SIST EN 16438:2014
(Main)Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step2)
Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step2)
This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation in hard water or in the case of ready-to-use products with water.
This European Standard applies to products for use in the veterinary area i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations.
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 2 test.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich auf nicht-porösen Oberflächen ohne mechanische Wirkung - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Diese Europäische Norm legt ein Prüfverfahren und die Mindestanforderungen an die fungizide oder levurozide Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die in Wasser standardisierter Härte oder - im Fall gebrauchsfertiger Produkte - mit Wasser eine homogene, physikalisch stabile Zubereitung bilden.
Diese Europäische Norm gilt für Produkte für die Anwendung im Veterinärbereich, d. h. bei der Aufzucht, Haltung, Produktion und beim Transport von Tieren sowie bei der Tierkörperbeseitigung, außer wenn die Tiere nach der Tötung durch Zuführung in die weiterverarbeitende Industrie in die Nahrungsmittelkette eintreten.
EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den 'Anwendungsempfehlungen' fest.
ANMERKUNG 1 Das beschriebene Verfahren ist für die Bestimmung der Wirkung von handelsüblichen Zubereitungen oder Wirkstoffen unter den Bedingungen, unter denen sie verwendet werden, bestimmt.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 2.
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface pour l'évaluation de l'activité fongicide ou levuricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire sur des surfaces non poreuses sans action mécanique (phase 2, étape 2)
La présente Norme européenne spécifie une méthode d’essai et les prescriptions minimales relatives à l’activité fongicide ou levuricide 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— dans l’eau.
La présente Norme européenne s'applique aux produits destinés à être utilisés dans le domaine vétérinaire, à savoir la reproduction, l'élevage, la production, le transport et l’abattage de tous les animaux, sauf au cours de la chaîne alimentaire qui suit l’abattage et l’entrée dans l’industrie de transformation.
L'EN 14885 spécifie en détail la relation entre les différents essais et les « recommandations d'emploi ».
NOTE 1 La méthode décrite vise à déterminer l’activité des formulations commerciales ou des substances actives dans les conditions dans lesquelles elles sont utilisées.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 2.
Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah brez mehanskega delovanja za vrednotenje fungicidnega delovanja ali delovanja kemičnih razkužil in antiseptikov na kvasovke v veterini - Preskusna metoda in zahteve (faza 2, stopnja 2)
EN 16438 določa preskusno metodo in minimalne zahteve za fungicidno delovanje ali delovanje kemičnih razkužil in antiseptikov na kvasovke, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo oziroma, pri proizvodih, ki so pripravljeni za uporabo, z vodo. Ta evropski standard se uporablja za izdelke v veterini, tj. pri vzreji, živinoreji, proizvodnji, prevozu in odstranjevanju vseh živali, razen če so v prehrambeni verigi po smrti in so del predelovalne industrije. EN 14885 podrobno določa razmerje med različnimi preskusi in priporočili za uporabo.
General Information
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich auf nicht-porösen Oberflächen ohne mechanische Wirkung - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)Antiseptiques et désinfectants chimiques - Essai quantitatif de surface pour l'évaluation de l'activité fongicide ou levuricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire sur des surfaces non poreuses sans action mécanique (phase 2, étape 2)Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step2)71.100.35Kemikalije za dezinfekcijo v industriji in domaChemicals for industrial and domestic disinfection purposes11.220VeterinarstvoVeterinary medicineICS:Ta slovenski standard je istoveten z:EN 16438:2014SIST EN 16438:2014en,fr,de01-julij-2014SIST EN 16438:2014SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16438
February 2014 ICS 71.100.35 English Version
Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface pour l'évaluation de l'activité fongicide ou levuricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire sur des surfaces non poreuses sans action mécanique - Méthode d'essai et prescriptions (phase 2, étape 2)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich auf nicht-porösen Oberflächen ohne mechanische Wirkung - Prüfverfahren und Anforderungen (Phase 2, Stufe 2) This European Standard was approved by CEN on 30 November 2013.
