DIN EN ISO 16187-2013 Footwear and footwear components - Test method to assess antibacterial activity (ISO 16187 2013) German version EN ISO 16187 2013《鞋和鞋类组件 评估抗菌活性的试验方法(ISO 16187.pdf

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1、December 2013 Translation by DIN-Sprachendienst.English price group 12No 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).I

2、CS 61.060!%*zH“2078737www.din.deDDIN EN ISO 16187Footwear and footwear components Test method to assess antibacterial activity (ISO 16187:2013);English version EN ISO 16187:2013,English translation of DIN EN ISO 16187:2013-12Schuhe und Schuhbestandteile Prfverfahren zur Bestimmung der antibakteriell

3、en Wirkung (ISO 16187:2013);Englische Fassung EN ISO 16187:2013,Englische bersetzung von DIN EN ISO 16187:2013-12Chaussure et composants de chaussure Mthode dessai pour valuer lactivit antibactrienne (ISO 16187:2013);Version anglaise EN ISO 16187:2013,Traduction anglaise de DIN EN ISO 16187:2013-12w

4、ww.beuth.deDocument comprises 22 pagesIn case of doubt, the German-language original shall be considered authoritative.11.13 DIN EN ISO 16187:2013-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 16187:2013) has been prepared by Technical Committee ISO/TC 216 “Foot

5、wear” in collaboration with Technical Committee CEN/TC 309 “Footwear” (Secretariat: AENOR, Spain). The responsible German body involved in its preparation was the Normenausschuss Materialprfung (Materials Testing Standards Committee), Working Committee NA 062-04-52 AA Schuhe. The DIN Standards corre

6、sponding to the International Standards referred to in this document are as follows: ISO 3696 DIN ISO 3696 ISO 5725 (all parts) DIN ISO 5725 (all parts) ISO 7218 DIN EN ISO 7218 ISO 19952 DIN EN ISO 19952 ISO 20645 DIN EN ISO 20645 ISO/TS 11133-1 DIN ISO/TS 11133-1 ISO/TS 11133-2 DIN ISO/TS 11133-2

7、ISO 20743 DIN EN ISO 20743 ISO/IEC 17025 DIN EN ISO/IEC 17025 IEC 60068-2-10 DIN EN 60068-2-10 DIN EN ISO 16187:2013-12 3 National Annex NA (informative) Bibliography DIN EN 60068-2-10, Environmental testing Part 2-10: Tests Test J and guidance: Mould growth DIN EN ISO 7218, Microbiology of food and

8、 animal feeding stuffs General requirements and guidance for microbiological examinations DIN EN ISO 19952, Footwear Vocabulary DIN EN ISO 20645, Textile fabrics Determination of antibacterial activity Agar diffusion plate test DIN EN ISO 20743, Textiles Determination of antibacterial activity of te

9、xtile products DIN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 5725 (all parts), Accuracy (trueness and precision) of measurement methods and results DIN ISO

10、/TS 11133-1, Microbiology of food and animal feeding stuffs Guidelines on preparation and production of culture media Part 1: General guidelines on quality assurance for the preparation of culture media in the laboratory DIN CEN ISO/TS 11133-2 (DIN SPEC 11133-2), Microbiology of food and animal feed

11、ing stuffs Guidelines on preparation and production of culture media Part 2: Practical guidelines on performance testing of culture media DIN EN ISO 16187:2013-12 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16187 August 2013 ICS 61.060 English Version

12、Footwear and footwear components - Test method to assess antibacterial activity (ISO 16187:2013) Chaussure et composants de chaussure - Mthode dessai pour valuer lactivit antibactrienne (ISO 16187:2013) Schuhe und Schuhbestandteile - Prfverfahren zur Bestimmung der antibakteriellen Wirkung(ISO 16187

13、:2013) This European Standard was approved by CEN on 12 July 2013. 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

14、 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

15、 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 Mac

16、edonia, 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 EU

17、ROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16187:2013: EContents PageForeword 31 Scope . 42 Normative references 43 Terms a

