EN 16777:2018

Chemical disinfectants and antiseptics - Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants 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 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 medical area for disinfecting non-porous surfaces including surfaces of medical devices without mechanical action.
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 on viruses in 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 Versuch auf nicht porösen Oberflächen ohne mechanische Einwirkung zur Bestimmung der viruziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)

Dieses Dokument legt ein Prüfverfahren für und die Mindestanforderungen an die viruzide Wirkung von chemischen Desinfektions¬mitteln fest, die bei Verdünnung mit Wasser standardisierter Härte als homogene, physikalisch stabile Zubereitung vorliegen, beziehungsweise bei gebrauchsfertigen Produkten bei Verdünnung mit Wasser.
Dieses Dokument gilt für Produkte, die im medizinischen Bereich zur Desinfektion von nicht porösen Oberflächen, einschließlich Oberflächen auf Medizinprodukten, ohne mechanische Einwirkung 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 Bereichen in Schulen, Kindergärten und Heimen
und können auch am Arbeitsplatz oder im privaten 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 handelsüblichen Zubereitungen oder Wirkstoffen auf Viren 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.

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 le domaine médical - 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 humaine pour la désinfection des surfaces non poreuses, y compris les surfaces des dispositifs médicaux, sans action mécanique.
Le présent document s’applique aux 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 sur les virus 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 les relations des différents essais entre eux et avec les « recommandations d’emploi ».

Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah brez mehanskega delovanja za vrednotenje virucidnega delovanja kemičnih razkužil 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 oziroma z vodo pri proizvodih, ki so pripravljeni za uporabo.
Ta evropski standard se uporablja za izdelke, ki se na zdravstvenem področju uporabljajo za razkuževanje neporoznih površin, vključno s površinami medicinskih pripomočkov, brez mehanskega delovanja.
Ta evropski standard se uporablja za področja in primere, ko obstajajo zdravniške indikacije za dezinfekcijo. Te indikacije se pojavljajo pri negi bolnikov, na primer:
– v bolnišnicah, javnih zdravstvenih in zobozdravstvenih ustanovah;
– v ambulantah šol, vrtcev in domov za starejše;
in lahko se pojavljajo 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 na virusih 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

• Status: Published
• Publication Date: 11-Dec-2018
• Withdrawal Date: 29-Jun-2019
• 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: 9060 - Closure of 2 Year Review Enquiry - Review Enquiry
• Start Date: 03-Jun-2024
• Completion Date: 03-Jun-2024
• Ref Project: SIST EN 16777:2019 - Chemical disinfectants and antiseptics - Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area - Test method and requirements (phase 2/step 2)

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2019
.HPLþQDUD]NXåLODLQDQWLVHSWLNL.YDQWLWDWLYQLSUHVNXVQDQHSRUR]QLKSRYUãLQDK
EUH]PHKDQVNHJDGHORYDQMD]DYUHGQRWHQMHYLUXFLGQHJDGHORYDQMDNHPLþQLK
UD]NXåLOYKXPDQLPHGLFLQL3UHVNXVQDPHWRGDLQ]DKWHYHID]DVWRSQMD
Chemical disinfectants and antiseptics - Quantitative non-porous surface test without
mechanical action for the evaluation of virucidal activity of chemical disinfectants used in
the medical area - Test method and requirements (phase 2/step 2)
Chemische Desinfektionsmittel und Antiseptika-Quantitativer Versuch auf nicht porösen
Oberflächen ohne mechanische Einwirkung zur Bestimmung der viruziden Wirkung im
humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface non-poreuse sans
action mécanique pour l'évaluation de l'activité virucide désinfectants chimiques utilisés
dans le domaine humain médicine - Méthode d'essai et prescriptions (phase 2/étape 2)
Ta slovenski standard je istoveten z: EN 16777:2018
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 16777
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Quantitative non-
porous surface test without mechanical action for the
evaluation of virucidal activity of chemical disinfectants
used in the medical area - Test method and requirements
(phase 2/step 2)
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de surface non poreuse sans action Quantitativer Versuch auf nicht porösen Oberflächen
mécanique pour l'évaluation de l'activité virucide des ohne mechanische Einwirkung zur Bestimmung der
désinfectants chimiques utilisés dans le domaine viruziden Wirkung im humanmedizinischen Bereich -
médical - Méthode d'essai et exigences (phase 2/étape Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
2)
This European Standard was approved by CEN on 24 September 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 16777:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Requirements for virucidal activity on surfaces. 7
5 Test methods . 8
5.1 Principle . 8
5.2 Materials and reagents, including cell cultures . 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 . 13
5.3.3 Test surfaces . 14
5.4 Preparation of test organism suspensions and product test solutions . 14
5.4.1 Test organisms suspensions (test virus suspension) . 14
5.4.2 Product test solution . 14
5.5 Procedure for assessing the virucidal activity of the product . 15
5.5.1 Experimental conditions . 15
5.5.2 Test procedure . 16
5.5.3 Cytotoxicity caused by product solutions . 17
5.5.4 Control of efficiency for suppression of disinfectant virucidal activity . 18
5.5.5 Reference test for virus inactivation . 19
5.5.6 Titration of the virus control . 19
5.6 Experimental data and calculation . 19
5.6.1 Protocol of the results . 19
5.6.2 Calculation of infectivity titre (TCID PFU) . 19
50 –
5.7 Verification of the methodology . 20
5.8 Expression of results . 20
5.8.1 General . 20
5.8.2 Calculation of the virucidal activity of products . 20
5.9 Test report . 21
Annex A (informative) Examples of viruses sorted according to their presence in the
human body in case of virus infection . 23
Annex B (normative) Detoxification of test mixtures by molecular sieving . 25
B.1 Molecular sieving with Sephadex™ LH 20 . 25
B.1.1 Principle . 25
B.1.2 Sephadex suspension . 25
B.1.3 Procedure. 25
B.2 Molecular sieving using MicroSpin™ S 400 HR . 27
B.3 Determination of the residual virus titre by the large-volume-plating (LVP) method . 27
B.3.1 General . 27
B.3.2 Example for the calculation of titres and the reduction according to the large-
volume-plating Method . 28
Annex C (informative) Calculation of the viral infectivity titre . 30
C.1 Quantal tests - Example of TCID determination by the Spaerman-Kärber method . 30
C.2 Plaque test . 30
C.3 Biometrical evaluation of experimental approaches and assessment of the
disinfecting effect on the virus (reduction [R]): . 31
C.3.1 General . 31
C.3.2 Calculating the virus titre with 95 % confidence interval - Example . 32
C.3.3 Calculating the reduction and its 95 % confidence interval . 32
C.3.4 Calculating the average reduction (R ) and its 95 % confidence interval . 33
(mi)
C.3.5 Practical example . 34
Bibliography . 37

European foreword
This document (EN 16777:2018) 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 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 document.
1 Scope
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 har
...