ASTM E2197-11
(Test Method)Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides
Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides
SIGNIFICANCE AND USE
The design of this test eliminates any loss of viable organisms through wash off, thus making it possible to produce statistically valid data using many fewer test carriers than needed for methods based on simple MPN estimates.
The stringency in the test is provided by the use of a soil load, the microtopography of the brushed stainless steel carrier surface, and the smaller ratio of test substance to surface area typical for many disinfectant applications. Thus, the test substance being assessed is presented with a reasonable challenge while allowing for efficient recovery of the test organisms from the inoculated carriers. The metal disks in the basic test are also compatible with a wide variety of actives.
The design of the carriers makes it possible to place onto each a precisely measured volume of the test organism (10 μL) as well as the control fluid or test substance (50 μL).
The inoculum is placed at the center of each disk whereas the volumes of the test substance covers nearly the entire disk surface, thus virtually eliminating the risk of any organisms remaining unexposed.
In all tests, other than those against viruses, the addition of 10 mL of an eluent/diluent gives a 1:200 dilution of the test substance immediately at the end of the contact time. While this step in itself may be sufficient to arrest the microbicidal activity of most actives, the test protocol permits the addition of a specific neutralizer to the eluent/diluent, if required. Except for viruses, the membrane filtration step also allows processing of the entire eluate from the test carriers and, therefore, the capture and subsequent detection of even low numbers of viable organisms that may be present. Subsequent rinsing of the membrane filters with saline also reduces the risk of carrying any inhibitory residues over to the recovery medium. Validation of the process of neutralization of the test substance is required by challenge with low numbers of the test organism.
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SCOPE
1.1 This test method is designed to evaluate the ability of test substances to inactivate vegetative bacteria, viruses, fungi, mycobacteria, and bacterial spores (1-7) on disk carriers of brushed stainless steel that represent hard, nonporous environmental surfaces and medical devices. It is also designed to have survivors that can be compared to the mean of no less than three control carriers to determine if the performance standard has been met. For proper statistical evaluation of the results, the number of viable organisms in the test inoculum should be sufficiently high to take into account both the performance standard and the experimental variations in the results.
1.2 The test protocol does not include any wiping or rubbing action. It is, therefore, not designed for testing wipes.
1.3 This test method should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at the appropriate biosafety level (8).
1.4 It is the responsibility of the investigator to determine whether Good Laboratory Practice Regulations (GLPs) are required and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions).
1.5 In this test method, SI units are used for all applications, except for distance in which case inches are used and metric units follow.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: E2197 − 11
Standard Quantitative Disk Carrier Test Method for
Determining Bactericidal, Virucidal, Fungicidal,
1
Mycobactericidal, and Sporicidal Activities of Chemicals
This standard is issued under the fixed designation E2197; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
The quantitative test method described here uses disks of stainless steel (1 cm in diameter) as
carriers. It employs the same basic set of materials and procedures to assess the ability of liquid
2
chemicals to inactivate vegetative bacteria, viruses, fungi, mycobacteria, and bacterial spores(1-7).
Performancestandardsfortestsubstances,thelevelofwaterhardness,thetypeandlevelofasoilload,
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 the
Antimicrobials Division of the U.S. Environmental Protection Agency.
1. Scope 1.5 Inthistestmethod,SIunitsareusedforallapplications,
except for distance in which case inches are used and metric
1.1 This test method is designed to evaluate the ability of
units follow.
test substances to inactivate vegetative bacteria, viruses, fungi,
1.6 This standard does not purport to address all of the
mycobacteria, and bacterial spores (1-7) on disk carriers of
safety concerns, if any, associated with its use. It is the
brushed stainless steel that represent hard, nonporous environ-
responsibility of the user of this standard to establish appro-
mentalsurfacesandmedicaldevices.Itisalsodesignedtohave
priate safety and health practices and determine the applica-
survivors that can be compared to the mean of no less than
bility of regulatory limitations prior to use.
three control carriers to determine if the performance standard
has been met. For proper statistical evaluation of the results,
2. Referenced Documents
the number of viable organisms in the test inoculum should be
3
sufficiently high to take into account both the performance 2.1 ASTM Standards:
standard and the experimental variations in the results. D1129Terminology Relating to Water
D1193Specification for Reagent Water
1.2 Thetestprotocoldoesnotincludeanywipingorrubbing
E2756Terminology Relating toAntimicrobial andAntiviral
action. It is, therefore, not designed for testing wipes.
Agents
1.3 This test method should be performed by persons with 4
2.2 CFR Standard:
traininginmicrobiologyinfacilitiesdesignedandequippedfor
21 CFR, Part 58Laboratory Practice for Nonclinical Labo-
work with infectious agents at the appropriate biosafety level
ratory Studies
(8).
