DIN EN 13727-2015 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requiremen.pdf

1、December 2015 English price group 20No 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 11.080.20!%KEnglish version EN

2、13727:2012+A2:2015,English translation of DIN EN 13727:2015-12Chemische Desinfektionsmittel und Antiseptika Quantitativer Suspensionsversuch zur Bestimmung der bakteriziden Wirkung im humanmedizinischen Bereich Prfverfahren und Anforderungen (Phase 2, Stufe 1);Englische Fassung EN 13727:2012+A2:2015

3、,Englische bersetzung von DIN EN 13727:2015-12Antiseptiques et dsinfectants chimiques Essai quantitatif de suspension pour lvaluation de lactivit bactricide en mdecine Mthode dessai et prescriptions (Phase 2, tape 1);Version anglaise EN 13727:2012+A2:2015,Traduction anglaise de DIN EN 13727:2015-12S

4、upersedesDIN EN 13727:2014-03www.beuth.deDocument comprises 54 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.12.15DIN EN 13727:2015-12 2 A comma is used as the decimal marker. National foreword This document (EN 13727:2012+A2

5、:2015) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics” (Secretariat: AFNOR, France), Working Group WG 1 “Human medicine” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Co

6、mmittee Medicine), Working Committee NA 063-04-07 AA Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin. Amendments This standard differs from DIN EN 13727:2014-03 as follows: a) Amendment A2:2015 concerning Subclauses 5.5.2.2, 5.5.2.4, 5.5.3.2, 5.6.2.2, 5.6.2.4, 5.8.3 and 5.8.4 has b

7、een incorporated. Previous editions DIN EN 13727: 2004-03, 2012-07, 2014-03 EUROPEAN 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 eval

8、uation of bactericidal activity in the medical 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 Desinfektionsm

9、ittel und Antiseptika - Quantitativer Suspensionsversuch 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. C

10、EN 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 standards may be obtained on ap

11、plication 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 notified to the CEN-CENELEC

12、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, Iceland, Ireland, Italy, L

13、atvia, 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 EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue M

14、arnix 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 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 definiti

15、ons . 6 4 Requirements . 6 5 Test method 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 5.3 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

16、 product test solutions 13 5.4.1 Test organism 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 . 1

17、9 5.5.4 Modified method for ready-to-use products 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 Expressi

18、on of results and precision 29 5.8.1 Reduction 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 Bact

19、ericidal activity for handrub and handwash 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 st

20、rains in national collections . 33 Annex B (informative) Neutralizers and rinsing liquids . 34 DIN EN 13727:2015-12 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) Preci

21、sion of the test result. 48 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 51 Bibliography . 52 DIN EN 13727:2015-12 EN 13727:2012+A2:2015 (E) 4 European foreword This document (EN 13727:2012+A2:2015) has been prepared by

22、 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 April 2016, and conflicting nat

23、ional standards shall be withdrawn at the latest by April 2016. 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. This document includes

24、 Amendment 1 approved by CEN on 2013-10-14 and Amendment 2 approved by CEN on 2015-08-03. This document supersedes #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 give

25、n to CEN by the European Commission and the European Free Trade Association, and supports essential requirements 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

26、EN 13727 may still be used, if a neutralization time of 10 s for all products with contact times of 10 min or 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 Regulat

27、ions, 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, France, Germany, Greece, Hungary, Iceland, Ireland, Ital

28、y, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 13727:2015-12 EN 13727:2012+A2:2015 (E)5 Introduction This European Standard specifies a suspension test for establishing whe

29、ther a chemical disinfectant or an antiseptic has a bactericidal activity in the area and 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 substances, i.e. con

30、ditions which may influence its action in practical situations. Each utilization concentration of the chemical disinfectant or antiseptic found by this test corresponds to the chosen experimental conditions. DIN EN 13727:2015-12 EN 13727:2012+A2:2015 (E) 6 1 Scope This European Standard specifies a

31、test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, 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 concentrat

32、ion of 80 % or less (97 % with a modified method for special cases) as some dilution is always produced by adding the test organisms 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

33、handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means. This European Standard applies to areas and situations where disinfection or antisepsis is medically indicated. Such indications occur in patient care, for example

34、: in hospitals, in community medical facilities and in dental institutions; in clinics of schools, of kindergartens and of nursing 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 T

35、he 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. NOTE 3 This method cannot be used to evaluate the activity of products against Legionella in

36、 watersystems against mycobacteria and against bacterial spores. EN 14885 specifies in detail the relationship of the various tests 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 in

37、dispensable 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 disinfectants and antiseptics - Preservation of test organisms used for the determinatio

38、n 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 purpose

39、s of this document, the terms and definitions given in EN 14885 apply. 4 Requirements The product shall demonstrate at least a 5 decimal log (lg) reduction (for hygienic hand wash at least a 3 lg reduction), when tested in accordance with Table 1 and Clause 5. DIN EN 13727:2015-12 EN 13727:2012+A2:2

40、015 (E) 7 Table 1 Minimum and additional test conditions Test Conditions Hygienic handrub and handwash Surgical handrub and handwash Instrument disinfection Surface disinfection Minimum spectrum of test organisms P. aeruginosa, S. aureus, E. hirae, E. coli K12 P. aeruginosa, S. aureus, E. hirae, E.

41、coli K12 P. aeruginosa, S. aureus, E. hirae, when temperature is 40 C or higher: only E. faecium P. aeruginosa, S. aureus, E. hirae additional Any relevant test organism Test temperature according to the manufacturers recommendation, but between 20 C and 20 C 20 C and 20 C 20 C and 70 C 4C and 30 C

42、Contact time according to the manufacturers recommendation but between but no longer than 30 s and 60 s 1 min and 5 min 60 min 5 min or 60 min aInterfering substance clean conditions 0,3 g/l bovine albumin solution (hygienic handrub) b0,3 g/l bovine albumin solution (surgical handrub) b0,3 g/l bovin

43、e albumin solution and/or 0,3 g/l bovine albumin solution and/or dirty conditions 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (hygienic handwash) c3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (surgical handwash) c3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes

44、 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes additional clean or dirty; any relevant substance clean or dirty; any relevant substance any relevant substance any relevant substance NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtai

45、ned under the minimum test conditions. aThe contact times for surface disinfectants stated in this table are chosen on the basis of the practical conditions of the product. The recommended contact time for the use of the product is within the responsibility of the manufacturer. Products intended to

46、disinfect surfaces that are likely to come into contact with the patient and / or the medical staff and surfaces, which are frequently touched by different people, leading to the transmission of microorganisms to the patient, shall be tested with a contact time of maximum 5 min. The same applies whe

47、re the contact time of the product shall be limited for practical reasons. Products for other surfaces than stated above may be tested with a contact time of maximum 60 min. bhygienic and surgical handrub shall be tested as a minimum under clean conditions. chygienic and surgical handwash shall be t

48、ested as a minimum under dirty conditions.DIN EN 13727:2015-12 EN 13727:2012+A2:2015 (E) 8 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 interfer

49、ing substance. The mixture is maintained at one of the temperatures and the contact times specified in Clause 4 and 5.5.1.1. At the end of this contact time, an aliquot is taken; the bactericidal and/or the bacteriostatic action in this portion is immediately neutralized or suppressed by a validated method. The method 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. NOTE Handwash