EN 1657-2005 8275 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antis.pdf

1、Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/12/2007 07:48, Uncontrolled Copy, (c) BSIg49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58t

2、est for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area Test method and requirements (phase 2, step 1)The European Standard EN 1657-1:2005 has the status of a British StandardICS 11.080.20; 71.100.35Chemical disinfectants and

3、 antiseptics Quantitative suspension BRITISH STANDARDBS EN 1657:2005Incorporating corrigendum no. 1BS EN 1657:2005Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/12/2007 07:48, Uncontrolled Copy, (c) BSIThis British Standard was published under the authority of the Standards Policy and Str

4、ategy Committee on 22 February 2006 BSI 2007ISBN 978 0 580 59780 0Amendments issued since publicationAmd. No. Date Comments17316 Corrigendum No. 131 August 2007 Change to 5.6.2.5This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its cor

5、rect application. Compliance with a British Standard cannot confer immunity from legal obligations.National forewordThis British Standard is the UK implementation of EN 1657:2005, incorporating corrigendum March 2007. It supersedes BS EN 1657:2000 which is withdrawn. The UK participation in its prep

6、aration was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on this committee can be obtained on request to its secretary.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 1657December 2005ICS 11.080.20; 71.100.35Incorporating corri

7、gendum March 2007Supersedes EN 1657:2000 English VersionChemical disinfectants and antiseptics - Quantitative suspensiontest for the evaluation of fungicidal or yeasticidal activity ofchemical disinfectants and antiseptics used in the veterinaryarea - Test method and requirements (phase 2, step 1)An

8、tiseptiques et dsinfectants chimiques - Essai quantitatifde suspension pour lvaluation de lactivit fongicide oulevuricide des antiseptiques et des dsinfectants chimiquesutiliss dans le domaine vtrinaire - Mthode dessai etprescriptions (phase 2, tape 1)Chemische Desinfektionsmittel und Antiseptika -Q

9、uantitativer Suspensionsversuch zur Bestimmung derfungiziden oder levuroziden Wirkung chemischerDesinfektionsmittel und Antiseptika fr denVeterinrbereich - Prfverfahren und Anforderungen(Phase 2, Stufe 1)This European Standard was approved by CEN on 28 July 2005.CEN members are bound to comply with

10、the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat o

11、r to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversion

12、s.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland

13、 and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 1657:20

14、05: ELicensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/12/2007 07:48, Uncontrolled Copy, (c) BSIEN 1657:2005 (E) 2 Contents Page Foreword 3 Introduction4 1 Scope .5 2 Normative references .5 3 Terms and definitions.5 4 Requirements 6 5 Test method.6 5.1 Principle.6 5.2 Materials and reagents

15、 .7 5.2.1 Test organisms .7 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 equipment and, in particular, the following:10 5.4 Preparation of test organism suspensions and product test solutions .11 5.4.1 Test organism suspens

16、ions (test and validation suspension)11 5.4.2 Product test solutions 14 5.5 Procedure for assessing the fungicidal or yeasticidal activity of the product.14 5.5.1 General 14 5.5.2 Dilution-neutralization method 16 5.5.3 Membrane filtration method.18 5.6 Experimental data and calculation 20 5.6.1 Exp

17、lanation of terms and abbreviations .20 5.6.2 Calculation.20 5.7 Verification of methodology.23 5.7.1 General 23 5.7.2 Control of weighted mean counts23 5.7.3 Basic limits24 5.8 Expression of results and precision24 5.8.1 Reduction 24 5.8.2 Control of active and non-active product test solution (5.4

18、.2) 24 5.8.3 Limiting test organism and fungicidal/yeasticidal concentration .24 5.8.4 Precision, replicates .25 5.9 Interpretation of results conclusion .25 5.9.1 General 25 5.9.2 Fungicidal activity for general purposes.25 5.9.3 Fungicidal activity for specific purposes25 5.9.4 Yeasticidal activit

19、y for general purposes25 5.9.5 Yeasticidal activity for specific purposes .25 5.10 Test report .26 Annex A (informative) Referenced strains in national collections28 Annex B (informative) Suitable neutralizers and rinsing liquids 29 Annex C (informative) Graphical representation of test procedures31

20、 Validation34 Annex D (informative) Example of a typical test report.35 Annex E (informative) Precision of the test result .39 Annex F (informative) Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics41 Bibliography.43 Licensed Copy: Wang

21、 Bin, ISO/EXCHANGE CHINA STANDARDS, 06/12/2007 07:48, Uncontrolled Copy, (c) BSIEN 1657:2005 (E) 3 Foreword This European Standard (EN 1657:2005) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR. This European Sta

22、ndard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2006, and conflicting national standards shall be withdrawn at the latest by June 2006. This European Standard supersedes EN 1657:2000. It was revised to includ

23、e the results of a collaborative trial (ANDISTAND), to correct obvious errors and ambiguities, to harmonize the structure and wording with other quantitative suspension tests of CEN/TC 216 existing or in preparation, and to improve the readability of the standard and thereby make it more understanda

