FprEN 16777

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 European Standard 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 European Standard applies to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices without mechanical action.
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 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)

Diese Europäische Norm legt ein Prüfverfahren für 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 bei Verdünnung mit Wasser.
Diese Europäische Norm gilt für Produkte, die im medizinischen Bereich zur Desinfektion von nicht porösen Oberflächen, einschließlich Oberflächen auf Medizinprodukten, ohne mechanische Einwirkung 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. 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 handelsüblicher Zubereitungen oder Wirkstoffe 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 prescriptions (phase 2/étape 2)

La présente Norme européenne décrit une méthode d’essai et les prescriptions 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.
La présente Norme européenne 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.
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 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, ki se uporabljajo v humani medicini - Preskusna metoda in zahteve (faza 2/stopnja 2)

General Information

• Status: Not Published
• Publication Date: 03-May-2016
• 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: 5098 - Decision to abandon - Formal Approval
• Completion Date: 16-Aug-2016
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: oSIST prEN 16777:2014 - 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-oktober-2014
.HPLþQDUD]NXåLODLQDQWLVHSWLNL.YDQWLWDWLYQLSUHVNXVQDQHSRUR]QLKSRYUãLQDK
EUH]PHKDQVNHJDGHORYDQMD]DYUHGQRWHQMHYLUXFLGQHJDGHORYDQMDNHPLþQLK
UD]NXåLONLVHXSRUDEOMDMRYKXPDQLPHGLFLQL3UHVNXVQDPHWRGDLQ]DKWHYHID]D
VWRSQMD
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 des désinfectants chimiques
utilisés dans le domaine médical - Méthode d'essai et prescriptions (phase 2/étape 2)
Ta slovenski standard je istoveten z: prEN 16777
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
DRAFT
prEN 16777
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
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 quantitatif Chemische Desinfektionsmittel und Antiseptika -
de surface non-poreuse sans action mécanique pour Quantitativer Versuch auf nicht porösen Oberflächen ohne
l'évaluation de l'activité virucide des désinfectants mechanische Einwirkung zur Bestimmung der viruziden
chimiques utilisés dans le domaine médical - Méthode Wirkung im humanmedizinischen Bereich - Prüfverfahren
d'essai et prescriptions (phase 2/étape 2) und Anforderungen (Phase 2, Stufe 2)
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, 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.
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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 16777:2014 E
worldwide for CEN national Members.

prEN 16777:2014 (E)
Contents
Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .5
4 Requirements for virucidal activity on surfaces .6
5 Test methods .6
5.1 Principle .6
5.2 Materials and reagents, including cell cultures .7
5.3 Apparatus and glassware . 10
5.4 Preparation of test organism suspensions and product test solutions . 12
5.5 Procedure for assessing the virucidal activity of the product . 13
5.6 Experimental data and calculation. 17
5.7 Verification of the methodology . 18
5.8 Expression of results . 19
5.9 Test report . 19
Annex A (informative) Examples of viruses sorted according to their presence in the human
body in case of virus infection . 21
Annex B (normative) Detoxification of test mixtures by molecular sieving . 23
B.1 Molecular sieving with SephadexTM LH 20 . 23
Annex C (informative) Calculation of the viral infectivity titre . 25
C.1 Quantal tests . 25
C.2 Plaque test . 26
C.3 Biometrical evaluation of experimental approaches and assessment of the disinfecting
effect on the virus (reduction [R]): . 26
Bibliography . 31

prEN 16777:2014 (E)
Foreword
This document (prEN 16777:2014) 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 16777:2014 (E)
Introduction
This European Standard 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 European Standard.
prEN 16777:2014 (E)
1 Scope
This European Standard 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 European Standard applies to products that are used in the medical area for disinfecting non-porous
surfaces including surfaces of medical devices without mechanical action.
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
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”.
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 14476, Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of
virucidal activity in the medical area — Test method and requirements (Phase 2/Step 1).
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.
EN 10088-1, Stainless steels - Part 1: List of stainless steels.
EN 10088-2, Stainless steels - Part 2: Technical delivery conditions for sheet/plate and strip of corrosion
resisting steels for general purposes.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 14885 and EN 14476 apply.
prEN 16777:2014 (E)
4 Requirements for virucidal activity on surfaces
The product shall demonstrate at least a decimal log (lg) reduction of 4 in virus titre of the Adenovirus and
Murine Norovirus test strains when tested in accordance with table 1 and Clauses 5, 6, 7, 8, and 9.
Table 1 — Minimum and additional test conditions
Test conditions
Test virus Adenovirus Type 5
Murine Norovirus
Test temperature between 18 °C ± 1 °C and 25 °C ± 1 °C
Contact time according to the manufacturer’s recommendation, but not longer than 5
a
min or 60 min
Interfering substances
a) clean 0,3 g/l bovine serum albumin
and/or
b) dirty 3,0 g/l bovine serum albumin plus 3,0 ml erythrocytes
b Further contact time(s), interfering substance(s) or virus(es)
Additional conditions
a
The contact times for surface disinfectants stated in this table are chosen on the basis of the practical conditions of
the product. The recommended contact time for the use of the product is within the responsibility of the manufacturer.
Products intended to disinfect surfaces that are likely to come into contact with the patient and / or the medical staff and
surfaces, which are frequently touched by different people, leading to the transmission of microorganisms to the patient,
shall be tested with a contact time of maximum 5 min. The same applies where the contact time of the product shall be
limited for practical reasons. Products for other surfaces than stated above may be tested with a contact time of
maximum 60 min.
b
Where appropriate (specific purposes), additional specific virucidal activity shall be determined under other conditions
of time, temperature, and interfering substances (see 5.2.3.3) in accordance with 6.2, in order to take into account
intended specific use conditions. Additional virus(es) can be tested, if relevant.

The determined virucidal concentration of the test product is suggested as being suitable for practical
situations of use.
5 Test methods
5.1 Principle
5.1.1 A test suspension of viruses in a solution of interfering substances is inoculated onto a test stainless
steel disc and dried. A prepared sample of the product under test is applied in a manner which covers the
dried film.
The disc is maintained at a specified temperature for a defined period of time. The disc is transferred to cell
maintenance medium so that the action of the disinfectant is immediately neutralised. The titre of the virus
recovered from the disc is determined.
The titre of the virus on a disc treated with hard water in place of the disinfectant is also determined and the
reduction in virus titre attributed to the product is calculated by difference.
5.1.2 The test is performed using the test organisms as specified in clause 4, table
...