1、June 2015 Translation by DIN-Sprachendienst.English price group 18No 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!%Bn“2319875www.din.deDDIN EN 16615Chemical disinfectants and antiseptics Quantitative test method for the evaluation of bactericidal andyeasticidal activity on non-porous surfaces with mechanical actionemploying wipes in the medical area (4-field test) Test method and requirements (phase 2,
3、 step 2);English version EN 16615:2015,English translation of DIN EN 16615:2015-06Chemische Desinfektionsmittel und Antiseptika Quantitatives Prfverfahren zur Bestimmung der bakteriziden und levuroziden Wirkungauf nicht-porsen Oberflchen mit mechanischer Einwirkung mit Hilfe von Tchern imhumanmedizi
4、nischen Bereich (4-Felder-Test) Prfverfahren und Anforderungen (Phase 2, Stufe 2);Englische Fassung EN 16615:2015,Englische bersetzung von DIN EN 16615:2015-06Antiseptiques et dsinfectants chimiques Mthode dessai quantitative pour lvaluation de lactivit bactricide et levuricide surdes surfaces non p
5、oreuses, avec action mcanique laide de lingettes dans le domainemdical (essai 4 zones) Mthode dessai et prescriptions (phase 2, tape 2);Version anglaise EN 16615:2015,Traduction anglaise de DIN EN 16615:2015-06www.beuth.deDocument comprises 42 pagesIn case of doubt, the German-language original shal
6、l be considered authoritative.04.15DIN EN 16615:2015-06 2 A comma is used as the decimal marker. National foreword This document (EN 16615:2015) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics” (Secretariat: AFNOR, France), Working Group WG 1 “Human medici
7、ne” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-04-07 AA Chemische Desinfektionsmittel und Antiseptika in der Humanmedizin. EUROPEAN STANDARD NORME EUROPENNE EURO
8、PISCHE NORM EN 16615 April 2015 ICS 11.080.20 English Version Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4- field test) - Test method
9、and requirements (phase 2, step 2) Antiseptiques et dsinfectants chimiques - Mthode dessai quantitative pour lvaluation de lactivit bactricide et levuricide sur des surfaces non poreuses, avec action mcanique laide de lingettes dans le domaine mdical (essai 4 zones) - Mthode dessai et prescriptions
10、(phase 2, tape 2) Chemische Desinfektionsmittel und Antiseptika - Quantitatives Prfverfahren zur Bestimmung der bakteriziden und levuroziden Wirkung auf nicht-porsen Oberflchen mit mechanischer Einwirkung mit Hilfe von Tchern im humanmedizinischen Bereich (4-Felder-Test) - Prfverfahren und Anforderu
11、ngen (Phase 2, Stufe 2) This European Standard was approved by CEN on 3 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
12、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 version in any other language made by translation under th
13、e 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 Yugos
14、lav 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. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN
15、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 16615:2015 EEN 16615:2015 (E) 2 Content Page Foreword 3 Introduct
16、ion .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements .5 5 Test methods 6 5.1 Principle 6 5.2 Materials and reagents 6 5.2.1 Test organism 6 5.2.2 Culture media and reagents .7 5.3 Apparatus and glassware 10 5.3.1 General . 10 5.3.2 Usual microbiological laboratory equi
17、pment . 10 5.4 Preparation of test organism suspensions and product test solutions . 13 5.4.1 Test organism suspensions 13 5.4.2 Product test solution 15 5.5 Procedure for assessing the bactericidal and yeasticidal activity of the product 15 5.5.1 General . 15 5.5.2 Method . 17 5.6 Experimental data
18、 and calculation 20 5.6.1 Explanation of terms and abbreviations 20 5.6.2 Calculation . 20 5.7 Verification of methodology 25 5.7.1 General . 25 5.7.2 Control of weighted mean counts . 25 5.7.3 Basic limits 26 5.8 Expression of results and precision . 26 5.8.1 Overview of the different suspensions /
19、 test mixtures . 26 5.8.2 VC-values 26 5.8.3 Limiting test organism and bactericidal and yeasticidal concentration . 27 5.8.4 Precision, repetitions . 27 5.9 Interpretation of results conclusion 27 5.10 Test report . 28 Annex A (informative) Referenced strains in national collections 30 Annex B (inf
20、ormative) Neutralizers . 31 Annex C (informative) Graphical representations of the test method 32 Annex D (informative) Example of a typical test report 35 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 39 Bibliography .
