DIN EN 1276-2010 en 3463 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics.pdf

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1、January 2010DEUTSCHE NORM English price group 17No part of this standard 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!$tb“1568163w

2、ww.din.deDDIN EN 1276Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity ofchemical disinfectants and antiseptics used in food, industrial, domesticand institutional areas Test method and requirements (phase 2, step 1)English version of DIN

3、 EN 1276:2010-01Chemische Desinfektionsmittel und Antiseptika Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung chemischerDesinfektionsmittel und Antiseptika in den Bereichen Lebensmittel, Industrie, Haushaltund ffentliche Einrichtungen Prfverfahren und Anforderungen (Phase 2,

4、 Stufe 1)Englische Fassung DIN EN 1276:2010-01SupersedesDIN EN 1276:1997-08www.beuth.deDocument comprises pages46National foreword This standard has been prepared by Technical Committee CEN/TC 216 ”Chemical disinfectants and antiseptics” (Secretariat: AFNOR, France), Working Group WG 3 “Food hygiene

5、 and domestic and institutional use” (Secretariat: AFNOR, France). 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 Desinfektionsmitt

6、el Tierhaltung/Lebensmittelbereich. Amendments This standard differs from DIN EN 1276:1997-08 as follows: a) The scope has been rendered more precise. b) The bacteriostatic activity has been added and the terms “clean conditions” (3.4) and “dirty conditions” (3.5) have been deleted. c) Requirements

7、relating to the incubation temperature of the test organisms have been added (5.2.1). d) Subclause 5.5 “Procedure for assessing the bactericidal activity of the product” has been revised (e.g. relating to validation suspensions, their incubation and counting). e) Subclause 5.6 “Experimental data and

8、 calculation” has been revised. f) Subclause 5.7 “Verification of methodology” has been revised. g) Annex A (normative) “Validation of dilution-neutralization and membrane filtration methods” has been deleted. h) Annex C (informative) “Graphical representations of dilution neutralization method and

9、membrane filtration method” has been included. i) Annex D (informative) “Example of a typical test report” has been revised. j) Annex E (informative) “Precision of the test result” has been included. k) Annex F (informative) “Information on the application and interpretation of European Standards on

10、 chemical disinfectants and antiseptics” has been deleted. l) The standard has been editorially revised. Previous editions DIN EN 1276: 1997-08 2 DIN EN 1276:2010-01 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1276 October 2009 ICS 71.100.35 Supersedes EN 1276:1997English Version Chemical d

11、isinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas Test method and requirements (phase 2, step 1) Antiseptiques et dsinfectants chimiques Essai quan

12、titatif de suspension pour lvaluation de lactivit bactricide des antiseptiques et des dsinfectants chimiques utiliss dans le domaine de lagro-alimentaire, dans lindustrie, dans les domaines domestiques et en collectivit Mthode dessai et prescriptions (Phase 2, tape 1) Chemische Desinfektionsmittel u

13、nd Antiseptika Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika in den Bereichen Lebensmittel, Industrie, Haushalt und ffentliche Einrichtungen Prfverfahren und Anforderungen (Phase 2, Stufe 1) This European Standard was approved

14、 by CEN on 20 September 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national s

15、tandards may be obtained on application to the CEN Management 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 notifi

16、ed to the CEN Management Centre has the same status as theofficial versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

17、 Netherlands, Norway, Poland, Portugal,Romania, 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 2009 CEN All rights of exploita

18、tion in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1276:2009: EEN 1276:2009 (E) 2 Contents Page Foreword 4Introduction .51 Scope 62 Normative references 73 Terms and definitions .74 Requirements .75 Test method 85.1 Principle 85.2 Materials and reagents 95.2.1

19、 Test organisms 95.2.2 Culture media and reagents .95.3 Apparatus and glassware 135.4 Preparation of test organism suspensions and product test solutions . 145.4.1 Test organism suspensions (test and validation suspension) 145.4.2 Product test solutions 155.5 Procedure for assessing the bactericidal

20、 activity of the product . 175.5.1 General . 175.5.2 Dilution-neutralization method 185.5.3 Membrane filtration method 205.6 Experimental data and calculation 225.6.1 Explanation of terms and abbreviations 225.6.2 Calculation . 235.7 Verification of methodology 265.7.1 General . 265.7.2 Control of w

21、eighted mean counts . 265.7.3 Basic limits 265.8 Expression of results and precision . 265.8.1 Reduction 265.8.2 Control of active and non-active product test solution (5.4.2) 275.8.3 Limiting test organism and bactericidal concentration 275.8.4 Precision, replicates . 275.9 Interpretation of result

22、s - conclusion . 275.9.1 General . 275.9.2 Bactericidal activity for general purposes . 27DIN EN 1276:2010-01 EN 1276:2009 (E) 3 5.9.3 Bactericidal activity for specific purposes . 275.10 Test report 28Annex A (informative) Referenced strains in national collections 30Annex B (informative) Neutraliz

