EN 12791-2016 en Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2 step 2)《化学消毒剂和抗菌剂 外科用手消毒剂 试验方法和要求(phase 2 step 2)》.pdf

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1、BSI Standards PublicationBS EN 12791:2016Chemical disinfectants andantiseptics Surgical handdisinfection Test method andrequirements (phase 2, step 2)BS EN 12791:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 12791:2016.It supersedes BS EN 12791:2005 which

2、 is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/216, Chemical disinfectants and antiseptics.A list of organizations represented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 to its secretary.This publication does not purport to include all the necessaryprov

3、isions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 83106 5ICS 11.080.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published

4、 under the authority of theStandards Policy and Strategy Committee on 29 February 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS EN 12791:2016EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12791 February 2016 ICS 11.080.20 Supersedes EN 12791:2005English Vers

5、ion Chemical disinfectants and antiseptics - Surgical hand disinfection - Test method and requirements (phase 2, step 2) Antiseptiques et dsinfectants chimiques - Dsinfection chirurgicale des mains - Mthodes dessai et prescriptions (phase 2/tape 2) Chemische Desinfektionsmittel und Antiseptika - Chi

6、rurgische Hndedesinfektionsmittel - Prfverfahren und Anforderungen (Phase 2, Stufe 2) This European Standard was approved by CEN on 13 December 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status

7、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 Standard exists in three official versions (English, French, Germa

8、n). 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 national standards bodies of Austria, Belgium, Bulgaria, Croatia,

9、 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, Switzerland, Turkey and Unite

10、d Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1

11、2791:2016 EBS EN 12791:2016EN 12791:2016 (E) 2 Contents Page European foreword . 3 1 Scope 4 2 Normative references 4 3 Terms and definitions . 4 4 Requirements . 4 5 Test methods 4 5.1 Principle . 4 5.2 Materials and reagents 5 5.2.1 Test organism . 5 5.2.2 Culture media and reagents 5 5.3 Apparatu

12、s and glassware . 7 5.3.1 General 7 5.3.2 Usual microbiological laboratory equipment . 7 5.4 Product test solutions 9 5.5 Procedure for assessing the microbicidal activity of the product on volunteers hands . 9 5.5.1 General 9 5.5.2 Preparatory handwash 10 5.5.3 Test procedure with volunteers . 11 5

13、.5.4 Incubation and counting of the test mixture 12 5.6 Experimental data and calculation 13 5.6.1 Determination of VC-values . 13 5.6.2 Calculation of the individual lg reduction (lg R; lg prevalue minus lg postvalue) 13 5.7 Verification of the methodology . 14 5.7.1 Acceptance criteria for test re

14、sults 14 5.7.2 Control of weighted mean counts . 15 5.8 Statistical evaluation (significance testing), expression of results and precision . 15 5.9 Conclusion. 15 5.10 Test report 16 Annex A (informative) Standard surgical handrub/-wash procedure 18 Annex B (informative) Quality control of soft soap

15、 19 Annex C (informative) Examples of reporting of results and significance testing 20 Annex D (informative) WILCOXONS matched-pairs signed-ranks test 31 Bibliography . 32 BS EN 12791:2016EN 12791:2016 (E) 3 European foreword This document (EN 12791:2016) has been prepared by Technical Committee CEN

16、/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 August 2016, and conflicting national standards shall b

17、e withdrawn at the latest by August 2016. 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 supersedes EN 12791:2005. It w

18、as revised to adapt it to the latest state of science, to correct errors and ambiguities, to harmonize 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 technical c

19、hanges have been made: neutralization (5.5.1.2); the number of volunteers (5.5.1.4); no rinse after the disinfection (5.5.3.2.2); the statistical evaluation (5.8); the annexes have been completely revised. Data obtained using the former version of EN 12791 may still be used, if it is supplemented by

20、 data on neutralization, additional results from more volunteers and the new statistical evaluation of the “mixed” (old and new) set of data. The additional results should be obtained preferably in the same laboratory and with volunteers not having participated in the previous (“old”) study. If the

21、neutralizer used in the test using the former version is not sufficiently neutralizing a complete new test should be run. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium

22、, 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, Switzerla

23、nd, Turkey and the United Kingdom. BS EN 12791:2016EN 12791:2016 (E) 4 1 Scope This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical handrub and handwash reduces the release of resident and eventually present transient microbia

24、l flora on hands when used for the treatment of clean hands of volunteers. This European Standard applies to products for surgical handrub or handwash for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: in hospitals, in comm

25、unity medical facilities and in dental institutions; 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 patient. EN 14885 specifies in detail the

26、 relationship of the various tests to one another and to “use recommendations”. NOTE This method corresponds to a 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 date

27、d references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 13624, Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medi

28、cal area - Test method and requirements (phase 2, step 1) EN 13727:2012+A2:2015, Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity in the medical area Test method and requirements (phase 2, step 1) EN 14885, Chemical disinfectants and ant

29、iseptics - 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 The mean reduction for immediate effect and 3 h effect of a product shall - when tested

30、 in accordance with Clause 5 - at least be not inferior to that achieved by a specified reference product (60 % volume concentration of propan-1-ol). To demonstrate additionally a “sustained effect”, the mean reduction for the 3 h effect of a product shall be superior to that achieved by the referen

31、ce product. 5 Test methods 5.1 Principle A specified preparatory handwash (pre-wash) is carried-out on volunteers in order to remove most of the transient flora and foreign material, which could otherwise influence the “prevalues”, i.e. the BS EN 12791:2016EN 12791:2016 (E) 5 number of microorganism

32、s on the hands before treatment. The following samples from the hands are taken for bacterial counts: immediately after the pre-wash (before treatment with a product or the reference handrub); immediately after the surgical handrub or wash procedure; 3 h after the surgical handrub or wash procedure.

