《BS-EN-1650-1998.pdf》由会员分享，可在线阅读，更多相关《BS-EN-1650-1998.pdf（28页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS EN 1650:1998 Incorporating Corrigendum No. 1 Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas Test method and requirem
2、ents (phase 2, step 1) The European Standard EN 1650:1997 has the status of a British Standard ICS 11.080 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:59 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1650:1998 This British Standard, having been prepared under the direction of th
3、e Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 May 1998 BSI 17 September 2002 ISBN 0 580 29449 8 National foreword This British Standard is the English language version of EN 1650:1997. Together with BS EN 1276:1997 it supe
4、rsedes DD 177:1998 which is withdrawn. 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
5、-references The 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 B
6、ritish 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 text; pre
7、sent 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. Summary of pages This document comprises a front cover, an inside front
8、cover, the EN title page, pages 2 to 25 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No.DateComments 13800 Corrigendum No. 1 17 September 2002 Addition of supersession details to national f
9、oreword Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:59 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1650 December 1997 ICS 07.100.01; 11.080 Descriptors: Disinfectant, chemical compounds, tests, estimation, fungicides, culture media
10、, dilution, neutralizing, preparation, filtration analysis English version Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas Test method a
11、nd requirements (phase 2, step 1) Antiseptiques et dsinfectants chimiques Essai quantitatif de suspension pour lvaluation de lactivit fongicide des antiseptiques et des dsinfectants chimiques utiliss dans le domaine de lagro-alimentaire, dans lindustrie, dans les domaines domestiques et en collectiv
12、it Mthode dessai et prescriptions (phase 2, tape 1) Chemische Desinfektionsmittel und Antiseptika Quantitativer Suspensionsversuch zur Bestimmung der fungiziden Wirkung chemischer Desinfektionsmittel und Antiseptika in den Bereichen Lebensmittel, Industrie, Haushalt und ffentliche Einrichtungen Prfv
13、erfahren und Anforderungen (Phase 2, Stufe 1) This European Standard was approved by CEN on 9 November 1997. 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 altera
14、tion. Up-to-date lists and bibliographical references concerning such national standards 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 transla
15、tion under the responsibility of a CEN member into its own language and notified to the Central Secretariat 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, It
16、aly, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any
17、form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1650:1997 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:59 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 1650:1997 BSI 17 September 20022 Foreword This European Standard has been prepared by Technical Com
18、mittee 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 1998, and conflicting national standards
19、shall be withdrawn at the latest by June 1998. A collaborative trial is currently being undertaken and will be used to provide a precision annex to this standard. Other methods to evaluate the efficacy of chemical disinfectants and antiseptics for different fields of application are in preparation.
20、Annex A is normative. Annex B, Annex C, Annex D, Annex E and Annex F 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, Finland,
21、France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 0Introduction3 1Scope3 2Normative references4 3Definitions4 3.1product (for chemical disinfection and/or antisepsis4 3.2fungicide4 3
22、.3fungicidal activity (EN 1650)4 3.4clean conditions4 3.5dirty conditions4 4Requirements5 5Test methods5 5.1Principle5 5.2Materials and reagents5 5.3Apparatus and glassware8 5.4Preparation of fungal suspensions and test solutions9 5.5Procedure10 5.6Calculation and expression of results13 5.7Conclusi
23、on15 5.8Test report15 Annex A (normative) Validation of dilution-neutralization and membrane filtration methods17 Annex B (informative) Neutralizers21 Annex C (informative) Rinsing liquids and neutralizers added to the agar for counting21 Annex D (informative) Example of a typical test report22 Anne
24、x E (informative) Referenced strains in national collections24 Annex F (informative) Information on the application and interpretation of European Standards on chemical disinfectants and antiseptics25 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:59 GMT+00:00 2006, Uncontrolled Copy,
25、(c) BSI EN 1650:1997 BSI 17 September 2002 3 0 Introduction This European Standard describes a suspension test method for establishing whether a chemical disinfectant or antiseptic has or does not have a fungicidal activity in the fields described in clause 1. The laboratory test closely simulates p
26、ractical conditions of application. Chosen conditions (contact time, temperature, organisms in suspension, .) reflect parameters which are found in practical situations, including conditions which may influence the action of antiseptics or disinfectants. Each utilization concentration found from thi
