DIN EN 14204-2013 en 5341 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants and antise.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!$F“1943598www.din.deDDIN EN 14204Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of mycobactericidalactivity of chemical disinfectants and antiseptics used in the veterinaryarea Test method and requirements (phase 2, step 1);English version EN 1420

3、4:2012,English translation of DIN EN 14204:2013-02Chemische Desinfektionsmittel und Antiseptika Quantitativer Suspensionsversuch zur Bestimmung der mykobakteriziden Wirkungchemischer Desinfektionsmittel und Antiseptika fr den Veterinrbereich Prfverfahren und Anforderungen (Phase 2, Stufe 1);Englisch

4、e Fassung EN 14204:2012,Englische bersetzung von DIN EN 14204:2013-02Antiseptiques et dsinfectants chimiques Essai quantitatif de suspension pour lvaluation de lactivit mycobactricide desantiseptiques et des dsinfectants chimiques utiliss dans le domaine vtrinaire Mthode dessai et prescriptions (Pha

5、se 2, tape 1);Version anglaise EN 14204:2012,Traduction anglaise de DIN EN 14204:2013-02SupersedesDIN EN 14204:2004-09www.beuth.deDocument comprises 38 pagesIn case of doubt, the German-language original shall be considered authoritative.01.13DIN EN 14204:2013-02 2 A comma is used as the decimal mar

6、ker. National foreword This document (EN 14204:2012) 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 Kingdom). The responsible German bodies involved in its prepar

7、ation was the Normenausschuss Lebensmittel und landwirtschaftliche Produkte (Food and Agricultural Products Standards Committee), Working Committee NA 057-02-03 AA Desinfektionsmittel Tierhaltung/Lebensmittelbereich. Amendments This standard differs from DIN EN 14204:2004-09 as follows: a) Introduct

8、ion 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 rendered more precise with regard to the test conditions and the bactericidal activity (a new table has been included); d) Subclauses

9、5.1 “Principle” and 5.2 “Materials and reagents” have been revised (among others, deletion of Subclause 5.2.2.9 “7H9 broth + 10 % ADC”) e) Subclause 5.3 “Apparatus and glassware” has been updated; f) Subclause 5.4 “Preparation of mycobacterial test suspension and product test solutions” has been rev

10、ised (inclusion of validation suspensions and related requirements); g) Subclause 5.5 “Procedure for assessing the mycobactericidal activity of the product” has been restructured and revised; h) Subclause 5.5.3 “Test procedure Membrane filtration method” has been added including the associated media

11、 and equipment; i) Subclause 5.6 “Experimental data and calculation” has been revised; j) Subclause 5.7 “Verification of methodology” has been revised; k) Subclause 5.9 “Interpretation of results conclusion” has been updated; l) the former Annex A (normative) “Test for validation of dilution-neutral

12、ization method” has been deleted; m) the former Annex B (informative) “Homogenization of mycobacterial test suspensions” has been deleted; n) Annex C (informative) “Graphical representations of dilution-neutralization method” has been added; o) Annex B (informative) “Examples of neutralizers of the

13、residual antimicrobial activity of chemical disinfectants and antiseptics and rinsing liquids” and Annex D (informative) “Example of a typical test report” have been revised; p) the former Annex F (informative) “Information on the application and interpretation of European Standards on chemical disi

14、nfectants and antiseptics” has been deleted; q) the standard has been editorially revised. Previous editions DIN EN 14204: 2004-09 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14204 November 2012 ICS 71.100.35 Supersedes EN 14204:2004English Version Chemical disinfectants and antiseptics - Q

15、uantitative suspension test for the evaluation of mycobactericidal 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 myc

16、obactricide des antiseptiques et des dsinfectants chimiques utiliss dans le domaine vtrinaire - Mthode dessai et prescriptions (Phase 2, tape 1) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der mykobakteriziden Wirkung chemischer Desinfektionsmittel

17、 und Antiseptika fr den Veterinrbereich - Prfverfahren und Anforderungen (Phase 2, Stufe 1) 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

18、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

19、, 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, C

20、roatia, 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 an

21、d United Kingdom. EUROPEAN COMMITTEE FOR 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 14204:

22、2012: EEN 14204:2012 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .54 Requirements .55 Test method 65.1 Principle 65.2 Materials and reagents 75.2.1 Test organisms 75.2.2 Culture media and reagents .75.3 Apparatus and glassware 105.3.1 General

23、 . 105.3.2 Usual microbiological laboratory equipment and, in particular, the following: . 105.4 Preparation of mycobacterial test suspension and product test solutions . 115.4.1 Mycobacterial test suspensions (test and validation suspension) . 115.4.2 Product test solutions 135.5 Procedure for asse

