DIN EN 1657-2016 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antisea.pdf

1、November 2016 English price group 19No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 71.100.35!%YK“2585440www.din.de

2、DIN EN 1657Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area Test method and requirements (phase 2, step 1);English version EN 1657:2016,English translatio

3、n of DIN EN 1657:2016-11Chemische Desinfektionsmittel und Antiseptika Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika fr den Veterinrbereich Prfverfahren und Anforderungen (Phase 2, Stufe 1);Englische Fassung EN 1

4、657:2016,Englische bersetzung von DIN EN 1657:2016-11Antiseptiques et dsinfectants chimiques Essai quantitatif de suspension pour lvaluation de lactivit fongicide ou levuricide des antiseptiques et des dsinfectants chimiques utiliss dans le domaine vtrinaire Mthode dessai et prescriptions (phase 2,

5、tape 1);Version anglaise EN 1657:2016,Traduction anglaise de DIN EN 1657:2016-11SupersedesDIN EN 1657:200603 andDIN EN 1657 Corrigendum 1:200706www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.Document comprises 47 pages

6、10.16 DIN EN 1657:2016-112 A comma is used as the decimal marker. National foreword This document (EN 1657:2016) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics” (Secretariat: AFNOR, France), Working Group WG 2 “Veterinary use” (Secretariat: BSI, United Ki

7、ngdom). The responsible German body involved in its preparation was DIN-Normenausschuss Lebensmittel und landwirtschaftliche Produkte (DIN Standards Committee Food and Agricultural Products), Working Committee NA 057-02-03 AA Desinfektionsmittel Tierhaltung/Lebensmittelbereich (DTL) (Spiegelausschus

8、s zu CEN/TC 216/WG 2). Amendments This standard differs from DIN EN 1657:2006-03 and DIN EN 1657 Corrigendum 1:2007-06 as follows: a) EN 14885 has been included in the normative references; b) Clause 3 “Terms and definitions” has been revised; c) Clause 4 “Requirements” has been revised (Table 1 “Ob

9、ligatory and additional test conditions” has been added); d) instead of Aspergillus niger, Aspergillus brasiliensis has been included as a new test organism; e) Subclause 5.2.2.8.4 “Milk for teat disinfectants” has been added; f) in 5.4.1.3.2, Figures 1 and 2, and in 5.4.1.4.2 Figures 3 and 4 have b

10、een added; g) Subclause 5.7.4 “Additional limits for Aspergillus brasiliensis” has been added; h) Subclause 5.9.6 “Yeasticidal activity for teat disinfectants” has been added; i) the abbreviations for reference strains in national collections have been included in Annex A; j) Annex B “Suitable neutr

11、alizers and rinsing liquids” has been revised and is now presented in tabular form; k) the former Annex F (informative) “Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics” has been deleted; l) the standard has been editorially revised.

12、Previous editions DIN EN 1657: 2000-04, 2006-03 DIN EN 1657 Corrigendum 1: 2007-06 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1657 April 2016 ICS 71.100.35 Supersedes EN 1657:2005English Version Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fun

13、gicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1) Antiseptiques et dsinfectants chimiques - Essai quantitatif de suspension pour lvaluation de lactivit fongicide ou levuricide des antiseptiques et de

14、s dsinfectants chimiques utiliss dans le domaine vtrinaire - Mthode dessai et prescriptions (phase 2, tape 1) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika fr den

15、Veterinrbereich - Prfverfahren und Anforderungen (Phase 2, Stufe 1) This European Standard was approved by CEN on 23 January 2016. 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 stand

16、ard 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 an

17、y 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 Repu

18、blic, 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 andUnited Kingdom. EUROPEAN

19、COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 worldwide for CEN national Members. Ref. No. EN 1657:2016 EEN 1657:20

20、16 (E) 2 Contents European foreword . 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Requirements . 6 5 Test method 7 5.1 Principle . 7 5.2 Materials and reagents 8 5.2.1 Test organisms . 8 5.2.2 Culture media and reagents 8 5.3 Apparatus and glassware 11 5.3.1 Gen

21、eral . 11 5.3.2 Usual microbiological laboratory equipment and, in particular, the following 11 5.4 Preparation of test organism suspensions and product test solutions 12 5.4.1 Test organism suspensions (test and validation suspension) . 12 5.4.2 Product test solutions . 17 5.5 Procedure for assessi

22、ng the fungicidal or yeasticidal activity of the product . 18 5.5.1 General . 18 5.5.2 Dilution-neutralization method . 19 5.5.3 Membrane filtration method . 21 5.6 Experimental data and calculation 23 5.6.1 Explanation of terms and abbreviations . 23 5.6.2 Calculation 24 5.7 Verification of methodo

23、logy . 26 5.7.1 General . 26 5.7.2 Control of weighted mean counts . 27 5.7.3 Basic limits . 27 5.7.4 Additional limits for Aspergillus brasiliensis . 27 5.8 Expression of results and precision 27 5.8.1 Reduction 27 5.8.2 Control of active and non-active product test solution (5.4.2) 27 5.8.3 Limiti

