1、BRITISH STANDARD BS EN 14348:2005 Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants Test methods and requirements (phase 2, step 1) The European Standard
2、 EN 14348:2005 has the status of a British Standard ICS 11.080.20 BS EN 14348:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 9 February 2005 BSI 9 February 2005 ISBN 0 580 45419 3 National foreword This British Standard is the official
3、English language version of EN 14348:2005. The UK participation in its preparation was entrusted to 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.
4、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 Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or
5、 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 not of itself confer immunity from legal obligations. aid enquirers to understand the text
6、; 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 developments and promulgate them in the UK. Summary of pages This document comprises a front cove
7、r, an inside front cover, the EN title page, pages 2 to 36, an inside back cover 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. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM
8、 EN14348 January2005 ICS11.080.20 Englishversion ChemicaldisinfectantsandantisepticsQuantitativesuspension testfortheevaluationofmycobactericidalactivityofchemical disinfectantsinthemedicalareaincludinginstrument disinfectantsTestmethodsandrequirements(phase2,step1) DsinfectantschimiquesEssaiquantit
9、atifdesuspension pourlevaluationdelactivitmycobactricidedes dsinfectantschimiquesutilissenmdecineycomprisles dsinfectantspourinstrumentsMthodedessaiet prescriptions(phase2,tape1) ChemischeDesinfektionsmittelundAntiseptika QuantitativerSuspensionsversuchzurBestimmungder mykobakterizidenWirkungchemisc
10、herDesinfektionsmittel imhumanmedizinischenBereicheinschlielichder InstrumentendesinfektionsmittelPrfverfahrenund Anforderungen(Phase2,Stufe1) ThisEuropeanStandardwasapprovedbyCENon22November2004. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthis
11、Europe an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherl
12、anguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Irelan
13、d,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2005CEN Allrightsofexp
14、loitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN14348:2005:EEN 14348:2005 (E) 2 Contents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements.6 5 Test methods7 5.1 Principle7 5.2 Materials and reagents7 5.3 Appar
15、atus and glassware .10 5.4 Preparation of test organism suspensions and product test solutions 11 5.5 Procedure for assessing the mycobactericidal activity of the product.14 5.6 Experimental data and calculation.16 5.7 Verification of methodology .22 5.8 Expression of results and precision23 5.9 Int
16、erpretation of results - conclusion 23 5.10 Test report 24 Annex A (informative) Referenced strains in national collections.26 Annex B (informative) Suitable neutralizers .27 Annex C (informative) Graphical representations of the test method .29 Annex D (informative) Example of a typical test report
17、.31 Annex E (informative) Information on the application and interpretation of European standards on chemical disinfectants and antiseptics .33 Annex ZA (informative) Clauses of this document addressing essential requirements or other provisions of EU Directives.35 Bibliography 36 EN 14348:2005 (E)
18、3 Foreword This document (EN 14348:2005) 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
19、endorsement, at the latest by July 2005, and conflicting national standards shall be withdrawn at the latest by July 2005. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Medica
20、l 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 and will be evaluated to provide a precision annex to this document. Other methods to evaluate the efficacy of chemical disin
21、fectants and antiseptics for different applications in the medical area are in preparation. 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, Denm
22、ark, 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 14348:2005 (E) 4 Introduction This document describes a suspension test
23、 for establishing whether a chemical disinfectant has or does not have a mycobactericidal activity in the area defined in the scope. This laboratory test takes into account practical conditions of application of the product ,including contact time, temperature, test organisms and interfering substan
24、ces, i.e. conditions which may influence its action in practical situations. The conditions are intended to cover general purposes and to allow reference between laboratories and product types. Each concentration of the chemical disinfectant found by this test corresponds to the chosen experimental
25、conditions. However, for some applications the instructions of use of a product may differ and therefore additional test conditions need to be used. EN 14348:2005 (E) 5 1 Scope This document specifies a test method and the minimum requirements for mycobactericidal (or tuberculocidal) activity of che
26、mical disinfectant products 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
