ASTM_E_2784_-_10_2015.pdf

Designation:E278410(Reapproved 2015)Standard Test Method forEvaluation of the Effectiveness of Handwash FormulationsUsing the Paper Towel(Palmar)Method of HandContamination1This standard is issued under the fixed designation E2784;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 the determination of the effec-tiveness of antimicrobial handwashing agents for the reductionof transient microbial flora when used in a handwashingprocedure.1.2 A knowledge of microbiological techniques is requiredfor these procedures.1.3 This test method may be used to evaluate topicalantimicrobial handwash formulations.1.4 Performance of this procedure requires the knowledgeof regulations pertaining to the protection of human subjects.21.5 In this test method,SI units are used for all applications,except for distance in which case inches are used and SI unitsfollow in parentheses.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.For more specificprecautionary statements see 8.5.2.Referenced Documents2.1 ASTM Standards:3E1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE1174 Test Method for Evaluation of the Effectiveness ofHealth Care Personnel Handwash Formulations2.2 Other Standards:AATCC Test Method 147 Antibacterial Assessment of Tex-tile Materials:Parallel Streak Method43.Terminology3.1 Definitions:3.1.1 active ingredient,na substance added to a formula-tion specifically for the inhibition or inactivation of microor-ganisms.3.1.2 cleansing wash,na procedure intended to removesoil or residue.This may also be referred to as a cosmetic wash.3.1.3 healthcare personnel handwash,na cleanser orwaterless agent intended to reduce transient bacteria on thehands.3.1.4 neutralization,nthe process for inactivating orquenching the activity of a microbiocide.Often achievedthrough chemical or physical means(for example,filtration ordilution).3.1.5 resident microbial skin flora,nmicroorganisms thatsurvive and multiply on the skin,forming a stable population.3.1.6 test material,na formulation which incorporatesantimicrobial ingredient(s).3.1.7 test organism,nan applied inoculum of an organismthat has characteristics which allow it to be readily identified.The test organism is used to simulate a transient topicalmicrobial contaminant.It may also be referred to as a markerorganism,bacterial simulant,or bacterial contaminant.3.1.8 transient microbial skin flora,nmicroorganisms thatcontaminate the skin but do not normally form a stablepopulation.4.Summary of Test Method4.1 This test method is conducted on a group of volunteersubjects who have refrained from using topical antimicrobialformulations for at least one week prior to the initiation of thetest.Activity of the test material is measured by comparing the1This 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 2010.Last previous edition approved in 2010 as E278410.DOI:10.1520/E278410R15.2Federal Register,Vol 46,No.17,Jan 27,1991.3For 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.4Technical Manual of the American Association of Textile Chemists andColorists,P.O.Box 12215,Research Triangle Park,North Carolina 27709.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 number of test organisms recovered from artificially contami-nated hands after use of a handwashing formulation to thenumber recovered from contaminated hands not exposed to thetest formulation.The method describes specific procedures tobe followed using Serratia marcescens as the test organism.The activity of the test material is measured following a singlewash in a single day using a neutralization recovery method.4.2 Alternative test organisms which may be used areEscherichia coli,Shigella flexneri,and Staphylococcus aureus.Culture media and incubation conditions appropriate for thealternative organisms should be employed.4.3 The investigator should be aware that there may behealth risks associated with the use of the test organisms andprecautions similar to those referenced in 8.5 should beundertaken.5.Significance and Use5.1 This procedure h