24、ng test organism and fungicidal/yeasticidal concentration . 28 5.8.4 Precision, replicates 28 5.9 Interpretation of results conclusion 28 5.9.1 General . 28 5.9.2 Fungicidal activity for general purposes . 28 5.9.3 Fungicidal activity for specific purposes . 28 5.9.4 Yeasticidal activity for general

25、 purposes 28 5.9.5 Yeasticidal activity for specific purposes 29 5.9.6 Yeasticidal activity for teat disinfectants 29 5.10 Test report 29 Annex A (informative) Referenced strains in national collections 31 DIN EN 1657:2016-11 EN 1657:2016 (E) 3 Annex B (informative) Suitable neutralizers and rinsing

26、 liquids . 32 Annex C (informative) Graphical representation of test procedures 34 C.1 Dilution-neutralization method 34 C.2 Membrane filtration method 36 Annex D (informative) Example of a typical test report . 38 Annex E (informative) Precision of the test result . 42 Bibliography . 45 DIN EN 1657

27、:2016-11 EN 1657:2016 (E) 4 European foreword This document (EN 1657:2016) 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 publi

28、cation of an identical text or by endorsement, at the latest by October 2016, and conflicting national standards shall be withdrawn at the latest by October 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

29、shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 1657:2005. This European Standard was revised to harmonize the preparation of the fungal spore suspension with other fungicidal tests of CEN/TC 216 and to incorporate amendments applicable to all

30、 European Standards. An additional requirement has been added for the Aspergillus spore suspension and therefore results obtained using EN 1657:2005 and not fulfilling this additional requirement will need to be confirmed by repeating the tests using EN 1657:2015. The test conditions for teat disinf

31、ectants have been added. 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

32、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. DIN EN 1657:2016-11 N1)N1) National footnote: using EN 1657:20

33、15” is an error in the English reference version. It should correctly read“using EN 1657:2016”. “EN 1657:2016 (E) 5 Introduction This European Standard specifies a suspension test for establishing whether a chemical disinfectant or antiseptic has a fungicidal or yeasticidal activity in the fields de

34、scribed 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 cov

35、er 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 d

36、iffer and therefore additional test conditions need to be used. DIN EN 1657:2016-11 EN 1657:2016 (E) 6 1 Scope 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,

37、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. This European Standard applies to

38、 products that are used 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

39、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 1 test 2 Normative references The following documents, in whole or

40、 in part, are normatively referenced in this document and are indispensable for its application. 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 antise

41、ptics Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity EN 14885, Chemical disinfectants and antiseptics Application of European Standards for chemical disinfect

42、ants and antiseptics ISO 4793, Laboratory sintered (fritted) filters Porosity grading, classification and designation 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 14885 apply. 4 Requirements The product shall demonstrate at least a 4 decimal log (l

43、g) reduction when diluted with hard water (5.2.2.7) or in the case of ready-to-use products with water (5.2.2.2) and tested in accordance with Table 1 and Clause 5 under simulated low level soiling (3,0 g/l bovine albumin) or high level soiling (10 g/l yeast extract and 10 g/l bovine albumin) or 10

44、g/l skimmed milk for teat disinfectants or in additional test conditions. DIN EN 1657:2016-11 EN 1657:2016 (E) 7 Table 1 Obligatory and additional test conditions Test conditions Fungicidal activity Yeasticidal activity Yeasticidal activity for teat disinfectants Test organisms obligatory Aspergillu

45、s brasiliensis Candida albicans Candida albicans Candida albicans additional any relevant test organism any relevant test organism any relevant test organism Test temperature obligatory 10C 1C 10C 1C 30C 1C additional 4C 1C; 20C 1C; 40C 1C; 4C 1C; 20C 1C; 40C 1C 20C 1C Contact time obligatory 30 min

46、 10 s 30 min 10 s 5 min 10 s for post-milking teat disinfectants 30 s 5 s for pre-milking teat disinfectants additional 5 min 10 s; 60 min 10 s; 120 min 10 sa5 min 10 s; 60 min 10 s; 120 min 10 sa1 min 5 s Interfering substance obligatory low level soiling high level soiling 3,0 g/l bovine albumin 1

47、0 g/l yeast extract plus 10 g/l bovine albumin 3,0 g/l bovine albumin 10 g/l yeast extract plus 10 g/l bovine albumin 10,0 g/l of reconstituted skimmed milk additional any relevant substance any relevant substance any relevant substance The obligatory contact times for disinfectants stated in Table

48、1 were chosen to enable comparison of standard conditions. NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions. aThe recommended contact time for the use of the product is within the responsibility of the m

49、anufacturer. 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 5.1.1 A sample of the product as delivered and/or diluted with hard water (or water for ready-to-use products) is added to a test suspension of fungi (yeast cells or mould spore