EN 14476:2013+A1:2015
(Main)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.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a phase 2, step 1 test.
NOTE 3 EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der viruziden Wirkung im humanmedizinischen Bereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Dieses Dokument legt ein Prüfverfahren für und die Mindestanforderungen an die viruzide Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die bei Verdünnung mit Wasser standardisierter Härte als homogene, physikalisch stabile Zubereitung vorliegen, bzw. bei gebrauchsfertigen Produkten, z. B. Produkte, die bei der Anwendung nicht mit Wasser verdünnt werden. Die Produkte können nur bei einer Konzentration von 80 % (97 % bei einem modifizierten Verfahren für Sonderfälle) geprüft werden, da durch Zugabe der Prüfkeime und der Belastungssubstanz immer eine gewisse Verdünnung bewirkt wird.
Diese Europäische Norm gilt für Produkte, die im medizinischen Bereich auf den Gebieten der hygienischen Händedesinfektion, hygienischen Händewaschung, Instrumentendesinfektion durch Eintauchen und Oberflächendesinfektion durch Abwischen, Besprühen, Überfluten oder auf sonstige Weise sowie für die Wäschedesinfektion 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 Wirksamkeit kommerziell erhältlicher Zuberei¬tungen oder Wirkstoffe unter den Bedingungen, unter denen sie angewendet werden.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 1.
ANMERKUNG 3 EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den „Anwendungsempfehlungen“ fest.
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour lévaluation de lactivité virucide dans le domaine médical - Méthode dessai et prescriptions (Phase 2/Étape 1)
La présente Norme européenne spécifie une méthode d’essai et les prescriptions minimales relatives à l’activité virucide des produits antiseptiques et désinfectants chimiques qui forment une préparation homogène, physiquement stable, lorsqu’ils sont dilués dans l’eau dure ou – dans le cas de produits prêts à l’emploi, c’est-à-dire de produits qui ne sont pas dilués lors de leur utilisation – dans l’eau. Les produits ne peuvent être soumis à essai qu’à une concentration de 80 % (97 % avec une méthode modifiée dans certains cas particuliers), car l’ajout des microorganismes d’essai et de la substance interférente s’accompagne forcément d’une dilution.
La présente Norme européenne s’applique aux produits utilisés dans le domaine médical pour le traitement hygiénique des mains par frictions, le lavage hygiénique des mains, la désinfection des instruments par immersion, la désinfection des surfaces par essuyage, pulvérisation, inondation ou d’autres moyens, et la désinfection des textiles.
La présente Norme européenne s’applique aux domaines et situations où la désinfection est indiquée en médecine humaine. De telles indications se produisent pour les soins des patients, par exemple :
- dans les hôpitaux, les centres médicaux communautaires et les institutions dentaires ;
- dans les cliniques d’écoles, de jardins d’enfants et de maisons de soins infirmiers ;
et peuvent se produire sur le lieu de travail et à la maison. Elles peuvent également inclure les services tels que les blanchisseries et les cuisines fournissant directement des produits aux patients.
NOTE 1 La méthode décrite a pour objet de déterminer l’activité de formulations commerciales ou de substances actives dans leurs conditions d’emploi.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 1.
NOTE 3 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 suspenzijski preskus za vrednotenje virucidnega delovanja v medicini - Preskusna metoda in zahteve (faza 2, stopnja 1)
Ta evropski standard določa preskusno metodo in minimalne zahteve za virucidno delovanje kemičnih razkužil in antiseptikov, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo ali, pri proizvodih, ki so pripravljeni za uporabo (tj. proizvodih, ki med uporabo niso razredčeni), z vodo. Proizvode je mogoče preskušati samo pri 80-odstotni koncentraciji (s prilagojeno metodo v posebnih primerih 97-odstotni), ker dodajanje preskusnih organizmov in moteče snovi vedno povzroči razredčenje.
Ta evropski standard velja za proizvode, ki se uporabljajo na področju zdravstva pri higienskem drgnjenju rok, higienskem umivanju rok, dezinfekciji instrumentov s potapljanjem, površinski dezinfekciji z brisanjem, pršenjem, zalivanjem ali na druge načine in dezinfekciji tekstilij.
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 nastanejo 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 pod pogoji, v katerih se uporabljajo.
OPOMBA 2: Ta metoda ustreza preskusu stopnje 1 faze 2.