18、nd definitions . 44 Safety 45 Apparatus and materials 56 Reagents and culture medium . 57 Test microorganisms 77.1 Test strains . 77.2 Storage of strains 78 Preparation of test inoculums 79 Preparation of test samples 79.1 General . 79.2 Test specimen . 89.3 Pre-treatment of the test specimen 810 Te

19、st procedure 811 Expression of results 812 Test report . 9Annex A (normative) Static challenge test 10Annex B (normative) Film contact method . 12Annex C (normative) Dynamic challenge test 15Annex D (informative) Summarized results of round robin tests .17Bibliography .18DIN EN ISO 16187:2013-12 EN

20、ISO 16187:2013 (E) 2 Foreword Le prsent document (EN ISO 16187:2013) a t labor par le Comit Technique ISO/TC 216 “Chaussure” en collaboration avec le Comit Technique CEN/TC 309 “Chaussure”, dont le secrtariat est tenu par AENOR. This European Standard shall be given the status of a national standard

21、, either by publication of an identical text or by endorsement, at the latest by February 2014, and conflicting national standards shall be withdrawn at the latest by February 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.

22、CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. 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, Cypru

23、s, 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, Spain, Sweden, Switzerland, Turkey and the United

24、Kingdom. Endorsement notice The text of ISO 16187:2013 has been approved by CEN as EN ISO 16187:2013 without any modification. DIN EN ISO 16187:2013-12 EN ISO 16187:2013 (E) 3 CAUTION Test methods specified herein require the use of bacteria. These tests are only to be carried out in facilities with

25、 containment techniques for handling microorganisms and by persons with training and experience in the use of microbiological techniques. Appropriate safety precautions are to be observed with due consideration given to country-specific regulations.1 ScopeThis International Standard specifies quanti

26、tative test methods to evaluate the antibacterial activity of footwear and components.This International Standard is applicable to all types of footwear and components employing non-diffusing antibacterial treatments.2 Normative referencesThe following documents, in whole or in part, are normatively

27、 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.ISO 3696, Water for analytical laboratory use Specification and test

28、methodsISO 19952, Footwear Vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 19952 and the following apply.3.1antibacterial activityefficacy of a material or finish used to prevent or mitigate the growth of bacteria, to reduce the number of ba

29、cteria or to kill bacteria3.2control samplematerial identical to the test material but without antibacterial treatment4 SafetyHandling of microorganisms which are potentially hazardous requires a high degree of technical competence and can be subject to current national legislation and regulations.

30、Only personnel trained in microbiological techniques should carry out such tests. Codes of practice for disinfection, sterilization and personal hygiene shall be strictly observed.NOTE It is recommended that workers consult IEC 600682-10, appendix A “Danger to personnel”, and ISO 7218.DIN EN ISO 161

31、87:2013-12 EN ISO 16187:2013 (E) 4 5 Apparatus and materials5.1 GeneralStandard laboratory equipment and the following.5.2 Biological safety cabinet.5.3 Incubator, capable of maintaining a temperature of (37 2) C.5.4 Autoclave.5.5 Humidity chamber, capable of maintaining a temperature of (37 2) C an

32、d a relative humidity not less than 90 %.5.6 Ultraviolet lamp.5.7 Wide mouth jars, with cap, 100 ml, capable of being used with an autoclave (5.4).5.8 Cover film that does not affect bacterial growth or absorb water, which can be made of either polyethylene, polypropylene or polyester poly (ethylene

33、 terephthalate). Film that is 0,05 mm to 0,10 mm thick is recommended. For example, disposal bag suitable for use with an autoclave (5.4).5.9 Vortex mixer.5.10 Dimensional shaker, two dimensional or three dimensional, capable of adjusting to 50 rpm.5.11 Shaking incubator, capable of maintaining a te

34、mperature of (37 2) C and a rotational frequency of (120 10) rpm.6 Reagents and culture medium6.1 PrincipleThe preparation and test shall be freshly prepared in order to ensure the culture quality.NOTE This can be done according to ISO/TS 11133-1, ISO/TS 11133-2, or according to national standards o

35、r regulations.Reagents used in tests shall be of analytical grade and/or suited for microbiological purposes.Use only water Grade 3 according to ISO 3696.6.2 Nutrient broth (NB)6.2.1 CompositionBeef extract, 3,0 g.Peptone, 5,0 g.Sodium chloride (NaCl), 5,0 g.Water, 1 000 ml.6.2.2 PreparationStir and

