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1、BRITISH STANDARD BS EN 13697:2001 Chemical disinfectants and antiseptics Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas Test method and requirements without mechan
2、ical action (phase 2/step 2) The European Standard EN 13697:2001 has the status of a British Standard ICS 11.080.20: 71.100.35 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c)
3、 BSI BS EN 13697:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 21 September 2001 BSI 21 September 2001 ISBN 0 580 38262 1 Nat
4、ional foreword This British Standard is the official English language version of EN 13697:2001. The UK participation in its preparation was entrusted to Technical Committee IH/57, Chemical Disinfectants and Antiseptics, which has the responsibility to: A list of organizations represented on this com
5、mittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by
6、using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immun
7、ity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Sum
8、mary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 29 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheff
9、ieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13697 August 2001 ICS 11.080.20; 71.100.35 English version Chemical disinfectants and antiseptics - Quantitative non-porous surface test for the evaluation of b
10、actericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas - Test method and requirements without mechanical action (phase 2/step2) Antiseptiques et dsinfectants chimiques - Essai quantitatif de surface non-poreuse pour lvaluation de l
11、activit bactricide et/ou fongicide des dsinfectants chimiques utiliss dans le domaine de lagro-alimentaire, dans lindustrie, dans les domaines domestiques et en collectivit - Mthode dessai sans action mcanique et prescriptions (phase 2/tape 2) Chemische Desinfektionsmittel und Antiseptika - Quantita
12、tiver Oberflchen-Versuch zur Bestimmung der bakteriziden und/oder fungiziden Wirkung chemischer Desinfektionsmittel in den Bereichen Lebensmittel, Industrie, Haushalt und ffentliche Einrichtungen - Prfverfahren ohne mechanische Behandlung und Anforderungen (Phase 2/Stufe 2) This European Standard wa
13、s approved by CEN on 25 July 2001. 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 nati
14、onal standards may be obtained on application to the Management Centre 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 noti
15、fied to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and
16、 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2001 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13697:
17、2001 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13697:2001 (E) 2 Contents page Introduction.4 1Scope 5 2Normative references 6 3Terms and definitions6 4Requirements.7 4.1Requirements for bactericidal activity on surfaces .7 4.2Requ
18、irements for fungicidal activity on surfaces 7 4.3Requirements for bactericidal and fungicidal activity on surfaces8 5Test method8 5.1Principle8 5.2Materials and reagents8 5.3Apparatus and glassware .12 5.4Preparation of bacterial and fungal suspensions and test solutions 13 5.5Procedure .16 5.6Calc
19、ulation and expression of results.18 5.7Test report 19 Annex A (normative) Test for validation of neutralisation21 A.1Principle21 A.2Preparation of neutralisation test suspensions and test surfaces.21 A.3Preparation of test solution21 A.4Test for validation of neutralisation.21 A.5Counting procedure
20、.21 A.6Validation22 Annex B (informative) Neutralisers23 Annex C (informative) Example of a typical test report.24 Annex D (informative) Corresponding referenced strains26 Annex E (informative) Information on the application and interpretation of European Standards on chemical disinfectants and anti
21、septics.27 E.1General guidelines for the application and interpretation of test methods in accordance with European Standards for chemical disinfectants and antiseptics.27 E.2Guide to interpretation of tests for chemical disinfectants and antiseptics .28 Bibliography29 Licensed Copy: sheffieldun she
22、ffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13697:2001 (E) 3 Foreword This European Standard 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 g
23、iven the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2002, and conflicting national standards shall be withdrawn at the latest by February 2002. Annexes designated “normative“ are part of the body of the standard. Annexes des
24、ignated “informative“ are given only for information. Annex A is normative. Annex B, C, D and E are informative. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech R
25、epublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13697:2001 (E) 4 In
26、troduction This European Standard describes a surface test method for establishing whether a product proposed as a disinfectant in the fields described in clause 1 has or does not have bactericidal and/or fungicidal activity on non-porous surfaces. The laboratory test closely simulates practical con
27、ditions of application. Chosen conditions (contact time, temperature, organisms on surfaces .) reflect parameters which are found in practical situations including conditions which may influence the action of disinfectants. Each use concentration found from this test corresponds to defined experimen
28、tal conditions. The conditions are intended to cover general purposes and to allow reference between laboratories and product types. However for some applications the recommendations of use of a product can differ and therefore additional test conditions need to be used. Licensed Copy: sheffieldun s
29、heffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13697:2001 (E) 5 1 Scope This European Standard specifies a test method (phase 2/step 2) and the minimum requirements for bactericidal and/or fungicidal activity of chemical disinfectants that form a homogeneous physic
30、ally stable preparation in hard water and that are used in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues. The scope of this European Standard applies at least to the following
31、 : a) Processing, distribution and retailing of : 1) Food of animal origin : ? milk and milk products ; ? meat and meat products ; ? fish, seafood and products ; ? eggs and egg products ; ? animal feeds ; ? etc. 2) Food of vegetable origin : ? beverages ; ? fruits, vegetables and derivatives (includ
32、ing sugar distillery) ; ? flour, milling and backing ; ? animal feeds ; ? etc. b) Institutional and domestic areas : ? catering establishments ; ? public areas ; ? public transports ; ? schools ; ? nurseries ; ? shops ; ? sports rooms ; ? waste container (bins) ; ? hotels ; ? dwellings ; ? clinicall
33、y non sensitive areas of hospitals ; Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13697:2001 (E) 6 ? offices ; ? etc. c) Other industrial areas : ? packaging material ; ? biotechnology (yeast, proteins, enzymes.) ; ? pharmaceutical ; ?
