EN 14476:2013/FprA1
(Amendment)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)
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)
This European Standard specifies a test method and the minimum requirements for virucidal activity of
chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation when
diluted with hard water – or in the case of ready-to-use products, i. e, products that are not diluted when
applied,– with water. Products can only be tested at a concentration of 80 % (97 %, with a modified method
for special cases) as some dilution is always produced by adding the test organisms and interfering
substance.
This European Standard applies to products that are used in the medical area in the fields of hygienic
handrub, hygienic handwash, instrument disinfection by immersion, surface disinfection by wiping, spraying,
flooding or other means and textile disinfection.
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.
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)
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje virucidnega delovanja v medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2015
.HPLþQDUD]NXåLODLQDQWLVHSWLNL.YDQWLWDWLYQLVXVSHQ]LMVNLSUHVNXV]D
YUHGQRWHQMHYLUXFLGQHJDGHORYDQMDYPHGLFLQL3UHVNXVQDPHWRGDLQ]DKWHYH ID]D
VWRSQMD
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/FprA1
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
FINAL DRAFT
EN 14476:2013
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
March 2015
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 quantitatif Chemische Desinfektionsmittel und Antiseptika -
de suspension pour l'évaluation de l'activité virucide dans le Quantitativer Suspensionsversuch zur Bestimmung der
domaine médical - Méthode d'essai et prescriptions (Phase viruziden Wirkung im humanmedizinischen Bereich -
2/Étape 1) Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 216.
This draft amendment A1, if approved, will modify the European Standard EN 14476:2013. 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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14476:2013/FprA:2015 E
worldwide for CEN national Members.
Contents
Page
Foreword .3
1 Modifications to Foreword .4
2 Modifications to Clause 4, Table 1 .4
3 Modifications to 5.2.1 .5
4 Modification to 5.5.1.1 .5
5 Modification to 5.5.4.1 .6
6 Modification to 5.7 .6
7 Modification to C.1 .6
8 Addition of an Annex ZA .6
Foreword
This document (EN 14476:2013/FprA1:2015) 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 Unique Acceptance Procedure.
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).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
NOTE Due to fact that the EC has not yet been able to confirm the financial commitment for the New Approach
Consultants’ work in 2015, there are currently no New Approach Consultants in place for 2015. Therefore the provisions of
CEN-CENELEC Guide 15 cannot be met.
This shall not prevent the processing of draft standards nor the offering of harmonized standards to the European
Commission. In particular, draft standards can be sent to vote without Consultant assessment.
This note will be removed from the Foreword of the finalized publication.
1 Modifications to Foreword
Add the following new paragraphs:
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).
For relationship with EU Directive(s), see informative Annex ZA, whichwhich is an integral part of this
document.
Add the following to the existing list of modifications :
"• For the hygienic handrub and handwash method a test for virucidal activity against enveloped viruses
with Vacciniavirus was added.
• The relationship between this Europaen Standard and the MDD was added (For
...
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