EN 1275-2005 en Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants.pdf

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1、BRITISH STANDARDBS EN 1275:2005Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics Test method and requirements (phase 1)The European Standard EN 1275:2005 has the status of

2、 a British StandardICS 11.080.20; 71.100.35g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 1275:2005This British Standard was published under

3、the authority of the Standards Policy and Strategy Committee on 16 January 2006 BSI 16 January 2006ISBN 0 580 46958 1National forewordThis British Standard is the official English language version of EN 1275:2005. It supersedes BS EN 1275:1997 which is withdrawn.The UK participation in its preparati

4、on was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European p

5、ublications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the

6、necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the

7、interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page, pages 2 to 44, an inside back cover and a ba

8、ck cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 1275December 2005ICS 11.080.20; 71.100.35 Supersedes EN 1275:1997 English VersionChemica

9、l disinfectants and antiseptics - Quantitative suspensiontest for the evaluation of basic fungicidal or basic yeasticidalactivity of chemical disinfectants and antiseptics - Test methodand requirements (phase 1)Antiseptiques et dsinfectants chimiques - Essai quantitatifde suspension pour lvaluation

10、de lactivit fongicide oulevuricide de base des antiseptiques et des dsinfectantschimiques - Mthode dessai et prescriptions (phase 1)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Suspensionsversuch zur Bestimmung derfungiziden oder levuroziden Wirkung (Basistest)chemischer Desinfektion

11、smittel und Antiseptika -Prfverfahren und Anforderungen (Phase 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 this EuropeanStandard the status of a national standard with

12、out any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained 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 mad

13、e by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Gre

14、ece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: ru

15、e 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 1275:2005: EEN 1275:2005 (E) 2 Contents Page Foreword 3 Introduction4 1 Scope .5 2 Normative references .5 3 Terms and definitions.5 4 Requirement

16、s 6 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 5.3 Apparatus and glassware.9 5.3.1 General 9 5.3.2 Usual microbiological laboratory equipment and, in particular, the following: 9 5.4 Preparation of test organism suspension

17、s and product test solutions .10 5.4.1 Test organism suspensions (test and validation suspension)10 5.4.2 Product test solutions 13 5.5 Procedure for assessing the fungicidal or yeasticidal activity of the product.13 5.5.1 General 13 5.5.2 Dilution-neutralization method 14 5.5.3 Membrane filtration

18、method.16 5.6 Experimental data and calculation 18 5.6.1 Explanation of terms and abbreviations .18 5.6.2 Calculation.19 5.7 Verification of methodology.22 5.7.1 General 22 5.7.2 Control of weighted mean counts22 5.7.3 Basic limits23 5.8 Expression of results and precision23 5.8.1 Reduction 23 5.8.2

19、 Control of active and non-active product test solution (5.4.2) 23 5.8.3 Limiting test organism and fungicidal/yeasticidal concentration .23 5.8.4 Precision, replicates .24 5.9 Interpretation of results - conclusion24 5.9.1 General 24 5.9.2 Fungicidal activity.24 5.9.3 Yeasticidal activity24 5.10 Te

20、st report .25 Annex A (informative) Referenced strains in national collections27 Annex B (informative) Suitable neutralizers and rinsing liquids 28 Annex C (informative) Graphical representation of test procedures30 Annex D (informative) Example of a typical test report.34 Annex E (informative) Prec

21、ision of the test result .39 Annex F (informative) Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics.42 Bibliography.44 EN 1275:2005 (E) 3 Foreword This European Standard (EN 1275:2005) has been prepared by Technical Committee CEN/TC 21

22、6 “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 June 2006, and conflicting national standards shall be withdr

23、awn at the latest by June 2006. This European Standard supersedes EN 1275:1997. 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

24、, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN 1275:2005 (E) 4 Introduction This European Standard specifies a suspension test for

25、 establishing whether a chemical disinfectant or antiseptic does or does not have a basic fungicidal or a basic yeasticidal activity in the fields described in the scope. The acceptability of a product for a defined purpose cannot be determined from this test method. Therefore products are subjected

