SIST EN 1656:2019
(Main)Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)
This document specifies a test method and the minimum requirements for bactericidal 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 - with water. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.
The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. This document applies to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and teat disinfection in the veterinary area - e.g. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry. This document also applies to products used for teat disinfection in these veterinary areas.
This method is not applicable to evaluate the activity of hand hygiene products. For these products reference is made to EN 14885, which specifies in detail the relationship of the various tests to one another and to "use recommendations".
NOTE This method corresponds to a phase 2 step 1 test.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Dieses Dokument legt ein Prüfverfahren für und die Mindestanforderungen an die bakterizide Wirkung von chemischen Desinfektionsmitteln und antiseptischen Produkten fest, die bei Verdünnung in Wasser standardisierter Härte oder - im Falle gebrauchsfertiger Produkte - in Wasser als homogenes und physikalisch stabiles Präparat vorliegen. Die Produkte können nur bei einer Konzentration von höchstens 80 % geprüft werden, da durch die Zugabe der Prüforganismen und der Belastungssubstanz immer eine bestimmte Verdünnung auftritt.
Das beschriebene Verfahren soll der Bestimmung der Wirkung handelsüblicher Zubereitungen oder von Wirkstoffen unter den Bedingungen dienen, unter denen sie in der Praxis angewendet werden. Dieses Dokument gilt für Produkte, die für die Instrumentendesinfektion durch Eintauchen und bei der Oberflächendesinfektion durch Abwischen, Besprühen, Überfluten oder auf sonstige Weise sowie bei der Zitzendesinfektion im Veterinärbereich verwendet werden - z. B. bei der Aufzucht, Haltung, Produktion, in veterinärischen Pflegeeinrichtungen, beim Transport von Tieren sowie bei der Tierkörperbeseitigung aller Tiere mit Ausnahme der Tiere, die nach der Tötung direkt als Nahrungsmittel verwendet oder der weiterverarbeitenden Industrie zugeführt werden. Dieses Dokument gilt auch für Produkte, die bei der Zitzendesinfektion in diesen Veterinärbereichen verwendet werden.
Dieses Verfahren kann nicht angewendet werden, um die Wirkung von Produkten der Handhygiene zu überprüfen. Für diese Produkte wird auf EN 14885 verwiesen, die im Einzelnen den Zusammenhang zwischen den verschiedenen Prüfungen sowie zu den "Anwendungsempfehlungen" festlegt.
ANMERKUNG Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 1.
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour l'évaluation de l'activité bactéricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions (phase 2, étape 1)
Le présent document spécifie une méthode d’essai et les exigences minimales relatives à l’activité bactéricide des produits antiseptiques et 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. Les produits ne peuvent être soumis à l’essai qu’à la concentration de 80 % ou à des concentrations inférieures, car l’ajout des microorganismes d’essai et de la substance interférente s’accompagne forcément d’une dilution.
La méthode décrite vise à déterminer l’activité des formulations commerciales ou des substances actives dans les conditions d’utilisation. Le présent document s’applique aux produits utilisés dans la désinfection des équipements par immersion, la désinfection de surfaces par essuyage, pulvérisation, inondation ou d’autres moyens, la désinfection des trayons dans le domaine vétérinaire, par exemple dans la reproduction, l’élevage, la production, les services vétérinaires, le transport et l’abattage de tous les animaux, à l’exception de la chaîne alimentaire qui suit l’abattage et l’entrée dans l’industrie de transformation. Le présent document s’applique également aux produits utilisés dans la désinfection des trayons dans ces domaines vétérinaires.
Cette méthode ne s’applique pas à l’évaluation de l’activité des produits d’hygiène des mains. Pour ces produits, se référer à l’EN 14885, qui spécifie de façon détaillée les relations des différents essais entre eux et avec les « recommandations d’emploi ».
NOTE Cette méthode correspond à un essai de phase 2, étape 1.
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za vrednotenje baktericidnega delovanja kemičnih razkužil in antiseptikov v veterini - Preskusna metoda in zahteve (faza 2, stopnja 1)
Ta evropski standard določa preskusno metodo in minimalne zahteve za baktericidno delovanje kemičnih razkužil in antiseptikov, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo oziroma z vodo pri izdelkih, ki so pripravljeni za uporabo. Izdelke je mogoče preskušati samo pri 80-odstotni ali nižji koncentraciji, ker dodajanje preskusnih organizmov in moteče snovi vedno povzroči razredčenje.
Ta evropski standard se uporablja za izdelke v veterini, tj. pri vzreji, živinoreji, prevozu in odstranjevanju vseh živali, razen če so v prehrambeni verigi po smrti in so del predelovalne industrije.
Standard EN 14885 podrobno določa razmerje med različnimi preizkusi in priporočili za uporabo.
