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ASTM E1054-08(2013)

(Test Method)

Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents

Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents

SIGNIFICANCE AND USE
5.1 The effectiveness of antimicrobial agents incorporated into disinfectants, sanitizers, and antiseptics is measured by their ability to kill microorganisms within a specified contact time. Hence, accurate determination of antimicrobial effectiveness requires complete and immediate inactivation (neutralization) of the antimicrobial agent. Inefficient or incomplete neutralization will permit killing or inactivation of microorganisms to continue beyond the experimental exposure time, resulting in an overestimation of antimicrobial activity.  
5.2 The neutralization methods commonly used in antimicrobial effectiveness evaluations are chemical inactivation, dilution, and filtration. All critical parameters of an antimicrobial effectiveness evaluation—for example, media, equipment, microorganism(s), and temperature of solutions—must be duplicated when evaluating a neutralization procedure to be used.  
5.3 The neutralization evaluation must include at least three replications (five replications in Section 9) so that a statistical analysis of the recovery data can be performed. The number of replicates used in the evaluation depends on the statistical significance required for the expected results, the variability encountered in the data, and the relative effectiveness of the neutralization procedure.  
5.4 A limitation of these evaluation procedures is that they use microorganisms that have not been exposed to an antimicrobial agent. Under experimental conditions, cells exposed to neutralization procedures are likely to be damaged to different degrees by the antimicrobial agent. Sublethal injury may be a factor in recovery, and the role of the neutralization procedure in recovery of injured organisms should be examined. This method is not intended to assess injured organism recovery.Note 3—Ideally, all microorganisms used in the antimicrobial effectiveness evaluation should be tested in the neutralization assay. However, representative organisms may be selected for ...
SCOPE
1.1 These test methods are used to determine the effectiveness of procedures and agents for inactivating (neutralizing, quenching) the microbicidal properties of antimicrobial agents, and to ensure that no components of the neutralizing procedures and agents, themselves, exert an inhibitory effect on microorganisms targeted for recovery.Note 1—Knowledge of microbiological and statistical techniques is required for these procedures. These methods are not suitable when testing the virucidal activity of microbicides (see Test Method E1482).  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 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.

General Information

Status
Historical
Publication Date
31-Mar-2013
ICS
11.080.20 - Disinfectants and antiseptics
71.100.35 - Chemicals for industrial and domestic disinfection purposes
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

