EN 13704-2018 Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food industrial .pdf

1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Chemical disinfectants Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas Test method and requirements (phase 2, s

2、tep 1)BS EN 13704:2018EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13704 July 2018 ICS 71.100.35 Supersedes EN 13704:2002English Version Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domesti

3、c and institutional areas - Test method and requirements (phase 2, step 1) Dsinfectants chimiques - Essai quantitatif de suspension pour lvaluation de lactivit sporicide des dsinfectants chimiques utiliss dans le domaine de lagro-alimentaire, dans lindustrie, dans les domaines domestiques et en coll

4、ectivit - Mthode dessai et prescriptions (phase 2, tape 1) Chemische Desinfektionsmittel - Quantitativer Suspensionversuch zur Bestimmung der sporiziden Wirkung chemischer Desinfektionsmittel in den Bereichen Lebensmittel, Industrie, Haushalt und ffentliche Einrichtungen - Prfverfahren und Anforderu

5、ngen (Phase 2, Stufe 1) This European Standard was approved by CEN on 16 March 2018. 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 a

6、nd 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 version in any other language made by translation under the

7、 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, Czech Republic, Denmark, Estonia, Finland, Former Yugosl

8、av Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT E

9、UROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13704:2018 ENational forewordThis British Standard is

10、the UK implementation of EN 13704:2018. It supersedes BS EN 13704:2002, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on this committee can be obtained on request to i

11、ts secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 95927 1ICS 71.100.35Compliance with a British Standard

12、 cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 13704:2018EUROPEAN STANDARD NORME EUROPENNE EURO

13、PISCHE NORM EN 13704 July 2018 ICS 71.100.35 Supersedes EN 13704:2002English Version Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements (ph

14、ase 2, step 1) Dsinfectants chimiques - Essai quantitatif de suspension pour lvaluation de lactivit sporicide 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) C

15、hemische Desinfektionsmittel - Quantitativer Suspensionversuch zur Bestimmung der sporiziden Wirkung chemischer Desinfektionsmittel in den Bereichen Lebensmittel, Industrie, Haushalt und ffentliche Einrichtungen - Prfverfahren und Anforderungen (Phase 2, Stufe 1) This European Standard was approved

16、by CEN on 16 March 2018. 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 references concerning such national stand

17、ards 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 a CEN member into its own language and no

18、tified 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 Macedonia, France, Germany, Greece, Hungary,

19、Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-C

20、ENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2018 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13704:2018 EBS EN 13704:2018EN 13704:2018 (E) 2 Contents Page European foreword 4 Introduction . 5 1 Scope . 6 2 N

21、ormative references . 7 3 Terms and definitions 7 4 Requirements 8 5 Test method . 8 5.1 Principle 8 5.2 Materials and reagents . 9 5.2.1 Test organisms 9 5.2.2 Culture media and reagents . 9 5.3 Apparatus and glassware . 11 5.3.1 General 11 5.3.2 Usual microbiological laboratory equipment and, in p

22、articular, the following . 11 5.4 Preparation of spore test suspension and test solutions . 12 5.4.1 Spore suspensions 12 5.4.2 Product test solution 14 5.5 Procedure. 15 5.5.1 Choice of experimental conditions . 15 5.5.2 Test procedure for assessing the sporicidal effect of the product 15 5.5.3 Val

23、idation of dilution neutralization and membrane filtration method 17 5.6 Calculation and expression of results 17 5.6.1 Overview of the different suspensions and test mixtures 17 5.6.2 Calculation . 18 5.7 Verification of methodology 23 5.7.1 General 23 5.7.2 Control of weighted mean counts 23 5.7.3

24、 Basic limits 23 5.7.4 Expression of results 24 5.8 Conclusion 24 5.9 Test report . 24 Annex A (normative) Preparation of Bacillus subtilis and Bacillus cereus spore stock suspensions . 26 A.1 Material and reagents 26 A.2 Preparation of Bacillus spore stock suspensions 26 Annex B (normative) Validat

25、ion of dilution-neutralization and membrane filtration methods . 28 B.1 Principle . 28 B.2 Preparation of spore suspension 28 B.3 Preparation of product test solution 28 B.4 Test for validation . 28 B.4.1 Dilution-neutralization method. 28 BS EN 13704:2018EN 13704:2018 (E) 3 B.4.1.1 General 28 B.4.1

26、2 Validation . 29 B.4.2 Membrane filtration method . 30 B.4.2.1 General 30 B.4.2.2 Validation . 30 B.5 Validation . 32 Annex C (informative) Preparation of Clostridium sporogenes spore stock suspension 33 C.1 Culture media and reagents . 33 C.2 Apparatus and glassware 34 C.3 Preparation of regenera

