ASTM_E_1053_-_11.pdf

Designation:E105311Standard Test Method toAssess Virucidal Activity of Chemicals Intended forDisinfection of Inanimate,Nonporous EnvironmentalSurfaces1This standard is issued under the fixed designation E1053;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 used to evaluate the virucidalefficacy of liquid,aerosol,or trigger-spray microbicides in-tended for use on inanimate,nonporous environmental sur-faces.This test method may be employed with most viruses,which can be grown in cultured cells.2However,other hostsystems(for example,embryonic eggs)may be used withproper justification and documentation.1.2 This test method should be performed only by thosetrained in microbiological and virological techniques in facili-ties designed and equipped for work with infectious agents atthe appropriate biosafety level.1.3 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).Refer to the appropriate regulatory agency forperformance standards of virucidal efficacy.1.4 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 laboratory safety recommendations.22.Referenced Documents2.1 ASTM Standards:3D1129 Terminology Relating to WaterE1153 Test Method for Efficacy of Sanitizers Recommendedfor Inanimate Non-Food Contact SurfacesE1482 Test Method for Neutralization of VirucidalAgents inVirucidal Efficacy EvaluationsE2197 Quantitative Disk Carrier Test Method for Determin-ing Bactericidal,Virucidal,Fungicidal,Mycobactericidal,and Sporicidal Activities of Chemicals2.2 Federal Standards:4Title 21,Code of Federal Regulations(CFR),Food and DrugAdministration,Part 58,Laboratory Practice for Nonclini-cal Laboratory StudiesTitle 40,Code of Federal Regulations(CFR),EnvironmentalProtection Agency,Subchapter E,Pesticide Programs;Part 160,Good Laboratory Practice Standards3.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 hard water,nwater with a standard hardness ascalcium carbonate.3.2.2 neutralization,na process which results in quench-ing the microbicidal activity of a test substance.This may beachieved through dilution of the test substance to reduce themicrobicidal activity,or through the use of chemical agents,called neutralizers,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 substance or test formulation,na formulationwhich incorporates microbicidal ingredients.4.Summary of Test Method4.1 The virus suspension is dried on an inanimate,nonpo-rous surface.The test substance is added over the dried film at1This 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 Jan.1,2011.Published March 2011.Originallyapproved in 1985.Last previous edition approved in 2002 as E1053 97(2002).DOI:10.1520/E1053-11.2Public Health Service,Centers for Disease Control and Prevention,andNational Institutes of Health,Biosafety in Microbiological and Biomedical Labo-ratories,U.S.Department of Health and Human Services,Washington,DC,December 2009,422 pp.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 Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 its use-dilution or sprayed from an aerosol can or trigger-sprayer following the manufacturers directions.Control carri-ers receive an equivalent volume of a buffer harmless to the testvirus and its host cells.After exposure at the appropriatetemperature(usually 22 6 2C)for the recommended time,theeluates from control and test carriers are assayed for infectivity.4.2 This test method is designed to be performed by aperson trained in