BS EN 14561-2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test meth.pdf

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1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58test for the evaluation of bactericidal activity for instruments used in the medical area Test meth

2、od and requirements (phase 2, step 2)The European Standard EN 14561:2006 has the status of a British StandardICS 11.080.20Chemical disinfectants and antiseptics Quantitative carrier BRITISH STANDARDBS EN 14561:2006BS EN 14561:2006This British Standard was published under the authority of the Standar

3、ds Policy and Strategy Committee on 30 June 2006 BSI 2006ISBN 0 580 48607 9request 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 the section entitled “International St

4、andards 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 Standa

5、rd does not of itself confer immunity from legal obligations.Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page, pages 2 to 37 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issu

6、ed since publicationAmd. No. Date CommentsA list of organizations represented on this committee can be obtained on present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international a

7、nd European developments and promulgate them in the UK.National forewordThis British Standard is the official English language version of EN 14561:2006.The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics, which has the responsib

8、ility to: aid enquirers to understand the text;EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 14561May 2006ICS 11.080.20English VersionChemical disinfectants and antiseptics - Quantitative carrier testfor the evaluation of bactericidal activity for instruments used inthe medical area - Test metho

9、d and requirements (phase 2, step2)Dsinfectants et antiseptiques chimiques - Essai quantitatifde porte germe pour lvaluation de lactivit bactricidepour instruments utiliss en mdecine humaine - Mthodedessai et prescriptions (phase 2, tape 2)Chemische Desinfektionsmittel und Antiseptika -Quantitativer

10、 Keimtrgerversuch zur Prfung derbakteriziden 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 bound to comply with the CEN/CENELEC Internal Regulations which stipulate th

11、e 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 Central Secretariat or to any CEN member.This European Standard exists in th

12、ree 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 as the officialversions.CEN members are the national standards bodies of Aust

13、ria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STA

14、NDARDIZATIONCOMIT 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 national Members.Ref. No. EN 14561:2006: EEN 14561:2006 (E) 2 Contents page Forewo

15、rd 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 .6 5.3 Apparatus and glassware.9 5.4 Preparation of test organism suspensions and product test solutions .11 5.5 Procedure for assessing the b

16、actericidal activity of the product .13 5.6 Experimental data and calculation 16 5.7 Verification of methodology.22 5.8 Expression of results and precision22 5.9 Interpretation of results conclusion .23 5.10 Test report .24 Annex A (informative) Referenced strains in national collections26 Annex B (

17、informative) Suitable neutralizers.27 Annex C (informative) Graphical representations of the test method 29 Annex D (informative) Example of a typical test report.31 Annex E (informative) Information on the application and interpretation of European Standards on chemical disinfectants and antiseptic

18、s34 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC36 Bibliography.37 EN 14561:2006 (E) 3 Foreword This European Standard (EN 14561:2006) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antise

19、ptics”, 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 by November 20

20、06. 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 a mandate gi

21、ven 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 Regulations, the na

22、tional 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, Norway, Poland,

23、Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN 14561:2006 (E) 4 Introduction This European Standard specifies a carrier test for establishing whether a chemical disinfectant for use on instruments (surgical instruments, anaesthesia material, endoscopes etc.)

24、 has a bactericidal activity in the fields described in the scope. The laboratory test closely simulates practical conditions of application including pre-drying bacteria on a carrier, contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence the actio

25、n 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 defined experimental cond

26、itions. However, for some applications the recommendations of use of a product may differ and therefore additional test conditions need to be used. EN 14561:2006 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfecta

27、nt products 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 disinfecting instruments by immersion even if they are not covered by t

28、he 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 facilities and in dental institutions; in clinics of schools, of kinder

29、gardens 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, step 2 test (see Annex E). 2 Normative references The following reference

30、d 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) applies. EN 12353, Chemical disinfectants and antiseptics Preservation o

31、f test organisms used for the determination of bactericidal, sporicidal 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 formulation used as a chemical disinfectant or antiseptic 3.2 b

32、actericide product that kills vegetative bacteria under defined conditions NOTE The adjective derived from “bactericide“ is “bactericidal“. 3.3 bactericidal activity capability of a product to produce a reduction in the number of viable bacterial cells of relevant test organisms under defined condit

33、ions 3.4 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 EN 14561:2006 (E) 6 3.5 dirty conditions conditions representative of surfaces which are known to or may contain or

34、ganic and/or inorganic substances 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 simulated dirty conditions (3 g/l bovine albumin

35、 solution, plus 3 ml/l washed sheep erythrocytes) according to its practical applications and under the obligatory test conditions (three selected test organisms, 20 C, 60 min), shall demonstrate at least a decimal log (lg) reduction in counts of 5. The bactericidal activity shall be evaluated using

36、 the following three test organisms: Pseudomonas aeruginosa, Staphylococcus aureus and Enterococcus hirae. Where indicated, additional specific bactericidal activity shall be determined applying other contact times, temperatures, test organisms and interfering substances (5.5.1.1) in order to take i

37、nto account intended specific use conditions. NOTE For these additional conditions, 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 bacteria in a solution of interfering substances i

38、s spread on a glass carrier. After drying the carrier 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 carr

39、ier is transferred into a neutralizer containing glass beads. The bacteria are to be severed from the surface by shaking. The numbers of surviving bacteria in each sample are determined and the reduction is calculated. 5.1.2 The test is performed using Pseudomonas aeruginosa, Staphylococcus aureus a

40、nd Enterococcus hirae as test-organisms (obligatory test conditions). 5.1.3 Additional and optional contact times and temperatures are specified. Additional interfering substances can be used. 5.2 Materials and reagents 5.2.1 Test organisms The bactericidal activity shall be evaluated using the foll

41、owing strains as test organisms1): Pseudomonas aeruginosa ATCC 15442 Staphylococcus aureus ATCC 6538 Enterococcus hirae ATCC 10541 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 user

42、s of this European Standard and does not constitute an endorsement by CEN of the product named. EN 14561:2006 (E) 7 NOTE See Annex A for strain references in some other culture collections. The required incubation temperature for these test organisms is 36 1 C or 37 C 1 (5.3.2.3). The same temperatu

43、re (either 36 C or 37 ) shall be used for all incubations performed during a test and its control and validation. 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 org

44、anisms selected do not correspond to the specified strains, their suitability for 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 th

45、e testing laboratory or national culture collection under a reference for five years. 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 requir

46、ed 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 reproducibility, it is recomm

47、ended 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 be fixed. 5.2.2.2 Wat

48、er The water shall be freshly glass distilled water and not demineralized water. 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 avai

49、lable, water for injections (see bibliographic reference 1) can be used. NOTE 3 See 5.2.2.7 for the procedure to prepare hard water. 5.2.2.3 Tryptone Soya Agar (TSA) Tryptone, pancreatic digest of casein 15,0 g Soya peptone, papaic digest of Soybean meal 5,0 g Sodium Chloride (NaCl) 5,0 g Agar 15,0 g Water (5.2.2.2) to 1 000,0 mlSterilize in the autoclave (5.3.1). After sterilization the pH of the medium shall be equivalent to 7,2 0,2 when measured at (20 1)