ASTM_E_1174_-_13.pdf

Designation:E117413Standard Test Method forEvaluation of the Effectiveness of Health Care PersonnelHandwash Formulations1This standard is issued under the fixed designation E1174;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 is designed to determine the effective-ness of antimicrobial handwashing agents for the reduction oftransient microbial flora when used in a handwashing proce-dure.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 The values stated in SI units are to be regarded asstandard;except for distance,in which case inches are used andmetric units follow 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 8.2.2.Referenced Documents2.1 ASTM Standards:3E1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE2755 TestMethodforDeterminingtheBacteria-Eliminating Effectiveness of Hand Sanitizer FormulationsUsing Hands of Adults3.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 non-antimicrobial wash intendedto remove gross soil or residues from the hands of the panelistsprior to the conduct of the study and as noted throughout thestudy.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,na process which results in quench-ing the antimicrobial activity of a test material.This may beachieved through dilution of the test material(s)to reduce theantimicrobial activity,or through the use of chemical agents,called neutralizers,to eliminate antibacterial activity.3.1.5 resident microorganisms,nmicroorganisms that liveand multiply on the skin,forming a permanent population.3.1.6 test formulation,na formulation which incorporatesantimicrobial ingredient(s).3.1.7 test organisman 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 microorganismsorganisms from the envi-ronment that contaminate but do not normally colonize theskin.4.Summary of Test Method4.1 This test method is conducted on a group of volunteerpanelists 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 thenumber 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 and may be measured following multiple washes in asingle day using a neutralization recovery method.1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of Subcommittee E35.15Antimicrobial Agents.Current edition approved Feb.15,2013.Published February 2013.Originallyapproved in 1987.Last previous edition approved in 2006 as E1174 06.DOI:10.1520/E1174-13.2Federal 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.2 An alternative test organism is Escherichia coli.Culturemedia and incubation conditions appropriate for this organismshould be employed.The investigator should also be aware thatthere may be health risks associated with the use of thisorganism and precautions similar to those referenced in 8.2should be undertaken.5.Significance and Use5.1 The procedure may be used to test the effectiveness ofantimicrobial handwashing agents.The test formula