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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1275 : 1997 The Eur
2、opean Standard EN 1275 : 1997 has the status of a British Standard ICS 11.080 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Chemical disinfectants and antiseptics Basic fungicidal activity Test method and requirements (phase 1) Licensed Copy: sheffieldun sheffieldun, na, Sat
3、 Oct 28 05:24:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1275 : 1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 September 1997 BSI 1997 The f
4、ollowing BSI references relate to the work on this standard: Committee reference IH/57 Draft for comment 93/509492 DC ISBN 0 580 28335 6 Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was entrust
5、ed to Technical Committee IH/57, Chemical disinfectants and antiseptics, upon which the following bodies were represented: Association of British Health-care Industries Association of Public Analysts British Association for Chemical Specialities Campden and Chorleywood Food Research Association Cons
6、umer Policy Committee of BSI Department of Health Institute of Trading Standards Administration Ministry of Agriculture, Fisheries and Food Ministry of Defence Public Health Laboratory Service Society for Applied Bacteriology Society of Chemical Industry Licensed Copy: sheffieldun sheffieldun, na, S
7、at Oct 28 05:24:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1275 : 1997 BSI 1997i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 12753 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI i
8、i BSI 1997 BS EN 1275 : 1997 National foreword This British Standard has been prepared by Technical Committee IH/57 and is the English language version of EN 1275 : 1997 Chemical disinfectants and antiseptics Basic fungicidal activity Test method and requirements (phase 1) published by the European
9、Committee for Standardization (CEN). Cross-reference International StandardCorresponding British Standard ISO 4793 : 1980BS 1752 : 1983 Specification of laboratory sintered or fritted filters including porosity grading (Identical) Compliance with a British Standard does not of itself confer immunity
10、 from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 16, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
11、CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 Copyright reserved to CEN members Ref. No. EN 1275 : 1997 E EUROPEAN STANDARDEN 1275 NORME EUROPE ENNE EUROPA ISCHE NORM March
12、 1997 ICS 11.080 Descriptors: Disinfectants, chemical compounds, fungicides, tests, effectiveness, culture media, preparation, counting, micro-organisms, filtration analysis, neutralization analysis English version Chemical disinfectants and antiseptics Basic fungicidal activity Test method and requ
13、irements (Phase1) Antiseptiques et de sinfectants chimiques Activite fongicide de base Me thode dessai et prescriptions (phase 1) Chemische Desinfektionsmittel und Antiseptika Fungizide Wirkung (Basistest) Pru fverfahren und Anforderungen (Phase 1) This European Standard was approved by CEN on 1997-
14、02-27. 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 bibliographical references concerning such national standards may be obtain
15、ed on application to the Central Secretariat 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 responsibility of a CEN member into its own language and notified to the Central Secret
16、ariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffiel
17、dun sheffieldun, na, Sat Oct 28 05:24:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 1275 : 1997 BSI 1997 Foreword This European Standard has been prepared by CEN Technical Committee 216, Chemical disinfectants and antiseptics, the secretariat of which is held by AFNOR. A collaborative tria
18、l is currently being undertaken and will be used to provide a precision annex to this standard. Other methods to evaluate the efficacy of chemical disinfectants and antiseptics for different fields of application are in preparation. This European Standard shall be given the status of a national stan
19、dard, either by publication of an identical text or by endorsement, at the latest by September 1997, and conflicting national standards shall be withdrawn at the latest by September 1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countri
20、es are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Annex A is normative, annexes B, C, D, E and F are informative. Conten
21、ts Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 3.1product (for chemical disinfection and/or antisepsis)3 3.2fungicide3 3.3fungicidal activity3 4Requirements3 5Test method3 5.1Principle3 5.2Materials and reagents4 5.3Apparatus and glassware4 5.4Preparation of fungal susp
22、ensions and test solutions5 5.5Procedure6 5.6Calculation and expression of results8 5.7Conclusion9 5.8Test report9 Annexes A(normative) Validation of dilution-neutralization and membrane filtration methods10 B(informative) Neutralizers12 C(informative) Rinsing liquids12 D(informative) Example of a t
23、ypical test report13 E(informative) Referenced strains in national collections15 F(informative) Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics15 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:36 GMT+00:00 2006, Uncontro
24、lled Copy, (c) BSI Page 3 EN 1275 : 1997 BSI 1997 1) CEN/TC 216 will develop relevant tests. Introduction This European Standard describes a suspension test method for establishing whether a chemical disinfectant or antiseptic has or does not have a fungicidal activity under the laboratory condition
25、s defined by this European Standard. If a product complies with the test requirements, it can be considered as possessing a fungicidal activity. The acceptability of a product as a chemical disinfectant or antiseptic for a defined purpose cannot be determined from this test method. Chemical disinfec
26、tants and antiseptics are subjected to further testing by relevant tests according to European Standards to evaluate their activity under conditions appropriate to their intended use1). There is no evidence that the strains used in this standard are virulent. 1 Scope This European Standard specifies
27、 a test method (phase 1) and the minimum requirements for fungicidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation in water. This European Standard is applicable to products for use in agricultural (but not crop protection), domestic
