EN 14562-2006 en Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical are.pdf

1、BRITISH STANDARDBS EN 14562:2006Chemical disinfectants and antiseptics Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area Test method and requirements(phase 2, step 2)The European Standard EN 14562:2006 has the status of a Brit

2、ish StandardICS 11.080.20g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 14562:2006This British Standard was published under the authority of

3、the Standards Policy and Strategy Committee on 30 June 2006 BSI 2006ISBN 0 580 48608 7National forewordThis British Standard is the official English language version of EN 14562:2006.The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and antis

4、eptics, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under

5、 the section entitled “International Standards 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 applic

6、ation. Compliance with a British Standard does 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 UK interests informed; monitor

7、 related international and European developments and promulgate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page, pages 2 to 40, an inside back cover and a back cover.The BSI copyright notice displayed in this document indicates when the

8、document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 14562May 2006ICS 11.080.20English VersionChemical disinfectants and antiseptics - Quantitative carrier testfor the evaluation of fungicidal or yeasticidal activity fori

9、nstruments used in the medical area - Test method andrequirements (phase 2, step 2)Dsinfectants et antiseptiques chimiques - Essai quantitatifde porte germe pour lvaluation de lactivit fongicide oulevuricide pour instruments utiliss en mdecine humaine -Mthode dessai et prescriptions (phase 2, tape 2

10、)Chemische Desinfektionsmittel und Antiseptika -Quantitativer Keimtrgerversuch zur Prfung der fungizidenoder levuroziden Wirkung fr Instrumente imhumanmedizinischen Bereich - Prfverfahren undAnforderungen (Phase 2, Stufe 2)This European Standard was approved by CEN on 29 August 2005.CEN members are

11、bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the

12、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 translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status a

13、s the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Sloven

14、ia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN nation

15、al Members.Ref. No. EN 14562:2006: EEN 14562:2006 (E) 2 Contents page Foreword 3 Introduction4 1 Scope .5 2 Normative references .5 3 Terms and definitions.5 4 Requirements 6 5 Test method.6 5.1 Principle.6 5.2 Materials and reagents .7 5.3 Apparatus and glassware.9 5.5 Procedure for assessing the f

16、ungicidal / yeasticidal activity of the product .14 5.6 Experimental data and calculation 18 5.7 Verification of methodology.23 5.8 Expression of results and precision24 5.9 Interpretation of results conclusion .25 5.10 Test report .26 Annex A (informative) Referenced strains in national collections

17、.28 Annex B (informative) Suitable neutralizers.29 Annex C (informative) Graphical representations of the test method 31 Annex D (informative) Example of a typical test report.33 Annex E (informative) Information on the application and interpretation of European Standards on chemical disinfectants a

18、nd antiseptics37 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC39 Bibliography.40 EN 14562:2006 (E) 3 Foreword This European Standard (EN 14562:2006) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectan

19、ts 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 November 2006, and conflicting national standards shall be withdrawn at the latest b

20、y November 2006. Other methods to evaluate the efficacy of chemical disinfectants and antiseptics for different applications in the medical field are in preparation. A collaborative trial will be undertaken to provide a precision annex to this standard. This European Standard has been prepared under

21、 a mandate given to CEN by the European Commission and the European Free Trade Association and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. According to the CEN/CENELEC Internal Regula

22、tions, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Nor

23、way, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN 14562:2006 (E) 4 Introduction This European Standard specifies a carrier test for establishing whether a chemical disinfectant for use on instruments (surgical instruments, anaesthesia material, end

24、oscopes etc.) has a fungicidal or yeasticidal activity in the fields described in the scope. The laboratory test closely simulates practical conditions of application including pre-drying fungi on a carrier, contact time, temperature, test organisms and interfering substances i.e. conditions which m

25、ay influence the action of chemical disinfectants in practical situations. The obligatory conditions are intended to cover general purposes and to allow reference between laboratories and product types. Each utilization concentration of the chemical disinfectant found by this test corresponds to def

26、ined experimental conditions. However, for some applications the recommendations and/or instructions of use of a product may differ and therefore additional test conditions need to be used. EN 14562:2006 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for fu

27、ngicidal or yeasticidal activity of chemical disinfectant products for instruments that form a homogeneous, physically stable preparation when diluted with hard water or in the case of ready-to-use products with water. This European Standard applies to products that are used in the medical area for

28、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 indications occur in patient care, for example: in hospitals, in community medical

