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

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; 71.100.35g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Licensed Copy: Wang Bin, na, Thu Apr 13 09:08:38 BST 2006

3、, Uncontrolled Copy, (c) BSIBS EN 1275:2005This British Standard was published under 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. I

4、t supersedes BS EN 1275:1997 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics, which has the responsibility to: A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 secret

5、ary.Cross-referencesThe British Standards which implement international or European publications 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

6、 or of British Standards Online.This publication does not purport to include all the 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 te

7、xt; present to the responsible international/European committee any enquiries on the 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, a

8、n inside front cover, the EN title page, pages 2 to 44, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsLicensed Copy: Wang Bin, na, Thu Apr 13 09:08:38 BST

9、2006, Uncontrolled Copy, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 1275December 2005ICS 11.080.20; 71.100.35 Supersedes EN 1275:1997 English VersionChemical disinfectants and antiseptics - Quantitative suspensiontest for the evaluation of basic fungicidal or basic yeasticidalactivity

10、of chemical disinfectants and antiseptics - Test methodand requirements (phase 1)Antiseptiques et dsinfectants chimiques - Essai quantitatifde suspension pour lvaluation de lactivit fongicide oulevuricide de base des antiseptiques et des dsinfectantschimiques - Mthode dessai et prescriptions (phase

11、1)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Suspensionsversuch zur Bestimmung derfungiziden oder levuroziden Wirkung (Basistest)chemischer Desinfektionsmittel und Antiseptika -Prfverfahren und Anforderungen (Phase 1)This European Standard was approved by CEN on 28 July 2005.CEN me

12、mbers are bound to comply with 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 applicati

13、on 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 translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the sam

14、e status as the officialversions.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,Slove

15、nia, Spain, Sweden, Switzerland 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 natio

16、nal Members.Ref. No. EN 1275:2005: ELicensed Copy: Wang Bin, na, Thu Apr 13 09:08:38 BST 2006, Uncontrolled Copy, (c) BSIEN 1275:2005 (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 Mater

17、ials 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 suspensions and product test solutions .10 5.4.1 Test o

18、rganism 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 method.16 5.6 Experimental data and calculati

19、on 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 Control of active and non-active product tes

20、t 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 Test report .25 Annex A (informative) Reference

21、d 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) Precision of the test result .39 Annex F (informa

22、tive) Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics.42 Bibliography.44 Licensed Copy: Wang Bin, na, Thu Apr 13 09:08:38 BST 2006, Uncontrolled Copy, (c) BSIEN 1275:2005 (E) 3 Foreword This European Standard (EN 1275:2005) has been p

23、repared by Technical 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 June 2006, and confli

24、cting national standards shall be withdrawn 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,

25、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 and United Kingdom. Licensed Copy: Wang Bin, na, Thu Apr 13 09:08:

26、38 BST 2006, Uncontrolled Copy, (c) BSIEN 1275:2005 (E) 4 Introduction This European Standard specifies a suspension test for 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

27、acceptability of a product for a defined purpose cannot be determined from this test method. Therefore products are subjected to further testing by relevant tests specified in European Standards to evaluate their activity under conditions appropriate to their intended use. These European Standards h

28、ave been or will be developed by CEN TC 216. Licensed Copy: Wang Bin, na, Thu Apr 13 09:08:38 BST 2006, Uncontrolled Copy, (c) BSIEN 1275:2005 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for basic fungicidal or basic yeasticidal activity of chemical disi

29、nfectant 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 produced by adding the test organisms and water. This European Standard applies to active substan

30、ces (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 fungicidal or yeasticidal activity of chemical antiseptics and disinfectants when appropriat

31、e 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 The following referenced documents are indispensable for the application of this European S

32、tandard. 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 Preservation of microbial strains used for the determination of bactericidal and f

33、ungicidal 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 definitions apply. 3.1 product chemical agent or formulation used as chemical disinfectant o

34、r 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 of a product to produce a reduction in the number of viable vegetative yeast cells and mou

35、ld 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 product that kills yeasts under defined conditions NOTE The adjective derived from “yeasticide“

36、 is “yeasticidal“. Licensed Copy: Wang Bin, na, Thu Apr 13 09:08:38 BST 2006, Uncontrolled Copy, (c) BSIEN 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 Requirements Th

37、e 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 niger s

38、pores), 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 additional con

39、tact 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 necessar

40、y 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 maintained

41、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 a sui

42、table 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 only t

43、he 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. Licensed Copy: Wang Bin, na, Thu Apr 13 09:08:38 BST 2006, Uncontrolled Co

44、py, (c) BSIEN 1275:2005 (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 using only Candida albicans

45、. 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, time, atmosphere, media) noted

46、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 identification characteristics shall be

47、 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

48、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. N

49、OTE 1 To improve 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. 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 glass-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