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ASTM E2720-10

(Test Method)

Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses

Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses

SIGNIFICANCE AND USE
The efficacy of disinfection technologies can be evaluated on finished products, as well as on developmental items.
This test method defines procedures for validation of the aerosol generator, preparation of the test specimen, application of the challenge virus, enumeration of viable viruses, assessing data quality, and calculation of decontamination efficacy.
This test method provides defined procedures for creating droplet nuclei that approximate those produced by human respiratory secretions with particular emphasis on particle size distribution and aerosolization media.
Safety concerns associated with aerosolizing microbial agents are not addressed as part of this test method. Individual users should consult with their local safety authority, and a detailed biological aerosol safety plan and risk assessment should be conducted prior to using this method. Users are encouraged to consult the manual Biosafety in Microbiological and Biomedical Laboratories published by the U.S. Centers for Disease Control and Prevention (CDC).  
This test method differs from Test Methods E1052 and E2197 in the presentation of the virus to surface. The aforementioned test methods use liquid inoculum to contaminate carrier surfaces, whereas this test method presents the virus in the absence of water as droplet nuclei.
This test method differs from Test Method  because (1) smaller particles are being formed, (2) the droplets will be dried, thus forming droplet nuclei, prior to application to air-permeable materials, and (3) unique equipment is required to create the droplet nuclei.
SCOPE
1.1 This test method is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on air-permeable materials contaminated with virus-containing droplet nuclei.
1.2 This test method defines the conditions for simulating respiratory droplet nuclei produced by humans.
1.3 The method is specific to influenza viruses but could be adapted for work with other types of respiratory viruses or surrogates (Appendix X6).
1.4 This test method is suitable only for air-permeable materials.
1.5 This test method does not address the performance of decontaminants against microbes expelled via blood splatter, vomit, or fecal contamination.
1.6 This test method should be performed only by those trained in bioaerosols, microbiology, or virology, or combinations thereof.
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.8 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
30-Sep-2010
ICS
11.080.99 - Other standards related to sterilization and disinfection
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

Relations

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-Oct-2010
Referred By
ASTM E3179-18 - Standard Test Method for Determining Antimicrobial Efficacy of Ultraviolet Germicidal Irradiation against Influenza Virus on Fabric Carriers with Simulated Soil
Effective Date
01-Oct-2010

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ASTM E2720-10 - Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic VirusesASTM E2720-10 - Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses
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ASTM E2720-10 - Standard Test Method for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses
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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: E2720 − 10
StandardTest Method for
Evaluation of Effectiveness of Decontamination Procedures
for Air-Permeable Materials when Challenged with Biological
1
Aerosols Containing Human Pathogenic Viruses
This standard is issued under the fixed designation E2720; 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
Many communicable diseases are often spread through the aerosol route of exposure. The droplet
nuclei formed in these aerosols may infect susceptible individuals directly or contaminate environ-
mental surfaces and render them fomites for further spread of disease. The characteristics of the
droplet nuclei (particle size and composition) will influence the viability of microorganisms when
exposed to environmental stresses but may also shield them from physical and chemical decontami-
nants. The wide variations in the types and levels of such protective/shielding ingredients can have
impact on the effectiveness of surface decontaminants. This test method is designed to simulate the
deposition of droplet nuclei from human respiratory secretions onto and into air-permeable
membranes. It is primarily focused on influenza viruses but other respiratory viruses or surrogate
viruses could be used. Protocols for assessing the microbicidal activity of disinfectants are also
described.
1. Scope 1.7 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
1.1 This test method is designed to evaluate decontamina-
standard.
tion methods (physical, chemical, self-decontaminating mate-
rials)whenusedonair-permeablematerialscontaminatedwith 1.8 This standard does not purport to address all of the
virus-containing droplet nuclei.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
1.2 This test method defines the conditions for simulating
priate safety and health practices and determine the applica-
respiratory droplet nuclei produced by humans.
bility of regulatory limitations prior to use.
1.3 The method is specific to influenza viruses but could be
adapted for work with other types of respiratory viruses or
2. Referenced Documents
surrogates (Appendix X6).
2
2.1 ASTM Standards:
1.4 This test method is suitable only for air-permeable
E1052Test Method to Assess the Activity of Microbicides
materials.
against Viruses in Suspension
1.5 This test method does not address the performance of
E2197Quantitative Disk Carrier Test Method for Determin-
decontaminants against microbes expelled via blood splatter,
ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
vomit, or fecal contamination.
and Sporicidal Activities of Chemicals
E2721Test Method for Evaluation of Effectiveness of De-
1.6 This test method should be performed only by those
contamination Procedures for Surfaces When Challenged
trained in bioaerosols, microbiology, or virology, or combina-
with Droplets Containing Human Pathogenic Viruses
tions thereof.
1
This test method is under the jurisdiction of ASTM Committee E35 on
2
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct For referenced ASTM standards, visit the ASTM website, www.astm.org, or
responsibility of Subcommittee E35.15 on Antimicrobial Agents. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Oct. 1, 2010. Published February 2011. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
E2720–10. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2720 − 10
2.2 IEST Standards: 4.1.1 Using an aerosol device capable of meeting the data
IEST-RP-CC003.3 Garment System Considerations for quality objectives set for in this test method, influenza virus or
3
Clean Rooms and Other Controlled Environments surrogates are aerosolized to form droplet nuclei that are
subsequently applied to air-permeable materials.
2.3 Department of Defense Standards:
CA06PRO411Method for EvaluatingAir Purification Tech-
4.1.2 The virus-contaminated carriers are subjected to dis-
nologies for Collective Protections Using Viable Micro-
infection protocols and incubated for the specified time and
4
bial Aerosols
conditions. Control samples are incubated under identical
2.4 EPA Standards:
conditions but are not exposed to the disinfection protocols.
EPA600⁄4-84⁄013(N16) USEPA Manual of Methods for
5 NOTE 1—Carriers with incorporated
...

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5.1 The efficacy of disinfection technologies can be evaluated on finished products, as well as on developmental items.  
5.2 This practice defines procedures for validation of the droplet generator, preparation of the test specimen, application of the challenge virus, enumeration of viable viruses, assessing data quality, and calculation of decontamination efficiency.  
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5.1 This guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.  
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5.2 This practice defines procedures for validation of the droplet generator, preparation of the test specimen, application of the challenge virus, enumeration of viable viruses, assessing data quality, and calculation of decontamination efficiency.  
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