ASTM E2197-17

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

• Status: Historical
• Publication Date: 30-Nov-2017
• ICS: 07.100.01 - Microbiology in general
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Relations

• Replaces: ASTM E2197-11 - Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides
• Effective Date: 01-Dec-2017
• Replaced By: ASTM E2197-17e1 - Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
• Effective Date: 01-Dec-2017
• Referred By: ASTM E2967-15 - Standard Test Method for Assessing the Ability of Pre-wetted Towelettes to Remove and Transfer Bacterial Contamination on Hard, Non-Porous Environmental Surfaces Using the Wiperator
• Effective Date: 01-Dec-2017
• Referred By: ASTM E3152-23 - Standard Guide for Standard Test Methods and Practices Available for Determining Antifungal Activity on Natural or Synthetic Substrates Treated with Antimicrobial Agents
• Effective Date: 01-Dec-2017
• Referred By: ASTM E3273-21 - Standard Practice to Assess Microbial Decontamination of Indoor Air using an Aerobiology Chamber
• Effective Date: 01-Dec-2017
• Referred By: ASTM E3092-18 - Standard Practice for Evaluating Efficacy of Vaporous Decontaminants on Materials Contaminated with <emph type="bdit">Bacillus</emph> Spores and Contained Within 0.2&#xb5;m Filter-Capped Tubes
• Effective Date: 01-Dec-2017
• Referred By: ASTM E2614-15(2020)e1 - Standard Guide for Evaluation of Cleanroom Disinfectants
• Effective Date: 01-Dec-2017
• Referred By: ASTM E1053-20 - Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
• Effective Date: 01-Dec-2017
• Referred By: ASTM E3218-21 - Standard Test Method for Quantitative Method for Testing Antimicrobial Agents against Spores of <emph type="ital">C. difficile</emph> on Hard, Nonporous Surfaces
• Effective Date: 01-Dec-2017
• Referred By: ASTM E3286-21 - Standard Practice for Preparation Of Cell Monolayers on Glass Surfaces for Evaluation of Microbicidal Properties of Non-Chemical Based Antimicrobial Treatment Technologies
• Effective Date: 01-Dec-2017
• Referred By: ASTM E2613-23 - Standard Practice for Determining the Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
• Effective Date: 01-Dec-2017
• Referred By: ASTM E1052-20 - Standard Practice to Assess the Activity of Microbicides against Viruses in Suspension
• Effective Date: 01-Dec-2017
• Referred By: ASTM E2721-16 - Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses
• Effective Date: 01-Dec-2017
• Referred By: ASTM E2800-11(2017) - Standard Practice for Characterization of <emph type="ital">Bacillus</emph> Spore Suspensions for Reference Materials
• Effective Date: 01-Dec-2017
• Referred By: ASTM E2895-19 - Standard Practice for Producing High Titers of Viable and Semi-Purified Spores of Clostridium difficile using a Liquid Medium
• Effective Date: 01-Dec-2017

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
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.
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,
mycobacteria, and bacterial spores (1-7) on disk carriers of 1.5 Inthistestmethod,SIunitsareusedforallapplications,
brushed stainless steel that represent hard, nonporous environ- except for distance in which case inches are used and metric
mentalsurfacesandmedicaldevices.Itisalsodesignedtohave units follow.
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
1
This test method is under the jurisdiction of ASTM Committee E35 on D1129Terminology Relating to Water
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
D1193Specification for Reagent Water
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/E2197-17. contact ASTM Customer Service at [e-mail]. 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 ----------------------
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: examined for cytopathology/infectious foci, which are esti-
21 CFR, Part 58Laboratory Practice for Nonclinical Labo- mated as the most probable number (MPN) or counted as foci
ratory Studies or plaques, and log are calculated.
10
40 CFR, Part 160
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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 − 11 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. 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. 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).
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
1.1 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 safety, health, and healthenvironmental 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 Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
3
2.1 ASTM Standards:
A967/A967M Specification for Chemical Passivation Treatments for Stainless Steel Parts
1
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 Jan. 1, 2011Dec. 1, 2017. Published March 2011December 2017. Originally approved in 2002. Last previous edition approved in 20022011 as
E2197 – 02.E2197 – 11. DOI: 10.1520/E2197-11.10.1520/E2197-17.
2
The boldface numbers in parenthesis refer to the list of references at the end of this standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2197 − 17
D1129 Terminology Relating to Water
D1193 Specification for Reagent Water
E2756 Terminology Relating to Antimicrob
...