DIN EN 14349-2013 en 3211 Chemical disinfectants and antiseptics Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics use.pdf

1、February 2013 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).I

2、CS 71.100.35!$GEnglish version EN 14349:2012,English translation of DIN EN 14349:2013-02Chemische Desinfektionsmittel und Antiseptika Quantitativer Oberflchenversuch zur Bestimmung der bakteriziden Wirkung chemischerDesinfektionsmittel und Antiseptika fr den Veterinrbereich auf nicht-porsenOberflche

3、n ohne mechanische Wirkung Prfverfahren und Anforderungen (Phase 2, Stufe 2);Englische Fassung EN 14349:2012,Englische bersetzung von DIN EN 14349:2013-02Antiseptiques et dsinfectants chimiques Essai quantitatif de surface pour lvaluation de lactivit bactricide des antiseptiques etdes dsinfectants c

4、himiques utiliss dans le domaine vtrinaire sur des surfaces nonporeuses sans action mcanique Mthode dessai et prescriptions (phase 2, tape 2);Version anglaise EN 14349:2012,Traduction anglaise de DIN EN 14349:2013-02SupersedesDIN EN 14349:2008-05www.beuth.deDocument comprises 38 pagesIn case of doub

5、t, the German-language original shall be considered authoritative.01.13DIN EN 14349:2013-02 2 A comma is used as the decimal marker. National foreword This document (EN 14349:2012) has been prepared by Technical Committee CEN/TC 216 ”Chemical disinfectants and antiseptics” (Secretariat: AFNOR, Franc

6、e), Working Group WG 2 “Veterinary use” (Secretariat: BSI, United Kingdom). The responsible German bodies involved in its preparation was the Normenausschuss Lebensmittel und landwirtschaftliche Produkte (Food and Agricultural Products Standards Committee), Working Committee NA 057-02-03 AA Desinfek

7、tionsmittel Tierhaltung/Lebensmittelbereich. Amendments This standard differs from DIN EN 14349:2008-05 as follows: a) Introduction and scope have been rendered more precise; b) for the purposes of this standard, the terms and definitions of EN 14885 apply; c) Clause 4 “Requirements” has been render

8、ed more precise with regard to the test conditions and the bactericidal activity (a new table has been included); d) Subclauses 5.1 “Procedure” and 5.2 “Materials and reagents” have been revised; e) Subclause 5.3 “Apparatus and glassware” has been updated; f) Subclause 5.4 “Preparation of test organ

9、ism suspensions and product test solutions” has been revised (inclusion of validation suspensions and related requirements); g) Subclause 5.5 “Procedure for assessing the bactericidal activity of the product” has been restructured and revised; h) Subclause 5.6 “Experimental data and calculation” has

10、 been revised; i) Subclause 5.7 “Verification of methodology” has been revised; j) Subclause 5.9 “Interpretation of results conclusion” has been updated; k) the former Annex A (normative) “Validation of dilution neutralization” has been deleted; l) Annex C (informative) “Graphical representation of

11、the method”, relating to the dilution neutralization, has been added; m) Annex B (informative) “Examples of neutralizers of the residual antimicrobial activity of chemical disinfectants and antiseptics” and Annex D (informative) “Example of a typical test report” have been revised; n) the former Ann

12、ex E (informative) “Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics” has been deleted; o) the standard has been editorially revised. Previous editions DIN EN 14349: 2004-12, 2008-01, 2008-05 EUROPEAN STANDARD NORME EUROPENNE EUROPISCH

13、E NORM EN 14349 November 2012 ICS 71.100.35 Supersedes EN 14349:2007English Version Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mech

14、anical 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 non poreuses sans action mca

15、nique - 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 nicht-porsen Oberflchen ohne mechanische Wirkung

16、- Prfverfahren und Anforderungen (Phase 2, Stufe 2) This European Standard was approved by CEN on 22 September 2012. 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 an

17、y 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 langua

18、ge 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,

19、 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

20、 STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14349:2012: EEN 14349:2012 (E) 2 Contents Page

21、 Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .54 Requirements .55 Test method 75.1 Principle 75.2 Materials and reagents 75.2.1 Test organisms 75.2.2 Culture media and reagents .85.2.3 Test surface . 105.3 Apparatus and glassware 105.3.1 General . 105.3.2 Usual

