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

1、BSI Standards PublicationBS EN 13697:2015Chemical disinfectants andantiseptics Quantitativenon-porous surface test forthe evaluation of bactericidaland/or fungicidal activity ofchemical disinfectants usedin food, industrial, domesticand institutional areas Testmethod and requirements without mechani

2、cal action (phase 2, step 2)BS EN 13697:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 13697:2015. It supersedes BS EN 13697:2001 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/216, Chemical disinfectants

3、and antiseptics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published

4、 by BSI Standards Limited 2015ISBN 978 0 580 78888 8ICS 11.080.20; 71.100.35Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2015.Amendments/corrigenda iss

5、ued since publicationDate T e x t a f f e c t e dBS EN 13697:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13697 April 2015 ICS 11.080.20; 71.100.35 Supersedes EN 13697:2001English Version Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of

6、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 dsinfectants chimiques - Essai quantitatif de surface non-poreuse pour lvaluation d

7、e 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 prescriptions (phase 2/tape 2) Chemische Desinfektionsmittel und Antiseptika - Quant

8、itativer Oberflchen-Versuch nicht porser Oberflchen zur Bestimmung der bakteriziden und/oder fungiziden Wirkung chemischer Desinfektionsmittel in den Bereichen Lebensmittel, Industrie, Haushalt und ffentliche Einrichtungen - Prfverfahren und Anforderungen ohne mechanische Behandlung (Phase 2, Stufe

9、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 national standard without any alteration. Up-to-date lists and bibliographical

10、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 language made by translation under the responsibility of

11、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, Estonia, Finland, Former Yugoslav Republic of Mace

12、donia, 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 STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUR

13、OPISCHES 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 EBS EN 13697:2015EN 13697:2015 (E) 2 Contents Page Foreword 3 Introduction

14、 .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 and glassware 13 5.4 Preparation of test organism suspens

15、ions 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 and expression of results 21 5.6.1 Elaboration of data:

16、 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) Neutralizers . 28 Annex C (informative) Expression of results with

17、 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 BS EN 13697:2015EN 13697:2015 (E) 3 Foreword This document (EN 13697:2015) ha

18、s 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 latest by October 2015

19、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 responsible for identifying any or all such patent rights. T

20、his 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 aeruginosa under clean conditions only; A. brasiliensis (ex A.

21、 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 harmonized with new CEN TC 216 standards (see 5.4.1.5, 5.5.2

22、, 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 new spore morphology requirement and the change in interfering

23、 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, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

24、 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. BS EN 13697:2015EN 13697:2015 (E) 4 Introduction This European Standard des

25、cribes 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 European Standard has been revised in order to modify the interferin

26、g 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 laboratory test closely simulates practical conditions of applicati

27、on. 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 from this test corresponds to defined experimental conditions. The

28、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 conditions need to be used. BS EN 13697:2015EN 13697:2015 (E) 5 1 Scope Thi

29、s 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 in hard water or in the case of ready-to-use products with water in foo

30、d, 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 following: a) Processing, distribution and retailing of: 1) Food of ani

31、mal 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 derivatives (including sugar distillery); iii) flour, milling and backing; iv

32、) 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); BS EN 13697:2015EN 13697:2015 (E) 6 9) hotels; 10) dwellings; 11) clinically non sensitive a

33、reas 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, computer industry; 7) etc. Using this European Standard, it is possible to determin

34、e 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 a homogeneous stable preparation in hard water. EN 14885 specifies in detail

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

36、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 references, only the edition cited applies. For undated references, the latest

37、 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), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophage

38、s) 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 and designation 3 Terms and definitions For the purposes of this document, th

39、e terms and definitions given in EN 14885 apply. BS EN 13697:2015EN 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) reduction for fungi, when tested in accordance with Table 1 and 5.5.1. Table 1 Obli

40、gatory 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 Ente

41、rococcus hirae Escherichia coli Pseudomonas aeruginosa Staphylococcus aureus Candida albicans Candida albicans Aspergillus brasiliensis (ex A. niger) example Salmonella typhimurium Lactobacillus brevis Enterobacter cloacae Saccharomyces cerevisiae (for breweries) Saccharomyces cerevisiae var. diasta

42、ticus (for breweries) any relevant test organism Test temperature obligatory Between 18 C 1 C and 25 C 1 C Between 18 C 1 C and 25 C 1 C Between 18 C 1 C and 25 C 1 C additional 4 C 1 C; 10 C 1 C; 40 C 1 C 4 C 1 C; 10 C 1 C; 40 C 1 C 4 C 1 C; 10 C 1 C; 40 C 1 C Contact time obligatory 5 min 10 s 15

43、min 10 s 15 min 10 s additional 1 min 5 s; 15 min 10 s; 30 min 10 s; 60 min 10 s 1 min 5 s; 5 min 10 s; 30 min 10 s; 60 min 10 s 1 min 5 s; 5 min 10 s; 30 min 10 s; 60 min 10 s Interfering substance obligatory clean conditions 0,3 g/l Bovine Albumin for Staphylococcus aureus, Enterococcus hirae and

44、Escherichia coli ; 8,5 g/l skim milk for Pseudomonas aeruginosa 0,3 g/l Bovine Albumin for C. albicans 0,3 g/l Bovine Albumin for C. albicans and A. brasiliensis dirty conditions 3,0 g/l Bovine Albumin for Staphylococcus aureus, Enterococcus hirae, Pseudomonas aeruginosa and Escherichia coli 3,0 g/l

45、 Bovine Albumin for C. albicans 3,0 g/l Bovine Albumin for C. albicans and A. brasiliensis additional any relevant substance any relevant substance any relevant substance Log reduction from a water control (decimal log) 4Log 3Log 3Log The obligatory contact times for surface disinfectants stated in

46、Table 1 were chosen to enable comparison of standard conditions. The referenced test conditions are by no means intended as requirements for the use of a product, nor as requirements for the evaluation and acceptance of products by regulatory authorities. The recommended contact time for the use of

47、the product is within the responsibility of the manufacturer. Where appropriate (specific purposes), additional specific bactericidal/yeasticidal/fungicidal activity shall be determined under other conditions of time, temperature, additional strains and interfering substances in order to take into a

48、ccount intended specific use conditions. NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions. BS EN 13697:2015EN 13697:2015 (E) 8 5 Test methods 5.1 Principle A test suspension of bacteria or fungi in a sol

49、ution of interfering substances is inoculated onto a test stainless steel surface and dried. A prepared sample of the product under test is applied in a manner which covers the dried film. The surface is maintained at a specified temperature for a defined period of time. The surface is transferred to a previously validated neutralization medium so that the action of the disinfectant is immediately neutralized. The number of surviving organisms which