ASTM E2197-17e1
(Test Method)Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
SIGNIFICANCE AND USE
5.1 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.
5.2 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.
5.3 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).
5.4 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.
5.5 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 te...
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World T...
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
´1
Designation: E2197 − 17
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.
1
ε NOTE—Sections 8.1 and 11.8 were editorially corrected in January 2018.
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 required and to follow them where appropriate (40 CFR, Part
160 for EPA submissions and 21 CFR, Part 58 for FDA
1.1 This test method is designed to evaluate the ability of
submissions).
test substances to inactivate vegetative bacteria, viruses, fungi,
1.5 Inthistestmethod,SIunitsareusedforallapplications,
mycobacteria, and bacterial spores (1-7) on disk carriers of
except for distance in which case inches are used and metric
brushed stainless steel that represent hard, nonporous environ-
units follow.
mentalsurfacesandmedicaldevices.Itisalsodesignedtohave
survivors that can be compared to the mean of no less than
1.6 This standard does not purport to address all of the
three control carriers to determine if the performance standard
safety concerns, if any, associated with its use. It is the
has been met. For proper statistical evaluation of the results,
responsibility of the user of this standard to establish appro-
the number of viable organisms in the test inoculum should be
priate safety, health, and environmental practices and deter-
sufficiently high to take into account both the performance
mine the applicability of regulatory limitations prior to use.
standard and the experimental variations in the results.
1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.2 Thetestprotocoldoesnotincludeanywipingorrubbing
ization established in the Decision on Principles for the
action. It is, therefore, not designed for testing wipes.
Development of International Standards, Guides and Recom-
1.3 This test method should be performed by persons with
mendations issued by the World Trade Organization Technical
traininginmicrobiologyinfacilitiesdesignedandequippedfor
Barriers to Trade (TBT) Committee.
work with infectious agents at the appropriate biosafety level
(8).
2. Referenced Documents
3
1.4 It is the responsibility of the investigator to determine
2.1 ASTM Standards:
whether Good Laboratory Practice Regulations (GLPs) are
A967/A967MSpecification for Chemical Passivation Treat-
ments for Stainless Steel Parts
D1129Terminology Relating to Water
1
D1193Specification for Reagent Water
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Dec. 1, 2017. Published December 2017. Originally
3
approved in 2002. Last previous edition approved in 2011 as E2197–11. DOI: For referenced ASTM standards, visit the ASTM website, www.astm.org, or
10.1520/E2197-17E01. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
2
The boldface numbers in parenthesis refer to the list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
´1
E2197 − 17
E2756Terminology Relating toAntimicrobial andAntiviral 4.3 Fortestswithviruses,appropriatedilutionsoftheeluate
Agents are inoculated into suitable cell cultures, the cultures are
4
2.2 CFR Standard: exami
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.