36、 adjust pH to (7,2 0,2) (at room temperature). Heat with stirring on a hotplate or in a boiling-water bath until the components are completely dissolved. Sterilize with autoclave (5.4) at (121 2) C for 15 min.6.3 Nutrient agar (NA)DIN EN ISO 16187:2013-12 EN ISO 16187:2013 (E) 5 6.3.1 CompositionBee

37、f extract, 5,0 g.Peptone, 10,0 g.Sodium chloride (NaCl), 5,0 g.Agar, 15,0 g.Water, 1 000 ml.NOTE If solidification is insufficient, 15 g to 18 g of agar can be used.6.3.2 PreparationStir and adjust pH to (7,2 0,2) (at room temperature). Heat with stirring on a hotplate or in a boiling-water bath unt

38、il the components are completely dissolved. Sterilize with autoclave (5.4) at (121 2) C for 15 min. Cool and shake solution well, then pour into the Petri dishes.6.4 Soybean casein digest broth with lecithin and polyoxyethylene medium (SCDLP)6.4.1 CompositionPeptone, digest of casein, 17,0 g.Peptone

39、, digest of soybean, 3,0 g.Sodium chloride (NaCl), 5,0 g.Potassium dihydrogen phosphate, 2,5 g.Glucose, 2,5 g.Lecithin, 1,0 g.Polysorbate 80, 7,0 g.Water, 1 000 ml.If the neutralizing power is insufficient, the content of polysorbate 80 or lecithin may be adjusted or another neutralizing agent may b

40、e added. The use of any unspecified neutralizer shall be recorded along with the name and concentration.NOTE Information about selection and evaluation of alternative antibacterial neutralizing agents can be found in ASTM E 1054 and EN 1040.6.4.2 PreparationAfter mixing well, adjust pH to (7,2 0,2)

41、(at room temperature) and sterilize with autoclave (5.4) at (121 2) C for 15 min.6.5 Sodium chloride solution (physiological saline)6.5.1 CompositionSodium chloride (NaCl), 8,5 g.Water, 1 000 ml.DIN EN ISO 16187:2013-12 EN ISO 16187:2013 (E) 6 6.5.2 PreparationAfter mixing well, adjust pH to (6,9 0,

42、2) (at room temperature) and sterilize at (121 2) C for 15 min.7 Test microorganisms7.1 Test strainsThe following species shall be used in all antibacterial activity tests.a) Staphylococcus aureus AS 1.89 or ATCC 6538.b) Klebsiella pneumoniae AS 1.1736 or ATCC 4352.NOTE 1 If required, other species

43、or other strains can be used. However, the selected organisms should contain at least one gram-positive and one gram-negative organism as the antibacterial agents may have different activities.Test strains shall be obtained from agencies of the World Federation of Culture Collection (WFCC).The bacte

44、ria species and their supply sources shall be included in the test report.NOTE 2 AS refers to the China General Microbiological Culture Collection Centre (CGMCC), ATCC is the American Type Culture Collection.7.2 Storage of strainsInoculate the strains to the nutrient agar (NA) (6.3), and incubate at

45、 (37 2) C for 24 h. Store at (5 3) C (maximum one month) and keep it as stock culture of the strains. Transfer and incubate one time each month.Strains can be preserved in accordance with the suppliers direction or EN 12353.8 Preparation of test inoculumsUsing a sterile inoculating loop, transfer on

46、e colony (7.2) into 20 ml of nutrient broth (NB) (6.2) and incubate in the shaking incubator (5.11) at (37 2) C for about 16 h (overnight culture). Estimate the number of bacteria with microscopic observation or other methods. Prepare physiological saline (6.5) with 1 % nutrient broth (NB) (6.2). Us

47、e this media to prepare a suspension with a bacterial concentration of (2,5 approximately 10) 105CFU/ml as test inoculum.If necessary, store the test inoculum on ice and use it within 4 h.9 Preparation of test samples9.1 GeneralTest only the components or material which are claimed to be antibacterial. If the whole footwear is claimed as antibac