1、Designation: E 1883 02 (Reapproved 2007)Standard Test Method forAssessment of an Antibacterial Handwash Product byMultiple Basin Wash Technique1This standard is issued under the fixed designation E 1883; the number immediately following the designation indicates the year oforiginal adoption or, in t
2、he case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This test method covers determining the effectiveness ofan antibacterial handwash fo
3、r reducing 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 all applica-tions, except for distance. In this case, inches are used andmet
4、ric units 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 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibil
5、ity 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 Documents2.1 ASTM Standards:2D 1193 Specification for Reagent WaterE 1054 Test Methods for Evaluation of Inactivators ofAntimic
6、robial Agents2.2 Other Standard:Title 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 1:10 dilution of the basin contents insoybean-casein digest agar.10.4 DilutionsSample dilutions are prepared in 9.0 mLbl
7、anks of Butterfields phosphate buffer.10.5 IncubationAll plates are incubated for 48 6 4 hrs at30 6 2C. After incubation, the colonies on the plates that arecountable are enumerated with the aid of a colony counter. Thetotal bacteria count per liter from the basin contents iscalculated.11. Neutraliz
8、er for the Test Formulation11.1 When neutralizers are added to culture media ordilution fluids, or both, validate the effectiveness of the systemsaccording to Practice E 1054.12. Analysis of Data12.1 Calculation of Bacterial Reduction:12.1.1 Bacterial counts per litre from the first and or fifthbasi
9、n 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 baselinecounts obtained from the first and or fifth basin samples areaveraged for each individual. Geometric means of the data arecal
10、culated.E 1883 02 (2007)312.1.2 The following percent reductions may be calculated:Percent Reduction Basin 1 Bacterial Population 51Geometric Mean of First2Basin Counts Test Day!Geometric Mean of the 2 Baseline First Basin Counts3 100(2)Percent Reduction Basin 5 Bacterial Population 51Geometric Mean
11、 of Fifth2Basin Counts Test Day!Geometric Mean of the 2 Baseline Fifth Basin Counts3 100(3)12.1.3 Estimate the standard deviation for each percentreduction value calculated above; using the assumption of a lognormal distribution, construct 95 % confidence interval for thepercent reduction value (S).
12、 Perform Students independentt-tests to determine if there is a statistically significant bacterialreduction of the transient and or resident bacterial populationson test formulation washed hands when compared to blandcleansing formulation (see 6.6) after twelve days of testformulation use.13. Preci
13、sion 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 takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. U
14、sers 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 responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed eve
15、ry five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible techn
16、ical 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 the 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).E 1883 02 (2007)4
