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1、BRITISH STANDARD BS EN 1657:2005 Incorporating corrigendum no. 1 Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area Test method and requirements (phase 2, s
2、tep 1) The European Standard EN 1657-1:2005 has the status of a British Standard ICS 11.080.20; 71.100.35 ? Licensed Copy: London South Bank University, London South Bank University, Sat Sep 01 03:05:37 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN 1657:2005 This British Standard was published un
3、der the authority of the Standards Policy and Strategy Committee on 22 February 2006 BSI 2007 ISBN 978 0 580 59780 0 National foreword This 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 It supersedes BS EN 1657:2000 which is withdrawn.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 partic
4、ipation in its preparation 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. This publication does not purport to include all the necessary provisions of a contract.
5、Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments 17316 Corrigendum No. 1 31 August 2007Change to 5.6.2.5 Licensed Copy: London South Bank University, London S
6、outh Bank University, Sat Sep 01 03:05:37 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1657 December 2005 ICS 11.080.20; 71.100.35 Incorporating corrigendum March 2007 Supersedes EN 1657:2000 English Version Chemical disinfectants and antiseptics -
7、Quantitative suspension test 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) Antiseptiques et dsinfectants chimiques - Essai quantitatif de suspension pour lvaluation de la
8、ctivit fongicide ou levuricide des antiseptiques 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 fungiziden oder levuroziden Wirkung
9、chemischer Desinfektionsmittel und Antiseptika fr den Veterinrbereich - 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 the CEN/CENELEC Internal Regulations which stipulate the conditions for giving th
10、is 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 Central Secretariat or to any CEN member. This European Standard exists in three official versions (
11、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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus
12、, 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 and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN
13、 DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2005 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1657:2005: E Licensed Copy: London South Bank University, London South Bank
14、 University, Sat Sep 01 03:05:37 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 1657:2005 (E) 2 Contents Page Foreword 3 Introduction4 1 Scope.5 2 Normative references .5 3 Terms and definitions.5 4 Requirements6 5 Test method.6 5.1 Principle.6 5.2 Materials and reagents .7 5.2.1 Test organisms .7 5.
15、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 suspensions (test and validation suspe
16、nsion)11 5.4.2 Product test solutions14 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 Explanation of terms and abbreviati
17、ons .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 (5.4.2)24 5.8.3 Limiting test organi
18、sm 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 activity for general purposes25 5.9.5 Yeast
19、icidal 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 Validation34 Annex D (informative) Ex
20、ample 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: London South Bank University, London South
21、 Bank University, Sat Sep 01 03:05:37 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 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 St
22、andard 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 inclu
23、de 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 understand
24、able. 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, Latv
25、ia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: London South Bank University, London South Bank University, Sat Sep 01 03:05:37 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 1657:2005 (E) 4 Int
26、roduction This European Standard specifies 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, inclu
27、ding 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 reference between laboratories and product types. Each utilization concentration of th
28、e chemical disinfectant or antiseptic found 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: London South Bank University, London Sou
29、th Bank University, Sat Sep 01 03:05:37 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 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, p
30、hysically 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, as some dilution is always produced by adding the test organisms and interfering substance. This European Standard applies to
31、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 death and entry to the processing industry. NOTE 1 The method described is intended to determine the activity of commercial formula
32、tions or active substances under the conditions in which they are used. NOTE 2 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
33、 cited applies. For undated references, the latest edition of the referenced document (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 sintere
34、d (fritted) filters Porosity grading, classification and designation 3 Terms and 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 f
35、ungi (moulds and yeasts) and their spores under defined conditions NOTE The adjective 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 defi
36、ned conditions 3.4 fungistatic activity capability of a product to inhibit the 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: London South
37、 Bank University, London South Bank University, Sat Sep 01 03:05:37 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 1657:2005 (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 Requirem
38、ents The product shall demonstrate at least a 4 decimal log (lg) reduction when diluted with hard water (5.2.2.7) or in 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 simulat
39、ed high-level soiling (10 g/l bovine albumin solution plus 10 g/l yeast extract 5.2.2.8.3) according to its practical 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 tes
40、t organisms: Candida albicans (vegetative cells); Aspergillus niger (spores). The yeasticidal activity shall be evaluated using the following test organism: Candida albicans (vegetative cells). Where indicated, additional specific fungicidal or yeasticidal activity shall be determined applying other
41、 contact times, temperatures and test organisms in accordance with 5.2.1 and 5.5.1.1 in order to take into account intended 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
42、Test method 5.1 Principle 5.1.1 A sample of the product as delivered and/or diluted with hard water (or water for ready-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
43、 s (obligatory test conditions). At the end of this contact time, an aliquot is taken, and the fungicidal and/or the fungistatic 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
44、be found, membrane filtration is used. The numbers of surviving fungi in each sample are determined and the reduction 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 Ca
45、ndida albicans (yeasticidal activity) as test organisms (obligatory test conditions). 5.1.3 Additional and optional contact times and temperatures are specified. Additional test organisms can be used. Licensed Copy: London South Bank University, London South Bank University, Sat Sep 01 03:05:37 GMT+
46、00:00 2007, Uncontrolled Copy, (c) BSI EN 1657:2005 (E) 7 5.2 Materials and reagents 5.2.1 Test organisms The fungicidal activity shall be evaluated using the following strains as test organisms:1) Candida albicans ATCC 10231; Aspergillus niger ATCC 16404. The yeasticidal activity shall be evaluated
47、 using only Candida albicans. NOTE See Annex A for strain references in some other culture collections. The required incubation temperature for these test organisms is (30 1) C (5.3.2.3). If additional test organisms are used, they shall be incubated under optimum growth conditions (temperature, tim
48、e, 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 a reference centre, their identificat
49、ion 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 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 reag
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