27、ted media and incubation conditions 34 C.4 Preparation of Clostridium spore stock suspension . 34 Annex D (informative) Neutralizers and rinsing liquids . 36 Annex E (informative) Example of a typical test report 38 Annex F (informative) Referenced strains in national collections 40 F.1 Bacillus sub

28、tilis . 40 F.2 Bacillus cereus . 40 F.3 Clostridium sporogenes 40 Bibliography 41 BS EN 13704:2018EN 13704:2018 (E) 4 European foreword This document (EN 13704:2018) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNO

29、R. 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 January 2019, and conflicting national standards shall be withdrawn at the latest by January 2019. Attention is drawn to the possibility that som

30、e of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 13704:2002. It was revised in order to include the spore susceptibility controls, to better detail spore preparation pr

31、ocedures and to harmonize counting and elaboration of the results with the other CEN/TC 216 current standards. EN 13704:2018 includes the following changes compared to EN 13704:2002: inclusion of spore suspension susceptibility controls; modification of spore preparation procedures; inclusion of spo

32、re maturation time; harmonization of counting and elaboration of the results with the other CEN/TC 216 current standards; deletion of obligatory conditions for contact time and temperature; inclusion of minimum and maximum conditions for contact time and temperature; inclusion of dirty conditions. R

33、esults obtained with the previous version are not valid. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Fi

34、nland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 13704:2018EN 137

35、04:2018 (E) 5 Introduction This European Standard describes a suspension test method for establishing whether a chemical disinfectant has or does not have a sporicidal activity in the fields described in Clause 1. The laboratory test closely simulates practical conditions of application. Chosen cond

36、itions (contact time, temperature, in suspension, etc.) reflect parameters which are found in practical situations including conditions which can influence the action of disinfectants. Each utilization concentration found from this test corresponds to defined experimental conditions. The conditions

37、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 13704:2018EN 13704:2018 (E) 6 1 Scope This document s

38、pecifies a test method (phase 2/step 1) and the minimum requirements for sporicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation in hard water and that are used in food, industrial, domestic and institutional areas, excluding areas and situations

39、where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. This European Standard applies at least to the following: a) processing, distribution and retailing of: 1) food of animal origin: milk and milk product

40、s; 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, distillery, etc.); flour, milling and baking; animal feeds; etc.; b) institutional and domestic area

41、s: catering establishments; public areas; public transports; schools; nurseries; shops; sports rooms; waste containers (bins, etc.); BS EN 13704:2018EN 13704:2018 (E) 7 hotels; dwellings; clinically non sensitive areas of hospitals; offices; etc.; c) other industrial areas: packaging material; biote

42、chnology (yeast, proteins, enzymes, etc.); pharmaceutical; cosmetics and toiletries; textiles; space industry, computer industry; etc. Using this European Standard, it is not possible to determine the sporicidal activity of undiluted product as some dilution is always produced by adding the inoculum

43、 and interfering substance. Products can only be tested at a concentration of 80 % or less. NOTE The method described is intended to determine the activity of commercial formulations or active substances on spores in the conditions in which they are used. 2 Normative references The following documen

44、ts, 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 any amendments) applies. EN 12353, Chemical disinfect

45、ants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity EN 14885, Chemical disinfectants and antiseptics - Application of European Standards for

46、 chemical disinfectants and antiseptics 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 14885 apply. BS EN 13704:2018EN 13704:2018 (E) 8 4 Requirements The product shall demonstrate at least 3 decimal log (lg) reduction, when tested in accordance with

47、 Table 1 here below and Clause 5. Table 1 Minimum and additional test conditions Test Conditions for Surface disinfection Minimum spectrum of test organisms Bacillus subtilis Additional sporicidal activity vs anaerobes for specific uses Clostridium sporogenes Additional sporicidal activity vs aerobe

48、s for specific uses Bacillus cereus Required reduction 3 lg Test temperature according to the manufacturers recommendation, but between 4 C and 75 C Contact time (in minutes) according to the manufacturers recommendation, but between 1 min and 60 min (only contact times of 1, 5, 10, 15, 20, 25, 30,

49、35, 40, 45, 50, 55 and 60 min are allowed in this range) Interfering substance Clean conditions: 0,3 g/l bovine albumin solution or Dirty conditions: 3,0 g/l bovine albumin solution Additional interfering substance for dairies 10,0 g / l of reconstituted milk Other additional strains and additional test conditions may be tested according to product claim. 5 Test method 5.1 Principle A test suspension of bacterial spores in a solution of interfering subst