24、ble. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvi

25、a, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/12/2007 07:48, Uncontrolled Copy, (c) BSIEN 1657:2005 (E) 4 Introduction This European Standard specifi

26、es a suspension test for establishing whether a chemical disinfectant or antiseptic has a fungicidal or yeasticidal activity in the fields described in the scope. This laboratory test takes into account practical conditions of application of the product, including contact time, temperature, test org

27、anisms 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 reference between laboratories and product types. Each utilization concentration of the chemical disinfectant or antiseptic fo

28、und by this test corresponds to defined experimental conditions. However, for some applications the recommendations of use of a product may differ and therefore additional test conditions need to be used. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/12/2007 07:48, Uncontrolled Copy, (c)

29、 BSIEN 1657:2005 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or in the case of rea

30、dy-to-use-products with water. Products can only be tested at a concentration of 80 % or less, 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,

31、production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2

32、This method corresponds to a phase 2 step 1 test (Annex F). 2 Normative references The following referenced documents are indispensable for the application of this European Standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced do

33、cument (including any amendments) applies. EN 12353, Chemical disinfectants and antiseptics Preservation of microbial strains used for the determination of bactericidal and fungicidal activity ISO 4793, Laboratory sintered (fritted) filters Porosity grading, classification and designation 3 Terms an

34、d definitions For the purposes of this European Standard, the following terms and definitions apply. 3.1 product chemical agent or formulation used as chemical disinfectant or antiseptic 3.2 fungicide product that kills fungi (moulds and yeasts) and their spores under defined conditions NOTE The adj

35、ective derived from “fungicide“ is “fungicidal“. 3.3 fungicidal activity capability of a product to produce a reduction in the number of viable vegetative yeast cells and mould spores of relevant test organisms under defined conditions 3.4 fungistatic activity capability of a product to inhibit the

36、growth of fungi (moulds and/or yeasts ) under defined conditions 3.5 yeasticide product that kills yeasts under defined conditions NOTE The adjective derived from “yeasticide“ is “yeasticidal“. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/12/2007 07:48, Uncontrolled Copy, (c) BSIEN 1657

37、:2005 (E) 6 3.6 yeasticidal activity capability of a product to produce a reduction in the number of viable yeast cells of relevant test organisms under defined conditions 4 Requirements The product shall demonstrate at least a 4 decimal log (lg) reduction when diluted with hard water (5.2.2.7) or i

38、n the case of ready-to-use products with water (5.2.2.2) and tested in accordance with Clause 5 under simulated low-level soiling (3 g/l bovine albumin solution 5.2.2.8.2) or simulated high-level soiling (10 g/l bovine albumin solution plus 10 g/l yeast extract 5.2.2.8.3) according to its practical

39、applications and under the other obligatory test conditions (one or two selected test organisms, 10 C, 30 min). The fungicidal activity shall be evaluated using the following two test organisms: Candida albicans (vegetative cells); Aspergillus niger (spores). The yeasticidal activity shall be evalua

40、ted using the following test organism: Candida albicans (vegetative cells). Where indicated, additional specific fungicidal or yeasticidal activity shall be determined applying other contact times, temperatures and test organisms in accordance with 5.2.1 and 5.5.1.1 in order to take into account int

41、ended specific use conditions. NOTE For these additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions. 5 Test method 5.1 Principle 5.1.1 A sample of the product as delivered and/or diluted with hard water (or water for read

42、y-to-use products) is added to a test suspension of fungi (yeast cells or mould spores) in a solution of an interfering substance. The mixture is maintained at (10 1) C for 30 min 10 s (obligatory test conditions). At the end of this contact time, an aliquot is taken, and the fungicidal and/or the f

43、ungistatic activity in this portion is immediately neutralized or suppressed by a validated method. The method of choice is dilution-neutralization. If a suitable neutralizer cannot be found, membrane filtration is used. The numbers of surviving fungi in each sample are determined and the reduction

44、is calculated. 5.1.2 The test is performed using the vegetative cells of Candida albicans and the spores of Aspergillus niger (fungicidal activity) or only the vegetative cells of Candida albicans (yeasticidal activity) as test organisms (obligatory test conditions). 5.1.3 Additional and optional co

45、ntact times and temperatures are specified. Additional test organisms can be used. Licensed Copy: Wang Bin, ISO/EXCHANGE CHINA STANDARDS, 06/12/2007 07:48, Uncontrolled Copy, (c) BSIEN 1657:2005 (E) 7 5.2 Materials and reagents 5.2.1 Test organisms The fungicidal activity shall be evaluated using th

46、e following strains as test organisms:1) Candida albicans ATCC 10231; Aspergillus niger ATCC 16404. The yeasticidal activity shall be evaluated using only Candida albicans. NOTE See Annex A for strain references in some other culture collections. The required incubation temperature for these test or

47、ganisms is (30 1) C (5.3.2.3). 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 suitability for s

48、upplying 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 year

49、s. 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 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 from substances that are toxic or inhibitory to the test organisms. NOTE 1 To improve reproducibility, it is recommended that com