EN 1650-2008 en Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antisep.pdf

1、BRITISH STANDARD BS EN1650:2008Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas Test method and requirements (phase 2, step

2、 1)ICS 71.100.35nullnull nullnullnullnullnullnullnull nullnullnullnullnullnullnull nullnullnull nullnullnullnullnullnullnullnullnullnull nullnullnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnull nullnullnullnullnullnullnullnullnull nullnullnull+A1:2013National forewordThis Brit

3、ish Standard is the UK implementation of EN 1650:2008+A1:2013. It supersedes BS EN 1650:2008 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to CEN text carry the number of the CEN amendment. For example, te

4、xt altered by CEN amendment A1 is indicated by !“.The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not pu

5、rport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN 1650:2008+A1:2013This British Standard waspublished under the authorityof the Standards Policy andStra

6、tegy Committeeon 30 June 2008 The British StandardsInstitution 2013. Publishedby BSI Standards Limited2013Amendments/corrigenda issued since publicationDate Comments 30 June 2013 Implementation of CEN amendment A1:2013ISBN 978 0 580 80140 2EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1650:20

7、08+A1 May 2013 ICS 71.100.35 Supersedes EN 1650:2008 English Version Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas - T

8、est method and requirements (phase 2, step 1) Antiseptiques et dsinfectants chimiques - Essai quantitatif de suspension pour lvaluation de lactivit fongicide ou levuricide des antiseptiques et des dsinfectants chimiques utiliss dans le domaine de lagro-alimentaire, dans lindustrie, dans les domaines

9、 domestiques et en collectivit - Mthode dessai et prescriptions (phase 2, tape 1) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika in den Bereichen Lebensmittel, Indu

10、strie, Haushalt und ffentliche Einrichtungen - Prfverfahren und Anforderungen (Phase 2, Stufe 1) This European Standard was approved by CEN on 5 April 2008 and includes Amendment 1 approved by CEN on 28 March 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipu

11、late the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European S

12、tandard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the

13、national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,

14、 Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reser

15、ved worldwide for CEN national Members. Ref. No. EN 1650:2008+A1:2013: E Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 6 3 Terms and definitions .6 4 Requirements .6 5 Test method 7 5.1 Principle 7 5.2 Materials and reagents 7 5.3 Apparatus and glassware 11 5.4 Preparatio

16、n of test organism suspensions and product test solutions . 13 5.5 Procedure for assessing the fungicidal or yeasticidal activity of the product 18 5.6 Experimental data and calculation 24 5.7 Verification of methodology 27 5.8 Expression of results and precision . 28 5.9 Interpretation of results -

17、 conclusion . 29 5.10 Test report . 29 Annex A (informative) Referenced strains in national collections 31 Annex B (informative) Examples of neutralizers of the residual antimicrobial activity of chemical disinfectants and antiseptics and rinsing liquids . 32 Annex C (informative) Graphical represen

18、tations of dilution-neutralization method and membrane filtration method 34 Annex D (informative) Example of a typical test report 38 Annex E (informative) Precision of the test result 44 Bibliography . 47 BS EN 1650:2008+A1:2013 EN 1650:2008+A1:2013 (E)2 Foreword This document (EN 1650:2008+A1:2013

19、) 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 endorsement, at the latest by November

20、2013, and conflicting national standards shall be withdrawn at the latest by November 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent ri

21、ghts. This document includes Amendment 1, approved by CEN on 2013-03-28. This document supersedes !EN 1650:2008“. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. This European Standard was revised to include the results of a collaborative trial (A

22、NDISTAND), to correct obvious errors and ambiguities, to harmonize the structure and wording with other quantitative suspension tests of CEN/TC 216 (existing or in preparation), and to improve the readability of the standard and thereby make it more understandable. According to the CEN/CENELEC Inter

23、nal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ir

24、eland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 1650:2008+A1:2013 EN 1650:2008+A1:2013 (E)3 Introduction This European Standard specifies a suspension test for est

25、ablishing whether a chemical disinfectant or antiseptic has or does not have a fungicidal or yeasticidal activity in the fields described in the scope. This laboratory test takes into account practical conditions of application of the product including contact time, temperature, test organisms and i

26、nterfering substance, 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 utilization concentration of the chemical disinfectant or antiseptic found by this t

27、est corresponds to defined experimental conditions. However, for some applications the recommendations of use of a product may differ and therefore additional test conditions should be used. BS EN 1650:2008+A1:2013 EN 1650:2008+A1:2013 (E)4 1 Scope This document specifies a test method and the minim