27、interfering substance. This document applies to products that are used in the medical area including those that are covered by the EEC/93/42 Directive on Medical Devices. This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care,
28、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 supplying products directly for the patient
29、s. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a phase 2, step 1 test (see Annex E). 2 Normative references The following referenced documents are indi
30、spensable for the application of this document. 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 microbial strains used for
31、the determination of bactericidal and fungicidal activity. EN 14820, Single-use containers for human venous blood specimen collection. 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 product chemical agent or formulation used as a chemical di
32、sinfectant or antiseptic 3.2 mycobactericide product which kills mycobacteria under defined conditions NOTE The adjective derived from “mycobactericide” is “mycobactericidal”. 3.3 mycobactericidal activity capability of a product to produce a reduction in the number of viable mycobacterial cells of
33、relevant test organisms under defined conditions EN 14348:2005 (E) 6 3.4 mycobacteriostatic activity capability of a product to inhibit the growth of mycobacteria under defined conditions 3.5 tuberculocide product which kills Mycobacterium tuberculosis under defined conditions NOTE The adjective der
34、ived from “tuberculocide” is “tuberculocidal”. 3.6 tuberculocidal activity capability of a product to kill Mycobacterium tuberculosis, demonstrated by the capability to produce a reduction in the number of viable cells of Mycobacterium terrae under defined conditions 3.7 clean conditions conditions
35、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 substances 4 Requir
36、ements 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 simulated dirty conditions (3 g/l bovine albumin solution, plus 3 ml/l washed sheep ery
37、throcytes) 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 concentration is
38、80 %). The mycobactericidal activity shall be evaluated using the following two test organisms: Mycobacterium avium and Mycobacterium terrae. The tuberculocidal activity shall be evaluated using the following test organism: Mycobacterium terrae. Where indicated, additional specific mycobactericidal
39、or tuberculocidal activity shall be determined applying other contact times, temperatures and interfering substances (5.5.1.1) in order to take into account intended specific use conditions. NOTE For these additional conditions, the concentration defined as a result can be lower than the one obtaine
40、d under the obligatory test conditions. EN 14348:2005 (E) 7 5 Test methods 5.1 Principle 5.1.1 A test suspension of mycobacteria in a solution of an interfering substance is added to a sample of the product as delivered and/or diluted with hard water (for ready to use products: water). The mixture i
41、s 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 mycobactericidal and/or the mycobacteriostatic activity in this portion is immediately neutralized or suppressed by a validated method. The numbers of surviving mycobacter
42、ia in each sample are determined and the reduction is calculated. 5.1.2 The test is performed using Mycobacterium avium and Mycobacterium terrae or only Mycobacterium terrae as test organisms (obligatory test conditions). 5.1.3 Additional and optional contact times and temperatures are specified. Ad
43、ditional interfering substances can be used. 5.2 Materials and reagents 5.2.1 Test organisms The mycobactericidal activity shall be evaluated using the following two test-organisms 1) : Mycobacterium avium ATCC 15769 Mycobacterium terrae ATCC 15755 The tuberculocidal activity shall be evaluated usin
44、g only Mycobacterium terrae. NOTE See annex A for corresponding strain reference in some other culture collections. 5.2.2 Culture media and reagents 5.2.2.1 General All weights of chemical substances given in this standard refer to the anhydrous salts. Hydrated forms may be used as an alternative, b
45、ut 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 toxic or inhibitory to the test organisms. NOTE 1 To improve reproduc
46、ibility, 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. NOTE 2 For each culture medium and reagent a limitation for use should
47、be fixed. 5.2.2.2 Water The water shall be freshly glass distilled water and not demineralized water. Sterilize in the autoclave (5.3.1). 1)The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collections (ATCC). This information is given for the convenience o
48、f users of this standard and does not constitute an endorsement by CEN of the product named. EN 14348:2005 (E) 8 NOTE 1 Sterilization is not necessary if the water is used - e.g. for preparation of culture 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 Middlebrook and Cohn 7 H 10 medium with 10 % OADC enrichment (MCO) Middlebrook 7 H 10 agar-powder 19,0 g Glycerol (C 3 H 8 O 3 ) (
