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; 71.100.35BS EN 1040:2005This British Standard was published under the authority of th
3、e 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 It supersedes BS EN 1040:1997 which is withdrawn.The UK participation in its preparation was entrusted to
4、 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 publications referre
5、d 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 necessary provision
6、s 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 interpretation, or
7、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 40, an inside back cover and a back cover.The BSI co
8、pyright notice displayed in this document indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 1040December 2005ICS 11.080.20; 71.100.35 Supersedes EN 1040:1997 English VersionChemical disinfectants and
9、 antiseptics - Quantitative suspensiontest for the evaluation of basic bactericidal activity of chemicaldisinfectants and antiseptics - Test method and requirements(phase 1)Antiseptiques et dsinfectants chimiques - Essai quantitatifde suspension pour lvaluation de lactivit bactricide debase des anti
10、septiques et des dsinfectants chimiques -Mthode dessai et prescriptions (phase 1)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Suspensionsversuch zur Bestimmung derbakteriziden Wirkung (Basistest) chemischerDesinfektionsmittel und Antiseptika - Prfverfahren undAnforderungen (Phase 1)T
11、his 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 without any alteration. Up-to-date lists and bibliographical reference
12、s 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 made by translationunder the responsibility of a CEN member into its
13、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, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembou
14、rg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, 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 exploitat
15、ion in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 1040:2005: EEN 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
16、.3 Apparatus and glassware 8 5.4 Preparation 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
17、 Interpretation of results conclusion 21 5.10 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
18、 A TYPICAL TEST REPORT . 31 ANNEX E (INFORMATIVE) 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 EN 1040:2005 (E) 3 Foreword This European Standard (EN 1040:20
19、05) 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 by endorsement, at the latest by June 20
20、06, 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 suspension tests of CEN TC 216 existing or in
21、 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: Austria, Belgium, Cyprus, Czech Republic,
22、 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. EN 1040:2005 (E) 4 Introduction This European Standard specifies a su
23、spension 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 acceptability of a product for a defined purpose cannot be determined from this test method. Therefore products are subjected to
24、further testing by relevant tests specified in European Standards in order 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 1040:2005 (E) 5 1 Scope This European Standard specifies a test method a
25、nd the minimum requirements for basic bactericidal 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 produced by adding th
26、e test organisms and water. This European Standard applies to active substances (antibacterial 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
27、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 The following referenced
28、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 antiseptics Preservation of
29、microbial strains used for the determination of bactericidal and fungicidal activity 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 bactericide pr
30、oduct that kills vegetative bacteria under defined conditions NOTE The adjective derived from “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 bact
31、eriostatic activity capability of a product to inhibit the growth of bacteria under defined conditions EN 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 a
32、t least 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 an
33、d 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 necessary to demonstrate a 5 lg reduction with the obligatory test conditions.
34、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 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 aliqu
35、ot is 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
36、in each 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
37、be used. 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 A
38、TCC 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 1040:2005 (E) 7 The required incubation t
39、emperature 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 test organisms are used, they shall be incubated under optimum growth conditions (
40、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. If these additional test organisms are not classified at a reference centre, t
41、heir 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 General All weights of chemical substances given in this European Standard refer to
42、 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 appropriate for microbiological purposes. They shall be free from substances that are
43、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 relating to the preparation of these products should be rigorously followed. NO
44、TE 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 Sterilization is not necessary if the water is used e.g. for preparation of culture
45、 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, consisting of: Tryptone, pancreatic digest of casein 15,0 gSoya peptone, papaic d
46、igest 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 at (20 1) C. NOTE In case of encountering problems with neutralization (5.5.1.2
47、 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. EN 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
48、 1 000,0 mlSterilize in the autoclave 5.3.2.1a). After sterilization, the pH of the diluent shall be equivalent to (7,0 0,2) when measured at (20 1) C. 5.2.2.5 Neutralizer The neutralizer shall be validated for the product being tested in accordance with 5.5.1.2, 5.5.1.3 and 5.5.2. It shall be steri
49、le. 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 Rinsing liquid (for membrane filtration) The rinsing liquid shall be validated for the product being tested in accordance with 5.5.1.2, 5.5.1.3 and 5.5.3. It shall be sterile, compatible with the filter membrane and capable of filtration through the filter membrane under the test conditions described in 5.5.3. NOTE Information on rinsing liquids that have been found to be suit
