DIN EN 16437-2014 Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in vi.pdf

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1、July 2014 Translation by DIN-Sprachendienst.English price group 16No 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 7

2、1.100.35!%2U“2159750www.din.deDDIN EN 16437Chemical disinfectants and antiseptics Quantitative surface test for the evaluation of bactericidal activity ofchemical disinfectants and antiseptics used in veterinary area onporous surfaces without mechanical action Test method and requirements (phase 2,

3、step 2);English version EN 16437:2014,English translation of DIN EN 16437:2014-07Chemische Desinfektionsmittel und Antiseptika Quantitativer Oberflchenversuch zur Bestimmung der bakteriziden Wirkung chemischerDesinfektionsmittel und Antiseptika fr den Veterinrbereich auf porsen Oberflchenohne mechan

4、ische Wirkung Prfverfahren und Anforderungen (Phase 2, Stufe 2);Englische Fassung EN 16437:2014,Englische bersetzung von DIN EN 16437:2014-07Antiseptiques et dsinfectants chimiques Essai quantitatif de surface pour lvaluation de lactivit bactricide des antiseptiques etdes dsinfectants chimiques util

5、iss dans le domaine vtrinaire sur des surfacesporeuses sans action mcanique Mthode dessai et prescriptions (phase 2, tape 2);Version anglaise EN 16437:2014,Traduction anglaise de DIN EN 16437:2014-07www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document

6、 comprises 39 pages 06.14 DIN EN 16437:2014-07 2 A comma is used as the decimal marker. National foreword This document (EN 16437:2014) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics” (Secretariat: AFNOR, France), Working Group WG 2 “Veterinary use” (Secr

7、etariat: BSI, United Kingdom). The responsible German bod involved in its preparation was the Normenausschuss Lebensmittel und landwirtschaftliche Produkte (Food and Agricultural Products Standards Committee), Working Committee NA 057-02-03 AA Desinfektionsmittel Tierhaltung/Lebensmittelbereich. yEU

8、ROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16437 February 2014 ICS 71.100.35 English Version Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces wit

9、hout mechanical action - Test method and requirements (phase 2, step 2) Antiseptiques et dsinfectants chimiques - Essai quantitatif de surface pour lvaluation de lactivit bactricide des antiseptiques et des dsinfectants chimiques utiliss dans le domaine vtrinaire sur des surfaces poreuses sans actio

10、n mcanique - Mthode dessai et prescriptions (phase 2, tape 2) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflchenversuch zur Bestimmung der bakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika fr den Veterinrbereich auf porsen Oberflchen ohne mechanische Wirkung -

11、 Prfverfahren 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

12、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

13、 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, E

14、stonia, 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 S

15、TANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 16437:2014 EEN 16437:2014 (E) 2 Cont

16、ents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements .5 5 Test method 6 5.1 Principle 6 5.2 Materials and reagents 7 5.2.1 Test organisms 7 5.2.2 Culture media and reagents .7 5.2.3 Test surface . 10 5.3 Apparatus and glassware 10 5.3.1 Ge

17、neral . 10 5.3.2 Usual microbiological laboratory equipment 10 5.4 Preparation of test organism suspension and product test solutions . 11 5.4.1 Test organism suspension (test and validation suspension) 11 5.4.2 Product test solution 13 5.5 Procedure for assessing the bactericidal activity of the pr

18、oduct . 13 5.5.1 General . 13 5.5.2 Test procedure (Dilution-neutralisation method) 14 5.6 Experimental data and calculation 17 5.6.1 Explanation of terms and abbreviations 17 5.6.2 Calculation . 18 5.7 Verification of methodology 21 5.7.1 General . 21 5.7.2 Control of weighted mean counts . 21 5.7.

19、3 Basic limits 21 5.8 Expression of results and precision . 22 5.8.1 Reduction 22 5.8.2 Control of active and non-active product test solution (5.4.2) 22 5.8.3 Limiting test organism and bactericidal concentration 22 5.8.4 Precision, repetitions . 22 5.9 Interpretation of results conclusion 22 5.9.1

20、 General . 22 5.9.2 Bactericidal activity for general purposes . 23 5.9.3 Qualification for certain fields of application 23 5.10 Test report . 23 Annex A (informative) Referenced strains in national collections 25 Annex B (informative) Neutralisers - Examples of neutralisers of the residual antimic

21、robial activity of chemical disinfectants and antiseptics 26 Annex C (informative) Graphical representations of dilution-neutralisation method . 28 Annex D (informative) Example of a typical test report 32 Bibliography . 37 DINEN 16437:2014-07EN 16437:2014 (E) 3 Foreword This document (EN 16437:2014

22、) 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 20

23、14 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.

