1、Designation:E111511Standard Test Method forEvaluation of Surgical Hand Scrub Formulations1This standard is issued under the fixed designation E1115;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in
2、 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 is designed to measure the reduction ofmicrobial flora on the skin.It is intended for determining bothimmediate and persistent(cont
3、inuing antimicrobial effect)microbial reductions,after single or repetitive treatments,orboth.It may also be used to measure cumulative antimicrobialactivity after repetitive treatments.1.2 A knowledge of microbiological techniques is requiredfor these procedures.1.3 Performance of this procedure re
4、quires the knowledgeof regulations pertaining to the protection of human subjects(21 CFR,Parts 50 and 56)1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4.1 In this test method,SI units are used for all applica-tions,except
5、 for distance,in which case inches are used and SIunits follow in parentheses.1.5 This 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 determin
6、e the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D1193 Specification for Reagent WaterE1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE2180 Test Method for Determining the Activity of Incor-porated Antimicrobial Agent(s)I
7、n Polymeric or Hydro-phobic Materials2.2 Other Documents:21 CFR Parts 50 and 563AATCC 1472004 Antibacterial Assessment of Textile Ma-terials:Parallel Streak Method4JIS Z 2801:2000,Antimicrobial ProductsTest for Antimi-crobial Activity and Efficacy5USP 32 United States Pharmacopeia,Chapter 61“Microbi
8、alLimits Test”,200963.Terminology3.1 Definitions:3.1.1 active ingredienta substance added to a formulationspecifically for the inhibition or inactivation of microorgan-isms.3.1.2 cleansing washa non-antimicrobial wash intendedto remove gross soil or residues from the hands.3.1.3 cleansing wash formu
9、lationa liquid castile soap orother liquid soap with neutral pH which does not contain anantimicrobial.3.1.4 cumulative effecta progressive decrease in the num-ber of microorganisms recovered following repeated applica-tions.3.1.5 internal reference formulationa formulation withdemonstrated performa
10、nce characteristics within the labora-tory.3.1.6 neutralizationa process that results in quenching orinactivation of the antimicrobial activity of a formulation.Thismay be achieved through dilution of the formulation or throughthe use of chemical agents called neutralizers.3.1.7 persistenceprolonged
11、 or extended antimicrobial ac-tivity that prevents or inhibits the proliferation or survival ofmicroorganisms after treatment.1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of Subcommittee E
12、35.15 on Antimicrobial Agents.Current edition approved Aug.1,2011.Published August 2011.Originallyapproved in 1986.Last previous edition approved in 2010 as E1115 10.DOI:10.1520/E1115-11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm
13、.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from U.S.Government Printing Office,732 N.Capitol St.,Washing-ton,DC 20401,U.S.Government Bookstore,http:/bookstore.gpo.gov/baskets/cfr-listing.jsp.4Technical Manual of
14、 the American Association of Textile Chemists andColorists(AATCC),2009,Vol 82,P.O.Box 12215,Research Triangle Park,NC27709,http:/www.aatcc.org.5Available from Japanese Industrial Standards Committee,Divisional Councilon Consumer Life,Japanese Standards Association(JSA),4-1-24 Akasaka Minato-Ku,Tokyo
15、,107-8440,Japan,http:/www.jsa.or.jp.6Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.8 sampling fluida buffered solution that aids in
16、 recov-ery of microorganisms from the skin and neutralization of theactive ingredient in test and internal reference formulations.3.1.9 test formulationa formulation containing an activeingredient(s).4.Summary of Test Method4.1 This test method is conducted on individuals selectedfrom a group of subjects who have refrained from using anyantimicrobials for at least one week prior to initiation of thetest.Subjects are selected from this group on the basis of highinitial bacterial count,$1 105CFU/p
