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ASTM E2720-16

(Practice)

Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses (Withdrawn 2023)

Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses (Withdrawn 2023)

SIGNIFICANCE AND USE
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 aerosol generator, preparation of the test specimen, application of the challenge virus, enumeration of viable viruses, assessing data quality, and calculation of decontamination efficacy.  
5.3 This practice 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.  
5.4 Safety concerns associated with aerosolizing microbial agents are not addressed as part of this practice. 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 practice. Users are encouraged to consult the manual Biosafety in Microbiological and Biomedical Laboratories7 published by the U.S. Centers for Disease Control and Prevention (CDC).  
5.5 This practice 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 practice presents the virus in the absence of water as droplet nuclei.  
5.6 This practice differs from Test Method E2721 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 practice 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 practice defines the conditions for simulating respiratory droplet nuclei produced by humans.  
1.3 The practice is specific to influenza viruses, but could be adapted for work with other types of respiratory viruses or surrogates.  
1.4 This practice is suitable only for air-permeable materials.  
1.5 This practice does not address the performance of decontaminants against microbes expelled via blood splatter, vomit, or fecal contamination.  
1.6 This practice 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.
WITHDRAWN RATIONALE
This practice is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on air-permeable materials contaminated with virus-containing droplet nuclei.
Formerly under the jurisdiction of Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents, this practice was withdrawn in January 2023. This standard is being withdrawn without replacement due to its limited use by industry.

General Information

Status
Withdrawn
Publication Date
31-Mar-2016
Withdrawal Date
23-Jan-2023
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

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ASTM E2720-16 - Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses (Withdrawn 2023)ASTM E2720-16 - Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses (Withdrawn 2023)
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ASTM E2720-16 - Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses (Withdrawn 2023)
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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 − 16
Standard Practice 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. A number 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 practice 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 1.6 This practice should be performed only by those trained
in bioaerosols, microbiology, or virology, or combinations
1.1 This practice is designed to evaluate decontamination
thereof.
methods (physical, chemical, self-decontaminating materials)
when used on air-permeable materials contaminated with 1.7 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
virus-containing droplet nuclei.
standard.
1.2 This practice defines the conditions for simulating
1.8 This standard does not purport to address all of the
respiratory droplet nuclei produced by humans.
safety concerns, if any, associated with its use. It is the
1.3 Thepracticeisspecifictoinfluenzaviruses,butcouldbe
responsibility of the user of this standard to establish appro-
adapted for work with other types of respiratory viruses or
priate safety and health practices and determine the applica-
surrogates.
bility of regulatory limitations prior to use.
1.4 This practice is suitable only for air-permeable materi-
2. Referenced Documents
als.
2
2.1 ASTM Standards:
1.5 This practice does not address the performance of
E1052 Test Method to Assess the Activity of Microbicides
decontaminants against microbes expelled via blood splatter,
against Viruses in Suspension
vomit, or fecal contamination.
E2197 Quantitative Disk Carrier Test Method for Determin-
ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
and Sporicidal Activities of Chemicals
1
This practice is under the jurisdiction ofASTM Committee E35 on Pesticides,
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
2
Subcommittee E35.15 on Antimicrobial Agents. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved April 1, 2016. Published May 2016. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2010. Last previous edition approved in 2010 as E2720–10. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E2720–16. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2720 − 16
E2721 Practice for Evaluation of Effectiveness of Decon- 4. Summary of Practice
tamination Procedures for Surfaces When Challenged
4.1 The practice describes the steps required to deposit
with Droplets Containing Human Pathogenic Viruses
droplet nuclei onto air-permeable membranes and quantita-
2.2 IEST Standards: tively assess decontamination efficiency.
IEST-RP-CC003.3 Garment System Considerations for 4.1.1 Using an aerosol device capable of meeting the data
3
Clean Rooms and Other Controlled Environments quality objectives set for in this practice, influenza virus or
surrogates are aerosolized to form droplet nuclei that are
2.3 Department of Defense Standards:
subsequently applied to air-permeable materials.
CA06PRO411 Method for EvaluatingAir Purification Tech-
4.1.2 The virus-contaminated carriers are subjected to dis-
nologies for Collective Protections Using Viable Micro-
4
infection protocols and incubated for the specified time and
bial Aerosols
conditi
...

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ASTM E2721-16(Practice)
Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses

SIGNIFICANCE AND USE
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.  
5.3 This practice provides defined procedures for creating droplets that approximate those produced by human respiratory secretions, with particular emphasis on droplet size distribution and aerosolization media.  
5.4 Safety concerns associated with aerosolizing microbial agents are not addressed as part of this practice. 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 practice. Users are encouraged to consult the manual Biosafety in Microbiological and Biomedical Laboratories5 published by the U.S. Centers for Disease Control and Prevention (CDC).  
5.5 This practice differs from Test Methods E1052 and E2197 in the presentation of virus to the surface. The aforementioned test methods use a liquid inoculum to contaminate carrier surfaces, whereas this practice presents the virus in droplets that are representative of human respiratory secretions  
5.6 This practice differs from Practice E2720, because (1) larger droplets are being formed, (2) the droplets will not be completely dried prior to application to surfaces, (3) the droplets can be applied to any surfaces, not just those that are air permeable, and (4) unique equipment is required to create droplets.
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1.1 This practice is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on surfaces contaminated with virus-containing droplets.  
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1.3 The practice is specific to influenza viruses but could be adapted for work with other types of respiratory viruses or surrogates.  
1.4 This practice is suitable for working with a wide variety of environmental surfaces.  
1.5 This practice does not address the performance of decontaminants against microbes expelled via blood splatter, vomit, or fecal contamination.  
1.6 This practice 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.  
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5.1 This test method may be employed to check the sterility of commercially procured sterile membrane filters. The test also confirms that sterilized filters have not been contaminated. Additionally, this test may be used to monitor the efficacy of in-house sterilization procedures. Filter packages that have obvious packaging defects should not be tested because sterility may have been compromised.
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1.1 This test method describes a test to confirm the sterility of either manufacturer presterilized or user-sterilized analytical membrane filters.  
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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.  
5.2 This guide helps medical device manufacturers to identify the best method(s) for extracting simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.  
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1.2 This is a part of a series of ASTM guides for validating cleaning instructions. The scope of the first guide in the series is regarding selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods that are used to inoculate medical devices with simulated-use test soil(s). This third in the series describes methods for extracting test soils in order to measure residual soil remaining on medical devices after the performance of cleaning procedures.  
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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ASTM E2721-16(Practice)
Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses

SIGNIFICANCE AND USE
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.  
5.3 This practice provides defined procedures for creating droplets that approximate those produced by human respiratory secretions, with particular emphasis on droplet size distribution and aerosolization media.  
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4.1 The primary use of these test methods is testing to determine the specified mechanical properties of steel, stainless steel, and related alloy products for the evaluation of conformance of such products to a material specification under the jurisdiction of ASTM Committee A01 and its subcommittees as designated by a purchaser in a purchase order or contract.  
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Portable  
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Keywords  
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Annex A2  
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Annex A5  
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Annex A6    
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Annex A7  
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Annex A8  
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Annex A9  
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Annex A10  
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1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined  
1.6 This standard shall not be used to describe or appraise the fire hazard or fire risk of materials, products, or assemblies under actual fire conditions. However, results of this test may be used as elements of a fire assessment that takes into account all of the factors, which are pertinent to an assessment of the fire hazard of a particular end use.  
1.7 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 s...

  • Standard
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  • Standard
    14 pages
    English language
    sale 15% off