BS EN 1040-2005 Chemical disinfectants and antispetics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - .pdf

1、BRITISH STANDARDBS EN 1040:2005Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics Test method and requirements (phase 1)The European Standard EN 1040:2005 has the status of a British Standard

2、g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58ICS 11.080.20; 71.100.35Licensed Copy: Wang Bin, na, Wed Apr 12 09:12:03 BST 2006, Uncontrolled Copy

3、, (c) BSIBS EN 1040:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 16 January 2006 BSI 16 January 2006ISBN 0 580 46960 3National forewordThis British Standard is the official English language version of EN 1040:2005. It supersedes BS EN

4、1040:1997 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics, which has the responsibility to: A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 secretary.Cross-reference

5、sThe 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 or of British Stan

6、dards 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 text; present to the

7、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, an inside front cove

8、r, the EN title page, pages 2 to 40, 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, Wed Apr 12 09:12:03 BST 2006, Uncontrolled

9、Copy, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 1040December 2005ICS 11.080.20; 71.100.35 Supersedes EN 1040:1997 English VersionChemical disinfectants and antiseptics - Quantitative suspensiontest for the evaluation of basic bactericidal activity of chemicaldisinfectants and antisept

10、ics - Test method and requirements(phase 1)Antiseptiques et dsinfectants chimiques - Essai quantitatifde suspension pour lvaluation de lactivit bactricide debase des antiseptiques et des dsinfectants chimiques -Mthode dessai et prescriptions (phase 1)Chemische Desinfektionsmittel und Antiseptika -Qu

11、antitativer Suspensionsversuch zur Bestimmung derbakteriziden Wirkung (Basistest) chemischerDesinfektionsmittel und Antiseptika - Prfverfahren undAnforderungen (Phase 1)This European Standard was approved by CEN on 28 July 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulation

12、s 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 or to any CEN member.This European S

13、tandard 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 officialversions.CEN members are the national stan

14、dards 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 and United Kingdom.EUROPEAN COMMIT

15、TEE 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 1040:2005: ELicensed Copy: Wang Bin, na, W

16、ed Apr 12 09:12:03 BST 2006, Uncontrolled Copy, (c) BSIEN 1040:2005 (E) 2 Contents Page FOREWORD 3 INTRODUCTION 4 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 6 5.3 Apparatus and glassware 8 5.4 Preparation

17、of test organism suspensions and product test solutions 9 5.5 Procedure for assessing the bactericidal activity of the product 11 5.6 Experimental data and calculation . 16 5.7 Verification of methodology 20 5.8 Expression of results and precision. 21 5.9 Interpretation of results conclusion 21 5.10

18、 Test report 22 ANNEX A (INFORMATIVE) REFERENCED STRAINS IN NATIONAL COLLECTIONS. 24 ANNEX B (INFORMATIVE) SUITABLE NEUTRALIZERS AND RINSING LIQUIDS 25 ANNEX C (INFORMATIVE) GRAPHICAL REPRESENTATION OF TEST PROCEDURES . 27 ANNEX D (INFORMATIVE) EXAMPLE OF A TYPICAL TEST REPORT . 31 ANNEX E (INFORMAT

19、IVE) PRECISION OF THE TEST RESULT . 34 ANNEX F (INFORMATIVE) INFORMATION ON THE APPLICATION AND INTERPRETATION OF EUROPEAN STANDARD ON CHEMICAL DISINFECTANTS AND ANTISEPTICS 38 BIBLIOGRAPHY 40 Licensed Copy: Wang Bin, na, Wed Apr 12 09:12:03 BST 2006, Uncontrolled Copy, (c) BSIEN 1040:2005 (E) 3 For

20、eword This European Standard (EN 1040:2005) has been prepared 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

21、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 1040:1997. It was revised to correct obvious errors and ambiguities, to harmonize the structure and wording with other quantitative suspe

22、nsion tests of CEN TC 216 existing or in preparation and to improve the readability and with that the understandability of the standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: A

23、ustria, 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 and United Kingdom. Licensed Copy: Wang Bin, na,

24、Wed Apr 12 09:12:03 BST 2006, Uncontrolled Copy, (c) BSIEN 1040:2005 (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 bactericidal activity in the fields described in the scope. The acce

25、ptability 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 in order to evaluate their activity under conditions appropriate to their intended use. These European Standa

