EN 16437-2014 en Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in ve.pdf

1、BSI Standards PublicationBS EN 16437:2014Chemical disinfectants and antiseptics Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces without mechanical action Test method and requirements (phase 2,

2、step 2)BS EN 16437:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 16437:2014.The UK participation in its preparation was entrusted to TechnicalCommittee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on this committee ca

3、n 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. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 76779 1ICS 71.100.35Complian

4、ce with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 May 2014.Amendments issued since publicationDate Text affectedBS EN 16437:2014EUROPEAN STANDARD NORME EUROPENNE EUROPISC

5、HE NORM EN 16437 February 2014 ICS 71.100.35 English Version Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in veterinary area on porous surfaces without mechanical action - Test method and

6、 requirements (phase 2, step 2) Antiseptiques et dsinfectants chimiques - Essai quantitatif de surface pour lvaluation de lactivit bactricide des antiseptiques et des dsinfectants chimiques utiliss dans le domaine vtrinaire sur des surfaces poreuses sans action mcanique - Mthode dessai et prescripti

7、ons (phase 2, tape 2) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflchenversuch zur Bestimmung der bakteriziden Wirkung chemischer Desinfektionsmittel und Antiseptika fr den Veterinrbereich auf porsen Oberflchen ohne mechanische Wirkung - Prfverfahren und Anforderungen (Phase 2

8、, Stufe 2) This European Standard was approved by CEN on 30 November 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 bibliog

9、raphical 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 responsib

10、ility 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 Yugoslav Republi

11、c 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 DE NORMALIS

12、ATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16437:2014 EBS EN 16437:2014EN 16437:2014 (E) 2 Contents Page Foreword 3 Int

13、roduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements .5 5 Test method 6 5.1 Principle 6 5.2 Materials and reagents 7 5.2.1 Test organisms 7 5.2.2 Culture media and reagents .7 5.2.3 Test surface . 10 5.3 Apparatus and glassware 10 5.3.1 General . 10 5.3.2 Usual m

14、icrobiological laboratory equipment 10 5.4 Preparation of test organism suspension and product test solutions . 11 5.4.1 Test organism suspension (test and validation suspension) 11 5.4.2 Product test solution 13 5.5 Procedure for assessing the bactericidal activity of the product . 13 5.5.1 General

15、 . 13 5.5.2 Test procedure (Dilution-neutralisation method) 14 5.6 Experimental data and calculation 17 5.6.1 Explanation of terms and abbreviations 17 5.6.2 Calculation . 18 5.7 Verification of methodology 21 5.7.1 General . 21 5.7.2 Control of weighted mean counts . 21 5.7.3 Basic limits 21 5.8 Ex

16、pression of results and precision . 22 5.8.1 Reduction 22 5.8.2 Control of active and non-active product test solution (5.4.2) 22 5.8.3 Limiting test organism and bactericidal concentration 22 5.8.4 Precision, repetitions . 22 5.9 Interpretation of results conclusion 22 5.9.1 General . 22 5.9.2 Bact

17、ericidal activity for general purposes . 23 5.9.3 Qualification for certain fields of application 23 5.10 Test report . 23 Annex A (informative) Referenced strains in national collections 25 Annex B (informative) Neutralisers - Examples of neutralisers of the residual antimicrobial activity of chemi

18、cal disinfectants and antiseptics 26 Annex C (informative) Graphical representations of dilution-neutralisation method . 28 Annex D (informative) Example of a typical test report 32 Bibliography . 37 BS EN 16437:2014EN 16437:2014 (E) 3 Foreword This document (EN 16437:2014) has been prepared by Tech

19、nical 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 August 2014 and conflicting national

20、 standards shall be withdrawn at the latest by August 2014. 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. According to the CEN/CENEL

21、EC Internal 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, Ice

22、land, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 16437:2014EN 16437:2014 (E) 4 Introduction This European Standard specifies a surface test for establishing

23、 whether a chemical disinfectant or antiseptic, for use on porous surfaces without mechanical action, in the veterinary area. has or does not have bactericidal activity under the laboratory conditions defined by this European Standard, which influence the action of disinfectants in practical use. Th