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 © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16438:2014 ESIST EN 16438:2014
................................................................................. 10 5.4 Preparation of test organism suspensions and product test solutions ....................................... 11 5.4.1 Test organism suspension (test and validation suspension) ........................................................ 11 5.4.2 Product test solutions ........................................................................................................................ 15 5.5 Procedure for assessing the fungicidal or yeasticidal activity of the product ............................ 16 5.5.1 General ................................................................................................................................................. 16 5.5.2 Test procedure (Dilution-neutralisation method) ............................................................................ 17 5.5.3 Observation of the test surface agar ................................................................................................ 20 5.6 Experimental data and calculation.................................................................................................... 20 5.6.1 Explanation of terms and abbreviations .......................................................................................... 20 5.6.2 Calculation ........................................................................................................................................... 21 5.7 Verification of methodology .............................................................................................................. 24 5.7.1 General ................................................................................................................................................. 24 5.7.2 Control of weighted mean counts ..................................................................................................... 24 5.7.3 Basic limits .......................................................................................................................................... 24 5.7.4 Microscopic observation ................................................................................................................... 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) ...................................................... 25 5.8.3 Fungicidal or yeasticidal concentration ........................................................................................... 25 5.8.4 Precision, repetitions ......................................................................................................................... 25 5.9 Interpretation of results - conclusion ............................................................................................... 25 5.9.1 General ................................................................................................................................................. 25 5.9.2 Fungicidal or yeasticidal activity for general purposes ................................................................. 26 5.9.3 Qualification for certain fields of application .................................................................................. 26 5.10 Test report ........................................................................................................................................... 26 Annex A (informative)
Referenced strains of national collections . 28 Annex B (informative)
Examples of neutralisers of the residual antimicrobial activity of chemical disinfectants and antiseptics . 29 Annex C (informative)
Graphical representations of dilution-neutralisation method . 31 Annex D (informative)
Example of a typical test report . 35 Bibliography . 39 SIST EN 16438:2014
Foreword This document (EN 16438:2014) 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 August 2014 and conflicting national standards shall be withdrawn at the latest by August 2014. 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. 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, 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 the United Kingdom. SIST EN 16438:2014
Fungicidal or yeasticidal activity on non-porous surfaces without mechanical action in the veterinary area Test organism Fungicidal activity a) obligatory Aspergillus brasiliensis (conidiospores) and Candida albicans (vegetative cells) Test organism Yeasticidal activity a) obligatory Candida albicans (vegetative cells) b) additional any relevant test organism Test temperature a) obligatory 10 °C ± 1 °C b) additional 4 °C ± 1 °C; 20 °C ± 1 °C; 40 °C ± 1 °C Contact time a) obligatory 60 min ± 10 s b) additional* 5 min ± 10 s; 30 min ± 10 s; 120 min ± 10 s Interfering substance a) obligatory low level soiling high level soiling 3,0 g/l bovine albumin 10 g/l yeast extract plus 10 g/l bovine albumin b) additional any relevant substance The obligatory contact times for surface disinfectants stated in Table 1 were chosen to enable comparison of standard conditions. *The recommended contact time for the use of the product is within the responsibility of the manufacturer. NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions. Any additional specific fungicidal activity shall be determined in accordance with 5.2.1 and 5.5.1.1 in order to take into account intended specific use conditions. 5 Test method 5.1 Principle A test suspension of fungal conidiospores or yeast and interfering substance is inoculated onto the test surface and dried. After a drying time, an aliquot of the product under test is transferred to the surface, in a manner which covers the dried film. The surface is maintained at a specified temperature for a defined period of time specified in Clause 4 and 5.5.1.1. At the end of that contact time the surface is transferred to a neutraliser so that the action of the disinfectant is immediately neutralised. The numbers of surviving organisms which can be recovered from the surface is determined quantitatively. The number of fungi or yeast on a surface treated with water in place of the disinfectant is also determined and the reduction is calculated. The test is performed using the conidiospores of Aspergillus brasiliensis (formerly niger) and the vegetative cells of Candida albicans (fungicidal activity) or only the vegetative cells of Candida albicans (yeasticidal SIST EN 16438:2014
1) The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collection (ATCC). This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of the product named. SIST EN 16438:2014
2) This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of the product named. Equivalent products may be used if they can be shown to lead to the same results. SIST EN 16438:2014
3) Decon concentrate is obtained from Decon Laboratories Ltd, Conway Street, Hove, East Sussex, BN3 3LY, UK Tel. 01273 756598. Studies have shown that this method of cleaning is satisfactory. A suitable ‘Generic’ will be specified at a later stage. 4) Disposable sterile equipment is an acceptable alternative to reusable glassware. SIST EN 16438:2014
5) Vortex ® is an example of a suitable product available commercially. This information is given for the convenience of users of this standard and does not constitute an endorsement by CEN of this product. SIST EN 16438:2014
Figure 1 — A. brasiliensis ATCC 16404 after 7 days of incubation at 30°C (correct appearance)
Figure 2 — A. brasiliensis ATCC 16404 after 7 days of incubation at 30°C (incorrect appearance) SIST EN 16438:2014
6) cfu/ml = colony forming unit(s) per millilitre SIST EN 16438:2014
Figure 3 — Observation of conidiospores under light microscope: presence of smooth (a) and spiny (b) spores (insufficient spiny spores)
Figure 4 — Observation of conidiospores under light microscope: High concentration of characteristic mature spores with spiny aspect (sufficient spiny spores) c) Adjust the number of conidiospores in the suspension to 1,5 × 108 cfu/ml to 5,0 × 108 cfu/ml using the diluent (5.2.2.4), estimating the number of cfu by any suitable means. Use the suspension within 48 h. It can be stored up to 2 days in the refrigerator and shall then be checked just before the test for absence of germinated conidiospores [see b)]. In any case, adjust the temperature according to 5.5.1.4 only immediately before the start of the test (5.5.2). SIST EN 16438:2014
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