EN 14349-2012 en Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in th.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 14349:2012Chemical disinfectants andantiseptics Quantitativesurface test for the evaluationof bactericidal activity ofchemical disinfectants andantiseptics used in theveter

2、inary area on non-poroussurfaces without mechanicalaction Test method andrequireBS EN 14349:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 14349:2012. Itsupersedes BS EN 14349:2007 which is withdrawn.The UK participation in its preparation was entrusted to

3、 TechnicalCommittee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication

4、. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 74074 9ICS 71.100.35Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on

5、28 February 2013.Amendments issued since publicationDate Text affectedBS EN 14349:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14349 November 2012 ICS 71.100.35 Supersedes EN 14349:2007English Version Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation o

6、f bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2) Antiseptiques et dsinfectants chimiques - Essai quantitatif de surface pour lvaluation de lactivit bactricid

7、e des antiseptiques et des dsinfectants chimiques utiliss dans le domaine vtrinaire sur des surfaces non poreuses sans action mcanique - Mthode dessai et prescriptions (phase 2, tape 2) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflchenversuch zur Bestimmung der bakteriziden Wi

8、rkung chemischer Desinfektionsmittel und Antiseptika fr den Veterinrbereich auf nicht-porsen Oberflchen ohne mechanische Wirkung - Prfverfahren und Anforderungen (Phase 2, Stufe 2) This European Standard was approved by CEN on 22 September 2012. CEN members are bound to comply with the CEN/CENELEC I

9、nternal 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 Centre or to

10、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 official

11、 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, Netherlands, Nor

12、way, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in

13、any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14349:2012: EBS EN 14349:2012EN 14349:2012 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .54 Requirements .55 Test method 75.1 Principle 75.2 Materials and reage

14、nts 75.2.1 Test organisms 75.2.2 Culture media and reagents .85.2.3 Test surface . 105.3 Apparatus and glassware 105.3.1 General . 105.3.2 Usual microbiological laboratory equipment 115.4 Preparation of test organism suspensions and product test solutions . 125.4.1 Test organism suspensions (test an

15、d validation suspension) 125.4.2 Product test solutions 145.5 Procedure for assessing the bactericidal activity of the product . 145.5.1 General . 145.5.2 Test procedure (Dilution-neutralization method). 155.5.3 Observation of test surface agar . 185.6 Experimental data and calculation 185.6.1 Expla

16、nation of terms and abbreviations 185.6.2 Calculation . 195.7 Verification of methodology 225.7.1 General . 225.7.2 Control of weighted mean counts . 225.7.3 Basic limits 225.8 Expression of results and precision . 225.8.1 Reduction 225.8.2 Control of active and non-active product test solution (5.4

17、.2) 235.8.3 Limiting test organism and bactericidal concentration 235.8.4 Precision, repetitions . 235.9 Interpretation of results conclusion 235.9.1 General . 235.9.2 Bactericidal activity for general purposes . 235.9.3 Qualification for certain fields of application 245.10 Test report . 24Annex A

18、(informative) Referenced strains in national collections 26Annex B (informative) Examples of neutralizers of the residual antimicrobial activity of chemical disinfectants and antiseptics 27Annex C (informative) Graphical representation of the method . 29Annex D (informative) Example of a typical tes

19、t report 33Bibliography . 36BS EN 14349:2012EN 14349:2012 (E) 3 Foreword This document (EN 14349:2012) 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 nation

20、al standard, either by publication of an identical text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the latest by May 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.

21、 CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 14349:2007. Data obtained using the former version of EN 14349 may still be used. It was revised to correct obvious errors and ambiguities, to harmonize the structure and word

22、ing with other tests of CEN/TC 216 (existing or in preparation), and to improve the readability of the standard and thereby make it more understandable. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this Euro

23、pean Standard: 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, Slo

24、venia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 14349:2012EN 14349:2012 (E) 4 Introduction This European Standard specifies a surface test for establishing whether a chemical disinfectant or antiseptic has bactericidal activity in the area and fields described in the scope. T

25、his laboratory 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. The conditions are intended to cover general purposes and

26、to allow reference between laboratories and product types. Each utilization concentration of the chemical disinfectant or antiseptic, found by this test corresponds to the chosen experimental conditions. However, for some applications, the instructions of use of a product may differ and therefore ad

27、ditional test conditions need to be used. BS EN 14349:2012EN 14349:2012 (E) 5 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 homogeneous physically stable preparation when dilu

28、ted with hard water, or in the case of ready-to-use-products with water. This European Standard applies to products that are used in the veterinary area on non-porous surfaces without mechanical action i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in

29、the food chain following death and entry to the processing industry. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under

