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

1、BSI Standards PublicationBS EN 13624:2013Chemical disinfectants andantiseptics Quantitativesuspension test for theevaluation of fungicidal oryeasticidal activity in themedical area Test methodand requirements (phase 2,step 1)BS EN 13624:2013 BRITISH STANDARDNational forewordThis British Standard is

2、the UK implementation of EN 13624:2013. It supersedes BS EN 13624:2003 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented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 it

3、s secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 69791 3 ICS 11.080.20 Compliance with a British Standa

4、rd cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2013.Amendments issued since publicationDate T e x t a f f e c t e dBS EN 13624:2013EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM

5、EN 13624 September 2013 ICS 11.080.20 Supersedes 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 a

6、ntiseptiques - Essai quantitatif de suspension pour lvaluation de lactivit fongicide ou levuricide en mdecine - Mthode dessai et prescriptions (phase 2, tape 1) Chemische Desinfektionsmittel und Antiseptika - Quantitativer Suspensionsversuch zur Bestimmung der fungiziden oder levuroziden Wirkung im

7、humanmedizinischen Bereich - Prfverfahren und Anforderungen (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 natio

8、nal 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 Standard exists in three official versions (English, French, German). A vers

9、ion 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 national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, C

10、zech 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, Switzerland, Turkey and United Kingdom.

11、 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 reserved worldwide for CEN national Members. Ref. No. EN 13624:2013: EBS EN 1362

12、4:2013EN 13624:2013 (E) 2 Contents Page Foreword 3 Introduction .4 1 Scope 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

13、 solutions . 12 5.5 Procedure for assessing the fungicidal and yeasticidal 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 (

14、informative) Referenced strains in national collections 35 Annex B (informative) 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 (modi

15、fied method for ready-to-use products) 42 C.4 Membrane filtration method (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

16、 and the Essential Requirements of EU Directive 93/42/EEC . 53 Bibliography . 54 BS EN 13624:2013EN 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 Eu

17、ropean Standard shall be given the status of a national standard, 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 eleme

18、nts 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 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

19、 harmonise the structure and wording with other tests of CEN/TC 216 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 follo

20、wing fields of application within the medical area, i.e. products 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 ch

21、osen within limits) that have to be performed to pass the test. An 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

22、 and the control methods) resulting from work done in WG 3 of CEN/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

23、 the former version of EN 13624 may still be used, if the quality 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 F

24、ree 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 document. According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countri

25、es 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Polan

26、d, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 13624:2013EN 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 a

27、ctivity in the area and 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 interfering substances, i.e. conditions which may influence its action in practical situations. Ea

28、ch utilisation concentration of the chemical disinfectant or antiseptic found by this test corresponds to the chosen experimental conditions. BS EN 13624:2013EN 13624:2013 (E) 5 1 Scope This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity

29、 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 % or less (97 % with a modified method for special cases

30、) as some dilution is always produced by adding the test 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,

31、and surface disinfection by wiping, spraying, flooding 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 inst

32、itutions; 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 patients. NOTE 1 The method described is intended to determine the activity of comme

33、rcial formulations or active substances under the conditions 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

34、, in whole or in part, are normatively referenced in this 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 disinfectan

35、ts and antiseptics Preservation of test organisms used 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 chemi

36、cal disinfectants and antiseptics ISO 4793:1980, 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 demonstrate at least

37、a 4 decimal log (lg) reduction (for hygienic handwash at least a 2 lg reduction), when tested in accordance with Table 1 and Clause 5. BS EN 13624:2013EN 13624:2013 (E) 6 Table 1 Minimum and additional test conditions Test conditions Hygienic handrub and handwash Surgical handrub and handwash Instru

38、ment disinfection Surface disinfection Minimum spectrum 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) f

39、ungicidal activity: Aspergillus brasiliensis (conidiospores) 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

40、 Contact time according to the manufacturers recommendation, 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

41、 albumin solution 0,3 g/l bovine albumin solution 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/o

42、r 3,0 g/l bovine albumin solution plus 3,0 ml/l erythrocytes 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 disin

43、fectants 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 disinfect surfaces that are likely to come into contact with the patient an

44、d/or the medical staff and surfaces, which are frequently touched by different people, leading to the transmission of microorganisms to the patient, shall be tested with a contact time of maximum 5 min. The same applies where the contact time of the product shall be limited for practical reasons. Pr

45、oducts for other surfaces than stated above may be tested with a contact time of maximum 60 min. bHygienic and surgical handrub shall be tested as a minimum under clean conditions. c Hygienic and surgical handwash shall be tested as a minimum under dirty conditions. BS EN 13624:2013EN 13624:2013 (E)

46、 7 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 mixture is maintained at the temperature a

47、nd the contact time specified in Clause 4 and 5.5.1.1. At the end of this contact time, an aliquot is taken; the fungicidal and/or the fungistatic action in this portion is immediately neutralized or suppressed by a validated method. The method of choice is dilution-neutralization. If a suitable neu

48、tralizer cannot be found, membrane filtration is used. The numbers of surviving fungi in each sample are determined and the reduction is calculated. NOTE Handwash products are always prediluted with hard water (5.2.2.7). The resulting solution is regarded as a ready-to-use product (5.4.2). 5.1.2 The

49、 test is performed using the vegetative cells of Candida albicans and the conidiospores of Aspergillus brasiliensis (fungicidal activity) or only the vegetative cells of Candida albicans (yeasticidal activity) as test-organisms (Clause 4, Table 1). 5.1.3 Additional contact times and temperatures are specified (Clause 4, Table 1). Additional interfering substances and test organisms may be used. 5.2 Materials and reagents 5.2.1 Test organisms The fungicidal activity shall be evaluated using the following strai