1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 1500:2013Chemical disinfectants andantiseptics Hygienichandrub Test method andrequirements (phase 2/step 2)BS EN 1500:2013 BRITISH STANDARDNational forewordThis British Sta
2、ndard is the UK implementation of EN 1500:2013. Itsupersedes BS EN 1500:1997 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented on this committee can beobtained on request t
3、o its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013.Published by BSI Standards Limited 2013 ISBN 978 0 580 74828 8 ICS 11.080.20; 71.100.35 Compliance with a B
4、ritish Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 May 2013. Amendments issued since publicationDate Text affectedBS EN 1500:2013EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN
5、1500 April 2013 ICS 11.080.20; 71.100.35 Supersedes EN 1500:1997English Version Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2) Antiseptiques et dsinfectants chimiques - Traitement hyginique de mains par frictions - Mthode dessai et prescript
6、ions (phase 2/tape 2) Chemische Desinfektionsmittel und Antiseptika - Hygienische Hndedesinfektion - Prfverfahren und Anforderungen (Phase 2/Stufe 2) This European Standard was approved by CEN on 1 March 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate
7、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 Standa
8、rd 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 natio
9、nal 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, Slov
10、akia, 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 reserved w
11、orldwide for CEN national Members. Ref. No. EN 1500:2013: EBS EN 1500:2013EN 1500:2013 (E) 2 Contents Page Foreword 3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Requirements .4 5 Test method 4 5.1 Principle 4 5.2 Materials and reagents 5 5.2.1 Test organism 5 5.2.2 Culture media
12、 and reagents .5 5.3 Apparatus and glassware .8 5.3.1 General 8 5.3.2 Usual microbiological laboratory equipmentand, in particular, the following: .8 5.4 Preparation of test organism suspensions and product test solutions 9 5.4.1 Test organism suspensions (test and validation suspension) .9 5.4.2 Pr
13、oduct test solutions 11 5.5 Procedure for assessing the bactericidal activity of the product on volunteers hands 11 5.5.1 General . 11 5.5.2 Neutralization control and validation 12 5.5.3 Test procedure with volunteers 13 5.5.4 Incubation and counting of the test mixture and the control and validati
14、on mixtures . 15 5.6 Experimental data and calculation 15 5.6.1 Explanation of terms and abbreviations 15 5.6.2 Calculation . 15 5.7 Verification of the methodology - Test validation . 18 5.7.1 Acceptance criteria for test results. 18 5.7.2 Control of weighted mean counts . 19 5.7.3 Basic limits 19
15、5.8 Statistical evaluation (significance testing), expression of results and precision 19 5.9 Conclusion 19 5.10 Test report . 20 Annex A (normative) Standard handrub procedure . 22 Annex B (informative) Neutralizers and rinsing liquids . 23 Annex C (informative) Control and validation of neutraliza
16、tion 25 Annex D (informative) Quality control of soft soap 26 Annex E (informative) Examples of reporting of results and significance testing 27 Annex F (normative) Test for non-inferiority 35 Bibliography . 37 BS EN 1500:2013EN 1500:2013 (E) 3 Foreword This document (EN 1500:2013) has been prepared
17、 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 October 2013, and conflictin
18、g national standards shall be withdrawn at the latest by October 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 rights. This document s
19、upersedes EN 1500:1997. This 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 216 existing or in preparation and to improve the readability of the standard and thereby make it more un
20、derstandable. The following technical changes have been made: Neutralization (5.5.1.2). The number of volunteers (5.5.1.4). The statistical evaluation (5.8). The annexes have been completely revised. Data obtained using the former version of EN 1500 may still be used, if it is supplemented by data o
21、n neutralization, additional results from more volunteers and the new statistical evaluation of the “mixed” (old and new) set of data. The additional results will be obtained preferably in the same laboratory and with volunteers not having participated in the previous (“old”) study. If the neutraliz
22、er used in the test using the former version is not sufficiently neutralizing, a complete new test will be run. The changed procedure in Annex A is regarded as having no (or negligible) influence on the results. According to the CEN-CENELEC Internal Regulations, the national standards organisations
23、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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Ne
24、therlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. BS EN 1500:2013EN 1500:2013 (E) 4 1 Scope This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handru
25、b reduces the release of transient microbial flora on hands when rubbed onto the artificially contaminated hands of volunteers. NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard appli
26、es to products for hygienic handrub for use in 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 kindergartens and of nursing homes;
27、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 patient. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. NOTE 2 This method corresponds to a
28、 phase 2, step 2 test. 2 Normative references The following documents, 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 docume
29、nt (including any amendments) applies. EN 12353, Chemical disinfectants 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 disi
30、nfectants and antiseptics Application of European Standards for chemical disinfectants and antiseptics 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 14885 apply. 4 Requirements When tested in accordance with Clause 5, the mean reduction of the relea
31、se of the test organism Escherichia coli K12 achieved by the hygienic handrub with the product under test shall be at least not inferior to that achieved by a specified reference hygienic handrub (60 % volume concentration of propan-2-ol). 5 Test method 5.1 Principle Hands of volunteers are artifici
32、ally contaminated with test organisms. The number of test organisms released from their fingertips into sampling fluids is assessed before and after the hygienic handrub. The ratio of the BS EN 1500:2013EN 1500:2013 (E) 5 two resulting values represents a measure for the antimicrobial activity of th
33、e product tested. The necessary precision is achieved by repeating the test on 18 to 22 volunteers. To compensate for extraneous influences it is compared with the reduction obtained by a reference handrub, which is performed with the same volunteers, on the same day and under comparable environment
34、al conditions. Prior to the test, a suitable neutralizer is validated. The neutralizer is used as a sampling fluid for recovering the test organisms after the hygienic handrub to ensure that the bactericidal and/or bacteriostatic activity in the sampling fluids is neutralized or suppressed. 5.2 Mate
35、rials and reagents 5.2.1 Test organism Escherichia coli K12 NCTC 10538; CIP 54.117; NCIMB 100831)NOTE This test organism has been specifically chosen to meet health and safety guidance and ethical committee considerations. It is a K12 strain of E. coli of normal flora origin internationally recognis
36、ed as being non-pathogenic. According to the UK catalogue of the National Collections of Industrial prepare solution B: dissolve 35,02 g sodium bicarbonate (NaHCO3) in water (5.2.2.2) and dilute to 1000 ml. Sterilise by membrane filtration (5.3.2.7). Store the solution in the refrigerator (5.3.2.8)
37、for no longer than one week; place 600 ml to 700 ml of water (5.2.2.2) in a 1 000 ml volumetric flask (5.3.2.12) and add 6,0 ml (5.3.2.9) of solution A, then 8,0 ml of solution B. Mix and dilute to 1000 ml with water (5.2.2.2). The pH of the hard water shall be 7,0 0,2, when measured at 20 C 1 C (5.