26、 to further testing by relevant tests specified in European Standards to evaluate their activity under conditions appropriate to their intended use. These European Standards have been or will be developed by CEN TC 216. EN 1275:2005 (E) 5 1 Scope This European Standard specifies a test method and th

27、e minimum requirements for basic fungicidal or basic yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produce

28、d by adding the test organisms and water. This European Standard applies to active substances (antifungal biocides) and to formulations under development that are planned to be used in food, industrial, domestic and institutional, medical and veterinary areas. It applies also to the evaluation of fu

29、ngicidal or yeasticidal activity of chemical antiseptics and disinfectants when appropriate standards are not available. NOTE 1 This European Standard does not evaluate the activity of a product for an intended use. NOTE 2 This method corresponds to a phase 1 test (Annex F). 2 Normative references T

30、he 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 document (including any amendments) applies. EN 12353, Chemical disinfectants and anti

31、septics 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 and definitions For the purposes of this European Standard, the following terms and de

32、finitions 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 adjective derived from “fungicide“ is “fungicidal“. 3.3 fungicidal activity capability

33、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 growth of fungi (moulds and/or yeasts) under defined conditions 3.5 yeasticide produ

34、ct that kills yeasts under defined conditions NOTE The adjective derived from “yeasticide“ is “yeasticidal“. EN 1275:2005 (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 Requiremen

35、ts The product, shall demonstrate at least a 4 decimal log (lg) reduction when tested in accordance with Clause 5. The fungicidal activity shall be evaluated using at least the following obligatory experimental test conditions: two test organisms (Candida albicans vegetative cells and Aspergillus ni

36、ger spores), 20 C, 15 min. The yeasticidal activity shall be evaluated using at least the following obligatory experimental test conditions: one test organism (Candida albicans vegetative cells), 20 C, 15 min. Where indicated, fungicidal or yeasticidal activity could be determined applying additiona

37、l contact times, temperatures and test organisms in accordance with 5.2.1 and 5.5.1.1. NOTE 1 For these additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions. NOTE 2 At the concentration defined as a result, it is not nec

38、essary to demonstrate a 4 lg reduction with the obligatory test conditions. 5 Test method 5.1 Principle 5.1.1 A sample of the product as delivered (highest test concentration = 80 %) and/or diluted with water is added to a test suspension of fungi (yeast cells or mould spores). The mixture is mainta

39、ined at (20 1) C for 15 min 10 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

40、a suitable neutralizer cannot 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 o

41、nly the vegetative cells of Candida 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. EN 1275:2005 (E) 7 5.2 Materials and reagents 5.2.1 Test organisms Th

42、e 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 using only Candida albicans. NOTE See Annex A for strain references in some other culture collections. The

43、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, time, atmosphere, media) noted in the test report. If the additional test organisms selected do not correspond

44、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 testing laboratory or national c

45、ulture 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

46、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 commercially available

47、dehydrated material is used for the preparation of culture media. The manufacturers instructions relating to the preparation of these products should be rigorously followed. NOTE 2 For each culture medium and reagent, a limitation for use should be fixed. 5.2.2.2 Water The water shall be freshly gla

48、ss-distilled water and not demineralized water. Sterilize in the autoclave 5.3.2.1 a). NOTE 1 Sterilization is not necessary if the water is used e.g. for preparation of culture media and subsequently sterilized. NOTE 2 If distilled water of adequate quality is not available, water for injections (s

49、ee bibliographic reference 1) can be used. 1) The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collection (ATCC). This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of the product named. EN 1275:2005 (E) 8 5.2.2.3 Malt Extract Agar (MEA) Malt extract agar, consisting of: Malt extract 30,0 gSoya peptone, papaic digest of soybean meal 3,0 gAgar 15,0 gWater (5.2.2.2) to 1 000,0 mlSterilize in the autoclave 5.3.2.1 a). Aft