24、 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, Ge

25、rmany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DINEN 16437:2014-07EN 16437:2014 (E) 4 Introduction This European Standard specifies a

26、 surface test for establishing whether a chemical disinfectant or antiseptic, for use on porous surfaces without mechanical action, in the veterinary area. has or does not have bactericidal activity under the laboratory conditions defined by this European Standard, which influence the action of disi

27、nfectants in practical use. The laboratory test takes into account practical conditions of application of the product including pre-drying test organisms and interfering substances on a surface, contact time and temperature, i.e. conditions which may influence its action in practical situations. The

28、 conditions are intended to cover general purposes and to allow reference between laboratories and product types. Each utilisation concentration of the chemical disinfectant or antiseptic, found by this test corresponds to the chosen experimental conditions. However, for some applications, the instr

29、uctions of use of a product can differ and therefore additional test conditions need to be used. DIN EN 16437:2014-07 EN 16437:2014 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectants and antiseptic products th

30、at form a homogeneous, physically stable preparation when diluted with hard water - or in the case of ready-to-use products - with water. This European Standard applies to products that are used in the veterinary area on porous surfaces without mechanical action i.e. in the breeding, husbandry, prod

31、uction, 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 a

32、ctivity 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. NOTE 3 This method cannot be used to evaluate the activity of products against mycobacteria or bacterial spores. 2 Normative references The fo

33、llowing documents, in whole or 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, Che

34、mical disinfectants and antiseptics - 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 Europea

35、n Standards for chemical disinfectants and antiseptics 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 (lg) reduction from a water control, when tested in accordance wi

36、th Table 1 and Clause 5 under simulated soiling (3,0 g/l bovine albumin). DIN EN 16437:2014-07 EN 16437:2014 (E) 6 Table 1 Obligatory and additional test conditions Test Conditions Bactericidal activity on porous surfaces without mechanical action in the veterinary area Test organism a) obligatory E

37、nterococcus hirae Proteus vulgaris Pseudomonas aeruginosa Staphylococcus aureus 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 1 min 5 s, 5 min 10 s, 15 min + 10 s, 30 min

38、 10 s; 120 min 10 s Interfering substance a) obligatory 3,0 g/l bovine albumin b) additional any relevant substance NOTE 1 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

39、 product is within the responsibility of the manufacturer. NOTE 2 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 bactericidal activity shall be determined in accordance with 5.2.1 a

40、nd 5.5.1.1 in order to take into account intended specific use conditions. 5 Test method 5.1 Principle A test suspension of bacteria mixed with interfering substance is inoculated onto the test surface and dried. After the drying time the test surface is immersed into a sample of the product as deli

41、vered and/or diluted with hard water (for ready to use products: water) ensuring that the test surface is totally covered for one minute. The test surface is removed from the product solution and maintained at a specified temperature for a defined period of time specified in Clause 4 and 5.5.1.1. At

42、 the end of that contact time, the test surface is transferred to a neutraliser so that the action of the disinfectant is immediately neutralised. The bacteria are removed from the surface by ultrasound treatment. The numbers of surviving bacteria which can be recovered from the surface is determine

43、d quantitatively. The number of bacteria on a surface treated with water in place of the disinfectant is also determined and the reduction is calculated. The test is performed using Enterococcus hirae, Proteus vulgaris, Pseudomonas aeruginosa and Staphylococcus aureus as test organisms (Clause 4, Ta

44、ble 1). DINEN 16437:2014-07EN 16437:2014 (E)7 Additional and optional contact times and temperatures are specified (Clause 4, Table 1). Additional interfering substances and test organisms may be used. 5.2 Materials and reagents 5.2.1 Test organisms The bactericidal activity shall be evaluated using

45、 the following strains1): Enterococcus hirae ATCC 10541; Proteus vulgaris ATCC 13315; Pseudomonas aeruginosa ATCC 15442; Staphylococcus aureus ATCC 6538. NOTE See Annex A for strain references in some other culture collections. The required incubation temperature for these organisms is 36 C + 1 C or

46、 37 C + 1 C (5.3.2.3). The same temperature (either 36 C or 37 C) shall be used for all incubations performed during a test and its control and validation. If additional test organisms are used, they shall be incubated under optimum growth conditions (temperature, time, atmosphere, media) noted in t

47、he test report. If the additional test organisms selected do not correspond to the specified strains, their suitability for supplying the required inocula shall be verified. If these additional test organisms are not classified at a reference centre, their identification characteristics shall be sta

48、ted. In addition, they shall be held by the testing laboratory or national culture collection under a reference for five years. 5.2.2 Culture media and reagents 5.2.2.1 General All weights of chemical substances given in this European Standard refer to the anhydrous salts. Hydrated forms may be used as an alternative, but the weights required shall be adjusted to allow for consequent molecular weight differences. The reagents shall be of analytical grade and/or appropriate fo