DIN EN 13623-2010 en 5141 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfect.pdf

1、December 2010 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!$ld“1736504www.din.deDDIN EN 13623Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activityagainst Legionella of chemical disinfectants for aqueous systems Test method and requirements (phase 2, step 1)English translation of DIN EN 1

3、3623:2010-12Chemische Desinfektionsmittel und Antiseptika Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung gegenLegionella von chemischen Desinfektionsmitteln fr wasserfhrende Systeme Prfverfahren und Anforderungen (Phase 2, Stufe 1)Englische bersetzung von DIN EN 13623:2010-

4、12Antiseptiques et dsinfectants chimiques Essai quantitatif de suspension pour lvaluation de lactivit bactricide contre deslgionelles des dsinfectants chimiques pour les systmes aqueux Mthode dessai et prescriptions (phase 2, tape 1)Traduction anglaise de DIN EN 13623:2010-12www.beuth.deDocument com

5、prises pagesIn case of doubt, the German-language original shall be considered authoritative.3612.10 DIN EN 13623:2010-12 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics“ (Secretariat:

6、AFNOR, France), Working Group WG 1 “Human medicine” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-04-07 AA Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin.

7、 2 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13623 September 2010 ICS 71.100.35 English Version Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity against Legionella of chemical disinfectants for aqueous systems Test method and

8、requirements (phase 2, step 1) Antiseptiques et dsinfectants chimiques Essai quantitatif de suspension pour lvaluation de lactivit bactricide contre des lgionelles des dsinfectants chimiques pour les systmes aqueux Mthode dessai et prescriptions (phase 2, tape 1) Chemische Desinfektionsmittel und An

9、tiseptika Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung gegen Legionella von chemischen Desinfektionsmitteln fr wasserfhrende Systeme Prfverfahren und Anforderungen (Phase 2, Stufe 1) This European Standard was approved by CEN on 15 April 2010. CEN members are bound to com

10、ply 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 Manage

11、ment 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 Management Centre has the same status as th

12、e official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania

13、, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved wor

14、ldwide for CEN national Members. Ref. No. EN 13623:2010: EEN 13623:2010 (E) Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .54 Requirements .55 Test methods 65.1 Principle 65.2 Materials and reagents 65.2.1 Test organism 65.2.2 Culture media and reage

15、nts .65.3 Apparatus and glassware 105.3.1 General . 105.3.2 Usual microbiological laboratory equipment 105.4 Preparation of test organism suspensions and test solutions 115.4.1 Test organism suspension (test and validation suspension) 115.4.2 Product test solution 135.5 Procedure for assessing the b

16、actericidal activity of the product . 135.5.1 General . 135.5.2 Dilution-neutralization method 155.5.3 Membrane filtration method 175.6 Experimental data and calculations 185.6.1 Explanation of terms and abbreviations 185.6.2 Calculation . 195.7 Verification of methodology 225.7.1 General . 225.7.2

17、Control of weighted mean counts . 235.7.3 Basic limits 235.8 Expression of results and precision . 235.8.1 Reduction 235.8.2 Control of active and non-active product test solution (5.4.2) 235.8.3 Bactericidal concentration . 235.8.4 Precision, repetition . 245.9 Interpretation of results conclusion

18、245.9.1 General . 245.9.2 Bactericidal activity for general purposes . 245.9.3 Bactericidal activity for specific purposes 245.10 Test report . 24Annex A (informative) Determination of the bactericidal activity against Legionella pneumophila . 26Annex B (informative) Neutralizer . 28Annex C (informa

19、tive) Graphical representation of test procedures 30C.1 Dilution-neutralization method 30C.2 Membrane filtration method 32Bibliography . 342DIN EN 13623:2010-12 EN 13623:2010 (E) Foreword This document (EN 13623:2010) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and an

20、tiseptics”, 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 March 2011, and conflicting national standards shall be withdrawn at the latest by March 2011

21、. 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 organizati

22、ons of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal

23、, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. 3DIN EN 13623:2010-12 EN 13623:2010 (E) Introduction This European Standard specifies a suspension test for establishing whether a chemical disinfectant has a bactericidal activity against Legionella pneumophila in the

24、 fields described in the scope. This standard is specifically prepared for water treatment products, but it may also be possible to use it for other products. Proliferation of Legionella only occurs in waters under certain conditions, and predominantly poses a risk when aerosolised. Many systems con

25、taining water do not require treatment. A decision to add chemical disinfectants to any water should be based on a risk assessment. If the product complies with the requirements of this standard, it can be considered bactericidal against Legionella pneumophila, but it should not necessarily be infer

26、red that the product is acceptable for a specific site of application without consideration of other relevant factors such as the pH, water, chemistry, temperature and degree of biological fouling at that site of application. It does not take into account the protective effect conveyed by biofilm on