24、e laboratory test takes into account practical conditions of application of the product including pre-drying test organisms and interfering substances on a surface, contact time and temperature, i.e. conditions which may influence its action in practical situations. The conditions are intended to co

25、ver general purposes and to allow reference between laboratories and product types. Each utilisation 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 ca

26、n differ and therefore additional test conditions need to be used. BS EN 16437:2014EN 16437:2014 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectants and antiseptic products that form a homogeneous, physically s

27、table preparation when diluted 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 porous surfaces without mechanical action i.e. in the breeding, husbandry, production, transport and disposal of a

28、ll animals except when in 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

29、or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a phase 2 step 2 test. NOTE 3 This method cannot be used to evaluate the activity of products against mycobacteria or bacterial spores. 2 Normative references The following documents, in whole or in p

30、art, 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 referenced document (including any amendments) applies. EN 12353, Chemical disinfectants and antiseptics

31、 - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity EN 14885, Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfecta

32、nts 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 from a water control, when tested in accordance with Table 1 and Clause 5 under simul

33、ated soiling (3,0 g/l bovine albumin). BS EN 16437:2014EN 16437:2014 (E) 6 Table 1 Obligatory and additional test conditionsTest Conditions Bactericidal activity on porous surfaces without mechanical action in the veterinary area Test organism a) obligatory Enterococcus hirae Proteus vulgaris Pseudo

34、monas aeruginosa Staphylococcus 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 CContact timea) obligatory 60 min 10 sb) additional 1 min 5 s, 5 min 10 s, 15 min + 10 s, 30 min 10 s; 120 min 10 s Interfering substance a)

35、 obligatory 3,0 g/l bovine albumin b) additional any relevant substance NOTE 1 The obligatory contact times for surface disinfectants stated in Table 1 were chosen to enable comparison of standard conditions. The recommended contact time for the use of the product is within the responsibility of the

36、 manufacturer. NOTE 2 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 5.5.1.1 in order to take into account int

37、ended specific use conditions. 5 Test method 5.1 Principle A test suspension of bacteria mixed with interfering substance is inoculated onto the test surface and dried. After the drying time the test surface is immersed into a sample of the product as delivered and/or diluted with hard water (for re

38、ady to use products: water) ensuring that the test surface is totally covered for one minute. The test surface is removed from the product solution and 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 test surf

39、ace is transferred to a neutraliser so that the action of the disinfectant is immediately neutralised. The bacteria are removed from the surface by ultrasound treatment. The numbers of surviving bacteria which can be recovered from the surface is determined quantitatively. The number of bacteria on

40、a surface treated with water in place of the disinfectant is also determined and the reduction is calculated. The test is performed using Enterococcus hirae, Proteus vulgaris, Pseudomonas aeruginosa and Staphylococcus aureus as test organisms (Clause 4, Table 1). BS EN 16437:2014EN 16437:2014 (E) 7

41、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 The bactericidal activity shall be evaluated using the following strains1): Enterococcus hirae A

42、TCC 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 required incubation temperature for these organisms is 36 C + 1 C or 37 C + 1 C (5.3.2.3). The same temperature (e

43、ither 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 optimum growth conditions (temperature, time, atmosphere, media) noted in the test report. If the additional test organis

44、ms 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 a reference centre, their identification characteristics shall be stated. In addition, they shall be held by the te

45、sting 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 European Standard refer to the anhydrous salts. Hydrated forms may be used as an alternative, but the weights required s

46、hall 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 from substances that are toxic or inhibitory to the test organisms. If additional strains do not grow on the media (5.2

47、.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 reproducibility, it is recommended that commercially available dehydrated material is used for the preparation of culture media. The manufacture

48、rs 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. 1) The ATCC numbers are the collection numbers of

49、 strains supplied by the American Type Culture Collections (ATCC). This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of this product. BS EN 16437:2014EN 16437:2014 (E) 8 5.2.2.2 WaterThe water shall be freshly glass-distilled water and not demineralised water. If distilled water of adequate quality is not available, water for injections (see bibliographic reference 1) may be used. Sterilise in the autoclave 5.3.2.1 a). Sterilisation is not nec