21、40 DIN EN 16615:2015-06 EN 16615:2015 (E) 3 Foreword This document (EN 16615:2015) 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
22、by publication of an identical 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 C
23、ENELEC shall not be held responsible for identifying any or all such patent rights. 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 of EU Directive(s). For relationship with EU Direct
24、ive(s), see informative Annex ZA, which is an integral part of this document. 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,
25、 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 the United Kingdom. DIN EN 16
26、615:2015-06 EN 16615:2015 (E) 4 Introduction This European Standard specifies a carrier test for establishing whether a chemical disinfectant for use on surfaces administered with wipes has a bactericidal and yeasticidal activity in the fields described in the scope. The laboratory test closely simu
27、lates practical conditions of application such as contact time, temperature and interfering substances, including pre-drying specified test organisms on a test-surface as carrier and wiping the product on the test-surface with a wipe. The conditions are intended to cover general purposes. However, i
28、f for some applications the recommendations of use of a product differ additional test conditions may be or need to be used. Each utilization concentration of the product found by this test corresponds to defined experimental conditions. DIN EN 16615:2015-06 EN 16615:2015 (E) 5 1 Scope This European
29、 Standard specifies a test method and the minimum requirements for bactericidal and yeasticidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water or in the case of ready-to-use products with water. This European Standard ap
30、plies to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping regardless if they are covered by the 93/42/EEC Directive on Medical Devices or not. This European Standard includes ready-to-use wipes which are impregnated with
31、a microbicidal solution. This European Standard applies to areas and situations where disinfection 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 nur
32、sing 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 This method corresponds to a phase 2, step 2. test. EN 14885 specifies in detail the relationship of the various tests to one ano
33、ther 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 of the refer
34、enced 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 13624, C
35、hemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area Test method and requirements (phase 2, step 1) EN 13727, Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bacterici
36、dal activity in the medical area Test method and requirements (phase 2, step 1) 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
37、EN 14885 apply. 4 Requirements The product, when diluted with hard water or in the case of ready-to-use products with water, and tested in accordance with Clause 5 under simulated clean conditions (0,3 g/l bovine albumin) or simulated dirty conditions (3,0 g/l bovine albumin + 3,0 ml/l sheep erythro
38、cytes) according to its practical applications and under the following test conditions: four selected test organisms, temperature between 4 C and 30 C, DIN EN 16615:2015-06 EN 16615:2015 (E) 6 contact time min. 1 min and max. either 5 min or 60 min1)shall demonstrate at least a decimal log (lg) redu
39、ction in counts of 5 (Staphylococcus aureus, Enterococcus hirae, Pseudomonas aeruginosa),or 4 (Candida albicans) on test field 1. The mean of the cfus on the test fields 2 to 4 shall be equal or less than 50, the mean of the cfus of the water control shall be equal or more than 10. The bactericidal
40、activity shall be evaluated using the following test organisms: Staphylococcus aureus, Enterococcus hirae, Pseudomonas aeruginosa. The yeasticidal activity shall be evaluated using the following test organism: Candida albicans. Where indicated, additional specific bactericidal and yeasticidal activi
41、ty shall be determined applying other contact times and test organisms in order to take into account intended specific use conditions. NOTE For these additional conditions, the concentration defined as a result can be lower than the one obtained under the minimum test conditions. 5 Test methods 5.1
42、Principle 5.1.1 A test-surface is marked with 4 squares of 5 5 cm, the “test fields”, in a row. Test field 1 on the test-surface is inoculated with a test suspension of bacteria or yeasts in a solution of interfering substances. The inoculum is dried. A wipe is soaked with a sample of the product as
43、 delivered and/or diluted with hard water (for ready to use products: water). The test-surface is wiped with the soaked wipe across the four marked test fields, starting in front of test field 1, turning immediately after test field 4 and wiped back to the starting point. In parallel a water control
44、 is performed: a wipe is soaked with water (5.5.2.2 e) instead of the product. Temperature, soiling and contact time are employed as recommended by the manufacturer. At the end of the contact time, the test organisms are recovered from each test field with moistened cotton swabs. The swabs are broug
45、ht into a tube containing broth and neutralizer and the test organisms are to be severed from the swab by shaking. The numbers of surviving test organisms in each sample are determined, and the reduction is calculated by comparing the results of the drying control DCtand the results obtained with th
46、e product. In parallel to the test with the product water is applied in the same way to ensure that the test organisms are spread on the 4 fields and their number reaches a certain level. The test is performed using P. aeruginosa, S. aureus, E. hirae and C. albicans as test organisms (minimum test c
47、onditions). 5.1.2 Additional test organisms (only bacterial or fungal strains), contact times and interfering substances can be used. 5.2 Materials and reagents 5.2.1 Test organism The bactericidal activity shall be evaluated using the following strains as test organisms2): Staphylococcus aureus ATC
48、C 6538; Pseudomonas aeruginosa, ATCC 15442; Enterococcus hirae ATCC 10541. 1) See 5.5.1.1 b). 2) The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collections (ATCC). This information is given for the convenience of users of this European Standard and does
49、not constitute an endorsement by CEN of the product named. DIN EN 16615:2015-06 EN 16615:2015 (E) 7 The yeasticidal activity shall be evaluated using the following strain as test organism3): Candida albicans ATCC 10231. See Annex A for strain references in some other culture collections. If additional test organisms are used, they shall be incubated under optimum growth conditions (temperature, time, atmosphere and media) noted in the test report. If the additional test organisms selec