27、 the organisms. The conditions are intended to cover general purposes and to allow reference between laboratories and product types. Each concentration of the chemical disinfectant found by this test corresponds to defined experimental conditions. However, for some applications the recommendations o

28、f use of a product may differ and therefore additional test conditions need to be used. 4DIN EN 13623:2010-12 EN 13623:2010 (E) 1 Scope This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant products intended to be used for trea

29、tment in aqueous systems against Legionella pneumophila that form a homogeneous, physically stable preparation when diluted with buffered ferrous hard water or hard water. Whenever Legionella pneumophila poses a risk to human health, this method is suitable for water used in cooling towers and water

30、 for general purposes, like spas, pools, showers and other uses. The method is not suitable for electro-chemical disinfection. The European Standard applies to products used to treat water in order to kill Legionella pneumophila. NOTE 1 The method described is intended to determine the activity of c

31、ommercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a phase 2 step 1 test . NOTE 3 This method does not take into account the fact that Legionella pneumophila is often found in cells of amoebae and/or biofilms and that thereby a

32、products activity against the bacteria may be reduced. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendation“. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references

33、, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 14885, Chemical disinfectants and antiseptics Application of European Standards for chemical disinfectants and antiseptics 3 Terms and definitions For the pu

34、rposes of this document, the terms and definitions given in EN 14885 and the following apply. 3.1 cooling water water used to remove heat from a process or environment 3.2 water for general purposes water used in premises other than water used as cooling water 4 Requirements The product shall demons

35、trate al least a four decimal log (lg) reduction, when diluted with buffered ferrous hard water (5.2.2.10) or hard water (5.2.2.7), and tested in accordance with Clause 5 under the obligatory test conditions (one selected test organism, at either 20 C or 30 C) within 60 min for rapid acting products

36、 or 15 h for slower acting products. The bactericidal activity shall be evaluated using the following test organism: Legionella pneumophila. Where indicated, additional specific bactericidal activity shall be determined applying other contact times and test organisms (in accordance with 5.2.1 and 5.

37、5.1.1) in order to take into account intended specific use conditions. 5DIN EN 13623:2010-12 EN 13623:2010 (E) NOTE For these additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions. 5 Test methods 5.1 Principle 5.1.1 A sam

38、ple of the product diluted with hard water (5.2.2.7 or 5.2.2.10) is added to a test suspension of bacteria in a solution of an interfering substance. The mixture is maintained at either (20 1) C or (30 1) C for 60 min 10 s or (15 1) h (obligatory test conditions). At the end of the chosen contact ti

39、me, an aliquot is taken, and the bactericidal and/or the bacteriostatic activity in this portion is immediately neutralized or suppressed by a validated method. The method of choice is dilution-neutralization. If a suitable neutralizer cannot be found membrane filtration is used. The numbers of surv

40、iving bacteria in each sample are determined and the reduction is calculated. 5.1.2 The test is performed using Legionella pneumophila as test organism (obligatory test conditions). 5.1.3 Additional and optional contact times are specified. Additional test organisms may be used. 5.2 Materials and re

41、agents 5.2.1 Test organism The bactericidal activity shall be evaluated using the following strain as test organism1): Legionella pneumophila: serogroup 1, Philadelphia (NCTC 11192; ATCC 33152). If required for specific applications, additional test organisms may be used, e.g. Legionella pneumophila

42、 serogroup 1 Benidorm (NCTC 12006, ATCC 43108). The required incubation temperature for this test organism is (36 1) C or (37 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 organi

43、sms are used, they shall be incubated under optimum growth conditions (temperature, time, atmosphere, media) noted in the 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 thes

44、e additional test organisms are not classified at a reference centre, their identification characteristics shall be stated. 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 Unle

45、ss specifically stated, all weights of chemical substances given in this 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

46、/or appropriate for microbiological purposes. They shall be free from substances that are toxic or inhibitory to the test organisms. 1) The NCTC and ATCC numbers are the collection numbers of strains supplied by the National Type Culture Collection (NCTC) and American Type Culture Collection (ATCC).

47、 This information is given for the convenience of users of this standard and does not constitute an endorsement by CEN of the product named. 6DIN EN 13623:2010-12 EN 13623:2010 (E) NOTE 1 To improve reproducibility, it is recommended that commercially available dehydrated material is used for the pr

48、eparation of culture media. The manufacturers instructions relating to the preparation of these products should be rigorously followed. NOTE 2 For each culture medium and reagent, a limitation for use should be fixed. 5.2.2.2 Water The water shall be freshly glass-distilled water and not demineralized water. If distilled water of adequate quality is not available, water for injections (bibliograph