OPOMBA 3: Standard EN 14885 podrobno določa razmerje med različnimi preskusi in priporočili za uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2015
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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)
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Ta slovenski standard je istoveten z: EN 14476:2013+A1:2015
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 14476:2013+A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN 14476:2013
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 European Standard was approved by CEN on 5 July 2013 and includes Amendment 1 approved by CEN on 27 July 2015.
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, 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: 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+A1:2015 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Requirements . 8
5 Test methods . 10
5.1 Principle . 10
5.2 Materials and reagents, including cell cultures . 10
5.2.1 Test organisms . 10
5.2.2 Culture media, reagents and cell cultures . 11
5.3 Apparatus and glassware . 14
5.4 Preparation of test organism suspensions and product test solutions . 15
5.4.1 Test organisms suspensions (test virus suspension) . 15
5.4.2 Product test solutions . 15
5.5 Procedure for assessing the virucidal activity of the product . 16
5.5.1 General . 16
5.5.2 Test procedure . 17
5.5.3 Modified method for ready-to-use products . 18
5.5.4 Cytotoxicity caused by product test solutions . 18
5.5.5 Control of efficiency of suppression of product’s activity . 20
5.5.6 Reference test for virus inactivation . 20
5.5.7 Titration of the virus control . 20
5.5.8 Titration of test samples . 20
5.6 Experimental data and calculation . 21
5.6.1 Protocol of results . 21
5.6.2 Calculation of infectivity titer (TCID50 or PFU) . 21
5.7 Verification of the methodology . 21
5.8 Expression of results . 22
5.8.1 General . 22
5.8.2 Calculation of the virucidal activity of products . 22
5.9 Test report . 22
Annex A (informative) Examples of viruses sorted according to their presence in the human
body in case of virus infection . 24
Annex B (informative) Detoxification of test mixtures by molecular sieving . 26
TM
B.1 Molecular sieving with Sephadex LH 20 . 26
B.1.1 Principle . 26
B.1.2 Sephadex suspension . 26
B.1.3 Procedure. 26
TM
B.2 Molecular sieving using MicroSpin S 400 HR . 28
Annex C (informative) Calculation of the viral infectivity titre . 29
C.1 Quantal tests — Example of TCID50 determination by the Spearman-Kärber method . 29
C.2 Plaque test . 29
C.3 Biometrical evaluation of experimental approaches and assessment of the
disinfecting effect on the virus (reduction [R]): . 30
C.3.1 General . 30
C.3.2 Calculating the virus titre with 95 % confidence interval . 31
C.3.3 Calculating the reduction and its 95 % confidence interval . 31
C.3.4 Calculating the average reduction (R ) and its 95 % confidence interval. . 32
(mi)
C.3.5 Practical example . 33
Annex D (informative) Presentation of test results of one active concentration . 35
Annex E (informative) Quantitative determination of formaldehyde concentrations . 38
Annex ZA (informative) !Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC" . 39
Bibliography . 40
European foreword
This document (EN 14476:2013+A1:2015) 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 March 2016 and conflicting national standards shall be
withdrawn at the latest by March 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes !EN 14476:2013".
This document includes Amendment 1 approved by CEN on 2015-07-27.
The start and finish of text introduced or altered by amendment is indicated in the text by tags !".
!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."
The document was revised to adapt it to the latest state of science, to correct errors and ambiguities, to
harmonise the structure and wording with other existing tests of CEN/TC 216 or in preparation and to
improve the readability of the standard and thereby make it more understandable. The following list is
a list of significant technical changes since the last edition:
• The scope was expanded for the following fields of application within the medical area, i.e. products
for textile disinfection.
• “Obligatory test conditions” were replaced by “minimum test conditions” (test temperatures and
contact times can be chosen within limits) that have to be performed to pass the test.
• An additional modified method is described to test ready-to-use products in a higher concentration
than 80 %, i.e. 9 7%;
!
• For the hygienic handrub and handwash method a test for virucidal activity against enveloped
viruses with Vacciniavirus was added.
• The relationship between this European Standard and the MDD was added (Foreword and
Annex ZA).
• The value of v in C.1 was corrected (0,001 instead of 0,0001)."
n
Data obtained using the former version of EN 14476 may still be used.
Other methods to evaluate the efficacy of chemical disinfectants and antiseptics for different
applications in the medical area are in preparation.
According to the CEN-CENELEC Internal Regulations, the national standards organizations 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, Nor
...
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