《BS-EN-13704-2002.pdf》由会员分享,可在线阅读,更多相关《BS-EN-13704-2002.pdf(38页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS EN 13704:2002 Chemical disinfectants Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas Test method and requirements (phase 2, step 1) The European Standard EN 13704:2002 has
2、the status of a British Standard ICS 71.100.35 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Mon Oct 30 04:53:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 13704:2002 This British Standard, having been prepared under the dire
3、ction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 05 March 2002 BSI 05 March 2002 ISBN 0 580 39201 5 National foreword This British Standard is the official English language version of EN 1370
4、4:2002 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 committee can be obtained on request to its secretary. Cross-references The British Standard
5、s 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 using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard d
6、oes 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 immunity from legal obligations. aid enquirers to understand the text; present to the responsi
7、ble 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. Summary of pages This document comprises a front cover, an inside front cover, the EN title
8、page, pages 2 to 34, and an inside back cover 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: sheffieldun sheffieldun, na, Mon Oct 30 04:53:32 GMT+00:00 2006, Unc
9、ontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13704 February 2002 ICS 71.100.35 English version Chemical disinfectants - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutiona
10、l areas - Test method and requirements (phase 2, step 1) Dsinfectants chimiques - Essai quantitatif de suspension pour lvaluation de lactivit sporicide des dsinfectants chimiques utiliss dans le domaine de lagro-alimentaire, dans lindustrie, dans les domaines domestiques et en collectivit - Mthode d
11、essai et prescriptions (phase 2, tape 1) Chemische Desinfektionsmittel - Quantitativer Suspensionsversuch zur Bestimmung der sporiziden Wirkung chemischer Desinfektionsmittel in den Bereichen Lebensmittel, Industrie, Haushalt und ffentliche Einrichtungen - Prfverfahren und Anforderungen (Phase 2, St
12、ufe 1) This European Standard was approved by CEN on 11 November 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 bibliograph
13、ical references concerning such national 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 m
14、ember into its own language and notified 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, Malta, Netherlands, Norwa
15、y, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2002 CENAll rights of exploitation in any form and by any means reserved worldwide f
16、or CEN national Members. Ref. No. EN 13704:2002 E Licensed Copy: sheffieldun sheffieldun, na, Mon Oct 30 04:53:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13704:2002 (E) 2 Contents page Foreword3 Introduction.4 1Scope 5 2Normative references 6 3Terms and definitions6 4Requirements.7 5Test metho
17、d7 5.1Principle7 5.2Materials and reagents8 5.3Apparatus and glassware .10 5.4Preparation of spore test suspension and test solutions .11 5.5Procedure .12 5.6Calculation and expression of results.15 5.7Conclusion17 5.8Test report 18 Annex A (normative) Preparation of Bacillus spore stock suspensions
18、 20 A.1Material and reagents20 A.2Preparation of Bacillus spore stock suspensions .20 Annex B (normative) Validation of dilution-neutralization and membrane filtration methods .21 B.1Principle21 B.2Preparation of spore suspension.21 B.3Preparation of product test solution21 B.4Test for validation21
19、B.5Validation24 Annex C (informative) Preparation of Clostridium sporogenes spore stock suspension.25 C.1Culture media and reagents25 C.2Apparatus and glassware .26 C.3Preparation of regenerated media and incubation conditions .26 C.4Preparation of Clostridium spore stock suspension.26 Annex D (info
20、rmative) Neutralizers27 Annex E (informative) Rinsing liquids.28 Annex F (informative) Example of a typical test report.29 Annex G (informative) Referenced strains in national collections.32 G.1Bacillus subtilis32 G.2Bacillus cereus.32 G.3Clostridium sporogenes32 Annex H (informative) Information on
21、 the application and interpretation of European standards on chemical disinfectants and antiseptics.33 H.1General guidelines for the application and interpretation of test methods in accordance with European Standards for chemical disinfectants and antiseptics.33 H.2Guide to interpretation of tests
22、for chemical disinfectants and antiseptics .34 Licensed Copy: sheffieldun sheffieldun, na, Mon Oct 30 04:53:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13704:2002 (E) 3 Foreword This European Standard has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics“,
23、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 August 2002, and conflicting national standards shall be withdrawn at the latest by August 2002. In this
24、standard the annexes A and B are normative. The annexes C, D, E, F, G and H 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 Republic, Denmark, Fi
25、nland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Mon Oct 30 04:53:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13704:2002 (E) 4 Introduction Th
26、is European Standard describes a suspension test method for establishing whether a chemical disinfectant has or does not have a sporicidal activity in the fields described in clause 1. The laboratory test closely simulates practical conditions of application. Chosen conditions (contact time, tempera
27、ture, in suspension, etc.) reflect parameters which are found in practical situations including conditions which can influence the action of disinfectants. Each utilization concentration found from this test corresponds to defined experimental conditions. The conditions are intended to cover general
28、 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 sheffieldun, na, Mon Oct 30 04:53:32 GMT+00:00 2006, Uncontro
29、lled Copy, (c) BSI EN 13704:2002 (E) 5 1 Scope This European Standard specifies a test method (phase 2/step 1) (see annex H) and the minimum requirements for sporicidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation in hard water and that are used i
30、n food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. This European Standard applies at least to the following : a) proc
31、essing, distribution and retailing of : 1) food of animal origin : ? milk and milk products ; ? meat and meat products ; ? fish, seafood, and related products ; ? eggs and egg products ; ? animal feeds ; ? etc. ; 2) food of vegetable origin : ? beverages ; ? fruits, vegetables and derivatives (inclu
32、ding sugar, distillery, etc.) ; ? flour, milling and baking ; ? animal feeds ; ? etc. ; b) institutional and domestic areas : ? catering establishments ; ? public areas ; ? public transports ; ? schools ; ? nurseries ; ? shops ; ? sports rooms ; ? waste containers (bins, etc.) ; ? hotels ; Licensed
33、Copy: sheffieldun sheffieldun, na, Mon Oct 30 04:53:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13704:2002 (E) 6 ? dwellings ; ? clinically non sensitive areas of hospitals ; ? offices ; ? etc. ; c) other industrial areas : ? packaging material ; ? biotechnology (yeast, proteins, enzymes, etc.)
