ASTM_E_1054_-_08_2013.pdf

Designation:E105408(Reapproved 2013)Standard Test Methods forEvaluation of Inactivators of Antimicrobial Agents1This standard is issued under the fixed designation E1054;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 These test methods are used to determine the effective-ness of procedures and agents for inactivating(neutralizing,quenching)the microbicidal properties of antimicrobial agents,and to ensure that no components of the neutralizing proce-dures and agents,themselves,exert an inhibitory effect onmicroorganisms targeted for recovery.NOTE1Knowledge of microbiological and statistical techniques isrequired for these procedures.These methods are not suitable when testingthe virucidal activity of microbicides(see Test Method E1482).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 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:2E645 Test Method for Efficacy of Microbicides Used inCooling Water SystemsE1115 Test Method for Evaluation of Surgical Hand ScrubFormulationsE1482 Practice for Use of Gel Filtration Columns for Cyto-toxicity Reduction and Neutralization3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 antimicrobial,adjdescribes an agent that kills orinactivates microorganisms or suppresses their growth orreproduction.3.1.2 antimicrobial effectiveness evaluation,adj/na deter-mination of microbicidal properties of an antimicrobial agentby methods,such as Test Methods E645 and E1115.3.1.3 CFU/mL(abbrev.)colony-forming units of a micro-organism per millilitre of fluid.3.1.4 neutralization,na physical or chemical procedurethat inactivates or quenches the microbicidal properties of anantimicrobial agent.3.1.5 neutralizer effectiveness,adj/nability of a neutral-ization procedure to inactivate or quench the microbicidalproperties of an antimicrobial agent.3.1.6 neutralizer toxicity,adj/nany inhibitory effects aneutralization procedure may have on the survival of a micro-bial population.3.1.7 test material control,adj/nan evaluation of theactivity of a test material in reducing a known population ofmicroorganisms.3.1.8 test organism viability,adj/nthe population of achallenge microorganism used in a neutralization assay.3.1.9 viability,nthe ability of a challenge microorganismto form colonies or grow on a nutrient medium.3.1.9.1 DiscussionIn the context of these test methods,“viability”is understood to be synonymous with culturability.4.Summary of Test MethodsNOTE2The neutralization test method selected must be consistentwith the methods of testing used in the antimicrobial effectivenessevaluation.4.1 Neutralization Assay with Recovery on Semi-solidMediumNeutralization assay for antimicrobial effectivenesstests that recover and quantify microbial populations on solid(agar)media.This method is appropriate for antimicrobialagents that are chemically inactivated or diluted to sub-inhibitory levels and performed entirely in vitro or including anin vivo component to verify neutralization of an antimicrobialformulation sampled from the skin of a human volunteer.4.2 Neutralization Assay with Recovery in Liquid MediumNeutralization assay for antimicrobial effectiveness tests thatrecover surviving microbial populations in liquid media for agrowth/no growth determination.This method is appropriatefor antimicrobial agents that are chemically inactivated ordiluted to sub-inhibitory levels.1These test methods are under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and are the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved April 1,2013.Published April 2013.Originallyapproved in 1985.Last previous edition approved in 2008 as E1054 08.DOI:10.1520/E1054-08R13.2For 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 4.3 Neutralization Assay with Recovery by MembraneFiltrationNeutralization assay for antimicrobial effectivenesstests that recover and quantify microbial populations by usingmembrane filtration.This method is appropriate for antimicro-bial agents that cannot be chemically inactivated or diluted tosub-inhibitory levels,as