26、rds have been or will be developed by CEN/TC 216. Licensed Copy: Wang Bin, na, Wed Apr 12 09:12:03 BST 2006, Uncontrolled Copy, (c) BSIEN 1040:2005 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for basic bactericidal activity of chemical disinfectant and a

27、ntiseptic 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 substances (antibacte

28、rial 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 bactericidal activity of chemical antiseptics and disinfectants when appropriate standards are not avai

29、lable. 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 Standard. For dated refer

30、ences, 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 fungicidal activity 3 Ter

31、ms 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 bactericide product that kills vegetative bacteria under defined conditions NOTE The adjective derived f

32、rom “bactericide” is “bactericidal”. 3.3 bactericidal activity capability of a product to produce a reduction in the number of viable bacterial cells of relevant test organisms under defined conditions 3.4 bacteriostatic activity capability of a product to inhibit the growth of bacteria under define

33、d conditions Licensed Copy: Wang Bin, na, Wed Apr 12 09:12:03 BST 2006, Uncontrolled Copy, (c) BSIEN 1040:2005 (E) 6 4 Requirements The product shall demonstrate at least a 5 decimal log (lg) reduction when tested in accordance with Clause 5. The bactericidal activity shall be evaluated using at lea

34、st the following obligatory experimental test conditions: two test organisms (Pseudomonas aeruginosa and Staphylococcus aureus), 20 C, 5 min. Where indicated, bactericidal activity could be determined applying additional contact times, temperatures and test organisms in accordance with 5.2.1 and 5.5

35、.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 necessary to demonstrate a 5 lg reduction with the obligatory test conditions. 5 Tes

36、t 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 bacteria. The mixture is maintained at (20 1) C for 5 min 10 s (obligatory test conditions). At the end of this contact time, an aliquot is

37、 taken; the bactericidal and/or the bacteriostatic 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 bacteria in ea

38、ch sample are determined and the reduction is calculated. 5.1.2 The test is performed using Pseudomonas aeruginosa and Staphylococcus aureus as test organisms (obligatory test conditions). 5.1.3 Additional and optional contact times and temperatures are specified. Additional test organisms can be us

39、ed. 5.2 Materials and reagents 5.2.1 Test organisms The bactericidal activity shall be evaluated using the following strains as test organisms:1) Pseudomonas aeruginosa ATCC 15442; Staphylococcus aureus ATCC 6538. NOTE See Annex A for strain references in some other culture collections. 1)The ATCC n

40、umbers 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. Licensed Copy: Wang Bin, na, Wed Apr 12 09:12:03

41、BST 2006, Uncontrolled Copy, (c) BSIEN 1040:2005 (E) 7 The required incubation temperature for these test organisms is (36 1) C or (37 1) C (5.3.2.3). The same temperature (either 36 C or 37 C) shall be used for all incubations performed during a test and its control and validation. If additional te

42、st 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 supplying the required inocula shall be verified

43、. 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 years. 5.2.2 Culture media and reagents 5.2.2.1 Gen

44、eral 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 approp

45、riate 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 dehydrated material is used for the preparation of culture media. The manufacturers instructions

46、 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 5.3.2.1a). NOTE 1 Ste

47、rilization 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 (see bibliographic reference 1) can be used. 5.2.2.3 Tryptone Soya Agar (TSA) Tryptone soya agar, c

48、onsisting of: Tryptone, pancreatic digest of casein 15,0 gSoya peptone, papaic digest of Soybean meal 5,0 gSodium chloride (NaCl) 5,0 gAgar 15,0 gWater (5.2.2.2) to 1 000,0 mlSterilize in the autoclave 5.3.2.1a). After sterilization the pH of the medium shall be equivalent to (7,2 0,2) when measured

49、 at (20 1) C. NOTE In case of encountering problems with neutralization (5.5.1.2 and 5.5.1.3) it may be necessary to add neutralizer to the TSA. Annex B gives guidance on the neutralizers that may be used. Licensed Copy: Wang Bin, na, Wed Apr 12 09:12:03 BST 2006, Uncontrolled Copy, (c) BSIEN 1040:2005 (E) 8 5.2.2.4 Diluent Tryptone sodium chloride solution, consisting of: Tryptone, pancreatic digest of casein 1,0 gSodium chloride (NaCl) 8,5 gWater (5.2.2.2) to 1 000,0 mlSterilize in the autoclave 5.3.2.1a). Afte