27、s test corresponds to defined experimental 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 may differ and therefore additional test conditions need
28、to be used. 1 Scope This European Standard specifies a test method (phase 2, step 1) and the minimum requirements for fungicidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation in hard water and that are used in food, industrial, domes
29、tic 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) processing, distribution and
30、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 (including sugar, distillery .); flour, milling and baking
31、; animal feeds; etc. b) institutional and domestic areas: catering establishments; public areas; public transport; schools; nurseries; shops; sports rooms; waste containers (bins .); hotels; dwellings; clinically non-sensitive areas of hospitals; offices; etc. Licensed Copy: sheffieldun sheffieldun,
32、 na, Fri Nov 17 08:03:59 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 1650:1997 4 BSI 17 September 2002 c) other industrial areas: packaging material; biotechnology (yeast, proteins, enzymes, .); pharmaceutical; cosmetics and toiletries; textiles; space industry, computer industry; etc. Using this
33、European Standard, it is not possible to determine the fungicidal activity of undiluted product as some dilution is always produced by adding the inoculum and interfering substance. Products can only be tested at a concentration of 80 % or less. NOTEThe method described is intended to determine the
34、activity of commercial formulations or active substances on fungi in the conditions in which they are used. 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
35、the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this draft European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication refer
36、red to applies. EN 1275, Chemical disinfectants and antiseptics Basic fungicidal activity Test method and requirements (phase 1). prEN 12353, Chemical disinfectants and antiseptics Preservation of microbial strains used for the determination of bactericidal and fungicidal activity. ISO 4793, Laborat
37、ory sintered (fritted) filters Porosity grading, classification and designation. 3 Definitions For the purposes of this European Standard, the following definitions apply: 3.1 product (for chemical disinfection and/or antisepsis) chemical agent or formulation used as a chemical disinfectant or antis
38、eptic EN 1040 3.2 fungicide product which kills fungi including their spores under defined conditions EN 1275 NOTEThe adjective derived from “fungicide” is “fungicidal”. 3.3 fungicidal activity (EN 1650) capability of a product to produce at least a 104 reduction in the number of viable vegetative y
39、east cells and mould spores belonging to reference strains of Candida albicans and Aspergillus niger 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
40、 levels of organic and/or inorganic materials 3.5 dirty conditions conditions representative of surfaces which are known to or may contain organic and/or inorganic materials Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:59 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 1650:1997 BSI 17
41、 September 2002 5 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) or dirty conditions (3 g/l bovine albumin, see 3.5) according to its practical applications and under the required test c
42、onditions (20?C, 15 min, two selected reference strains), shall demonstrate at least a 104 log reduction in viable counts. The fungicidal activity shall be evaluated using the following two strains: Candida albicans and Aspergillus niger. The determined fungicidal concentration of the test product i
43、s suggested as being suitable for practical situations of use. Where appropriate, additional specific fungicidal activity shall be determined under other conditions of time, temperature, additional strains and interfering substances (see 5.2.1 and 5.5.1) in accordance with 5.5.1 in order to take int
44、o account intended specific use conditions. NOTEFor these additional conditions, the concentration defined as a result can be lower than the one obtained under the initial test conditions of 20?C, 15 min and two selected reference strains. 5 Test method 5.1 Principle 5.1.1 A test suspension of yeast
45、 cells or mould spores in a solution of interfering substances is added to a prepared sample of the product under test diluted in hard water. The mixture is maintained at 20?C 1?C for 15 min 10 s (required test conditions). After this contact time, an aliquot is taken; the fungicidal action in this
46、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 number of surviving yeast cells or mould spores in each sample is determined and the reduction in viabl
47、e counts is calculated. 5.1.2 The test is performed using vegetative cells of Candida albicans and spores of Aspergillus niger. Additional and optional exposure times, temperatures, strains, and interfering substances are specified. 5.2 Materials and reagents 5.2.1 Test organisms The fungicidal acti
48、vity shall be evaluated using the following two strains: 1) NOTESee Annex E for corresponding strain numbers in some other culture collections. If additional strains are used, they shall be incubated under optimum growth conditions (temperature, time, atmosphere) and noted in the test report. If the
49、 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 addition, they shall be held by the testing laboratory or national collection under a ref