34、 ; ? pharmaceutical ; ? cosmetics and toiletries ; ? textiles ; ? space industry, computer industry ; ? etc. Using this European Standard, it is not possible to determine the sporicidal activity of undiluted product as some dilution is always produced by adding the inoculum and interfering substance
35、. Products can only be tested at a concentration of 80 % or less. NOTEThe method described is intended to determine the activity of commercial formulations or active substances on spores in the conditions in which they are used. 2 Normative references This European Standard incorporates by dated or
36、undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only
37、when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN 1040, Chemical disinfectants and antiseptics Basic bactericidal activity Test method and requirements (phase 1). 3 Terms and definitions For t
38、he purposes of this European 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 or antiseptic EN 1040 3.2 sporicide (in this standard) product which kills spores of the genus Bac
39、illus NOTEThe adjective derived from sporicide is sporicidal . Licensed Copy: sheffieldun sheffieldun, na, Mon Oct 30 04:53:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13704:2002 (E) 7 3.3 sporicidal activity (in this standard) capability of the product to produce at least a reduction of 103 in
40、 the number of bacterial spores belonging to reference strain of Bacillus subtilis under conditions defined by this European Standard 3.4 clean conditions conditions representative of surfaces which have received a satisfactory cleaning programme and/or are known to contain minimal levels of organic
41、 and/or inorganic materials 4 Requirements The product, when diluted in hard water and tested in accordance with clause 5 under simulated clean conditions (0,3 g/l bovine albumin see 3.4) according to its practical applications and under the required test conditions (20 C, 60 min, 1 selected referen
42、ce strain), shall demonstrate at least a 103 reduction in viable counts. The sporicidal activity shall be evaluated using the test organism Bacillus subtilis. The determined sporicidal concentration of the test product is suggested as being suitable for practical situations of use. Where appropriate
43、, additional specific sporicidal activity shall be determined under other conditions of time, temperature and additional strains (see 5.2.1 and 5.5.1) in accordance with 5.5.1 in order to take into account intended specific use conditions. NOTEFor these additional conditions, the concentration defin
44、ed as a result can be lower than the one obtained under the initial test conditions of 20 C, 60 min, 1 selected reference strain. 5 Test method 5.1 Principle 5.1.1A test suspension of bacterial spores in a solution of interfering substance, simulating clean conditions, is added to a prepared sample
45、of the product under test diluted in hard water. The mixture is maintained at 20 C 1 C for 60 min 10 s (required test conditions). At this contact time, an aliquot is taken ; the sporicidal action in this portion is immediately neutralized or suppressed by a validated method. The method of choice is
46、 dilution-neutralization. If a suitable neutralizer cannot be found, membrane filtration is used. The number of surviving bacterial spores in each sample are determined and the reduction in viable counts is calculated. 5.1.2The test is performed using spores of Bacillus subtilis. Additional and opti
47、onal exposure times, temperatures and strains are specified. Licensed Copy: sheffieldun sheffieldun, na, Mon Oct 30 04:53:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13704:2002 (E) 8 5.2 Materials and reagents 5.2.1 Test organisms The sporicidal activity shall be evaluated by using spores of th
48、e following strain : ? Bacillus subtilis ATCC 6633 1). If required for specific applications, additional strains may be chosen from, for example : ? Bacillus cereus ATCC 12826 1) ; ? Clostridium sporogenes CIP 7939 1). NOTE 1See annex G for corresponding strain numbers in some other culture collecti
49、ons. NOTE 2See annex C for particular culture and handling conditions for Clostridium sporogenes. If additional strains are used, they shall be incubated under optimum growth conditions (temperature, time, atmosphere) and noted in the test report. If the additional strains selected do not correspond to the specified strains, their suitability for supplying inocula of sufficient concentration shall be verified. If the additional strains tested are not classified at a reference centre their identification characteristics shall be stated. In a
链接地址:https://www.31doc.com/p-3739191.html