ASTM_E_1052_-_11.pdf

Designation:E105211Standard Test Method toAssess the Activity of Microbicides against Viruses inSuspension1This standard is issued under the fixed designation E1052;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 intended to demonstrate the virucidalactivity of test substances with viruses in suspension.1.2 It is the responsibility of the investigator to determinewhether Good Laboratory Practice regulations(GLPs)arerequired and to follow them where appropriate(40 CFR,Part160 for EPA submissions and 21 CFR,Part 58 for FDAsubmissions).1.3 Refer to the appropriate regulatory agency for perfor-mance standards of virucidal efficacy.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.The user shouldconsult a reference for the laboratory safety recommenda-tions.22.Referenced Documents2.1 ASTM Standards:3E1053 Test Method to Assess Virucidal Activity of Chemi-cals Intended for Disinfection of Inanimate,NonporousEnvironmental SurfacesE1482 Test Method for Neutralization of VirucidalAgents inVirucidal Efficacy EvaluationsE1838 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 ChemicalsE2756 Terminology Relating to Antimicrobial and AntiviralAgents2.2 Federal Standards:421 CFR Code of Federal Regulations(CFR),Food and DrugAdministration,Part 58,Laboratory Practice for Nonclini-cal Laboratory Studies40 CFR Code of Federal Regulations(CFR),EnvironmentalProtection Agency,Part 160,Good Laboratory PracticeStandard3.Terminology3.1 DefinitionsFor definitions of general terms used in thistest method,refer to Terminology E2756.3.2 Definitions of Terms Specific to This Standard:3.2.1 hard water,nwater with a standard hardness ascalcium carbonate.3.2.2 neutralization,nthe process for inactivating orquenching the activity of a microbicide,often achieved throughphysical(for example,filtration or dilution)or chemical means.3.2.2.1 DiscussionThis neutralization may be achievedthrough dilution of the test substance to reduce the microbi-cidal activity,or through the use of chemical agents,calledneutralizers,to eliminate microbicidal activity.3.2.3 soil load,na solution of one or more organic and/orinorganic substances added to the suspension of the testorganism to simulate the presence of body secretions,excre-tions,or other extraneous substances.3.2.4 test substances or test formulation,na formulationwhich incorporates microbicidal ingredients.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 Oct.1,2011.Published October 2011.Originallyapproved in 1985.Last previous edition published in 2002 as E1052 96(2002),which was withdrawn in July 2011 and reinstated in October 2011.DOI:10.1520/E1052-11.2CDC-NIH,Biosafety in Microbiological and Biomedical Laboratories,FifthEdition,U.S.Department of Health and Human Services,Washington,DC,May2009.3For 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 U.S.Government Printing Office,Superintendent of Docu-ments,Washington,DC 20402.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.Summary of Test Method4.1One part of the virus suspension is added to nine partsof the test substance,the mixture held at the desired tempera-ture for the required contact time and then assayed for viablevirus in an appropriate host system.For control,one part of thevirus is added to nine parts of a buffer harmless to the virus andits host cells.Cell culture,cytotoxicity,and virus susceptibilitycontrols must also be included in each test.4.2 This test method must be performed by a trainedmicrobiologist or virologist who is responsible for choosing theappropriate host system for the test virus,and applying thetechniques necessary for propagation and maintenance of hostcell lines and test virus.For a reference text,refer to Schmidtet al.55.Significance and Use