1、BRITISH STANDARDBS EN 12791:2005Chemical disinfectants and antiseptics Surgical hand disinfection Test method and requirement (phase 2/step 2)The European Standard EN 12791:2005 has the status of a British StandardICS 11.080.20g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g5
2、3g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Licensed Copy: Wang Bin, na, Mon May 08 08:46:44 BST 2006, Uncontrolled Copy, (c) BSIBS EN 12791:2005This British Standard was published under the authority of the Standards
3、 Policy and Strategy Committee on 17 February 2006 BSI 17 February 2006ISBN 0 580 46930 1National forewordThis British Standard is the official English language version of EN 12791:2005.The UK participation in its preparation was entrusted to Technical Committee CH/216, Chemical disinfectants and an
4、tiseptics, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue un
5、der the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct app
6、lication. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; moni
7、tor related international and European developments and promulgate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page, pages 2 to 29 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last i
8、ssued.Amendments issued since publicationAmd. No. Date CommentsLicensed Copy: Wang Bin, na, Mon May 08 08:46:44 BST 2006, Uncontrolled Copy, (c) BSIEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 12791July 2005ICS 11.080.20English VersionChemical disinfectants and antiseptics - Surgical handdisinf
9、ection - Test method and requirement (phase 2/step 2)Antiseptiques et dsinfectants chimiques - Dsinfectantschirurgicaux pour les mains - Mthodes dessai etprescriptions (phase 2/tape 2)Chemische Desinfektionsmittel und Antiseptika -Chirurgische Hndedesinfektionsmittel - Prfverfahren undAnforderungen
10、(Phase 2/Stufe 2)This European Standard was approved by CEN on 21 March 2005.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and biblio
11、graphical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a C
12、EN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
13、Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All
14、rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 12791:2005: ELicensed Copy: Wang Bin, na, Mon May 08 08:46:44 BST 2006, Uncontrolled Copy, (c) BSIEN 12791:2005 (E) 2 Contents page Foreword 4 1 Scope .5 2 Normative references .5 3 Terms and d
15、efinitions.5 4 Requirements 6 5 Test methods.6 5.1 Principle.6 5.2 Experimental design.7 5.3 Volunteers .7 5.4 Media and reagents.7 5.4.1 General 7 5.4.2 Water7 5.4.3 Tryptone soya agar (TSA).7 5.4.4 Tryptone soya broth (TSB).8 5.4.5 Neutralizer .8 5.4.6 Dilute soft soap, 200 g/1000 g 8 5.4.7 Propan
16、-1-ol 60 % (volume concentration).9 5.5 Apparatus and glassware.9 5.5.1 General 9 5.5.2 Usual microbiological laboratory equipment9 5.6 Procedure 9 5.6.1 Preparatory handwash .9 5.6.2 Prevalues.10 5.6.3 Surgical hand disinfection procedure .10 5.6.4 Postvalues.11 5.6.5 Incubation11 5.7 Calculation.1
17、1 5.8 Test validation.12 5.9 Evaluation of P 12 5.10 Significance testing 13 5.11 Test report .13 Annex A (normative) Standard handwash/handrub procedure.14 Annex B (informative) Demonstration of antibacterial properties of surgical gloves.15 Annex C (informative) Examples of neutralizers16 Licensed
18、 Copy: Wang Bin, na, Mon May 08 08:46:44 BST 2006, Uncontrolled Copy, (c) BSIEN 12791:2005 (E) 3 Annex D (informative) Preparation of a solution of propan-1-ol 60 % (volume concentration)17 Annex E (informative) Quality control of soft soap18 Annex F (informative) Examples of reporting of results an
19、d significance testing 19 Annex G (informative) Information on the application and interpretation of the European Standard on chemical disinfectants and antiseptics .27 G.1 Introduction.27 G.2 General guidelines for the application and interpretation of test methods in accordance with European Stand
20、ards for chemical disinfectants and antiseptics .27 G.3 Guide to interpretation of tests for chemical disinfectants and antiseptics 28 Bibliography.29 Licensed Copy: Wang Bin, na, Mon May 08 08:46:44 BST 2006, Uncontrolled Copy, (c) BSIEN 12791:2005 (E) 4 Foreword This document (EN 12791:2005) has b
