ASTM_E_2197_-_11.pdf

Designation:E219711Standard Quantitative Disk Carrier Test Method forDetermining Bactericidal,Virucidal,Fungicidal,Mycobactericidal,and Sporicidal Activities of Chemicals1This standard is issued under the fixed designation E2197;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.INTRODUCTIONThe quantitative test method described here uses disks of stainless steel(1 cm in diameter)ascarriers.It employs the same basic set of materials and procedures to assess the ability of liquidchemicals to inactivate vegetative bacteria,viruses,fungi,mycobacteria,and bacterial spores(1-7).2Performance standards for test substances,the level of water hardness,the type and level of a soil load,the test organism(s),and other test conditions may vary depending on the target regulatory agency.This basic test can also be adapted for use with other carrier materials of similar dimensions.The development of this test method was made possible with financial support from theAntimicrobials Division of the U.S.Environmental Protection Agency.1.Scope1.1 This test method is designed to evaluate the ability oftest substances to inactivate vegetative bacteria,viruses,fungi,mycobacteria,and bacterial spores(1-7)on disk carriers ofbrushed stainless steel that represent hard,nonporous environ-mental surfaces and medical devices.It is also designed to havesurvivors that can be compared to the mean of no less thanthree control carriers to determine if the performance standardhas been met.For proper statistical evaluation of the results,the number of viable organisms in the test inoculum should besufficiently high to take into account both the performancestandard and the experimental variations in the results.1.2 The test protocol does not include any wiping or rubbingaction.It is,therefore,not designed for testing wipes.1.3 This test method should be performed by persons withtraining in microbiology in facilities designed and equipped forwork with infectious agents at the appropriate biosafety level(8).1.4 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).1.5 In this test method,SI units are used for all applications,except for distance in which case inches are used and metricunits follow.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.2.Referenced Documents2.1 ASTM Standards:3D1129 Terminology Relating to WaterD1193 Specification for Reagent WaterE2756 Terminology Relating to Antimicrobial and AntiviralAgents2.2 CFR Standard:421 CFR,Part 58 Laboratory Practice for Nonclinical Labo-ratory Studies40 CFR,Part 160 Good Laboratory Practice Standards3.Terminology3.1 DefinitionsFor definitions of general terms used in thistest method,refer to Terminology E2756.3.2 Definitions of Terms Specific to This Standard: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 Jan.1,2011.Published March 2011.Originallyapproved in 2002.Last previous edition approved in 2002 as E2197 02.DOI:10.1520/E2197-11.2The boldface numbers in parenthesis refer to the list of references at the end ofthis standard.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 3.2.1 carrier,nan inanimate surface or object inoculatedwith the test organism.3.2.2 eluate,nan eluent,which contains the recoveredorganism(s).3.2.3 eluent,nany solution that is harmless to the testorganism(s)and that is added to a carrier to recover theorganism(s)in or on it.3.2.4 neutralization,na process to quench the antimicro-bial activity of a test substance.This process may be achievedby dilution of the organism/test substance mixture and/or byadding to it one or more chemical neutralizers.3.2.5 soil load,na solution of one or more organic,orinorganic substances,or both,added to the suspension of thetest organism to simulate the presence of body secretions,