34、 cosmetics and toiletries ; ? textiles ; ? space industry, computer industry ; ? etc. Using this European Standard, it is possible to determine the bactericidal or fungicidal activity of the undiluted product. As three concentrations have to be tested, in the active to non active range, dilution of
35、the product is required and, therefore, the product shall form a homogeneous stable preparation in hard water. NOTE 1The method described is intended to determine the activity of commercial formulations or active substances on bacteria and/or fungi in the conditions in which they are used. NOTE 2Thi
36、s method corresponds to a phase 2/step 2 test (see annex E). 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 herea
37、fter. For dated references, subsequent 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 (including amendments). EN 1040, Chem
38、ical disinfectants and antiseptics - Basic bactericidal activity - Test method and requirements (phase 1). EN 1275, Chemical disinfectants and antiseptics - Basic fungicidal activity - Test method and requirements (phase 1). EN 10088-1, Stainless steels Part 1: List of stainless steel. EN 10088-2, S
39、tainless steels. Technical delivery conditions for sheet/plate and strip for general purposes. EN 12353, Chemical disinfectants and antiseptics - Preservation of microbial strains used for the determination of bactericidal and fungicidal activity. 3 Terms and definitions For the purposes of this Eur
40、opean Standard, the following terms and definitions apply : 3.1 product (for chemical disinfection and/or antisepsis) chemical agent or formulation used as a chemical disinfectant EN 1040 3.2 bactericide product which kills vegetative bacteria under defined conditions EN 1040 Licensed Copy: sheffiel
41、dun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13697:2001 (E) 7 NOTEThe adjective derived from “bactericide“ is “bactericidal“. 3.3 bactericidal activity on surfaces capability of a product to produce at least a 104 reduction in the number of viable bacterial
42、cells belonging to reference strains of Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Enterococcus hirae within 5 min at 20 C under conditions defined by this European Standard 3.4 fungicide product which kills fungi including their spores under defined conditions EN 1275 3.5 f
43、ungicidal activity on surfaces capability of a product to produce at least a 103 reduction in number of viable fungi belonging to reference strains of Candida albicans and Aspergillus niger within 15 min at 20 C under conditions defined by this European Standard 3.6 clean conditions conditions repre
44、sentative of surfaces which have received a satisfactory cleaning programme and/or are known to contain minimal levels of organic and/or inorganic materials EN 1276 3.7 dirty conditions conditions representative or surfaces which are known to or may contain, organic and/or inorganic materials EN 127
45、6 4 Requirements 4.1 Requirements for bactericidal activity on surfaces The product, when diluted in hard water and tested in accordance with clause 5, under simulated clean conditions (0,3 g/l bovine albumin and 1g/l tryptone, see 3.6) or dirty conditions (3 g/l bovine albumin and 1g/l tryptone, se
46、e 3.7) according to its practical applications and under the required test conditions shall demonstrate at least a 104 reduction in viable bacterial counts For a claim of bactericidal activity on surfaces for general purposes, the bactericidal activity shall be evaluated using the following four str
47、ains : Pseudomonas aeruginosa, Staphylococcus aureus, Enterococcus hirae and Escherichia coli at a temperature between 18C 1C and 25C 1C and a contact time of 5 min. The determined bactericidal concentration of the test product is suggested as being suitable for practical situations of use. Where ap
48、propriate (specific purposes), additional specific bactericidal activity shall be determined under other conditions of time, temperature, additional strains and interfering substances (see 5.2.1 and 5.2.2.8) in accordance with 5.5.1 in order to take into account intended specific use conditions. NOT
49、EFor these additional conditions the concentration defined as a result can be lower than the one obtained under the initial conditions, at a temperature between 18 C 1 C and 25 C 1 C, 5 min, 4 selected reference strains. Products under test shall at least possess a bactericidal activity as specified in EN 1040. 4.2 Requirements for fungicidal activity on surfaces The product, when diluted in hard water and tested in accordance with clause 5, under simulated clean conditions (0,3 g/l bovine albumin and 1g/l tryptone, see 3.6) or