DIN EN 13624-2013 en 7502 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test .pdf

1、December 2013 Translation by DIN-Sprachendienst.English price group 21No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I

2、CS 11.080.20!%*zK“2078740www.din.deDDIN EN 13624Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of fungicidal oryeasticidal activity in the medical area Test method and requirements (phase 2, step 1);English version EN 13624:2013,English translation of DIN EN 1

3、3624:2013-12Chemische Desinfektionsmittel und Antiseptika Quantitativer Suspensionsversuch zur Prfung der fungiziden oder levuroziden Wirkungim humanmedizinischen Bereich Prfverfahren und Anforderungen (Phase 2, Stufe 1);Englische Fassung EN 13624:2013,Englische bersetzung von DIN EN 13624:2013-12Ds

4、infectants chimiques et antiseptiques Essai quantitatif de suspension pour lvaluation de lactivit fongicide ou levuricide enmdecine Mthode dessai et prescriptions (phase 2, tape 1);Version anglaise EN 13624:2013,Traduction anglaise de DIN EN 13624:2013-12SupersedesDIN EN 13624:2004-02www.beuth.deIn

5、case of doubt, the German-language original shall be considered authoritative.Document comprises 56 pages 11.13 DIN EN 13624:2013-12 2 A comma is used as the decimal marker. National foreword This document (EN 13624:2013) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants an

6、d antiseptics” (Secretariat: AFNOR, France), Working Group WG 1 “Human medicine” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-04-07 AA Chemische Desinfektionsmittel und Ant

7、iseptika in der Humanmedizin. Amendments This standard differs from DIN EN 13624:2004-02 as follows: a) Clause 1 “Scope” has been expanded for the following fields of application within the medical area: products for surgical and/or hygienic handrub and/or handwash and disinfectants for other surfac

8、es than instrument surfaces; b) “Obligatory test conditions” have been replaced by “minimum test conditions” (test temperatures and contact times can be chosen within limits) that have to be performed to pass the test; c) an additional modified method to test ready-to-use products in a higher concen

9、tration than 80 %, e. g. 97 %, has been included; d) the quality of the cultured conidiospores of Aspergillus brasilienses is described in greater detail (media, limits and the control methods) resulting from work done in WG 3 of CEN/TC 216; e) the neutralization time has been shortened to 10 s for

10、products with contact times of 10 min or less; f) Annex ZA has been reformulated to more accurately describe the relationship with the Medical Device Directive. Previous editions DIN EN 13624: 2004-02 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13624 September 2013 ICS 11.080.20 Supersedes

11、EN 13624:2003English Version Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)Dsinfectants chimiques et antiseptiques - Essai quantitatif de suspension po

12、ur lvaluation de lactivit fongicide ou levuricide en mdecine - Mthode dessai et prescriptions (phase 2, tape 1) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur der fungiziden oder levuroziden Wirkung im humanmedizinischen Bereich - Prfverfahren und Anforderungen

13、(Phase 2, Stufe 1) This European Standard was approved by CEN on 3 August 2013. 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-date lists and bi

14、bliographical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 resp

15、onsibility 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 national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Re

16、public of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NOR

17、MALISATION 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 reserved worldwide for CEN national Members. Ref. No. EN 13624:2013: EPrfungEN 13624:2013 (E) 2 Contents Page Foreword 3 Introduction .4 1 S

18、cope 5 2 Normative references 5 3 Terms and definitions .5 4 Requirements .5 5 Test method 7 5.1 Principle 7 5.2 Materials and reagents 7 5.3 Apparatus and glassware 10 5.4 Preparation of test organism suspensions and product test solutions . 12 5.5 Procedure for assessing the fungicidal and yeastic

19、idal activity of the product . 17 5.6 Experimental data and calculation 24 5.7 Verification of methodology 30 5.8 Expression of results and precision . 30 5.9 Interpretation of results conclusion 31 5.10 Test report . 32 Annex A (informative) Referenced strains in national collections 35 Annex B (in

20、formative) Neutralizers and rinsing liquids . 36 Annex C (informative) Graphical representation of test procedures 38 C.1 Dilution-neutralization method 38 C.2 Membrane filtration method 40 C.3 Dilution-neutralization method (modified method for ready-to-use products) 42 C.4 Membrane filtration meth

21、od (modified method for ready-to-use products) . 44 Annex D (informative) Example of a typical test report 46 Annex E (informative) Precision of the test result 50 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 53 Bibliog

22、raphy . 54 DIN EN 13624:2013-12 EN 13624:2013 (E) 3 Foreword This document (EN 13624:2013) 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,