40 CFR, Part 160Good Laboratory Practice Standards
1.4 It is the responsibility of the investigator to determine
3. Terminology
whether Good Laboratory Practice Regulations (GLPs) are
required and to follow them where appropriate (40 CFR, Part
3.1 Definitions—Fordefinitionsofgeneraltermsusedinthis
160 for EPA submissions and 21 CFR, Part 58 for FDA
test method, refer to Terminology E2756.
submissions).
3.2 Definitions of Terms Specific to This Standard:
1
This test method is under the jurisdiction of ASTM Committee E35 on
3
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct For referenced ASTM standards, visit the ASTM website, www.astm.org, or
responsibility of Subcommittee E35.15 on Antimicrobial Agents. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Jan. 1, 2011. Published March 2011. Originally Standards volume information, refer to the standard’s Document Summary page on
approved in 2002. Last previous edition approved in 2002 as E2197–02. DOI: the ASTM website.
4
10.1520/E2197-11. AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
2
The boldface numbers in parenthesis refer to the list of references at the end of 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
this standard. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E2197 − 11
3.2.1 carrier, n—an inanimate surface or object inoculated 5.3 Thedesignofthecarriersmakesitpossibletoplaceonto
with the test organism. eachapreciselymeasuredvolumeofthetestorganism(10µL)
as well as the control fluid or test substance (50 µL).
3.2.2 eluate, n—an eluent, which contains the recovered
organism(s).
5.4 The inoculum is placed at the center of e
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This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:E2197–02 Designation:E2197–11
Standard Quantitative Disk Carrier Test Method for
Determining the Bactericidal, Virucidal, Fungicidal,
Mycobactericidal and Sporicidal Activities of Liquid
Chemical GermicidesDetermining Bactericidal, Virucidal,
Fungicidal, Mycobactericidal, and Sporicidal Activities of
1
Chemicals
This standard is issued under the fixed designation E2197; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
The quantitative test method described here uses disks of stainless steel (1 cm in diameter) as
carriers. Because it It employs the same basic set of materials and procedures to assess the ability of
liquid chemical germicides chemicals to inactivate vegetative bacteria, viruses, fungi, mycobacteria,
2
and bacterial spores (1,21-7). it unifies the test methodology against a wide array of microorganisms.
Performancestandardsforthecategoriesofproductstobetested,andthespecifictypesoforganism(s)
to be used may vary depending on the regulatory agency. This basic test can also be adapted for use
with other carrier materials of similar dimensions.
The development of this method was made possible with financial support from theAntimicrobials
Division of the U.S. Environmental ProtectionAgency. Performance 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 the
Antimicrobials Division of the U.S. Environmental Protection Agency.
1. Scope
1.1The method is designed to evaluate the ability of liquid chemical germicides to inactivate vegetative bacteria, viruses, fungi,
mycobacteria and bacterial spores in the presence of a soil load
1.1 This test method is designed to evaluate the ability of test substances to inactivate vegetative bacteria, viruses, fungi,
mycobacteria,andbacterialspores(1,21-7)ondiskcarriersofbrushedstainlesssteelthatrepresenthard,nonporousenvironmental
surfaces and medical devices. It is also designed to have survivors that can be compared to the mean of no less than three control
carriers to determine if the performance standard has been met. For proper statistical evaluation of the results, the sizenumber of
viable organisms in the test inoculum should be sufficiently largehigh to take into account both the performance standard and the
experimental variations in the results.
1.2 The test protocol does not include any wiping or rubbing action. It is, therefore, not designed for testing germicide-soaked
wipes.
1.3 This test method should be performed by persons with training in microbiology in facilities designed and equipped for work
with infectious agents at the appropriate biosafety level (38).
1.4In this test method, metric units are used for all applications, except for distance in which case inches are used and metric
units follow.
1.5It is the responsibility of the investigator to determine whether Good Laboratory Practice Regulations (GLPs) are required
and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions).
1
This test method is under the jurisdiction of ASTM Committee E35 on Pesticides and is the direct responsibility of Subcommittee on Pesticides, Antimicrobials, and
Alternative Control Methods and is the direct responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 10, 2002. Published June 2002. DOI: 10.1520/E2197-02.
Current edition approved Jan. 1, 2011. Published March 2011. Originally approved in 2002. Last previous edition approved in 2002 as E2197 – 02. DOI:
10.1520/E2197-11.
2
The boldface numbers in parenthesis refer to the list of references at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
E2197–11
1.4 It is the responsibility of the investigator to determine whether Good Laboratory Practice Regulations (GLPs) are required
and to follow them where appropriate (40 CFR, Part 160 for EPA submissions a
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