar, distillery, etc.);
— flour, milling and baking;
— animal feeds;
— etc.;
b) institutional and domestic areas:
— catering establishments;
— public areas;
— public transports;
— schools;
— nurseries;
— shops;
— sports rooms;
— waste containers (bins, etc.);
— hotels;
— dwellings;
— clinically non sensitive areas of hospitals;
— offices;
— etc.;
c) industries other than food:
— packaging material;
— biotechnology (yeast, proteins, enzymes, etc.);
— pharmaceutical;
— cosmetics and toiletries;
— textiles;
— space industry, computer industry;
— etc.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
Chemische Desinfektionsmittel und Antiseptika - Quantitative Keimträgerprüfung zur Bestimmung der viruziden Wirkung chemischer Desinfektionsmittel auf harten nicht-porösen Oberflächen in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Dieses Dokument legt ein Prüfverfahren für und die Mindestanforderungen an die viruzide Wirkung von chemischen Desinfektionsmitteln fest, die bei Verdünnung mit Wasser standardisierter Härte bzw. bei gebrauchsfertigen Produkten mit Wasser als homogene, physikalisch stabile Zubereitung vorliegen.
Dieses Dokument gilt für Produkte, die in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche Einrichtungen zur Desinfektion von nicht-porösen Oberflächen ohne mechanische Behandlung verwendet werden, mit Ausnahme von Bereichen und Bedingungen, wo eine Desinfektion aus medizinischen Gründen angezeigt ist.
Dieses Dokument gilt mindestens für den folgenden Anwendungsbereich:
a) Verarbeitung, Vertrieb und Verkauf von:
1) Lebensmitteln tierischer Herkunft:
Milch und Milchprodukte;
Fleisch und Fleischprodukte;
Fisch, Meerestiere und daraus hergestellte Erzeugnisse;
Eier und Eiprodukte;
Tiernahrung;
usw.;
2) Lebensmittel pflanzlicher Herkunft:
Getränke;
Früchte, Gemüse und daraus hergestellte Erzeugnisse (einschließlich Zucker, Destillationsprodukte usw.);
Mehl, gemahlene und gebackene Produkte;
Tiernahrung;
usw.;
b) gewerbliche Einrichtungen und Haushaltsbereiche:
Verpflegungseinrichtungen;
öffentliche Bereiche;
öffentliche Verkehrsmittel;
Schulen;
Kindergärten;
Geschäfte;
Sportstätten;
Abfallbehälter (Mülltonnen usw.);
Hotels;
Wohngebäude;
klinisch nicht relevante Bereiche von Krankenhäusern;
Büroräume;
usw.;
c) andere industrielle Bereiche als der Lebensmittelbereich:
Verpackungsmaterial;
Biotechnologie (Hefe, Proteine, Enzyme usw.);
Hersteller von Pharmazeutika;
Hersteller von Kosmetika und Toilettenartikeln;
Hersteller von Textilien;
Weltraumforschungsindustrie und Computerindustrie;
usw.
EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den „Anwendungsempfehlungen“ fest.
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface non poreuse sans action mécanique pour l’évaluation de l’activité virucide des désinfectants chimiques utilisés dans l’agroalimentaire, l’industrie, la sphère domestique et les collectivités - 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 de l’eau.
Le présent document s’applique aux produits utilisés dans l’agroalimentaire, l’industrie, la sphère domestique et les collectivités pour la désinfection des surfaces non poreuses sans action mécanique, à l’exclusion des lieux et des situations dans lesquels la désinfection est soumise à une indication médicale et à l’exclusion des produits utilisés sur des tissus vivants.
Le présent document s’applique au moins aux éléments suivants :
a) la transformation, la distribution et le commerce de détail des :
1) aliments d’origine animale :
— lait et produits laitiers ;
— viande et produits carnés ;
— poisson, fruits de mer et leurs dérivés ;
— œufs et produits dérivés ;
— alimentation animale ;
— etc. ;
2) aliments d’origine végétale :
— boissons ;
— fruits, légumes et leurs dérivés (y compris le sucre, les produits de distillation, etc.) ;
— farine, minoterie et boulangerie ;
— alimentation animale ;
— etc. ;
b) les domaines domestiques et les collectivités :
— établissements de restauration ;
— lieux publics ;
— transports publics ;
— écoles ;
— crèches ;
— magasins ;
— salles de sport ;
— conteneurs pour déchets (poubelles, etc.) ;
— hôtels ;
— locaux d’habitation ;
— zones cliniquement non sensibles des hôpitaux ;
— bureaux ;
— etc. ;
c) des secteurs autres que celui de l’agroalimentaire :
— matériaux d’emballage ;
— biotechnologie (levures, protéines, enzymes, etc.) ;
— industrie pharmaceutique ;
— cosmétiques et produits d’hygiène corporelle ;
— textiles ;
— industrie spatiale, secteur informatique ;
— etc.
L’EN 14885 spécifie en détail la relation entre les différents essais et les « recommandations d’usage ».