22、microbiological laboratory equipment 115.4 Preparation of test organism suspensions and product test solutions . 125.4.1 Test organism suspensions (test and validation suspension) 125.4.2 Product test solutions 145.5 Procedure for assessing the bactericidal activity of the product . 145.5.1 General

23、. 145.5.2 Test procedure (Dilution-neutralization method). 155.5.3 Observation of test surface agar . 185.6 Experimental data and calculation 185.6.1 Explanation of terms and abbreviations 185.6.2 Calculation . 195.7 Verification of methodology 225.7.1 General . 225.7.2 Control of weighted mean coun

24、ts . 225.7.3 Basic limits 225.8 Expression of results and precision . 225.8.1 Reduction 225.8.2 Control of active and non-active product test solution (5.4.2) 235.8.3 Limiting test organism and bactericidal concentration 235.8.4 Precision, repetitions . 235.9 Interpretation of results conclusion 235

25、.9.1 General . 235.9.2 Bactericidal activity for general purposes . 235.9.3 Qualification for certain fields of application 245.10 Test report . 24Annex A (informative) Referenced strains in national collections 26Annex B (informative) Examples of neutralizers of the residual antimicrobial activity

26、of chemical disinfectants and antiseptics 27Annex C (informative) Graphical representation of the method . 29Annex D (informative) Example of a typical test report 33Bibliography . 36DIN EN 14349:2013-02 EN 14349:2012 (E) 3 Foreword This document (EN 14349:2012) has been prepared by Technical Commit

27、tee 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 May 2013, and conflicting national standards sha

28、ll be withdrawn at the latest by May 2013. 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 14349:2007. Dat

29、a obtained using the former version of EN 14349 may still be used. It was revised to correct obvious errors and ambiguities, to harmonize the structure and wording with other tests of CEN/TC 216 (existing or in preparation), and to improve the readability of the standard and thereby make it more und

30、erstandable. 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

31、, 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 14349:2013-02 EN 14349:2012 (E) 4 Introduction This European Standa

32、rd specifies a surface test for establishing whether a chemical disinfectant or antiseptic has bactericidal activity in the area and fields described in the scope. This laboratory test takes into account practical conditions of application of the product including contact time, temperature, test org

33、anisms 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, f

34、ound by this test corresponds to the chosen experimental conditions. However, for some applications, the instructions of use of a product may differ and therefore additional test conditions need to be used. DIN EN 14349:2013-02 EN 14349:2012 (E) 5 1 Scope This European Standard specifies a test meth

35、od 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. This European Standard applies to products that are used

36、in the veterinary area on non-porous surfaces without mechanical action 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

37、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. This method cannot be used to eva

38、luate the activity of products against mycobacteria. 2 Normative references The following 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 ed

39、ition of the referenced document (including any amendments) applies. EN 12353, Chemical disinfectants and antiseptics Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity EN 14885, Chemical disinfectants and antiseptics Appli

40、cation of European 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

41、 in accordance with Table 1 and Clause 5 under simulated low level (3,0 g/l bovine albumin) or high level soiling (10 g/l yeast extract and 10 g/l bovine albumin) on a surface. DIN EN 14349:2013-02 EN 14349:2012 (E) 6 Table 1 - Obligatory and additional test conditions Test conditions Bactericidal a

42、ctivity on non-porous surfaces without mechanical action in the veterinary area Test organism a) obligatory Enterococcus 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

43、C + 1 C; 40 C + 1 C Contact time a) obligatory 30 min + 10 s b) additional 1 min + 5 s; 5 min + 10 s; 60 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

44、 obligatory contact time 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 r

45、esult 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 and 5.5.1.1 in order to take into account intended specific use conditions. DIN EN 14349:2013-02 EN 14349:2012 (E) 7 5 Test method

46、 5.1 Principle A test suspension of bacteria mixed with interfering substance is inoculated onto the test surface and dried. After a drying time, 0,1 ml of the product is transferred to the surface, in a manner which covers the dried film. The surface is maintained at a specified temperature for a d

47、efined 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 neutralizer so that the action of the disinfectant is immediately neutralized. The numbers of surviving organisms which can be recovered from the surface is determined quantitativ

48、ely. 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, Table 1). Addit

49、ional 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 the following strains1): Enterococcus hirae ATCC 10541; Proteus vulgaris ATCC 13315; Pseudomonas aeruginosa