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SLOVENSKI STANDARD
SIST EN 14476:2013+A1:2015/oprA2:2017
01-januar-2017
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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)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der viruziden 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 virucide dans le domaine médical - Méthode d'essai et
prescriptions (Phase 2/Étape 1)
Ta slovenski standard je istoveten z: EN 14476:2013+A1:2015/prA2
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
SIST EN en,fr,de
14476:2013+A1:2015/oprA2:2017
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN 14476:2013+A1:2015/oprA2:2017
SIST EN 14476:2013+A1:2015/oprA2:2017
DRAFT
EUROPEAN STANDARD
EN 14476:2013+A1:2015
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA2
November 2016
ICS 11.080.20
English Version
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)
Antiseptiques et désinfectants chimiques - Essai Chemische Desinfektionsmittel und Antiseptika -
quantitatif de suspension pour l'évaluation de l'activité Quantitativer Suspensionsversuch zur Bestimmung der
virucide dans le domaine médical - Méthode d'essai et viruziden Wirkung im humanmedizinischen Bereich -
prescriptions (Phase 2/Étape 1) Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 216.
This draft amendment A2, if approved, will modify the European Standard EN 14476:2013+A1:2015. If this draft becomes an
amendment, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
inclusion of this amendment into the relevant national standard without any alteration.
This draft amendment 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
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14476:2013+A1:2015/prA2:2016 E
worldwide for CEN national Members.
SIST EN 14476:2013+A1:2015/oprA2:2017
EN 14476:2013+A1:2015/prA2:2016 (E)
Contents Page
European foreword . 3
1 Modifications to the Foreword . 4
2 Modifications to Clause 4, Table 1 . 4
3 Modification to 5.2.1 c) 1) . 5
4 Modification to 5.2.2.8.3 . 5
5 Modification to 5.5.1.1 e) . 5
6 Modification of 5.5.4.3 . 6
7 Modification to 5.5.5.1 . 6
8 Modification of Annex B . 6
B.3 Determination of the residual virus titre by the large-volume-plating (LVP) method . 6
B.3.1 General . 6
B.3.2 Example for the calculation of titres and the reduction according to the large-
volume-plating method . 7
SIST EN 14476:2013+A1:2015/oprA2:2017
EN 14476:2013+A1:2015/prA2:2016 (E)
European foreword
This document (EN 14476:2013+A1:2015/prA2:2016) 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.
This document will supersede EN 14476:2013+A1:2015.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
SIST EN 14476:2013+A1:2015/oprA2:2017
EN 14476:2013+A1:2015/prA2:2016 (E)
1 Modifications to the Foreword
Add the following to the existing list of modifications: “
• For the surface disinfection a test for virucidal activity against enveloped viruses with Vaccinia Virus
was added.
• The spelling of Vaccinavirus is corrected to Vaccinia Virus (Table 1).
• The Vaccinia Virus Elstree was added as alternative strain (5.2.1 c) 1)), (5.5.1.1 e)).
• For dirty conditions (5.2.2.8.3) the resuspension shall be done in PBS and not in water.
• The dilution in ice-cold medium for the control of efficiency of suppression of products activity
(5.5.5.1) was clarified.
• Addition of the large-volume-platting method (5.5.4.3, B.3).”.
2 Modifications to Clause 4, Table 1
a
In Table 1, 4th column, add “Limited spectrum virucidal activity ”, “Adenovirus, Murine Norovirus”,
b
“Virucidal activity against enveloped viruses ” and “Vaccinia Virus” to read as follows:
“Table 1 — Minimum and additional test conditions
Test Hygienic handrub Instrument Surface Textile
Conditions and handwash disinfection disinfection
disinfection
Minimum Poliovirus Poliovirus Poliovirus Parvovirus
spectrum of
Adenovirus Adenovirus Adenovirus
test organisms
Murine Norovirus Murine Norovirus Murine Norovirus
Limited spectrum when temperature is Limited spectrum
a a
virucidal activity 40 °C or higher: only virucidal activity
Adenovirus Parvovirus Adenovirus
Murine Norovirus Murine Norovirus
!Virucidal Virucidal activity
activity against against enveloped
b b
enveloped viruses viruses
Vaccinia Virus" Vaccinia Virus
additional Any relevant test organism
Test
according to the manufacturer’s recommendation, but at / between
temperature
20 °C 20 °C and 70 °C 4 °C and 30 °C 30 °C and 70 °C
Contact time according to the manufacturer’s recommendation
but between but no longer than but no longer than but no longer than
30 s and 120 s 60 min 5 min or 20 min
c
60 min
Interfering substance
SIST EN 14476:2013+A1:2015/oprA2:2017
EN 14476:2013+A1:2015/prA2:2016 (E)
Test Hygienic handrub Instrument Surface Textile
Conditions and handwash disinfection disinfection
disinfection
clean 0,3 g/l bovine 0,3 g/l bovine 0,3 g/l bovine
conditions albumin solution albumin solution albumin solution
d
(hygienic handrub)
and/or and/or
dirty 3,0 g/l bovine 3,0 g/l bovine 3,0 g/l bovine 3,0 g/l bovine
conditions albumin solution albumin solution album
...