ASTM_E_2276_-_10.pdf

Designation:E227610Standard Test Method forDetermining the Bacteria-Eliminating Effectiveness ofHygienic Handwash and Handrub Agents Using theFingerpads of Adults1This standard is issued under the fixed designation E2276;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.INTRODUCTIONHands can spread many types of pathogens directly(1)2or by transfer of such organisms to othersurfaces and objects during casual contact(2,3).Therefore,regular and proper decontamination ofhands by caregivers and food-handlers in particular is crucial for infection control.Hygienic handantisepsis is meant to reduce the load of transient microflora on hands,thereby reducing the risk ofdisease transmission.Such reduction in the bacterial load may be due to a combination of bacterialinactivation and removal of viable bacteria from the skin.In this method the test bacterial suspensionis placed on the thumb-and fingerpads of adults to simulate the contamination of hands with transientmicroflora,the inoculum on the fingerpads is allowed to dry and is then treated with test and controlsolutions.Since in each test all ten digits on any given subject can be used,the protocol permits theinclusion of the required controls and several replicates of the test formulation in the same trial.1.Scope1.1 This test method is designed to determine the activity ofhygienic handwash and handrub(4)agents against transientbacterial flora on hands and is not meant for use with surgicalhand scrubs or preoperative skin preps.1.2 Performance of this procedure requires the knowledgeof regulations pertaining to the protection of human subjects.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(5).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 WaterE1115 Test Method for Evaluation of Surgical Hand ScrubFormulationsE1173 Test Method for Evaluation of Preoperative,Precatheterization,or Preinjection Skin PreparationsE1174 Test Method for Evaluation of the Effectiveness ofHealth Care Personnel Handwash FormulationsE1838 Test Method for Determining the Virus-EliminatingEffectiveness of Hygienic Handwash and Handrub AgentsUsing the Fingerpads of AdultsE2613 Test Method for Determining Fungus-EliminatingEffectiveness of Hygienic Handwash and Handrub AgentsUsing Fingerpads of Adults3.Terminology3.1 DefinitionsFor definitions of general terms used in thistest method,refer to Terminology D1129.3.2 Definitions of Terms Specific to This Standard:3.2.1 active ingredient,na substance added to a formula-tion specifically for the inhibition or inactivation of microor-ganisms.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 1,2010.Published May 2010.Originallyapproved in 2003.Last previous edition approved in 2003 as E2276 031.DOI:10.1520/E2276-10.2The boldface numbers in parentheses refer to the 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 3.2.2 dry control,na control to determine the number ofcolony forming units of the test bacterium remaining viableafter the initial drying of the inoculum on the skin.3.2.3 handrub,na liquid or gel which is applied byrubbing to decontaminate lightly soiled hands between hand-washings and generally do not require a post-treatment waterrinse;such agents usually contain alcohol alone or with otheractive ingredients.3.2.4 hard water,nwater with a standard hardness ofcalcium 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