Kemična razkužila in antiseptiki - Kvantitativna preskusna metoda s steklenim nosilcem za vrednotenje virucidnega delovanja kemičnih razkužil na trdih neporoznih površinah v živilski in drugih industrijah, gospodinjstvu in javnih ustanovah - Preskusna metoda in zahteve (faza 2, stopnja 2)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2022
Kemična razkužila in antiseptiki - Kvantitativna preskusna metoda s steklenim
nosilcem za vrednotenje virucidnega delovanja kemičnih razkužil na trdih
neporoznih površinah v živilski in drugih industrijah, gospodinjstvu in javnih
ustanovah - Preskusna metoda in zahteve (faza 2, stopnja 2)
Chemical disinfectants and antiseptics - Quantitative carrier test method for the
evaluation of virucidal activity of chemical disinfectants on hard non-porous surfaces in
food, industrial, domestic and institutional areas - Test method and requirements (phase
2, step 2)
Chemische Desinfektionsmittel und Antiseptika – Quantitative Keimträgerprüfung zur
Bestimmung der viruziden Wirkung chemischer Desinfektionsmittel auf harten nicht-
porösen Oberflächen in den Bereichen Lebensmittel, Industrie, Haushalt und öffentliche
Einrichtungen – Prüfverfahren und Anforderungen (Phase2, Stufe2)
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface non poreuse sans
action mécanique pour l’évaluation de l’activité virucide des désinfectants chimiques
utilisés dans l’agroalimentaire, l’industrie, la sphère domestique et les collectivités -
Méthode d’essai et exigences (phase 2, étape 2)
Ta slovenski standard je istoveten z: prEN 17915
ICS:
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.
DRAFT
EUROPEAN STANDARD
prEN 17915
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2022
ICS 11.080.20; 71.100.35
English Version
Chemical disinfectants and antiseptics - Quantitative
carrier test method for the evaluation of virucidal activity
of chemical disinfectants on hard non-porous surfaces in
food, industrial, domestic and institutional areas - Test
method and requirements (phase 2, step 2).
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de surface non poreuse sans action Quantitative Keimträgerprüfung zur Bestimmung der
mécanique pour l'évaluation de l'activité virucide des viruziden Wirkung chemischer Desinfektionsmittel auf
désinfectants chimiques utilisés dans l'agroalimentaire, harten nicht-porösen Oberflächen in den Bereichen
l'industrie, la sphère domestique et les collectivités - Lebensmittel, Industrie, Haushalt und öffentliche
Méthode d'essai et exigences (phase 2, étape 2) Einrichtungen - Prüfverfahren und Anforderungen
(Phase2, Stufe2)
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 216.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17915:2022 E
worldwide for CEN national Members.
prEN 17915 :2022 (E)
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 7
3 Terms and definitions . 8
4 Requirements for virucidal activity on surfaces. 9
5 Test methods . 10
5.1 Principle . 10
5.2 Materials and reagents, including cell cultures . 11
5.2.1 Test organisms . 11
5.2.2 Culture media, reagents and cell cultures . 11
5.3 Apparatus and glassware . 14
5.3.1 General . 14
5.3.2 Usual microbiological laboratory equipment . 15
5.3.3 Test surfaces . 16
5.4 Preparation of test organism suspensions and product test solutions . 16
5.4.1 Test organism suspension (test virus suspension) . 16
5.4.2 Product test solution . 17
5.5 Procedure for assessing the virucidal activity of the product . 17
5.5.1 Experimental conditions . 17
5.5.2 Test procedure . 18
5.5.3 Cytotoxicity caused by product solutions . 20
5.5.4 Control of efficiency for suppression of disinfectant virucidal activity . 21
5.5.5 Reference test for virus inactivation . 21
5.5.6 Titration of the virus control . 21
5.6 Experimental data and calculation . 21
5.6.1 Protocol of the results . 21
5.6.2 Calculation of infectivity titre (TCID PFU) . 21
50 –
5.7 Verification of the methodology . 22
5.8 Expression of results . 23
5.8.1 General . 23
5.8.2 Calculation of the virucidal activity of products used in chemo-thermal processes . 23
5.8.3 Calculation of the virucidal activity of products . 23
5.8.4 Calculation of the virucidal activity against enveloped viruses . 23
5.9 Test report . 24
Annex A (normative) Detoxification of test mixtures by molecular sieving . 26
A.1 Molecular sieving with Sephadex™ LH 20 . 26
A.1.1 Principle . 26
A.1.2 Sephadex suspension . 26
A.1.3 Procedure. 26
A.2 Molecular sieving using MicroSpin™ S 400 HR . 28
A.3 Determination of the residual virus titre by the large-volume-plating (LVP) method . 28
prEN 17915 :2022 (E)
A.3.1 General . 28
A.3.2 Example for the calculation of titres and the reduction according to the large-
volume-plating Method . 29
Annex B (informative) Calculation of the viral infectivity titre . 31
B.1 Quantal tests — Example of TCID determination by the Spearman-Kärber method . 31
B.2 Plaque test . 32
B.3 Biometrical evaluation of experimental approaches and assessment of the
disinfecting effect on the virus (reduction [R]) . 32
B.3.1 General . 32
B.3.2 Calculating the virus titre . 32
B.3.3 Calculating the reduction . 33
B.3.4 Practical example . 33
B.3.4.1 Introduction. 33
B.3.4.2 Calculating the virus titre w: . 34
B.3.4.3 Calculating the reduction: . 34
Bibliography . 35
prEN 17915 :2022 (E)
European foreword
This document (prEN 17915:2022) has been prepared by Technical Committee CEN/TC 216 “Chemical
disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
prEN 17915 :2022 (E)
Introduction
This document describes a surface test method for establishing whether a product proposed as a
disinfectant in the fields described in Clause 1 has or does not have virucidal activity on non-porous
surfaces.
The laboratory test closely simulates practical conditions of application. Chosen conditions (contact time,
temperature, organisms on surfaces etc.) reflect parameters which are found in practical situations
including conditions which may influence the action of disinfectants. Each use concentration found from
this test corresponds to defined experimental conditions.
The conditions are intended to cover general purposes and to allow reference between laboratories and
product types. Each utilization concentration of the chemical disinfectant or antiseptic found by this test
corresponds to defined experimental conditions.
However for special applications the recommendations of use of a product can differ and therefore
additional test conditions might be needed, which cannot be covered by this
...
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