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1、BRITISH STANDARD BS EN 13624:2003 Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area Test method and requirements (phase 2, step 1) The European Standard EN 13624:2003 has th
2、e status of a British Standard ICS 11.080.20 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 13624:2003 This British Standard, was published under the authority of the Standards Policy and Strategy Committee on 15 December 2003 BSI 1
3、5 December 2003 ISBN 0 580 43089 8 National foreword This British Standard is the official English language version of EN 13624:2003. The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics, which has the responsibility to: A list o
4、f organizations represented on this committee 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 Catalogue under the section entitled “International Standards
5、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 provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does
6、 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 proposals for change, and keep the UK interests informed; monitor related international and European develo
7、pments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 39 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication
8、 Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13624 December 2003 ICS 11.080.20 English version Chemical disinfectants and antiseptics - Quantitative suspension te
9、st for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1) Antiseptiques et dsinfectants chimiques - Essai quantitatif de suspension pour lvaluation de lactivit fongicide desdsinfectants chimiques u
10、tiliss pour les instruments en mdecine - Mthode dessai et prescriptions (phase 2, tape 1) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Prfung der fungiziden Wirkung chemischer Desinfektionsmittel fr Instrumente im humanmedizinischen Bereich - Prfverfahren und
11、Andforderungen (Phase 2, Stufe 1) This European Standard was approved by CEN on 3 November 2003. 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-
12、date lists and bibliographical 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
13、 responsibility of a CEN member 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, Hungary, Iceland, Ireland, Italy, Lu
14、xembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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 2003 CENAll rights of exploitation in a
15、ny form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13624:2003 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13624:2003 (E) 2 ContentsPage Foreword. 3 Introduction 4 1Scope . 5 2Normative references . 5 3
16、Terms and definitions. 5 4Requirements 6 5Test methods. 7 5.1Principle. 7 5.2Materials and reagents. 7 5.3Apparatus and glassware 10 5.4Preparation of test organism suspensions and product test solutions . 11 5.5Procedure for assessing the fungicidal activity of the product. 14 5.6Experimental data
17、and calculation 19 5.7Verification of methodology 23 5.8Expression of results and precision. 24 5.9Interpretation of results - conclusion . 25 5.10Test report . 25 Annex A (informative) Referenced strains in national collections 27 Annex B (informative) Neutralizer and Rinsing liquids 28 B.1Neutrali
18、zers 28 B.2Rinsing liquids 29 B.3Neutralizer added to the agar for counting : 29 Annex C (informative) Flow diagrams 30 C.1Dilution neutralization method 30 C.2Membrane filtration method. 31 Annex D (informative) Example of a typical test report 34 Annex E (informative) Information on the applicatio
19、n and interpretation of European standards on chemical disinfectants and antiseptics 36 E.1Introduction 36 E.2General guidelines for the application and interpretation of test methods in accordance with European Standards for chemical disinfectants and antiseptics 36 E.3Guide to the interpretation o
20、f tests for chemical disinfectants and antiseptics 37 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives. 38 Bibliography. 39 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy
21、, (c) BSI EN 13624:2003 (E) 3 Foreword This document (EN 13624:2003) 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
22、 of an identical text or by endorsement, at the latest by June 2004, and conflicting national standards shall be withdrawn at the latest by June 2004. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essenti
23、al requirements of EU Medical Devices Directive 93/42. For relationship with EU Directive, see informative annex ZA, which is an integral part of this document. A collaborative trial has been undertaken to provide a precision annex to this standard. Other methods to evaluate the efficacy of chemical
24、 disinfectants and antiseptics for different applications in the medical field are in preparation. Annexes A, 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 Standa
25、rd: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00
26、2006, Uncontrolled Copy, (c) BSI EN 13624:2003 (E) 4 Introduction This European Standard describes a suspension test for establishing whether a chemical disinfectant for use on instruments (surgical instruments, anaesthesia material, endoscopes etc.) has or does not have a fungicidal activity in the
27、 area described in the scope. In this laboratory test chosen conditions include contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence the action of chemical disinfectants in practical situations. The conditions are intended to cover general purpose
28、s and to allow reference between laboratories and product types. Each concentration of the chemical disinfectant found by this test corresponds to the chosen experimental conditions. However, for some applications the instructions of use of a product may differ and therefore additional test conditio
