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Standard Practices for Evaluation of Inactivators of Antimicrobial Agents
NORMA vydaná dňa 1.10.2022
Označenie normy: ASTM E1054-22
Dátum vydania normy: 1.10.2022
Kód tovaru: NS-1088485
Počet strán: 10
Približná hmotnosť: 30 g (0.07 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Dezinfekční a antiseptické prostředky
Chemikálie pro účely průmyslové a domácí dezinfekce
Keywords:
antimicrobial agents, antimicrobial effectiveness evaluations, inactivation, neutralization, neutralizer toxicity,, ICS Number Code 11.080.20 (Disinfectants and antiseptics),71.100.35 (Chemicals for industrial and domestic desinfection purposes)
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 evaluationfor example, media, equipment, microorganism(s), and temperature of solutionsmust 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 organisms may be selected for
testing, as judged appropriate by the investigator. The
investigator is cautioned that failure to identify neutralizer
efficacy and toxicity for all microorganisms could result in biased
microbial reductions in an antimicrobial effectiveness evaluation.
Also, for a study testing multiple antimicrobial formulations, and
in which samples will contain multiple species of microorganisms
(for example, skin flora) that are exposed to the formulations, a
single procedure and/or combination of agents suitable for
neutralizing the antimicrobial activities of the multiple
formulations must be used for testing.
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1. 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. |
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2. Referenced Documents | ||||||
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