21、een 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 January 2006, an
22、d conflicting national standards shall be withdrawn at the latest by January 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Esto
23、nia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: Wang Bin, na, Mon May 08 08:46:44 BST 2006, Uncontrolled Copy, (c) B
24、SIEN 12791:2005 (E) 5 1 Scope This European Standard specifies a test method simulating practical conditions for establishing whether a product for surgical hand disinfection reduces the release of hand flora according to requirements described in clause 4 when used for the disinfection of the clean
25、 hands of volunteers. 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 referenced document (including any amendments) applies. prEN
26、 12054, Chemical disinfectants and antiseptics Quantitative suspension test for the evaluation of bactericidal activity of products for hygienic and surgical handrub and handwash used in human medicine Test method and requirements (phase 2/step 1). 3 Terms and definitions For the purposes of this do
27、cument, the following terms and definitions apply. 3.1 product chemical agent or formulation used as a chemical disinfectant or antiseptic 3.2 surgical hand disinfection preoperative treatment procedure that involves applying a bactericidal product directed against the bacterial flora of hands to pr
28、event the risk of transmission of bacteria into the surgical wound NOTE This procedure may consist of a handrub alone or a handwash alone or a combination of both. This treatment can be performed with products claiming or not claiming to have a sustained effect (see 3.5) 3.3 immediate effect reducti
29、on of the release of skin flora from the hands as assessed immediately after surgical hand disinfection 3.4 3-hour effect reduction of the release of skin flora from the hands as assessed after wearing surgical gloves for 3 h following disinfection 3.5 sustained effect 3-hour effect of the product s
30、ignificantly larger than that of a reference disinfection procedure with propan-1-ol 60 % (volume concentration) (see 5.6.3.2) 3.6 prevalue (immediate) number of colony-forming units (cfu) sampled immediately before treatment from the hand from which the immediate effect has to be assessed Licensed
31、Copy: Wang Bin, na, Mon May 08 08:46:44 BST 2006, Uncontrolled Copy, (c) BSIEN 12791:2005 (E) 6 3.7 prevalue (3-hour) number of colony-forming units (cfu) sampled immediately before treatment from the hand from which the sustained effect has to be assessed 3.8 postvalue (immediate) number of colony-
32、forming units (cfu) sampled immediately after treatment from the hand sampled for the prevalue (immediate) 3.9 postvalue (3-hour) number of colony-forming units (cfu) sampled 3 h after treatment from the hand sampled for the prevalue (sustained) 3.10 reduction factor (RF) (immediate) ratio of preval
33、ue (immediate) and postvalue (immediate), generally expressed by decimal logarithms: lg RF(immediate) = lg prevalue(immediate) lg postvalue(immediate) 3.11 reduction factor (3-hour) ratio of prevalue (3-hour) and postvalue (3-hour), generally expressed by decimal logarithms: lg RF (3-hour) = lg prev
34、alue (3-hour) lg postvalue (3-hour) 3.12 surgical glove sterile, un-powdered medical latex glove free of antimicrobial activity, as demonstrated by agar diffusion test on Mueller-Hinton agar (see Annex B) intended for use in invasive surgery 4 Requirements When tested and evaluated in accordance wit
35、h clause 5, the mean reduction factors for immediate (see 3.10) and 3 hours (3.11) effects shall not be significantly smaller than the respective ones obtained with propan-1-ol 60 % (volume concentration). If the explicit claim for a sustained effect exists, the mean reduction factor for the 3-hour
36、effect shall, additionally, be significantly larger than that obtained with propan-1-ol 60 % (volume concentration). 5 Test methods 5.1 Principle A preparatory handwash (see 5.6.1) is carried-out in order to remove transient flora and foreign material, that would otherwise influence the presample co
