ASTM E1054-22 PDF
Standard Practices for Evaluation of Inactivators of Antimicrobial Agents
Standard Practices for Evaluation of Inactivators of Antimicrobial Agents
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 10
- Дата публикации:
- 1 октября 2022 г.
- Издание:
- E1054
- ICS:
- 11.080.20
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 in the performance of selected neutralization procedure. 5.3 The neutralization evaluation must include at least three replications (five replications in Section 9) so that a statistical analysis of the microbial 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 effect of the neutralization procedure on recovery of injured organisms should be examined. This method is not intended to assess recovery of injured organisms. Note 3: Ideally, all microorganisms used in the antimicrobial effectiveness evaluation should be tested in the neutralization assay. However, representative organism... SCOPE 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. 1.2 Knowledge of microbiological and statistical techniques is required for these procedures. Note 1: These methods are not suitable when testing the virucidal activity of microbicides (see Test Method E1482). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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.
Abstract
Overview
ASTM E1054-22: Standard Practices for Evaluation of Inactivators of Antimicrobial Agents establishes test procedures to determine the effectiveness of methodologies, procedures, and materials intended for inactivating or neutralizing antimicrobial agents. These practices are critical in antimicrobial effectiveness testing for disinfectants, sanitizers, and antiseptics to ensure that results accurately reflect the true microbicidal activity within a defined exposure time. Proper neutralization prevents carryover effects and avoids overestimation of antimicrobial efficacy by halting antimicrobial activity at the conclusion of the intended exposure.
Compliance with ASTM E1054-22 enables laboratories, product developers, and quality assurance professionals to standardize the evaluation of neutralizers used in microbiological assays.
Key Topics
-
Antimicrobial Neutralization: The standard covers several methods for inactivating antimicrobial agents:
- Chemical neutralization
- Dilution
- Membrane filtration
-
Significance of Immediate Inactivation: Accurate measurement of antimicrobial effectiveness requires complete, rapid neutralization to prevent continued action after the exposure time.
-
Replicates and Statistical Analysis: Neutralizer effectiveness must be evaluated with statistical significance, requiring at least three to five replicates based on the chosen procedure.
-
Assessment of Neutralizer Toxicity: Procedures ensure that neutralizers do not themselves inhibit or affect the recovery of target microorganisms.
-
Limitations: Standard tests are not designed to evaluate recovery of injured organisms or to assess virucidal activity (see ASTM E1482 for virucidal testing).
-
Data Interpretation: Results are analyzed statistically (using t-tests, ANOVA, or Chi-square) to confirm equivalency in microbial recovery between test conditions and controls.
Applications
ASTM E1054-22 is widely used in several scenarios involving antimicrobial agents:
-
Validation of Disinfectants and Sanitizers: Ensures that neutralizers used in effectiveness tests do not contribute to biased reductions in microbial counts.
-
Antiseptic Product Testing: Essential for products requiring demonstration of microbicidal efficacy, such as hand sanitizers and wound cleansers.
-
Environmental and Industrial Hygiene: Used in quality control for antimicrobial agents in settings such as healthcare, food processing, pharmaceuticals, and water treatment.
-
Product Development and Regulatory Submission: Supports claims for antimicrobial activity by providing reliable, reproducible, and internationally recognized test methods.
-
Laboratory Quality Control: Ensures consistency and reliability in testing by standardizing materials, procedures, and result interpretation.
Related Standards
For comprehensive antimicrobial testing, the following ASTM standards should be considered:
- ASTM E645: Practice for the Evaluation of Microbicides Used in Cooling Water Systems
- ASTM E1115: Test Method for Evaluation of Surgical Hand Scrub Formulations
- ASTM E1482: Practice for the Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization (also used for virucidal activity testing)
- ASTM E2756: Terminology Relating to Antimicrobial and Antiviral Agents
Practical Value
Implementing ASTM E1054-22 enhances the reliability and international acceptability of antimicrobial agent testing by:
-
Reducing Experimental Errors: Prevents overestimation of alive microorganisms due to incomplete neutralization.
-
Supporting Regulatory Compliance: Contributes to meeting regulatory requirements for product approval and labeling in global markets.
-
Ensuring Accurate Product Claims: Confirms that measured antimicrobial effects result solely from the tested agent, not residual activity or neutralizer interference.
Keywords: ASTM E1054-22, antimicrobial neutralization, inactivation, efficacy testing, disinfectants, antiseptics, neutralizer toxicity, laboratory quality assurance, statistical analysis of microbiological data, antimicrobial agents
Технические детали
- Технический комитет
- E35 - Pesticides, Antimicrobials, and Alternative Control Agents
- SKU
- ASTM E1054-22
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