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ASTM E1054-08(2013) - Standard Test Methods for Evaluation of Inactivators of Antimicrobial AgentsASTM E1054-08(2013) - Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents
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ASTM E1054-08(2013) - Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents
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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: E1054 − 08 (Reapproved 2013)
Standard Test Methods for
1
Evaluation of Inactivators of Antimicrobial Agents
This standard is issued under the fixed designation E1054; 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.
1. Scope 3.1.2 antimicrobial effectiveness evaluation, adj/n—a deter-
mination of microbicidal properties of an antimicrobial agent
1.1 These test methods are used to determine the effective-
by methods, such as Test Methods E645 and E1115.
ness of procedures and agents for inactivating (neutralizing,
quenching)themicrobicidalpropertiesofantimicrobialagents, 3.1.3 CFU/mL (abbrev.)—colony-forming units of a micro-
organism per millilitre of fluid.
and to ensure that no components of the neutralizing proce-
dures and agents, themselves, exert an inhibitory effect on
3.1.4 neutralization, n—a physical or chemical procedure
microorganisms targeted for recovery.
that inactivates or quenches the microbicidal properties of an
NOTE 1—Knowledge of microbiological and statistical techniques is
antimicrobial agent.
requiredfortheseprocedures.Thesemethodsarenotsuitablewhentesting
the virucidal activity of microbicides (see Test Method E1482). 3.1.5 neutralizer effectiveness, adj/n—ability of a neutral-
ization procedure to inactivate or quench the microbicidal
1.2 The values stated in SI units are to be regarded as
properties of an antimicrobial agent.
standard. No other units of measurement are included in this
3.1.6 neutralizer toxicity, adj/n—any inhibitory effects a
standard.
neutralization procedure may have on the survival of a micro-
1.3 This standard does not purport to address all of the
bial population.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- 3.1.7 test material control, adj/n—an evaluation of the
priate safety and health practices and determine the applica- activity of a test material in reducing a known population of
bility of regulatory limitations prior to use. microorganisms.
3.1.8 test organism viability, adj/n—the population of a
2. Referenced Documents
challenge microorganism used in a neutralization assay.
2
2.1 ASTM Standards:
3.1.9 viability, n—the ability of a challenge microorganism
E645 Test Method for Efficacy of Microbicides Used in
to form colonies or grow on a nutrient medium.
Cooling Water Systems
3.1.9.1 Discussion—In the context of these test methods,
E1115 Test Method for Evaluation of Surgical Hand Scrub
“viability” is understood to be synonymous with culturability.
Formulations
E1482 Practice for Use of Gel Filtration Columns for Cyto-
4. Summary of Test Methods
toxicity Reduction and Neutralization
NOTE 2—The neutralization test method selected must be consistent
with the methods of testing used in the antimicrobial effectiveness
evaluation.
3. Terminology
4.1 Neutralization Assay with Recovery on Semi-solid
3.1 Definitions of Terms Specific to This Standard:
Medium—Neutralization assay for antimicrobial effectiveness
3.1.1 antimicrobial, adj—describes an agent that kills or
tests that recover and quantify microbial populations on solid
inactivates microorganisms or suppresses their growth or
(agar) media. This method is appropriate for antimicrobial
reproduction.
agents that are chemically inactivated or diluted to sub-
inhibitorylevelsandperformedentirely in vitroorincludingan
in vivo component to verify neutralization of an antimicrobial
1
These test methods are under the jurisdiction of ASTM Committee E35 on
formulation sampled from the skin of a human volunteer.
Pesticides, Antimicrobials, and Alternative Control Agents and are the direct
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
4.2 NeutralizationAssay with Recovery in Liquid Medium—
Current edition approved April 1, 2013. Published April 2013. Originally
Neutralization assay for antimicrobial effectiveness tests that
approved in 1985. Last previous edition approved in 2008 as E1054 – 08. DOI:
10.1520/E1054-08R13.
recover surviving microbial populations in liquid media for a
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
growth/no growth determination. This method is appropriate
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
for antimicrobial agents that are chemically inactivated or
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. diluted to sub-inhibitory levels.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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5.1 This practice is to be used for the removal of virucidal agents from test product-virus mixtures, or from test product-neutralizer-virus mixtures, at or after the contact period and before the inoculation of these mixtures into host systems for assay of viral infectivity.  
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1.1 This practice is intended to be used to reduce the cytotoxic level of the virus-test product mixture prior to assaying for viral infectivity. It is used in conjunction with evaluations of the virucidal efficacy of disinfectant solutions, wipes, trigger sprays, or pressurized disinfectant spray products intended for use on inanimate, nonporous environmental surfaces. This practice may also be used in the evaluation of hygienic handwashes/handrubs, or for other special applications. The practice may be employed with all viruses and host systems.
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Standard Practices for Evaluation of Inactivators of Antimicrobial Agents

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5.1 The effectiveness of antimicrobial agents incorporated into disinfectants, sanitizers, and antiseptics is measured by their ability to kill microorganisms within a specified contact time. Hence, accurate determination of antimicrobial effectiveness requires complete and immediate inactivation (neutralization) of the antimicrobial agent. Inefficient or incomplete neutralization will permit killing or inactivation of microorganisms to continue beyond the experimental exposure time, resulting in an overestimation of antimicrobial activity.  
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1.1 These test procedures are used to determine the effectiveness of methodologies procedures and materials intended for inactivating (neutralizing, quenching) the microbicidal properties of antimicrobial agents; to ensure that no components of the neutralizing procedures and materials, themselves, exert an inhibitory effect on microorganisms targeted for recovery; and to demonstrate that the antimicrobial chemistry tested is microbicidal.  
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Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces

