EN 13727-2012 en Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirement.pdf

1、BSI Standards PublicationBS EN 13727:2012+A2:2015Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity in the medical area Test method and requirements (phase 2, step 1)BS EN 13727:2012+A1:2013BS EN 13727:2012+A2:2015 BRITISH STANDARDNational

2、 forewordThis British Standard is the UK implementation of EN 13727:2012+A2:2015. It supersedes BS EN 13727:2012+A1:2013 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to CEN text carry the number of the CE

3、N amendment. For example, text altered by CEN amendment A1 is indicated by .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 its secretary.Th

4、is publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2015. Published by BSI Standards Limited 2015ISBN 978 0 580 89232 5ICS 11.080.20Compliance with a British Standard cannot confer

5、 immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012.Amendments/corrigenda issued since publicationDate Text affected28 February 2014 Implementation of CEN amendment A1:201330 November 2015 Implemen

6、tation of CEN amendment A2:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13727:2012+A2 October 2015 ICS 11.080.20 Supersedes EN 13727:2012+A1:2013English Version Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medica

7、l area - Test method and requirements (phase 2, step 1) Antiseptiques et dsinfectants chimiques - Essai quantitatif de suspension pour lvaluation de lactivit bactricide en mdecine - Mthode dessai et prescriptions (Phase 2, tape 1) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspens

8、ionsversuch zur Bestimmung der bakteriziden Wirkung im humanmedizinischen Bereich - Prfverfahren und Anforderungen (Phase 2, Stufe 1)This European Standard was approved by CEN on 14 October 2013 and includes Amendment 2 approved by CEN on 3 August 2015. CEN members are bound to comply with the CEN/C

9、ENELEC 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-CENELEC Management Centr

10、e 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-CENELEC Management Centre has the same status as the

11、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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherla

12、nds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN 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

13、 of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13727:2012+A2:2015 EEN 13727:2012+A2:2015 (E) 2 Contents Page European foreword . 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Requirements . 6 5 Test method 8

14、5.1 Principle . 8 5.2 Materials and reagents 8 5.2.1 Test organisms . 8 5.2.2 Culture media and reagents 9 5.3 Apparatus and glassware 11 5.3.1 General . 11 5.3.2 Usual microbiological laboratory equipment 12 5.4 Preparation of test organism suspensions and product test solutions 13 5.4.1 Test organ

15、ism suspensions (test and validation suspension) . 13 5.4.2 Product test solutions . 15 5.5 Procedure for assessing the bactericidal activity of the product . 15 5.5.1 General . 15 5.5.2 Dilution-neutralization method 17 5.5.3 Membrane filtration method . 19 5.5.4 Modified method for ready-to-use pr

16、oducts 21 5.6 Experimental data and calculation 23 5.6.1 Explanation of terms and abbreviations . 23 5.6.2 Calculation 23 5.7 Verification of methodology . 28 5.7.1 General . 28 5.7.2 Control of weighted mean counts . 28 5.7.3 Basic limits . 29 5.8 Expression of results and precision 29 5.8.1 Reduct

17、ion 29 5.8.2 Control of active and non-active product test solution (5.4.2) . 29 5.8.3 Limiting test organism and bactericidal concentration . 30 5.8.4 Precision, repetitions . 30 5.9 Interpretation of results - conclusion . 30 5.9.1 General . 30 5.9.2 Bactericidal activity for handrub and handwash

18、products 30 5.9.3 Bactericidal activity for instrument disinfection products 30 5.9.4 Bactericidal activity for surface disinfection products 31 5.9.5 Qualification for certain fields of application 31 5.10 Test report 31 Annex A (informative) Referenced strains in national collections . 33 Annex B

19、(informative) Neutralizers and rinsing liquids . 34 BS EN 13727:2012+A2:2015EN 13727:2012+A2:2015 (E) 2 Contents Page European foreword . 4 Introduction 5 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Requirements . 6 5 Test method 8 5.1 Principle . 8 5.2 Materials and reagents 8

20、5.2.1 Test organisms . 8 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 12 5.4 Preparation of test organism suspensions and product test solutions 13 5.4.1 Test organism suspensions (test and validation suspension

21、) . 13 5.4.2 Product test solutions . 15 5.5 Procedure for assessing the bactericidal activity of the product . 15 5.5.1 General . 15 5.5.2 Dilution-neutralization method 17 5.5.3 Membrane filtration method . 19 5.5.4 Modified method for ready-to-use products 21 5.6 Experimental data and calculation

