DIN EN 13697-2015 Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and or fungicidal activity of chemical disinfectat.pdf

1、June 2015 Translation by DIN-Sprachendienst.English price group 15No 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 1

2、1.080.20; 71.100.35!%Bm“2319874www.din.deDDIN EN 13697Chemical disinfectants and antiseptics Quantitative non-porous surface test for the evaluation of bactericidaland/or fungicidal activity of chemical disinfectants used in food,industrial, domestic and institutional areas Test method and requireme

3、nts without mechanical action (phase 2,step 2);English version EN 13697:2015,English translation of DIN EN 13697:2015-06Chemische Desinfektionsmittel und Antiseptika Quantitativer Oberflchen-Versuch nicht porser Oberflchen zur Bestimmung derbakteriziden und/oder fungiziden Wirkung chemischer Desinfe

4、ktionsmittel in denBereichen Lebensmittel, Industrie, Haushalt und ffentliche Einrichtungen Prfverfahren und Anforderungen ohne mechanische Behandlung (Phase 2, Stufe 2);Englische Fassung EN 13697:2015,Englische bersetzung von DIN EN 13697:2015-06Antiseptiques et dsinfectants chimiques Essai quantit

5、atif de surface non-poreuse pour lvaluation de lactivit bactricide et/oufongicide des dsinfectants chimiques utiliss dans le domaine de lagro-alimentaire, danslindustrie, dans les domaines domestiques et en collectivit Mthode dessai sans action mcanique et prescriptions (phase 2, tape 2);Version ang

6、laise EN 13697:2015,Traduction anglaise de DIN EN 13697:2015-06SupersedesDIN EN 13697:2002-01www.beuth.deDocument comprises 36 pagesIn case of doubt, the German-language original shall be considered authoritative.04.15DIN EN 13697:2015-06 2 A comma is used as the decimal marker. National foreword Th

7、is European Standard (EN 13697:2015) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics” (Secretariat: AFNOR, France), Working Group WG 3 “Food hygiene and domestic and institutional use” (Secretariat: UNI, Italy). The responsible German body involved in its

8、preparation was the DIN-Normenausschuss Lebensmittel und landwirtschaftliche Produkte (DIN Standards Committee Food and Agricultural Products), Working Committee NA 057-02-03 AA Desinfektionsmittel Tierhaltung/Lebensmittelbereich (DTL). Amendments This standard differs from DIN EN 13697:2002-01 as f

9、ollows: a) the standard now also covers the yeasticidal activity of chemical disinfectants; b) a reference to EN 14885 has been included in the scope; c) normative references have been updated; d) Clause 3 “Terms and definitions” has been updated and now also covers the terms “yeasts” and “yeasticid

10、al activity”; e) Clause 4 “Requirements” has been restructured with regard to test conditions and the yeasticidal activity (a new table has been included); f) Clause 5 “Test methods” has been updated and rendered more precise (among others, Subclause 5.5.2 “Test procedure” has been further subdivide

11、d; Subclause 5.5.4 “Validation of neutralization” has been deleted); g) the expression of results has been given in more detail (see Subclause 5.6.1. “Elaboration of data: counting of weighed average values”); h) the Annexes have been rearranged; i) the former Annex A (normative) “Test for validatio

12、n of neutralization” has been deleted; j) the former Annex C (informative) “Example of a typical test report” has been split up into a new Annex C (informative) “Expression of results with the dilution-neutralization method” and Annex D (informative) “Bactericidal activity in surfaces in general use

13、 conditions”; k) the former Annex D (informative) “Corresponding referenced strains” is now Annex A; l) the former Annex E (informative) “Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics” has been deleted; m) a new informative Annex E

14、“Precision of the test results” has been included; n) the standard has been editorially revised. Previous editions DIN EN 13697: 2002-01 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13697 April 2015 ICS 11.080.20; 71.100.35 Supersedes EN 13697:2001English Version Chemical disinfectants and a

15、ntiseptics - Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements without mechanical action (phase 2, step 2) Antiseptiques et dsinfectant

16、s chimiques - Essai quantitatif de surface non-poreuse pour lvaluation de lactivit bactricide et/ou fongicide des dsinfectants chimiques utiliss dans le domaine de lagro-alimentaire, dans lindustrie, dans les domaines domestiques et en collectivit - Mthode dessai sans action mcanique et prescription

17、s (phase 2/tape 2) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflchen-Versuch nicht porser Oberflchen zur Bestimmung der bakteriziden und/oder fungiziden Wirkung chemischer Desinfektionsmittel in den Bereichen Lebensmittel, Industrie, Haushalt und ffentliche Einrichtungen - Prf

18、verfahren und Anforderungen ohne mechanische Behandlung (Phase 2, Stufe 2) This European Standard was approved by CEN on 20 January 2015. 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 nationa

19、l 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, German). A versio

20、n 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, Croatia, Cyprus, Cze

21、ch 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 and United Kingdom. E

22、UROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13697:2015 EE

23、N 13697:2015 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 6 3 Terms and definitions .6 4 Requirements .7 5 Test methods 8 5.1 Principle 8 5.2 Materials and reagents 8 5.2.1 Test organisms 8 5.2.2 Culture media and reagents .9 5.2.3 Test surface . 12 5.3 Apparatus a

24、nd glassware 13 5.4 Preparation of test organism suspensions and product test solutions . 14 5.4.1 Test organism suspensions 14 5.4.2 Product test solutions 17 5.5 Procedure 17 5.5.1 Choice of experimental conditions . 17 5.5.2 Test procedure 18 5.5.3 Counting of the test mixtures 20 5.6 Calculation

