ASTM E3092-18
(Practice)Standard Practice for Evaluating Efficacy of Vaporous Decontaminants on Materials Contaminated with Bacillus Spores and Contained Within 0.2µm Filter-Capped Tubes
Standard Practice for Evaluating Efficacy of Vaporous Decontaminants on Materials Contaminated with <emph type="bdit">Bacillus</emph> Spores and Contained Within 0.2µm Filter-Capped Tubes
SIGNIFICANCE AND USE
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).
5.2.1 Quantitative—The total number of spores per coupon is determined by dilution-plating, and all spores remaining on the coupon are assayed for activity in the extraction tube to provide confidence that 100 % of spores were assayed.
5.2.2 Statistical Confidence—The use of five independent preparations of spore inoculum for a statistical N of 5.
5.2.3 Sensitivity—Allows for complete detection of all viable spores inoculated on a coupon, including the spores that remain attached to the coupon.
5.2.4 Safety—Inoculated coupons are contained within 0.2 µm filter-capped 50-ml conical tubes. The 0.2 µm filter allows vaporous decontaminants to pass through while preventing escape of spores, thereby providing an important level of containment when working with pathogenic strains.
5.2.5 Simplicity of Testing—Tests and extractions are performed in the same 50-ml conical tube to minimize handling steps.
5.2.6 Scalable and Rapid—A maximum of 36 samples can be processed in 1 h by two technicians; a total of 300 samples have been processed by six technicians in 5 h (1-3).
5.2.7 Wide application for numerous Bacillus species and strains.
Note 1: This practice differs from similar quantitative methods (E2111, E2197 and E2414) in the size and variety of coupon materials available for testing, in the practical confidence of the statistics, the application of the decontaminant, scalability and sensitivity.
SCOPE
1.1 This practice is used to quantify the efficacy of vaporous decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials and contained within 0.2µm filter-capped tubes.
1.2 This practice should be performed only by those trained in microbiological techniques, are familiar with antimicrobial (sporicidal) agents and with the end use of such products.
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.
General Information
Relations
Buy Standard
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.
Designation: E3092 − 18
Standard Practice for
Evaluating Efficacy of Vaporous Decontaminants on
Materials Contaminated with Bacillus Spores and Contained
1
Within 0.2µm Filter-Capped Tubes
This standard is issued under the fixed designation E3092; 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. Scope ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
and Sporicidal Activities of Chemicals
1.1 Thispracticeisusedtoquantifytheefficacyofvaporous
E2414Test Method for Quantitative Sporicidal Three-Step
decontaminants on Bacillus spores dried on the surface of
Method (TSM) to Determine Sporicidal Efficacy of
coupons made from porous and non-porous materials and
Liquids, Liquid Sprays, and Vapor or Gases on Contami-
contained within 0.2µm filter-capped tubes.
3
nated Carrier Surface (Withdrawn 2014)
1.2 This practice should be performed only by those trained
E2756Terminology Relating toAntimicrobial andAntiviral
in microbiological techniques, are familiar with antimicrobial
Agents
(sporicidal) agents and with the end use of such products.
3. Terminology
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
3.1 For definitions of terms used in this guide, see Termi-
standard.
nology E2756.
1.4 This standard does not purport to address all of the
3.2 For inactivators and neutralizers of decontaminants see
safety concerns, if any, associated with its use. It is the
Test Methods E1054.
responsibility of the user of this standard to establish appro-
3.3 Definitions of Terms Specific to This Standard:
priate safety, health, and environmental practices and deter-
3.3.1 decontaminant, n—a physical or chemical agent or
mine the applicability of regulatory limitations prior to use.
process that destroys pathogenic or potentially pathogenic
1.5 This international standard was developed in accor-
microorganisms in/on surfaces or objects.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the 3.3.2 endospore, n—a dormant, robust and non-
Development of International Standards, Guides and Recom- metabolically active structure produced by certain bacteria
mendations issued by the World Trade Organization Technical from the Firmicutes phylum.
Barriers to Trade (TBT) Committee.
3.3.3 exosporium, n—the outermost layer of spores of Ba-
cillus anthracis and its close relatives Bacillus thuringiensis
2. Referenced Documents
and Bacillus cereus.
2
2.1 ASTM Standards:
3.3.4 macrobacillus, n—a Bacillus endospore that possess
E1054Test Methods for Evaluation of Inactivators of Anti-
an exosporium.
microbial Agents
3.3.5 microbacillus, n—a Bacillus endospore that does not
E2111Quantitative Carrier Test Method to Evaluate the
possess an exosporium.
Bactericidal,Fungicidal,Mycobactericidal,andSporicidal
3.3.6 vapor,n—asubstanceinthegasphaseatatemperature
Potencies of Liquid Chemicals
lower than its critical temperature, such that it can be con-
E2197Quantitative Disk Carrier Test Method for Determin-
densed back into a liquid by increasing the pressure on it
without reducing the temperature.
1
This practice is under the jurisdiction ofASTM Committee E35 on Pesticides,
3.3.7 vaporous decontaminant, n—for the purpose of this
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
practice, a vaporous decontaminant can be interpreted to
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved March 1, 2018. Published May 2018. DOI: 10.1520/ includegases,vapors,fogs,mistsandthermaldecontaminants.
E3092–18
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on The last approved version of this historical standard is referenced on
the ASTM website. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E3092 − 18
4. Summary of Practice 5.2.4 Safety—Inoculated coupons are contained within
0.2µm filter-capped 50-ml conical tubes. The 0.2µm filter
4.1 This practice quantitatively evaluates the efficacy of
allows vaporous decontaminants to pass through while pre-
vaporous decontaminants on coupons contaminated with Ba-
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.