30、 the conditions in which they are used. NOTE 2 This method corresponds to a Phase 2 Step 2 test. This method cannot be used to evaluate the activity of products against mycobacteria. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and

31、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 disinfectants and antiseptics Preservation of test organisms used for the determin

32、ation of bactericidal, mycobactericidal, sporicidal and fungicidal 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 1

33、4885 apply. 4 Requirements The product shall demonstrate at least a 4 decimal log (lg) reduction from a water control, when tested in accordance with Table 1 and Clause 5 under simulated low level (3,0 g/l bovine albumin) or high level soiling (10 g/l yeast extract and 10 g/l bovine albumin) on a su

34、rface. BS EN 14349:2012EN 14349:2012 (E) 6 Table 1 - Obligatory and additional test conditions Test conditions Bactericidal activity on non-porous surfaces without mechanical action in the veterinary area Test organism a) obligatory Enterococcus hirae Proteus vulgaris Pseudomonas aeruginosa Staphylo

35、coccus aureus b) additional any relevant test organism Test temperature a) obligatory 10 C + 1 C b) additional 4 C + 1 C; 20 C + 1 C; 40 C + 1 C Contact time a) obligatory 30 min + 10 s b) additional 1 min + 5 s; 5 min + 10 s; 60 min + 10 s Interfering substance a) obligatory low level soiling high

36、level soiling 3,0 g/l bovine albumin 10 g/l yeast extract plus 10 g/l bovine albumin b) additional any relevant substance The obligatory contact time for surface disinfectants stated in Table 1 were chosen to enable comparison of standard conditions. The recommended contact time for the use of the p

37、roduct is within the responsibility of the manufacturer. NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions. Any additional specific bactericidal activity shall be determined in accordance with 5.2.1 and 5

38、.5.1.1 in order to take into account intended specific use conditions. BS EN 14349:2012EN 14349:2012 (E) 7 5 Test method 5.1 Principle A test suspension of bacteria mixed with interfering substance is inoculated onto the test surface and dried. After a drying time, 0,1 ml of the product is transferr

39、ed to the surface, in a manner which covers the dried film. The surface is maintained at a specified temperature for a defined period of time specified in Clause 4 and 5.5.1.1. At the end of that contact time the surface is transferred to a neutralizer so that the action of the disinfectant is immed

40、iately neutralized. The numbers of surviving organisms which can be recovered from the surface is determined quantitatively. The number of bacteria on a surface treated with water in place of the disinfectant is also determined and the reduction is calculated. The test is performed using Enterococcu

41、s hirae, Proteus vulgaris, Pseudomonas aeruginosa and Staphylococcus aureus as test organisms (Clause 4, Table 1). Additional and optional contact times and temperatures are specified (Clause 4, Table 1). Additional interfering substances and test organisms may be used. 5.2 Materials and reagents 5.

42、2.1 Test organisms The bactericidal activity shall be evaluated using the following strains1): Enterococcus hirae ATCC 10541; Proteus vulgaris ATCC 13315; Pseudomonas aeruginosa ATCC 15442; Staphylococcus aureus ATCC 6538. NOTE See Annex A for strain references in some other culture collections. The

43、 required incubation temperature for these test organisms is 36 C 1 C or 37 C 1 C (5.3.2.3). The same temperature (either 36 C or 37 C) shall be used for all incubations performed during a test and its control and validation. If additional test organisms are used, they shall be incubated under optim

44、um growth conditions (temperature, time, atmosphere, media) noted in the test report. If the additional test organisms selected do not correspond to the specified strains, their suitability for supplying the required inocula shall be verified. If these additional test organisms are not classified at

45、 a reference centre, their identification characteristics shall be stated. In addition, they shall be held by the testing laboratory or national culture collection under a reference for five years. 1) The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collec

46、tion (ATCC). This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of the product named. BS EN 14349:2012EN 14349:2012 (E) 8 5.2.2 Culture media and reagents 5.2.2.1 General All weights of chemical substances given in this Euro

47、pean Standard refer to the anhydrous salts. Hydrated forms may be used as an alternative, but the weights required shall be adjusted to allow for consequent molecular weight differences. The reagents shall be of analytical grade and/or appropriate for microbiological purposes. They shall be free fro

48、m substances that are toxic or inhibitory to the test organisms. If additional strains do not grow on the media (5.2.2.3) or cannot be used with diluent (5.2.2.4) additional media shall be used and shall be reported as well as additional incubation conditions. To improve the reproducibility, it is r

49、ecommended that commercially available dehydrated material is used for the preparation of culture media. The manufacturers instructions relating to the preparation of these products should be rigorously followed. Ready-to-use media may be used if it complies with the required specification. For each culture medium and reagent, a time limitation for use should be fixed.