23、 either by publication of an identical text or by endorsement, at the latest by March 2014, and conflicting national standards shall be withdrawn at the latest by March 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and

24、/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 13624:2003. The document was revised to adapt it to the latest state of science, to correct errors and ambiguities, to harmonise the structure and wording with other tests of CEN/TC 2

25、16 existing or in preparation and to improve the readability of the standard and thereby make it more understandable. The following is a list of significant technical changes since the last edition: The Scope was expanded for the following fields of application within the medical area, i.e. products

26、 for surgical and/or hygienic handrub and/or handwash and disinfectants for other surfaces than instrument surfaces. “Obligatory test conditions” were replaced by “minimum test conditions” (test temperatures and contact times can be chosen within limits) that have to be performed to pass the test. A

27、n additional modified method is described to test ready-to-use products in a higher concentration than 80 %, i.e. 97 %. The quality of the cultured conidiospores of Aspergillus brasiliensis is described in greater detail (media, limits and the control methods) resulting from work done in WG 3 of CEN

28、/TC 216. The neutralization time was shortened to 10 s for products with contact times of 10 min or less. The Annex ZA was reformulated to more accurately describe the relationship with the Medical Device Directive. Data obtained using the former version of EN 13624 may still be used, if the quality

29、 of the conidiospores of Aspergillus brasiliensis had been controlled and had met the requirements in this standard (5.4.1.4.2). 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

30、Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgiu

31、m, 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, Slovakia, Slovenia, Spain, Sweden, Switzerl

32、and, Turkey and the United Kingdom. DIN EN 13624:2013-12 EN 13624:2013 (E) 4 Introduction This European Standard specifies a suspension test for establishing whether a chemical disinfectant or an antiseptic has a fungicidal or yeasticidal activity in the area and fields described in the scope. This

33、laboratory test takes into account practical conditions of application of the product including contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence its action in practical situations. Each utilisation concentration of the chemical disinfectant or

34、 antiseptic found by this test corresponds to the chosen experimental conditions. DIN EN 13624:2013-12 EN 13624:2013 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that

35、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 (97 % with a modified method for special cases) as some dilution is always produced by adding the tes

36、t organisms and interfering substance. This European Standard applies to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding

37、or other means. This European Standard applies to areas and situations where disinfection or antisepsis 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 kindergartens and o

38、f 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 1 The method described is intended to determine the activity of commercial formulations or active substances under the condi

39、tions in which they are used. NOTE 2 This method corresponds to a phase 2 step 1 test. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. 2 Normative references The following documents, in whole or in part, are normatively referenced in th

40、is document and are indispensable for its application. 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 test organisms used

41、for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity EN 14885, Chemical disinfectants and antiseptics Application of European Standards for chemical disinfectants and antiseptics ISO 4793:1980, Labora

42、tory 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 demonstrate at least a 4 decimal log (lg) reduction (for hygienic handwash a

43、t least a 2 lg reduction), when tested in accordance with Table 1 and Clause 5. DIN EN 13624:2013-12 EN 13624:2013 (E) 6 Table 1 Minimum and additional test conditions Test conditions Hygienic handrub and handwash Surgical handrub and handwash Instrument disinfection Surface disinfection Minimum spe

44、ctrum of test organisms Candida albicans (vegetative cells) Candida albicans (vegetative cells) a) fungicidal activity: Aspergillus brasiliensis (conidiospores) Candida albicans (veg. cells) b) yeasticidal activity: Candida albicans (veg. cells) a) fungicidal activity: Aspergillus brasiliensis (coni

45、diospores) Candida albicans (veg. cells) b) yeasticidal activity: Candida albicans (veg. cells) additional Any relevant test organism Test temperature according to the manufacturers recommendation, but at/ between 20 C 20 C 20 C and 70 C 4 C and 30 C Contact time according to the manufacturers recom

46、mendation, but between but no longer than 30 s and 60 s 1 min and 5 min 60 min 5 min or 60 minaInterfering substance clean conditions 0,3 g/l bovine albumin solution (hygienic handrub)b0,3 g/l bovine albumin solution (surgical handrub)b0,3 g/l bovine albumin solution 0,3 g/l bovine albumin solution

47、dirty conditions 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (hygienic handwash)c3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes (surgical and handwash)cand/or 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes and/or 3,0 g/l bovine albumin solution plus 3,0 ml/l er

48、ythrocytes b) additional any relevant substance any relevant substance NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtained under the minimum test conditions.aThe contact times for surface disinfectants stated in this table are chosen on the basis of the practical conditions of the product. The recommended contact time for the use of the product is within the responsibility of the manufacturer. Products intended to dis