29、ns need to be used. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13624:2003 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant produ
30、cts that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use products - 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 interfering substance. T
31、his European Standard applies to products that are used in the medical area for disinfecting instruments by immersion - even if they are not covered by the EEC/93/42 Directive on Medical Devices. This European Standard applies to areas and situations where disinfection is medically indicated. Such i
32、ndications occur in patient care, for example : in hospitals, in community medical facilities and in dental institutions ; in clinics of schools, of kindergartens and of nursing homes ; and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supply
33、ing products directly for the patients. NOTE 1The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2This method corresponds to a phase 2 step 1 test (see annex E). 2 Normative references This Euro
34、pean 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 hereafter. For dated references, subsequent amendments to or revisions of any of these publications
35、 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 12353, Chemical disinfectants and antiseptics Preservation of microbial strains used for the determinati
36、on of bactericidal and fungicidal activity. ISO 4793, Laboratory sintered (fritted) filters Porosity grading, classification and designation. ISO 6710, Single-use containers for venous blood specimen collection. 3 Terms and definitions For the purposes of this European Standard, the following terms
37、and definitions apply. 3.1 product chemical agent or formulation used as chemical disinfectant or antiseptic Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13624:2003 (E) 6 3.2 fungicide product which kills fungi and their spores under d
38、efined conditions Adjective : fungicidal 3.3 fungicidal activity capability of a product to produce a reduction in the number of viable vegetative yeast cells and mould spores of relevant test organisms under defined conditions 3.4 fungistatic activity capability of a product to inhibit the growth o
39、f fungi under defined conditions 3.5 yeasticide product which kills yeasts under defined conditions Adjective : yeasticidal 3.6 yeasticidal activity capability of a product to produce a reduction in the number of viable yeast cells of relevant test organisms under defined conditions 3.7 clean condit
40、ions conditions representative of surfaces which have received a satisfactory cleaning programme and/or are known to contain minimal levels of organic and/or inorganic substances 3.8 dirty conditions conditions representative of surfaces which are known to or may contain, organic and/or inorganic su
41、bstances 4 Requirements The product, when diluted with hard water or - in the case of ready-to-use products - with water and tested in accordance with clause 5 under simulated clean conditions (0,3 g/l bovine albumin solution) or dirty conditions (3 g/l bovine albumin solution plus 3 ml/l washed she
42、ep erythrocytes) according to its practical applications and under the obligatory test conditions (one or two selected test organisms, 20 C, 60 min), shall demonstrate at least a decimal log (lg) reduction in counts of 4. It is possible to test also the product as delivered (highest test concentrati
43、on = 80 %). The fungicidal activity shall be evaluated using the following two test organisms : Aspergillus niger and Candida albicans. The yeasticidal activity shall be evaluated using the following test organism : Candida albicans. Where indicated, additional specific fungicidal or yeasticidal act
44、ivity shall be determined applying other contact times, temperatures and interfering substances (see 5.5.1.1) in order to take into account intended specific use conditions. NOTEFor these additional conditions, the concentration defined as a result can be lower than the one obtained under the obliga
45、tory test conditions. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13624:2003 (E) 7 5 Test methods 5.1 Principle 5.1.1A test suspension of fungi (yeast cells and mould spores) in a solution of an interfering substance is added to a sam
46、ple of the product as delivered and/or diluted with hard water (for ready to use products: water). The mixture is maintained at 20 C 1 C for 60 min 10 s (obligatory test conditions). At the end of this contact time, an aliquot is taken; the fungicidal and/or the fungistatic action in this portion is
47、 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 fungi in each sample are determined and the reduction is calculated. 5.1.2The test is perfor
48、med using the spores of Aspergillus niger and the vegetative cells of Candida albicans or only the vegetative cells of Candida albicans as test organisms (obligatory test conditions). 5.1.3Additional and optional contact times and temperatures are specified. Additional interfering substances can be
49、used. 5.2 Materials and reagents 5.2.1 Test organisms The fungicidal activity shall be evaluated using the following two test organisms1) : Candida albicansATCC 10231 ; Aspergillus nigerATCC 16404. The yeasticidal activity shall be evaluated using only Candida albicans. NOTESee annex A for corresponding strain reference in some other culture collections. 5.2.2 Culture media and reagents 5.2.2.1 General The reagents shall be of analytical grade and/or appropriate for microbiol