ASTM_E_2613_-_14.pdf

Designation:E261314Standard Test Method forDetermining Fungus-Eliminating Effectiveness of HygienicHandwash and Handrub Agents Using Fingerpads ofAdults1This standard is issued under the fixed designation E2613;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.INTRODUCTIONHuman hands are frequently in contact with other surfaces and can readily acquire transientmicrobial contamination.Fungi are common among these types of contaminants(1,2),2particularlyin healthcare settings and where food is handled.Standardized methods to assess the fungus-eliminating potential of handwash and handrub agents have not been available and this test methodaddresses the gap.1.Scope1.1 This test method is designed to assess the ability ofhygienic handwash and handrub agents to reduce levels offungal contamination on hands(3).This test method is notmeant for use with surgical hand scrubs(Test Method E1115)or preoperative skin preps(Test Method E1173).1.2 Performance of this procedure requires the knowledgeof regulations pertaining to human experimentation.31.3 The test method should be performed by persons withtraining in microbiology in facilities designed and equipped forwork with infectious agents at biosafety level 2(4).1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.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 determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:4D1129 Terminology Relating to WaterE1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE1115 Test Method for Evaluation of Surgical Hand ScrubFormulationsE1173 Test Method for Evaluation of Preoperative,Precatheterization,or Preinjection Skin PreparationsE1838 Test Method for Determining the Virus-EliminatingEffectiveness of Hygienic Handwash and Handrub AgentsUsing the Fingerpads of AdultsE2197 Quantitative Disk Carrier Test Method for Determin-ing Bactericidal,Virucidal,Fungicidal,Mycobactericidal,and Sporicidal Activities of ChemicalsE2276 TestMethodforDeterminingtheBacteria-Eliminating Effectiveness of Hygienic Handwash andHandrub Agents Using the Fingerpads of AdultsE2756 Terminology Relating to Antimicrobial and AntiviralAgents3.Terminology3.1 DefinitionsFor definitions of general terms used in thistest method,refer to Terminologies D1129 and E2756.3.2 Definitions of Terms Specific to This Standard: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 April 1,2014.Published May 2014.Originallyapproved in 2008.Last previous edition approved in 2008 as E261308.DOI:10.1520/E2613-14.2The boldface numbers in parentheses refer to a list of references at the end ofthis standard.3Federal Register,Vol 46,No.17,Jan.27,1991.4For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.1 active ingredient,na substance added to a formula-tion specifically for the inhibition or inactivation of microor-ganisms.3.2.2 dry controla control to determine the number ofcolony forming units(CFU)of the test fungus remaining viableafter the initial drying of the inoculum on the skin.3.2.3 handrub,na liquid,gel,or foam,which is applied byrubbing to decontaminate lightly soiled hands between hand-washings and generally does not require a post-treatment waterrinse;such agents usually contain alcohol alone or with otheractive ingredients.3.2.4 hard water,nwater with a defined level of hardnessas calcium carbonate.3.2.5 hygienic handwash agent,nan agent generally usedfor handwashing by personnel in hospitals,other health-carefacilities,day-care centers,nursing homes,and food-handlingestablishments to eliminate transient microorganisms fromintact skin.3.2.6 input control,na control to determine the number ofcolony forming units of the test fungus placed on each digit.3.2.7 neutralizationa process which results in quenchingthe antifungal activity of a test material.This may be achievedthrough dilution of the test material(s)to reduce the antifungalactivity,or through the use of chemical agents,calledneutralizers,to eliminate antifungal activity.3.2.8 soil load,na solution of one or mo