ASTM_E_2011_-_13.pdf

Designation:E201113Standard Test Method forEvaluation of Hygienic Handwash and HandrubFormulations for Virus-Eliminating Activity Using the EntireHand1This standard is issued under the fixed designation E2011;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.INTRODUCTIONMechanical removal and/or in situ inactivation of viruses by hygienic handwash and handrub agentscan be assessed using artificially-contaminated hands of adults.This test method uses the entiresurface of both hands(including both the palmar and dorsum sides of the hands)in contrast to onlythe fingerpads in the procedure described in Test Method E1838.However,the reported results fromthese two methods are comparable.(1,2)21.Scope1.1 This test method is designed to evaluate handwash orhandrub agents for their ability to reduce or eliminate viableviruses from the skin of human hands.NOTE1Aknowledge of virological techniques is required for this testmethod.1.2 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.3 This standard may involve hazardous materials,opera-tions and equipment.This standard does not purport to addressall of the safety concerns,if any,associated with its use.It isthe responsibility of the user of this standard to establishappropriate safety and health practices and determine theapplicability of regulatory limitations prior to use.The usershould consult a reference for laboratory safety recommenda-tions.(3-5)2.Referenced Documents2.1 ASTM Standards:3E1482 Practice for Use of Gel Filtration Columns for Cyto-toxicity Reduction and NeutralizationE1838 Test Method for Determining the Virus-EliminatingEffectiveness of Hygienic Handwash and Handrub AgentsUsing the Fingerpads of Adults2.2 AOAC Standard:AOAC 960.9 Official Methods of Analysis(2007)43.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 hygienic handwash agents,nagents generally usedfor handwashing by personnel in hospitals,other health-carefacilities,day-care centers,nursing homes,and food-handlingestablishments;should be safe for repeated use,non-irritating,fast-acting,and efficient in eliminating transient microorgan-isms from intact skin.3.1.2 hygienic handrub agents(that is,hand sanitizers),nagents not requiring rinsing and generally used for handhygiene by personnel in hospitals,other health-care facilities,day-care centers,nursing homes,and food-handling establish-ments;should be safe for repeated use,non-irritating,fast-acting,and efficient in eliminating transient microorganismsfrom intact skin.3.1.3 non-medicated soap,na soap or detergent that ismild to the skin and does not contain any germicidal chemicals.3.1.4 soil(organic)load,na solution of one or moreorganic and/or inorganic substances added to the suspension ofthe test organism to simulate the presence of body secretions,excretions or other extraneous substances.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 1,2013.Published May 2013.Originallyapproved in 1999.Last previous edition approved in 2009 as E2011 09.DOI:10.1520/E2011-13.2The boldface numbers in parentheses refer to a list of references at the end ofthis test method.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.4Available from AOAC International,481 North Frederick Ave.,Suite 500,Gaithersburg,Maryland 20877-2417,http:/www.aoac.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.5 virus-eliminating(inactivating/removing)agent,nany agent that rids hands of viruses by either inactivatingthem on the skin or by dislodging them for subsequentwash-off.3.1.6 virus-inactivating agent,nany agent that renders avirus noninfectious.4.Summary of Test Method4.1 This test method uses adult subjects who have provideda written informed consent and whose hands have beendetermined to be free from any apparent damage at the time oftheir participation in the study.4.1.1 Since both hands,including nail beds,of the testsubject are exposed to high-titer suspensions of virus,eachsubject shall be carefully examined for any skin irritations,micro-breaches,or breaks in the hand skin and around the nailsusing a magnifying glass under well-lighted conditions.Thosewith any breaches,breaks,or other apparent skin damages shallnot participate in the test.4.1.2 While no fewer than six subjects are recommended foreach vir