ASTM_E_1883_-_02_2015.pdf

Designation:E188302(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 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 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 allapplications,except for distance.In this case,inches are usedand metric 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 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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 determine 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 Agents2.2Other Standard:3Title 21Code of Federal Regulations(CFR),Part 50Protection of Human Subjects:Informed Consent Verifi-cation&Part 56,Institutional Review Boards3.Terminology3.1 Definitions:3.1.1 active ingredienta substance performing a functiondefined by this method.3.1.2 active test formulationa formulation with an activeingredient.3.1.3 control test formulationa formulation without anactive in this test method.Frequently a bland soap.3.1.4 neutralizationa process that results in quenching orinactivation of the antimicrobial activity of a formulation.Thismay be achieved with dilution of the formulation or with theuse of chemical agents,called neutralizers.3.1.5 neutralizera procedure or chemical agent used toinactivate,neutralize,or quench the microbiocidal properties ofan antimicrobial agent.3.1.6 resident microorganismsmicroorganisms that liveand multiply on skin,forming a permanent population.3.1.7 test formulationa formulation containing an activeingredient.3.1.8 transient microorganismsmicroorganisms that con-taminate but do not normally permanently colonize skin.4.Summary of Test Method4.1 This hand degerming protocol is a modification of theCade Handwashing Procedure,that is a serial basin hand washsampling technique.4,54.1.1 Two baseline bacterial counts will be determined forthe hands and a post-usage count will be done after twelve daysof antibacterial handwash usage.The samples are collectedfrom basin wash water following one or more 60-s washes witha bar soap that does not contain an antimicrobial.At eachsampling interval samples may be collected from the first andor fifth hand wash in a series of five washes.1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved Oct.1,2015.Published November 2015.Originallyapproved in 1997.Last previous edition approved in 2007 as E1883 02(2007).DOI:10.1520/E1883-02R15.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from U.S.Government Publishing Office,732 N.Capitol St.,NW,Washington,DC 20401-0001,http:/www.gpo.gov.4Cade,A.R.,“A Method for Testing Degerming Efficacy of HexachloropheneSoaps,”Journal of the Society of Cosmetic Chemistry,Vol.2:1951,pp 181291.5Price,P.B.,“The bacteriology of normal skin:a new quantitative test applied toa study of the bacterial flora and disinfectant action of mechanical cleansing,”Journal Infection Control,Vol.63:1938,pp 301318.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.1.2 The data will be used to calculate the reduction ofbacterial flora resulting from the use of the antibacterial testhandwash product as described within the protocol.Reductionsin bacterial populations calculated from baseline and post-treatment samples collected after the first basin wash arereflective of the antimicrobial test soaps ability to reduce thepopulation of transient organisms on the hands.Reductions inbacterial populations calculated from baseline and post-treatment samples collected after the fifth basin wash arereflective of the ant