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4.1 This test method shall be used to determine if a chemical intended for use as a non-food contact sanitizer or as a one-step cleaner-sanitizer provides percent reductions of the selected test organisms on treated carriers as compared to control.
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1.1 This test method is used to evaluate the antimicrobial efficacy of sanitizers on precleaned, inanimate, hard, nonporous, non-food contact surfaces against Staphylococcus aureus, or Klebsiella pneumoniae or Klebsiella aerogenes, or a combination thereof. Appropriate modifications to the method may be required when testing organisms not specified herein. When utilizing test surfaces not described herein (see Test Method E2274) or when evaluating spray-based or towelette-based antimicrobial products, modifications may also be required.  
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5.1 Hand hygiene is considered one of the most important measures for preventing the spread of infectious microorganisms. Hand rubs reduce the microbial load on the hands without the use of soap and water, and are thus an important tool in the practice of good hand hygiene. Alcohol-based hand rubs are recommended in healthcare settings for use on hands that are not visibly soiled. They are formulated to be applied full strength to dry hands, “rubbed in” until dry, and are not rinsed off.  
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5.1 The practice can be used to evaluate coupon materials of any composition, insofar as the coupon can be prepared small enough to fit inside a 50-ml conical tube.  
5.2 This practice defines procedures that are quantitative, scalable, rapid, sensitive, safe, reduces consumables, minimizes labor and addresses statistical confidence (1, 2, 4).  
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Standard Test Method for Evaluation of Surgical Hand Scrub Formulations

SIGNIFICANCE AND USE
5.1 The procedure in this test method should be used to evaluate the activity of the test formulation in reducing the bacterial population of the hands immediately after a single use and to determine persistent activity (inhibition of growth) after 6 h. Optionally, measurements of persistent activity after a 3 h period and measurements of cumulative activity may be made after repetitive uses over a five day period.
SCOPE
1.1 This test method is designed to measure the reduction of microbial flora on the skin. It is intended for determining both immediate and persistent (continuing antimicrobial effect) microbial reductions, after single or repetitive treatments, or both. It may also be used to measure cumulative antimicrobial activity after repetitive treatments.  
1.2 A knowledge of microbiological techniques is required for these procedures.  
1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR, Parts 50 and 56)  
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1.4.1 In this test method, SI units are used for all applications, except for distance, in which case inches are used and SI units follow in parentheses.  
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5.1 The procedure is used to evaluate personal cleansing products containing antibacterial ingredients that are intended to reduce the number of organisms on intact skin. It also may be used to demonstrate the effect of residual antibacterial activity by means of inhibition of the proliferation of bacteria on the skin after contact.
SCOPE
1.1 This guide is designed to demonstrate the effectiveness of an antibacterial personal cleansing product in reducing the numbers of a marker organism (representing transients) both immediately and after prolonged exposure to (cleansing) washing when used as recommended under simulated use conditions. The method demonstrates the effect of residual antibacterial activity by means of inhibition of proliferation of bacteria on the skin after the contact period. Antimicrobial activity is compared with a vehicle or to a baseline organism count.  
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SIGNIFICANCE AND USE
5.1 This practice is to be used for the removal of virucidal agents from test product-virus mixtures, or from test product-neutralizer-virus mixtures, at or after the contact period and before the inoculation of these mixtures into host systems for assay of viral infectivity.  
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SCOPE
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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.

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Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate, Hard, Nonporous Non-Food Contact Surfaces

SIGNIFICANCE AND USE
4.1 This test method shall be used to determine if a chemical intended for use as a non-food contact sanitizer or as a one-step cleaner-sanitizer provides percent reductions of the selected test organisms on treated carriers as compared to control.
SCOPE
1.1 This test method is used to evaluate the antimicrobial efficacy of sanitizers on precleaned, inanimate, hard, nonporous, non-food contact surfaces against Staphylococcus aureus, or Klebsiella pneumoniae or Klebsiella aerogenes, or a combination thereof. Appropriate modifications to the method may be required when testing organisms not specified herein. When utilizing test surfaces not described herein (see Test Method E2274) or when evaluating spray-based or towelette-based antimicrobial products, modifications may also be required.  
1.2 This test method may also be used to evaluate the antimicrobial efficacy of one-step cleaner-sanitizer formulations recommended for use on lightly soiled, inanimate, nonporous, non-food contact surfaces.  
1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP) are required and to follow them where appropriate (see section 40 CFR, 160 or as revised.)  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard may involve hazardous materials, chemicals and microorganisms and should be performed only by persons who have had formal microbiological training.  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.  
1.6 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.

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  • Standard
    6 pages
    English language
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