24、ssing the mycobactericidal activity of the product 145.5.1 General . 145.5.2 Test procedure - Dilution-neutralization method 155.5.3 Test procedure - Membrane filtration method . 175.6 Experimental data and calculation 195.6.1 Explanation of terms and abbreviations 195.6.2 Calculation . 195.7 Verifi

25、cation of methodology 235.7.1 General . 235.7.2 Control of weighted mean counts . 235.7.3 Basic limits 235.8 Expression of results . 245.8.1 Reduction 245.8.2 Control of active and non-active product test solution (5.4.2) 245.8.3 Mycobactericidal concentration 245.9 Interpretation of results - concl

26、usion . 245.9.1 General . 245.9.2 Mycobactericidal activity for general purposes 245.9.3 Qualification for certain fields of application 245.10 Test report . 25Annex A (informative) Referenced strain in national collections 27Annex B (informative) Examples of neutralizers of the residual antimicrobi

27、al activity of chemical disinfectants and antiseptics and rinsing liquids . 28Annex C (informative) Graphical representations of dilution-neutralization method . 30Annex D (informative) Example of a typical test report 32Bibliography . 36DIN EN 14204:2013-02 EN 14204:2012 (E) 3 Foreword This documen

28、t (EN 14204:2012) 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 lat

29、est by May 2013, and conflicting national standards shall 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 pat

30、ent rights. This document supersedes EN 14204:2004. Data obtained using the former version of EN 14204 may still be used. This document was revised to correct obvious errors and ambiguities, to harmonize the structure and wording with other quantitative suspension tests of CEN/TC 216 (existing or in

31、 preparation), and to improve the readability of the standard and thereby make it more understandable. The following technical changes have been made: Membrane filtration (5.5.3) method and associated media and equipment have been added. According to the CEN/CENELEC Internal Regulations, the nationa

32、l 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, Lithua

33、nia, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 14204:2013-02 EN 14204:2012 (E) 4 Introduction This European Standard specifies a suspension test for establishing whether a chemical disinfec

34、tant or antiseptic has mycobactericidal 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 organisms and interfering substances, i.e. conditions which may influen

35、ce 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 the chosen experimental conditions.

36、 However, for some applications the instructions of use of a product may differ and therefore additional test conditions need to be used. DIN EN 14204:2013-02 EN 14204:2012 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for mycobactericidal activity of chem

37、ical 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 org

38、anisms and interfering substance. This European Standard applies to 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

39、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

40、 1 test. 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 edition of the referenced document (including

41、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 Application of European Standards for chemical di

42、sinfectants 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 when tested in accordance with Table 1 and Clause 5 under simulated low level

43、 (3,0 g/l bovine albumin) or high level soiling (10 g/l yeast extract and 10 g/l bovine albumin). DIN EN 14204:2013-02 EN 14204:2012 (E) 6 Table 1 - Obligatory and additional test conditions Test conditions Mycobactericidal activity Test organism a) obligatory Mycobacterium avium b) additional any r

44、elevant test organism Test temperature a) obligatory 10C 1C b) additional 4C 1C; 20C 1C; 40C 1C Contact time a) obligatory 60 min 10 sab) additional 1 min 5 s; 5 min 10 s; 10 min 10 s, 15 min 10 s, 30 min 10 s, 120 min 10 s Interfering substance a) obligatory low level soiling high level soiling 3,0

45、 g/l bovine albumin 10 g/l yeast extract plus 10 g/l bovine albumin b) additional any relevant substance NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions.a The obligatory contact time for disinfectants s

46、tated in Table 1 was chosen to enable comparison of standard conditions. The referenced test conditions are by no means intended as requirements for the use of a product. The recommended contact time for the use of the product is within the responsibility of the manufacturer. Any additional specific

47、 mycobactericidal 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 sample of the product as delivered and/or diluted in hard water (or water for ready to use products) is added to a test su

48、spension of mycobacteria in a solution of an interfering substance. The mixture is maintained at (10 1) C for 60 min 10 s. At the end of this contact time, an aliquot is taken and the mycobactericidal action in this portion is immediately neutralized or suppressed by a validated method. The number o

49、f surviving mycobacteria in each sample is determined and the reduction in viable counts calculated. DIN EN 14204:2013-02 EN 14204:2012 (E) 7 The test is performed using Mycobacterium avium as the test organism (Clause 4, Table 1). Additional and optional contact times and temperatures are specified (Clause 4, Table 1). Additional