29、facilities and in dental institutions; in clinics of schools, of kindergardens 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 patients. NOTE This method corresponds to a phase 2, st

30、ep 2 test (see Annex E). 2 Normative references The following referenced documents are indispensable for the application of this European Standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) a

31、pplies. 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 European Standard, the following terms and definitions apply. 3.1 product chemical agent or f

32、ormulation used as a chemical disinfectant or antiseptic 3.2 fungicide product that kills fungi (moulds and yeasts) and their spores under defined conditions NOTE The adjective derived from “fungicide“ is “fungicidal“. 3.3 fungicidal activity capability of a product to produce a reduction in the num

33、ber of viable vegetative yeast cells and mould spores of relevant test organisms under defined conditions 3.4 yeasticide product that kills yeasts under defined conditions NOTE The adjective derived from “yeasticide“ is “yeasticidal“. EN 14562:2006 (E) 6 3.5 yeasticidal activity capability of a prod

34、uct to produce a reduction in the number of viable yeast cells of relevant test organisms under defined conditions 3.6 clean conditions conditions representative of surfaces which have been cleaned satisfactorily and/or are known to contain minimal levels of organic and/or inorganic substances 3.7 d

35、irty conditions conditions representative of surfaces which are known to or may contain organic and/or inorganic substances 4 Requirements The product, when diluted with hard water or in the case of ready-to-use products with water (5.2.2.2), and tested in accordance with Clause 5 under simulated cl

36、ean conditions (0,3 g/l bovine albumin solution) or simulated dirty conditions (3 g/l bovine albumin solution, plus 3 ml/l washed sheep erythrocytes) according to its practical applications and under the obligatory test conditions (two selected test organisms, 20 C, 60 min), shall demonstrate at lea

37、st adecimal log (lg) reduction in counts of 4. The fungicidal activity shall be evaluated using the following two test organisms: Candida albicans (vegetative cells) and Aspergillus niger (spores). The yeasticidal activity shall be evaluated using the following test organism: Candida albicans (veget

38、ative cells). Where indicated, additional specific fungicidal or yeasticidal activity shall be determined applying other contact times, temperatures, test organisms and interfering substances (5.5.1.1) in order to take into account intended specific use conditions. NOTE For these additional conditio

39、ns, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions. 5 Test method 5.1 Principle 5.1.1 A test suspension of fungi (yeast cells or mould spores) in a solution of interfering substances is spread on a glass carrier. After drying the carrier

40、 is immersed into a sample of the product as delivered and/or diluted with hard water (for ready to use products: water). The carrier is maintained at 20 C 1 C for 60 min 10 s (obligatory test conditions). At the end of this contact time, the carrier is transferred into a neutralizer containing glas

41、s beads. The yeast cells or mould spores are to be severed from the surface by shaking. The numbers of surviving yeast cells or mould spores in each sample are determined and the reduction is calculated. 5.1.2 The test is performed using Candida albicans and Aspergillus niger or only Candida albican

42、s as test organisms (obligatory test conditions). 5.1.3 Additional and optional contact times and temperatures are specified. Additional interfering substances can be used. EN 14562:2006 (E) 7 5.2 Materials and reagents 5.2.1 Test organisms The fungicidal activity shall be evaluated using the follow

43、ing strains as test or organisms1): Candida albicans ATCC 10231 Aspergillus niger ATCC 16404 The yeasticidal activity shall be evaluated using only Candida albicans ATCC 10231. NOTE See Annex A for strain references in some other culture collections. The required incubation temperature for these tes

44、t organisms is 30 C 1 C (5.3.2.3) If additional test organisms are used, they shall be incubated under optimum growth conditions (temperature, time, atmosphere, media) noted in the test report. If the additional test organisms selected do not correspond to the specified strains, their suitability fo

45、r supplying the required inocula shall be verified. If these additional test organisms 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 culture collection under a reference for five y

46、ears. 5.2.2 Culture media and reagents 5.2.2.1 General All weights of chemical substances given in this European Standard refer to the anhydrous salts. Hydrated forms may be used as an alternative, but the weights required shall be adjusted to allow for consequent molecular weight differences. The r

47、eagents 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 reproducibility, it is recommended that commercially available dehydrated material is used for the preparatio

48、n 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 be fixed. 5.2.2.2 Water The water shall be freshly glass distilled water and not demineralized water.

49、 Sterilize in the autoclave (5.3.1). 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. NOTE 3 See 5.2.2.7 for the procedure to prepare hard water. 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 of users of thi