BS EN 14204-2012 Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants and antiseptics used n.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 14204:2012Chemical disinfectants andantiseptics Quantitativesuspension test for theevaluation of mycobactericidalactivity of chemicaldisinfectants and antisepticsused in th

2、e veterinary area Test method and requirements(phase 2, step 1)Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 14204:2012 BRITISH STANDARDNational forewordThis British Stan

3、dard is the UK implementation of EN 14204:2012. Itsupersedes BS EN 14204:2004 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on this committee can beobtained on request

4、to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 74073 2ICS 71.100.35Compliance with a British Standa

5、rd cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 28 February 2013.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under licens

6、e with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 14204:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 14204 November 2012 ICS 71.100.35 Supersedes EN 14204:2004English Version Chemical disinfectants and antiseptics - Quantitative suspension

7、 test for the evaluation of mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1) Antiseptiques et dsinfectants chimiques - Essai quantitatif de suspension pour lvaluation de lactivit mycobactricide des antise

8、ptiques et des dsinfectants chimiques utiliss dans le domaine vtrinaire - Mthode dessai et prescriptions (Phase 2, tape 1) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der mykobakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika fr de

9、n Veterinrbereich - Prfverfahren und Anforderungen (Phase 2, Stufe 1) This European Standard was approved by CEN on 22 September 2012. 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 s

10、tandard 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 any CEN member. This European Standard exists in three official versions (English, French, German). A version i

11、n 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 versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech

12、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 United Kingdom. EURO

13、PEAN 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 any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14204:2012: ECopyright Europ

14、ean Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 14204:2012EN 14204:2012 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .54 Requireme

15、nts .55 Test method 65.1 Principle 65.2 Materials and reagents 75.2.1 Test organisms 75.2.2 Culture media and reagents .75.3 Apparatus and glassware 105.3.1 General . 105.3.2 Usual microbiological laboratory equipment and, in particular, the following: . 105.4 Preparation of mycobacterial test suspe

16、nsion and product test solutions . 115.4.1 Mycobacterial test suspensions (test and validation suspension) . 115.4.2 Product test solutions 135.5 Procedure for assessing the mycobactericidal activity of the product 145.5.1 General . 145.5.2 Test procedure - Dilution-neutralization method 155.5.3 Tes

17、t procedure - Membrane filtration method . 175.6 Experimental data and calculation 195.6.1 Explanation of terms and abbreviations 195.6.2 Calculation . 195.7 Verification of methodology 235.7.1 General . 235.7.2 Control of weighted mean counts . 235.7.3 Basic limits 235.8 Expression of results . 245

18、.8.1 Reduction 245.8.2 Control of active and non-active product test solution (5.4.2) 245.8.3 Mycobactericidal concentration 245.9 Interpretation of results - conclusion . 245.9.1 General . 245.9.2 Mycobactericidal activity for general purposes 245.9.3 Qualification for certain fields of application

19、 245.10 Test report . 25Annex A (informative) Referenced strain in national collections 27Annex B (informative) Examples of neutralizers of the residual antimicrobial activity of chemical disinfectants and antiseptics and rinsing liquids . 28Annex C (informative) Graphical representations of dilutio

20、n-neutralization method . 30Annex D (informative) Example of a typical test report 32Bibliography . 36Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 14204:2012EN 14204:201

21、2 (E) 3 Foreword This document (EN 14204:2012) 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 national standard, either by publication of an identical text

22、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. CEN and/or CENELEC shall not be held responsible for id

23、entifying any or all such patent rights. This document supersedes EN 14204:2004. Data obtained using the former version of EN 14204 may still be used. This document was revised to correct obvious errors and ambiguities, to harmonize the structure and wording with other quantitative suspension tests

24、of CEN/TC 216 (existing or in preparation), and to improve the readability of the standard and thereby make it more understandable. The following technical changes have been made: Membrane filtration (5.5.3) method and associated media and equipment have been added. According to the CEN/CENELEC Inte

25、rnal Regulations, the national standards organisations 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, I

26、reland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or

27、networking permitted without license from IHS-,-,-BS EN 14204:2012EN 14204:2012 (E) 4 Introduction This European Standard specifies a suspension test for establishing whether a chemical disinfectant or antiseptic has mycobactericidal activity in the area and fields described in the scope. This labor

28、atory 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 to allow

29、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 additional t

30、est conditions need to be used. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 14204:2012EN 14204:2012 (E) 5 1 Scope This European Standard specifies a test method and the

31、 minimum requirements for mycobactericidal 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 concentration of 80 % or less,

32、 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 veterinary area i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following deat

33、h 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 the conditions in which they

34、 are used. NOTE 2 This method corresponds to a phase 2 step 1 test. 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

35、, the latest edition of the referenced document (including any amendments) applies. EN 12353, Chemical disinfectants and antiseptics Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity EN 14885, Chemical disinfectants and an

36、tiseptics 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 product shall demonstrate at least a 4 decimal log (lg) reduction when tested in acc

37、ordance 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). Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted wi

38、thout license from IHS-,-,-BS EN 14204:2012EN 14204:2012 (E) 6 Table 1 - Obligatory and additional test conditions Test conditions Mycobactericidal activity Test organism a) obligatory Mycobacterium avium b) additional any relevant test organism Test temperature a) obligatory 10C 1C b) additional 4C

39、 1C; 20C 1C; 40C 1C Contact time a) obligatory 60 min 10 sab) additional 1 min 5 s; 5 min 10 s; 10 min 10 s, 15 min 10 s, 30 min 10 s, 120 min 10 s Interfering substance a) obligatory low level soiling high level soiling 3,0 g/l bovine albumin 10 g/l yeast extract plus 10 g/l bovine albumin b) addit

40、ional any relevant substance NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions.a The obligatory contact time for disinfectants stated in Table 1 was chosen to enable comparison of standard conditions. The

41、 referenced test conditions are by no means intended as requirements for the use of a product. The recommended contact time for the use of the product is within the responsibility of the manufacturer. Any additional specific mycobactericidal activity shall be determined in accordance with 5.2.1 and

42、5.5.1.1 in order to take into account intended specific use conditions. 5 Test method 5.1 Principle A sample of the product as delivered and/or diluted in hard water (or water for ready to use products) is added to a test suspension of mycobacteria in a solution of an interfering substance. The mixt

43、ure is maintained at (10 1) C for 60 min 10 s. At the end of this contact time, an aliquot is taken and the mycobactericidal action in this portion is immediately neutralized or suppressed by a validated method. The number of surviving mycobacteria in each sample is determined and the reduction in v

44、iable counts calculated. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 14204:2012EN 14204:2012 (E) 7 The test is performed using Mycobacterium avium as the test organism

45、(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 5.2.1 Test organisms 5.2.1.1 The mycobactericidal activity shall be evaluated using the followin

46、g strain : Mycobacterium avium ATCC 157691)NOTE See Annex A for corresponding strain numbers in some other culture collections. The required incubation temperature for this test organism is (36 1) C or (37 1) C. The same temperature (either 36 C or 37 C) shall be used for all incubations performed d

47、uring a test and its control and validation. If additional test organisms are used, they shall be incubated under optimum 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 sui

48、tability for supplying the required inocula shall be verified. If these additional test organisms are not classified at 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. 5.2.2 Culture media and reagents 5.2.2.1 General All weights of chemical substances given in this Europ