22、 23 5.6.1 Explanation of terms and abbreviations . 23 5.6.2 Calculation 23 5.7 Verification of methodology . 28 5.7.1 General . 28 5.7.2 Control of weighted mean counts . 28 5.7.3 Basic limits . 29 5.8 Expression of results and precision 29 5.8.1 Reduction 29 5.8.2 Control of active and non-active p

23、roduct test solution (5.4.2) . 29 5.8.3 Limiting test organism and bactericidal concentration . 30 5.8.4 Precision, repetitions . 30 5.9 Interpretation of results - conclusion . 30 5.9.1 General . 30 5.9.2 Bactericidal activity for handrub and handwash products 30 5.9.3 Bactericidal activity for ins

24、trument disinfection products 30 5.9.4 Bactericidal activity for surface disinfection products 31 5.9.5 Qualification for certain fields of application 31 5.10 Test report 31 Annex A (informative) Referenced strains in national collections . 33 Annex B (informative) Neutralizers and rinsing liquids

25、. 34 EN 13727:2012+A2:2015 (E) 3 Annex C (informative) Graphical representation of test procedures . 36 Annex D (informative) Example of a typical test report 44 Annex E (informative) Precision of the test result. 48 Annex ZA (informative) Relationship between this European Standard and the Essentia

26、l Requirements of EU Directive 93/42/EEC . 51 Bibliography . 52 BS EN 13727:2012+A2:2015EN 13727:2012+A2:2015 (E) 4 European foreword This document (EN 13727:2012+A2:2015) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held b

27、y 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 April 2016, and conflicting national standards shall be withdrawn at the latest by April 2016. Attention is drawn to the possibility that s

28、ome 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. This document includes Amendment 1 approved by CEN on 2013-10-14 and Amendment 2 approved by CEN on 2015-08-03. This document supe

29、rsedes #EN 13727:2012+A1:2013$. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“ and #$. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirem

30、ents of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. #deleted text$ !Data obtained using the former version of EN 13727 may still be used, if a neutralization time of 10 s for all products with contact times of 10 min o

31、r shorter has been demonstrated to be sufficient. Data obtained by using the prEN 12054 should not be used as this project was abandoned in 2001.“ According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European S

32、tandard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech 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,

33、 Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 13727:2012+A2:2015EN 13727:2012+A2:2015 (E) 4 European foreword This document (EN 13727:2012+A2:2015) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AF

34、NOR. 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 2016, and conflicting national standards shall be withdrawn at the latest by April 2016. Attention is drawn to the possibility that some

35、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. This document includes Amendment 1 approved by CEN on 2013-10-14 and Amendment 2 approved by CEN on 2015-08-03. This document supersed

36、es #EN 13727:2012+A1:2013$. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“ and #$. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements

37、 of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. #deleted text$ !Data obtained using the former version of EN 13727 may still be used, if a neutralization time of 10 s for all products with contact times of 10 min or sh

38、orter has been demonstrated to be sufficient. Data obtained by using the prEN 12054 should not be used as this project was abandoned in 2001.“ According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Stand

39、ard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech 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, Spa

40、in, Sweden, Switzerland, Turkey and the United Kingdom. EN 13727:2012+A2:2015 (E) 5 Introduction This European Standard specifies a suspension test for establishing whether a chemical disinfectant or an antiseptic has a bactericidal activity in the area and fields described in the scope. This labora

41、tory test takes into account practical conditions of application of the product including contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence its action in practical situations. Each utilization concentration of the chemical disinfectant or antis

42、eptic found by this test corresponds to the chosen experimental conditions. BS EN 13727:2012+A2:2015EN 13727:2012+A2:2015 (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 h

43、omogeneous, 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 (97 % with a modified method for special cases) as some dilution is always produced by adding the test organi

44、sms and interfering substance. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other

45、 means. This European Standard applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example: in hospitals, in community medical facilities and in dental institutions; in clinics of schools, of kindergartens and of nursin

46、g homes; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patients. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in

47、 which they are used. NOTE 2 This method corresponds to a phase 2 step 1 test. NOTE 3 This method cannot be used to evaluate the activity of products against Legionella in watersystems against mycobacteria and against bacterial spores. EN 14885 specifies in detail the relationship of the various tes

48、ts to one another and to “use recommendations”. 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 edition

49、 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 bacteriophages) activity EN 14885, Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 14885 apply. 4 Requirements The produ