25、 and expression of results 21 5.6.1 Elaboration of data: counting of weighed average values . 21 5.6.2 Verification of methodology 22 5.6.3 Expression of results . 23 5.6.4 Conclusion 23 5.7 Test report . 24 Annex A (informative) Corresponding referenced strains . 26 Annex B (informative) Neutralize

26、rs . 28 Annex C (informative) Expression of results with the dilution-neutralization method . 30 Annex D (informative) Bactericidal activity in surfaces in general use conditions (for clean conditions) . 32 Annex E (informative) Precision of the test result 33 Bibliography . 34 DIN EN 13697:2015-06

27、EN 13697:2015 (E) 3 Foreword This document (EN 13697:2015) 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 ide

28、ntical text or by endorsement, at the latest by October 2015 and conflicting national standards shall be withdrawn at the latest by October 2015. 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

29、 responsible for identifying any or all such patent rights. This document supersedes EN 13697:2001. The changes between this edition and EN 13697:2001 are the following: interfering substance has been changed from 0,03 % bovine albumin to 0,85 % skimmed milk (see Clause 4, Table 1) for Pseudomonas a

30、eruginosa under clean conditions only; A. brasiliensis (ex A. niger) spore preparation has been updated in order to harmonize this step with the QST fungicidal test method amendment issued in 2012 (see 5.4.1.3 b); Calculations of the weighed means and of the results have been modified in order to be

31、 harmonized with new CEN TC 216 standards (see 5.4.1.5, 5.5.2, 5.5.3 and 5.6); Other paragraphs have been harmonized to new CEN TC 216 standards (e.g. preparation of hard water, 5.2.2.7). Results obtained from the previous standard for Aspergillus niger need to be repeated to take into account the n

32、ew spore morphology requirement and the change in interfering substance. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denm

33、ark, 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 the United Kingdom. DIN EN 13697:2

34、015-06 EN 13697:2015 (E) 4 Introduction This European Standard describes a surface test method for establishing whether a product proposed as a disinfectant in the fields described in Clause 1 has or does not have bactericidal and/or fungicidal or yeasticidal activity on non-porous surfaces. This Eu

35、ropean Standard has been revised in order to modify the interfering substance under “clean conditions” adopted for P. aeruginosa; in order to modify the calculation of N, NC, NT, Nc, Na and consequently the final results and to harmonize the standard with the other recent CEN TC 216 standards. The l

36、aboratory test closely simulates practical conditions of application. Chosen conditions (contact time, temperature, organisms on surfaces .) reflect parameters which are found in practical situations including conditions which may influence the action of disinfectants. Each use concentration found f

37、rom this test corresponds to defined experimental conditions. The conditions are intended to cover general purposes and to allow reference between laboratories and product types. However, for some applications the recommendations of use of a product can differ and therefore additional test condition

38、s need to be used. DIN EN 13697:2015-06 EN 13697:2015 (E) 5 1 Scope This European Standard specifies a test method (phase 2/step 2) and the minimum requirements for bactericidal and/or fungicidal or yeasticidal activity of chemical disinfectants that form a homogeneous physically stable preparation

39、in hard water or in the case of ready-to-use products with water in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues. The scope of this European Standard applies at least to the

40、following: a) Processing, distribution and retailing of: 1) Food of animal origin: i) milk and milk products; ii) meat and meat products; iii) fish, seafood and products; iv) eggs and egg products; v) animal feeds; vi) etc. 2) Food of vegetable origin: i) beverages; ii) fruits, vegetables and deriva

41、tives (including sugar distillery); iii) flour, milling and backing; iv) animal feeds; v) etc. b) Institutional and domestic areas: 1) catering establishments; 2) public areas; 3) public transports; 4) schools; 5) nurseries; 6) shops; 7) sports rooms; 8) waste container (bins); DIN EN 13697:2015-06

42、EN 13697:2015 (E) 6 9) hotels; 10) dwellings; 11) clinically non sensitive areas of hospitals; 12) offices; 13) etc. c) Other industrial areas: 1) packaging material; 2) biotechnology (yeast, proteins, enzymes.); 3) pharmaceutical; 4) cosmetics and toiletries; 5) textiles; 6) space industry, compute

43、r industry; 7) etc. Using this European Standard, it is possible to determine the bactericidal or fungicidal or yeasticidal activity of the undiluted product. As three concentrations are tested, in the active to non active range, dilution of the product is required and, therefore, the product forms

44、a homogeneous stable preparation in hard water. 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 activity of commercial formulations or active substances on bacteria and/or fungi in

45、the conditions in which they are used. NOTE 2 This method cannot be used to evaluate 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 re

46、ferences, 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 organisms used for the determination of bactericidal (including Legionella), myc

47、obactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity EN 14885, Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics ISO 4793, Laboratory sintered (fritted) filters - Porosity grading, classification a

48、nd designation 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 14885 apply. DIN EN 13697:2015-06 EN 13697:2015 (E) 7 4 Requirements The product shall demonstrate at least a 4 decimal log (lg) reduction for bacteria and at least a 3 decimal log (lg) re

49、duction for fungi, when tested in accordance with Table 1 and 5.5.1. Table 1 Obligatory and additional conditions Test Conditions Bactericidal activity on non-porous surfaces without mechanical action Yeasticidal activity on non-porous surfaces without mechanical action Fungicidal activity on non-porous surfaces without mechanical action Test organism (see 5.2.1) obligatory Enterococcus hirae Escherichia coli Pseudomonas aeruginosa Staphylococcus aureus Candida albicans Candida albicans Aspergillus brasiliensis (ex A.