28、service, food hygiene and other industrial fields, institutional, medical and veterinary applications. NOTE 1. Using this European Standard it is not possible to determine the fungicidal activity of the undiluted product as some dilution is always produced by adding the inoculum. NOTE 2. This Europe
29、an Standard does not evaluate the activity of a product for an intended use. More specific test methods described in European Standards (see introduction) are used for further assessment of the efficacy of chemical disinfectants and antiseptics for a defined purpose. NOTE 3. This method corresponds
30、to a phase 1 test (see annex F). 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, s
31、ubsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. prEN 12353Chemical disinfectants and antiseptics Preservation of
32、microbial strains used for the determination of bactericidal and fungicidal activity ISO 4793Laboratory sintered (fritted) filters Porosity grading, classification and designation 3 Definitions For the purposes of this European Standard the following definitions apply: 3.1 product (for chemical disi
33、nfection and/or antisepsis) Chemical agent or formulation used as a chemical disinfectant or antiseptic EN 1040. 3.2 fungicide Product which kills fungi including their spores under defined conditions. NOTE. The adjective derived from fungicide is fungicidal. 3.3 fungicidal activity Capability of a
34、product to produce a reduction in the number of viable vegetative yeast cells and mould spores of relevant organisms under conditions defined by this European Standard EN 1275. 4 Requirements The product, when tested in accordance with clause 5, shall demonstrate at least a 104logarithmic reduction
35、in viable counts when the test organisms are vegetative cells of Candida albicans and the spores of Aspergillus niger. 5 Test method 5.1 Principle 5.1.1 A test suspension of yeast cells or mould spores is added to a prepared sample of the product under test. The mixture is maintained at 20 C. At a s
36、pecified contact time chosen from one of the following, 5 min10 s, 15 min10 s, 30 min10 s or 60 min10 s, an aliquot is taken; the fungicidal action in this portion is immediately neutralized or suppressed by a validated method. The method of choice is dilution-neutralization. If a suitable neutraliz
37、er cannot be found, membrane filtration is used. The number of surviving yeast cells or mould spores in each sample is determined and the reduction in viable counts calculated. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 1275 :
38、 1997 BSI 1997 2)ATCC 10231 and ATCC 16404 are the collection numbers of strains supplied by the American Type Culture Collections. This information is given for the convenience of users of this standard and does not constitute an endorsement by CEN of the product named. Corresponding strains suppli
39、ed by other culture collections may be used if they can be shown to lead to the same results. 3) Disposable equipment is an acceptable alternative to reusable glassware. 4) Vortex is an example of a suitable product available commercially. This information is given for the convenience of users of th
40、is standard and does not constitute an endorsement by CEN of this product. 5.1.2 The test is performed using vegetative cells of Candida albicans and spores of Aspergillus niger. 5.2 Materials and reagents 5.2.1 Test organisms The fungicidal activity shall be evaluated using the following two strain
41、s : Candida albicansATCC 102312) Aspergillus nigerATCC 164042) NOTE. See annex E for corresponding strain numbers in some other culture collections. 5.2.2 Culture media and reagents 5.2.2.1 General The reagents shall be of analytical grade and/or appropriate for microbiological purposes. NOTE. To im
42、prove reproducibility, it is recommended 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. 5.2.2.2 Water The water shall be free from substances tha
43、t are toxic or inhibiting to the yeast cells and the fungus spores. It shall be freshly glass distilled and not demineralized water. Sterilize in the autoclave (see 5.3.1). NOTE 1. If the water is sterilized during the sterilization of the reagents, this is not necessary. NOTE 2. If distilled water
44、of adequate quality is not available, water for injectable preparations (see European Pharmacopaeia) can be used. 5.2.2.3 Malt extract agar (MEA) Malt extract30,0 g Soya peptone3,0 g Agar15,0 g Water (see 5.2.2.2)1000,0 ml Sterilize in the autoclave (see 5.3.1). After sterilization the pH of the med
45、ium shall be equivalent to 5,60,2 when measured at 20 C. 5.2.2.4 Diluent Tryptone Sodium Chloride Solution: Tryptone, pancreatic digest of casein1,0 g NaCl8,5 g Water (see 5.2.2.2)1000,0 ml Sterilize in the autoclave (see 5.3.1). After sterilization the pH of the medium shall be equivalent to 7,00,2
46、 when measured at 20 C. 5.2.2.5 Neutralizer The neutralizer shall be validated for the product under test in accordance with annex A. The neutralizer shall be sterile. NOTE. Information on neutralizers that have been found to be suitable for some categories of products is given in annex B. 5.2.2.6 R
47、insing liquid (for membrane filtration) The liquid shall be sterile, compatible with the filter membrane and capable of filtration through the filter membrane under the test conditions described in annex A. NOTE. Information on rinsing liquids that have been found to be suitable for some categories
48、of products is given in annex C. 5.3 Apparatus and glassware 5.3.1 General Sterilize all glassware and parts of the apparatus that will come into contact with the culture media and reagents or the sample, except those which are supplied sterile, by one of the following methods: a) in the autoclave (
49、see 5.3.2.1) by maintaining it at () C for a minimum holding time of 15 min;121 0 +3 b) in the dry heat sterilizer (see 5.3.2.1) by maintaining it at 180 C for a minimum holding time of 30 min, at 170 C for a minimum holding time of 1 h or at 160 C for a minimum holding time of 2 h. 5.3.2 Usual microbiological laboratory equipment3)and in particular, the following: 5.3.2.1 Apparatus for sterilization a) for moist heat sterilization, an autoclave capable of being maintained at () C for a minimum121 0 +3 holding time of 15 m
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