1、Designation: E1883 02 (Reapproved 2015)Standard Test Method forAssessment of an Antibacterial Handwash Product byMultiple Basin Wash Technique1This standard is issued under the fixed designation E1883; the number immediately following the designation indicates the year oforiginal adoption or, in the
2、 case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method covers determining the effectiveness ofan antibacterial handwash for r
3、educing the level of aerobicbacterial flora on the hands, following an extended period ofuse.1.2 A knowledge of microbiological techniques is requiredfor these procedures.1.3 In this test method metric units are used for allapplications, except for distance. In this case, inches are usedand metric u
4、nits follow in parentheses.1.4 Performance of this procedure requires the knowledgeof regulations pertaining to the protection of human subjects.(Title 21 CFR, Part 50).1.5 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.6 Thi
5、s standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2. Referenced Document
6、s2.1 ASTM Standards:2D1193 Specification for Reagent WaterE1054 Test Methods for Evaluation of Inactivators of Anti-microbial Agents2.2 Other Standard:3Title 21 Code of Federal Regulations (CFR), Part 50Protection of Human Subjects: Informed Consent Verifi-cation and, 1.0 mLand 0.1 mL aliquots of a
7、1:10 dilution of the basin contents insoybean-casein digest agar.10.4 DilutionsSample dilutions are prepared in 9.0 mLblanks of Butterfields phosphate buffer.10.5 IncubationAll plates are incubated for 48 6 4hat306 2C. After incubation, the colonies on the plates that arecountable are enumerated wit
8、h the aid of a colony counter. Thetotal bacteria count per liter from the basin contents iscalculated.E1883 02 (2015)311. Neutralizer for the Test Formulation11.1 When neutralizers are added to culture media ordilution fluids, or both, validate the effectiveness of the systemsaccording to Test Metho
9、ds E1054.12. Analysis of Data12.1 Calculation of Bacterial Reduction:12.1.1 Bacterial counts per litre from the first and or fifthbasin or each sampling day are determined and converted tolog10in order to minimize the effect of variability in countsobtained from different subjects. Data from the two
10、 baselinecounts obtained from the first and or fifth basin samples areaveraged for each individual. Geometric means of the data arecalculated.12.1.2 The following percent reductions may be calculated:Percent Reduction Basin 1 Bacterial Population5 (2)1 2 Geometric Mean of First 2 Basin Counts Test D
11、ay!Geometric Mean of the 2 Baseline First Basin Counts3100Percent Reduction Basin 5 Bacterial Population5 (3)1 2 Geometric Mean of Fifth 2 Basin Counts Test Day!Geometric Mean of the 2 Baseline Fifth Basin Counts310012.1.3 Estimate the standard deviation for each percentreduction value calculated ab
12、ove; using the assumption of a lognormal distribution, construct 95 % confidence interval for thepercent reduction value (S). Perform Students independentt-tests to determine if there is a statistically significant bacterialreduction of the transient and or resident bacterial populationson test form
13、ulation washed hands when compared to blandcleansing formulation (see 6.6) after twelve days of testformulation use.13. Precision and Bias13.1 A precision and bias statement cannot be made for thistest method at this time.14. Keywords14.1 antimicrobial; Cade; efficacy; handwashASTM International tak
14、es no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own re
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16、sed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at th
17、e address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 02 (2015)4