38、3.2.4). If necessary, adjust the pH by using a solution of approximately 40 g/l (about 1 mol/l) of sodium hydroxide (NaOH) or approximately 36,5 g/l (about 1 mol/l) of hydrochloric acid (HCl). The hard water shall be freshly prepared under aseptic conditions and used within 12 h. NOTE When preparing
39、 the product test solutions (5.4.2), the addition of the product to the hard water produces a different final water hardness in each test tube. In any case, the final hardness, expressed as calcium carbonate (CaCO3) in the test tube, is lower than 375 mg/l. 5.2.2.8 Propan-2-ol as reference handrub 5
40、2,3 % (weight concentration) corresponding to 60 % (volume concentration) at 20 C Fill 471 g propan-2-ol 1 with a purity of min. 99,5 % V/V (determined by gas chromatography; density 0,785) in a 1000 ml flask equipped with a glass stopper on the weighing platform of a scale (precision 0,1 g). Add 42
41、9 g water (5.2.2.2). This will give a volume of approximately 1 000 ml. Close the flask with the matching glass stopper and shake the contents of the flask thoroughly. NOTE This solution can be kept indefinitely at approximately room temperature if protected from light. BS EN 1500:2013EN 1500:2013 (
42、E) 8 5.3 Apparatus and glassware 5.3.1 General Sterilise all glassware and parts of the apparatus that will come into contact with the culture media and reagents or the sample, except those which are supplied sterile, by one of the following methods: a) by moist heat, in the autoclave 5.3.2.1 a); b)
43、 by dry heat, in the hot air oven 5.3.2.1 b). 5.3.2 Usual microbiological laboratory equipment2) and, in particular, the following: 5.3.2.1 Apparatus for sterilisation a) for moist heat sterilisation, an autoclave capable of being maintained at (12130+) C for a minimum holding time of 15 min; b) for
44、 dry heat sterilisation, a hot air oven capable of being maintained at (18050+) C for a minimum holding time of 30 min, at (170 50+) C for a minimum holding time of 1 h or at (16050+) C for a minimum holding time of 2 h. 5.3.2.2 Water baths, capable of being controlled at 20 C 1 C and at 45 C 1 C (t
45、o maintain melted TSA and TSSA in case of pour plate technique) 5.3.2.3 Incubator, capable of being controlled either at 36 C 1 C or 37 C 1 C (5.2.1). The same temperature shall be used for incubations performed during a test and its control and validation. 5.3.2.4 pH-meter, having an inaccuracy of
46、calibration of no more than 0,1 pH units at 20 C 1 C. A puncture electrode or a flat membrane electrode should be used for measuring the pH of the agar media (5.2.2.3). 5.3.2.5 Stopwatch 5.3.2.6 Shakers a) electromechanical agitator, e.g. Vortexmixer3); b) mechanical shaker. 5.3.2.7 Membrane filtrat
47、ion apparatus, constructed of a material compatible with the substances to be filtered The apparatus shall have a filter holder of at least 50 ml volume. It shall be suitable for use with filters of diameter 47 mm to 50 mm and 0,45 m pore size for sterilisation of hard water (5.2.2.7). The vacuum so
48、urce used shall give an even filtration flow rate. To prevent overlong filtration, the device shall be set so as to obtain the filtration of 100 ml of rinsing liquid in 20 s to 40 s. 2)Disposable equipment is an acceptable alternative to reusable glassware. 3) Vortexin an example of a suitable produ
49、ct available commercially. This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of this product. BS EN 1500:2013EN 1500:2013 (E) 9 5.3.2.8 Refrigerator, capable of being controlled at 2 C to 8 C 5.3.2.9 Graduated pipettes, of nominal capacities 10 ml and 1 ml and 0,1 ml, or calibrated automatic pipettes 5.3.2.10 Petri dishes, (plates) of size 90 mm to 100 mm 5.3.2.11 Glass beads (diameter 3 mm to 4 mm) 5.3.2.12 Volumetric flas
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