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.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2019
Nadomešča:
SIST EN 1656:2010
SIST EN 1656:2010/AC:2010
Kemična razkužila in antiseptiki - Kvantitativni suspenzijski preskus za
vrednotenje baktericidnega delovanja kemičnih razkužil in antiseptikov v veterini -
Preskusna metoda in zahteve (faza 2, stopnja 1)
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation
of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary
area - Test method and requirements (phase 2, step 1)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur
Bestimmung der bakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika
für den Veterinärbereich - Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
Antiseptiques et désinfectants chimiques - Essai quantitatif de suspension pour
l'évaluation de l'activité bactéricide des antiseptiques et des désinfectants chimiques
utilisés dans le domaine vétérinaire - Méthode d'essai et prescriptions (phase 2, étape 1)
Ta slovenski standard je istoveten z: EN 1656:2019
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
11.220 Veterinarstvo Veterinary medicine
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 1656
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2019
EUROPÄISCHE NORM
ICS 71.100.35 Supersedes EN 1656:2009
English Version
Chemical disinfectants and antiseptics - Quantitative
suspension test for the evaluation of bactericidal activity of
chemical disinfectants and antiseptics used in the
veterinary 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
bactéricide des antiseptiques et des désinfectants bakteriziden Wirkung chemischer Desinfektionsmittel
chimiques utilisés dans le domaine vétérinaire - und Antiseptika für den Veterinärbereich -
Méthode d'essai et exigences (phase 2, étape 1) Prüfverfahren und Anforderungen (Phase 2, Stufe 1)
This European Standard was approved by CEN on 28 July 2019.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1656:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 6
5 Test method . 8
5.1 Principle . 8
5.2 Materials and reagents . 8
5.2.1 Test organisms . 8
5.2.2 Culture media and reagents . 9
5.3 Apparatus and glassware . 11
5.3.1 General . 11
5.3.2 Usual microbiological laboratory equipment and, in particular, the following: . 12
5.4 Preparation of test organism suspensions and product test solutions . 13
5.4.1 Test organism suspensions (test and validation suspension) . 13
5.4.2 Product test solutions . 14
5.5 Procedure for assessing the bactericidal activity of the product . 15
5.5.1 General . 15
5.5.2 Dilution-neutralization method . 16
5.5.3 Membrane filtration method. 18
5.6 Experimental data and calculation . 20
5.6.1 Explanation of terms and abbreviations . 20
5.6.2 Calculation . 20
5.7 Verification of methodology . 23
5.7.1 General . 23
5.7.2 Control of weighted mean counts . 23
5.7.3 Basic limits . 24
5.8 Expression of results and precision . 24
5.8.1 Reduction . 24
5.8.2 Control of active and non-active product test solution (5.4.2) . 24
5.8.3 Limiting test organism and bactericidal concentration . 24
5.8.4 Precision, replicates . 24
5.9 Interpretation of results - conclusion . 25
5.9.1 General . 25
5.9.2 Bactericidal activity for surface disinfection products . 25
5.9.3 Bactericidal activity for teat disinfection products . 25
5.10 Test report . 25
Annex A (informative) Referenced strains in national collections . 27
Annex B (informative) Examples of neutralizers of the residual antimicrobial activity of chemical
disinfectants and antiseptics and rinsing liquids . 29
Annex C (informative) Dilution-neutralization method . 31
Annex D (informative) Example of a typical test report . 36
Bibliography . 40
European foreword
This document (EN 1656:2019) 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 2020, and conflicting national standards shall be
withdrawn at the latest by March 2020.
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.
This European Standard supersedes EN 1656:2009 and was revised to harmonize the structure and
wording with other quantitative suspension tests of CEN/TC 216 (existing or in preparation).
Results obtained using the previous version of this standard are still valid.
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, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
Introduction
This document specifies a suspension test for establishing whether a chemical disinfectant or antiseptic
has a bactericidal activity in the fields described in the scope.
This laboratory test takes into account practical conditions of application of the product, including
contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence
its action in practical situations.
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 some applications the recommendations
of use of a product may differ and therefore additional test conditions need to be used.
1 Scope
This document specifies a test method and the minimum requirements for bactericidal 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 - with water. Products can only be
tested at a concentration of 80 % or less, as some dilution is always produced by adding the test
organisms and interfering substance.
The method described is intended to determine the activity of commercial formulations or active
substances under the conditions in which they are used. This document applies to products that are used
for equipment disinfection by immersion, surface disinfection by wiping, spraying, flooding or other
means and teat disinfection in the veterinary area – e.g. in the breeding, husbandry, production,
veterinary care facilities, transport and disposal of all animals except when in the food chain following
death and entry into processing industry. This document also applies to products used for teat
disinfection in these veterinary areas.
This method is not applicable to evaluate the activity of hand hygiene products. For these products
reference is made to EN 14885, which specifies in detail the relationship of the various tests to one
another and to “use recommendations”.
NOTE This method corresponds to a phase 2 step 1 test.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 12353, Chemical disinfectants and antiseptics — Preservation of test organisms used for the
determination of bactericidal (including Legionell
...
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