23、ers and rinsing liquids 31Annex C (informative) Graphical representations of dilution neutralization method and membrane filtration method . 33C.1 Dilution-neutralization method 33C.2 Membrane filtration method . 35Annex D (informative) Example of a typical test report 37Test results (bactericidal s

24、uspension test) . 39Annex E (informative) Precision of the test result . 41Bibliography 44DIN EN 1276:2010-01 EN 1276:2009 (E) 4 Foreword This document (EN 1276:2009) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AFN

25、OR. 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 April 2010, and conflicting national standards shall be withdrawn at the latest by April 2010. Attention is drawn to the possibility that some o

26、f 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 1276:1997. It was revised to include the results of a collaborative trial (ANDISTAND), to correct obvious e

27、rrors and ambiguities, to harmonize the structure and wording with other quantitative suspension tests of CEN/TC 216 (existing or in preparation) and to improve the readability of the standard and thereby make it more understandable. According to the CEN/CENELEC Internal Regulations, the national st

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

29、 Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. DIN EN 1276:2010-01 EN 1276:2009 (E) 5 Introduction This European Standard specifies a suspension test for establishing whether a chemical disinfectant or antiseptic has or does not have bactericidal activity

30、in the 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 substance, i.e. conditions which may influence its action in practical situations. The conditions are

31、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 defined experimental conditions. However, for some applications, the recommendations of use of

32、 a product may differ and therefore additional test conditions need to be used. DIN EN 1276:2010-01 EN 1276:2009 (E) 6 1 Scope This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneou

33、s, 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 document applies to p

34、roducts that are used in food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. The following areas are at least included: a

35、) processing, distribution and retailing of: 1) food of animal origin: milk and milk products; meat and meat products; fish, seafood, and related products; eggs and egg products; animal feeds; etc. 2) food of vegetable origin: beverages; fruits, vegetables and derivatives (including sugar, distiller

36、y, etc.); flour, milling and baking; animal feeds; etc. b) institutional and domestic areas: catering establishments; public areas; public transports; schools; nurseries; shops; sports rooms; waste containers (bins, etc.); hotels; dwellings; clinically non sensitive areas of hospitals; offices; etc.

37、 DIN EN 1276:2010-01 EN 1276:2009 (E) 7 c) other industrial areas: packaging material; biotechnology (yeast, proteins, enzymes, etc.); pharmaceutical; cosmetics and toiletries; textiles; space industry, computer industry; etc. EN 14885 specifies in detail the relationship of the various tests to one

38、 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 1 test. 2 Normative references The following referenc

39、ed documents are indispensable for the application of this document. 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 antiseptics Preservation of test o

40、rganisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity EN 14885:2006, Chemical disinfectants and antiseptics Application of European Standards for chemical disinfectants and antiseptics 3 Terms and definitions For the purposes of this document, the

41、terms and definitions given in EN 14885:2006 apply. 4 Requirements The product shall demonstrate at least a 5 decimal log (lg) 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 Clause 5 under simulated clea

42、n conditions (0,3 g/l bovine albumin solution- 5.2.2.8.2) or simulated dirty conditions (3 g/l bovine albumin solution - 5.2.2.8.3) according to its practical applications and under the other obligatory test conditions (four selected test organisms, 20 C, 5 min or 1 min (for hands disinfection). The

43、 bactericidal activity shall be evaluated using the following four test organisms: Pseudomonas aeruginosa; Escherichia coli; DIN EN 1276:2010-01 EN 1276:2009 (E) 8 Staphylococcus aureus; Enterococcus hirae. Where indicated, additional specific bactericidal activity shall be determined applying other

44、 contact times, temperatures, interfering substances and test organisms (in accordance with 5.2.1, 5.2.2.8 and 5.5.1.1) in order to take into account intended specific use conditions. NOTE For these additional conditions, the concentration defined as a result can be lower than the one obtained under

45、 the obligatory test 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 bacteria in a solution of an interfering substance. The mixture is maintained at (20 1) C for 5

46、 min 10 s (obligatory test conditions) during 1 min (obligatory test conditions for hands disinfection). At the end of this contact time, 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 m

47、ethod of choice is dilution-neutralization. If a suitable neutralizer cannot be found, membrane filtration is used. The numbers of surviving bacteria in each sample are determined and the reduction is calculated. 5.1.2 The test is performed using Pseudomonas aeruginosa, Escherichia coli, Staphylococ

48、cus aureus and Enterococcus hirae as test organisms. 5.1.3 Additional and optional contact times and temperatures are specified. Additional test organisms can be used. DIN EN 1276:2010-01 EN 1276:2009 (E) 9 5.2 Materials and reagents 5.2.1 Test organisms The bactericidal activity shall be evaluated using the following strains as test organisms1): Pseudomonas aeruginosa ATCC 15442; Escherichia coli ATCC 10536; Staphylococcus aureus ATCC 6538; Enterococcus hirae ATCC 10541. If required for specific applications, additional strains may be chosen, for example from: Salmonella Typhimurium ATCC 133