28、um requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic 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 % o

29、r less as some dilution is always produced by adding the test organisms and interfering substance. This document applies to products that are used in food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products use

30、d on living tissues except those for hand hygiene in the above considered areas. The following areas are at least included: a) processing, distribution and retailing of: 1) food of animal origin: 2) food of vegetable origin: milk and milk products; beverages; meat and meat products; fruits, vegetabl

31、es and derivatives (including sugar, distillery .); fish, seafood, and related products; flour, milling and baking; eggs and egg products; animal feeds; animal feeds; etc. etc. b) institutional and domestic areas: catering establishments; public areas; public transports; schools; nurseries; shops; s

32、ports rooms; waste containers (bins .); hotels; dwellings; clinically non-sensitive areas of hospitals; offices; etc. BS EN 1650:2008+A1:2013 EN 1650:2008+A1:2013 (E)5 c) other industrial areas: packaging material; biotechnology (yeast, proteins, enzymes, .); pharmaceutical; cosmetics and toiletries

33、; textiles; space industry, computer industry; etc. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions i

34、n which they are used. NOTE 2 This method corresponds to a phase 2 step 1 test. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the re

35、ferenced document (including any amendments) applies. EN 12353, Chemical disinfectants and antiseptics Preservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity EN 14885, Chemical disinfectants and antiseptics Application of Europ

36、ean Standards for chemical disinfectants and antiseptics ISO 4793, Laboratory sintered (fritted) filters Porosity grading, classification and designation 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 14885 apply. 4 Requirements The product shall dem

37、onstrate a reduction of at least a 4 decimal log (lg) when diluted with hard water (5.2.2.7) or - in the case of ready-to-use products - with water (5.2.2.2) and tested in accordance with Clause 5 under simulated clean conditions (0,3 g/l bovine albumin solution - 5.2.2.8.2) or simulated dirty condi

38、tions (3 g/l bovine albumin solution - 5.2.2.8.3) according to its practical applications and under the other obligatory test conditions (one or two selected test organisms, 20 C, 15 min). The fungicidal activity shall be evaluated using the following two test organisms: Candida albicans (vegetative

39、 cells); BS EN 1650:2008+A1:2013 EN 1650:2008+A1:2013 (E)6 Aspergillus niger (spores). The yeasticidal activity shall be evaluated using the following test organism: Candida albicans (vegetative cells); Where indicated, additional specific fungicidal or yeasticidal activity shall be determined apply

40、ing other contact times, temperatures, interfering substances and test organisms (in accordance with 5.2.1, 5.2.2.8 and 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 obtai

41、ned under the obligatory test conditions. 5 Test method 5.1 Principle 5.1.1 A sample of the product as delivered and/or diluted with hard water (or water for ready to use products) is added to a test suspension of fungi (yeast cells or mould spores) in a solution of an interfering substance. The mix

42、ture is maintained at (20 1) C for 15 min 10 s (obligatory test conditions). At the end of this contact time, an aliquot is taken, and the fungicidal and/or the fungistatic activity in this portion is immediately neutralized or suppressed by a validated method. The method of choice is dilution-neutr

43、alization. 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. 5.1.2 The test is performed using the vegetative cells of Candida albicans and the spores of Aspergillus niger (fungicidal

44、activity) or only the vegetative cells of Candida albicans (yeasticidal activity) as test organisms (obligatory test conditions). 5.1.3 Additional and optional contact times and temperatures are specified. Additional test organisms can be used. 5.2 Materials and reagents 5.2.1 Test organisms The fun

45、gicidal activity shall be evaluated using the following strains as test organisms:1) Candida albicans ATCC 10231 Aspergillus niger ATCC 16404 The yeasticidal activity shall be evaluated using only Candida albicans. NOTE See annex A for strain references in some other culture collections. The require

46、d incubation temperature for these test organisms is (30 1) C (5.3.2.3). If required for specific applications, additional strains may be chosen from, e.g. for breweries: 1)The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collection (ATCC). This informatio

47、n is given for the convenience of users of this standard and does not constitute an endorsement by CEN of the product named. BS EN 1650:2008+A1:2013 EN 1650:2008+A1:2013 (E)7 Saccharomyces cerevisiae DSM 1333 Saccharomyces cerevisiae var. diastaticus DSM 70487 If additional test organisms are used,

48、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 for supplying the required inocula shall be verified. If these additional t