33、 The ratio of the resulting values before and after treatment (reduction in numbers) represents a measure for the antimicrobial activity of the product under test. The immediate effect is characterized by the reduction achieved immediately after the procedure with the product. The 3 h effect is char

34、acterized by the reduction achieved three hours after the procedure with a product. To compensate for extraneous influences, these reductions from surgical handrub or surgical handwash procedures are compared individually with the corresponding reductions of a reference surgical handrub performed in

35、 parallel on the same volunteers. Prior to the test a suitable neutralizer is validated. The neutralizer is used as sampling fluids for recovering the test organisms (5.2.1) after the surgical handrub or handwash procedure to ensure that the bactericidal and/or bacteriostatic activity in the samplin

36、g fluids is neutralized or suppressed. 5.2 Materials and reagents 5.2.1 Test organism The test is performed on the resident microbial flora of volunteers hands and not on specified test organisms. 5.2.2 Culture media and reagents 5.2.2.1 General All weights of chemical substances given in this Europ

37、ean Standard refer to the anhydrous salts. Hydrated forms may be used as an alternative, but the weights required 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

38、 substances that are toxic or inhibitory to the test organisms. All specified pH values are measured at (20 1) C. To improve reproducibility, it is recommended that commercially available dehydrated material is used for the preparation of culture media. The manufacturers instructions relating to the

39、 preparation of these products should be rigorously followed. For each culture medium and reagent, a time limitation for use should be fixed. 5.2.2.2 Water The water shall be freshly glass-distilled water and not demineralised water. If distilled water of adequate quality is not available, water for

40、 injections (see 1) may be used. Sterilize in the autoclave 5.3.2.1a). Sterilization is not necessary if the water is used e.g. for preparation of culture media and subsequently sterilized. NOTE See 5.2.2.7 for the procedure to prepare hard water. BS EN 12791:2016EN 12791:2016 (E) 6 5.2.2.3 Tryptone

41、 Soya Agar (TSA) Tryptone soya agar, consisting of: 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 1000,0 ml Sterilize in the autoclave 5.3.2.1a). After sterilization the pH of the medium shal

42、l be equivalent to 7,2 0,2. 5.2.2.4 Tryptone Soya Broth (TSB) Tryptone soya broth, consisting of Tryptone, pancreatic digest of casein 15,0 g Soya peptone, papaic digest of soybean meal 5,0 g Sodium chloride (NaCl) 5,0 g Water (5.2.2.2) to 1000,0 ml Sterilize in the autoclave 5.3.2.1a). After steril

43、ization the pH of the medium shall be equivalent to 7,0 0,2. 5.2.2.5 Neutralizer The neutralizer shall be chosen, controlled and validated for the product under test in accordance with EN 13727 and EN 13624 (only yeasticidal activity). See 5.5.1.2 for more details. 5.2.2.6 Diluted soft soap Linseed

44、oil 50,0 parts by weight Potassium hydroxide 1 9,5 parts by weight Ethanol (min. 95 %) 1 7,0 parts by weight Hot distilled water (75 C 5 C) as needed Prepare a solution of 9,5 parts potassium hydroxide in 15 parts water (5.2.2.2) and add 50 parts linseed oil. Heat up to approximately 70 C while cons

45、tantly stirring. Add the ethanol and continue heating while stirring until the saponification process is completed and a sample dissolves clearly in water and almost clearly in alcohol. The weight of the soft soap is then brought up to 100 parts by addition of water (5.2.2.2), heated up to 75 C 5 C

46、to dilute the soft soap. Take 200 g of the soft soap, fill up to 1000 g with water (5.2.2.2) and sterilize in the autoclave 5.3.2.1a). The pH of the final diluted soft soap shall range between 10,0 and 11,0. For quality control of the soft soap see Annex B. BS EN 12791:2016EN 12791:2016 (E) 7 5.2.2.

47、7 Hard water for dilution of products For the preparation of 1 l of hard water, the procedure is as follows: prepare solution A: dissolve 19,84 g magnesium chloride (MgCl2) and 46,24 g calcium chloride (CaCl2) in water (5.2.2.2) and dilute to 1000 ml. Sterilize by membrane filtration (5.3.2.7) or in

48、 the autoclave 5.3.2.1a). Autoclaving if used - may cause a loss of liquid. In this case make up to 1000 ml with water (5.2.2.2) under aseptic conditions. Store the solution in the refrigerator (5.3.2.8) for no longer than one month; prepare solution B: dissolve 35,02 g sodium bicarbonate (NaHCO3) i

49、n water (5.2.2.2) and dilute to 1000 ml. Sterilize by membrane filtration (5.3.2.7). Store the solution in the refrigerator (5.3.2.8) for no longer than one week; place 600 ml to 700 ml of water (5.2.2.2) in a 1000 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 (5.3.2.4). If necessary, adjust the pH by using a solution of approximately 40 g/l (about 1 mol/l) of