37、unts. Hand samples, for bacterial counts, are then taken: immediately after the prewash (before treatment); immediately after the disinfection procedure; 3 h after the disinfection procedure. Licensed Copy: Wang Bin, na, Mon May 08 08:46:44 BST 2006, Uncontrolled Copy, (c) BSIEN 12791:2005 (E) 7 The
38、 ratio of the resulting values before and after treatment is called the reduction factor. It represents a measure for the antimicrobial activity of the disinfection product tested. The immediate effect is characterized by the reduction factor (immediate), which is the ratio of the two values (preval
39、ue and postvalue) assessed on the hand from which the postvalue (immediate) is derived. The 3-hour effect is characterized by the reduction factor (3-hour), which is the ratio of prevalue and postvalue (3-hour) of the other hand. To compensate for extraneous influences, these reduction factors are c
40、ompared individually with the corresponding reduction factors of a reference surgical hand disinfection procedure (R) performed in parallel with the same subjects. 5.2 Experimental design For testing a single product, a crossover design is used. The volunteers are randomly divided into two groups of
41、 the same size. In a first run, volunteers of group 1 use the reference procedure, those of group 2 the procedure with the test product. After at least one week, allowing reconstitution of the normal skin flora, the test is repeated with changed roles in a second run. For testing more than one produ
42、ct at a time, a Latin-square design is used with as many groups of volunteers and as many experimental runs as there are disinfection products (including the reference propan-1-ol). In each run all disinfection procedures are employed in parallel. At least one week is required between the individual
43、 experimental runs, allowing reconstitution of the normal skin flora. At the end of the whole series every subject shall have used each disinfection product, including propan-1-ol, once. NOTE In a Latin-square design, only products can be simultaneously tested for which either no neutralisation is n
44、ecessary or for which the same neutraliser can be used for the assessment of postvalues. 5.3 Volunteers The test shall be performed on 20 healthy persons who have hands with healthy skin, without cuts or abrasions, and with short and clean fingernails. Starting from one week prior to the test, they
45、should not use substances with antimicrobial action (e.g. medicated soaps, medicated hand creams). Although, in general, age is not a limiting factor, volunteers should be at least 18 years of age. 5.4 Media and reagents 5.4.1 General The reagents shall be of analytical grade and/or appropriate for
46、microbiological purposes. NOTE To improve reproducibility, it is recommended that commercially available dehydrated material be used for the preparation of culture media. The manufacturers instructions relating to the preparation of these products should be rigorously followed. 5.4.2 Water The water
47、 shall be free from substances that are toxic or inhibiting to the bacteria. It shall be freshly glass distilled and not demineralized water. Sterilize in the autoclave ( 5.5.2.1). NOTE 1 Sterilization is not necessary if the water is used e.g. for the preparation of culture media and subsequently s
48、terilized. NOTE 2 If distilled water of adequate quality is not available, water for injectable preparations (see 1) can be used. 5.4.3 Tryptone soya agar (TSA) For quantitative surface cultures. Licensed Copy: Wang Bin, na, Mon May 08 08:46:44 BST 2006, Uncontrolled Copy, (c) BSIEN 12791:2005 (E) 8
49、 Tryptone, pancreatic digest of casein 15,0 g Soya peptone, papaic digest of Soybean meal 5,0 g NaCl 5,0 g Agar 15,0 gWater (5.4.2) to 1000,0 ml Sterilize in the autoclave (5.5.2.1). After sterilization the pH of the medium shall be equivalent to 7,2 0,2 when measured at 20 C 1 C. 5.4.4 Tryptone soya broth (TSB) Serves as a sampling fluid and diluent. Tryptone, pancreatic digest of casein 15,0 g Soya peptone, papaic digest of Soybean meal 5,0 g NaCl 5,0 g Water (5.4.2) to 1000,0 ml Sterilize in the autoclave (5.5.2.1). After sterilization the p
