ASTM E2721-16
(Practice)Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses (Withdrawn 2024)
Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses (Withdrawn 2024)
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.
SCOPE
1.1 This practice is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on surfaces contaminated with virus-containing droplets.
1.2 This practice defines the conditions for simulating respiratory droplets produced by humans and depositing the droplets onto surfaces.
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.
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 surfaces contaminated with virus-containing droplets.
Formerly under the jurisdiction of Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents, this practice was withdrawn in April 2024. This standard is being withdrawn without replacement due to its limited use by industry.
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: E2721 − 16
Standard Practice for
Evaluation of Effectiveness of Decontamination Procedures
for Surfaces When Challenged with Droplets Containing
1
Human Pathogenic Viruses
This standard is issued under the fixed designation E2721; 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 can often spread through droplets containing infectious agents. Such
“contagious droplets” may expose susceptible individuals directly or contaminate environmental
surfaces in the immediate vicinity and render them as fomites for further spread of the disease. The
characteristics of the droplets (particle size and composition) will influence the viability of the
microorganisms when exposed to environmental stresses but also shield them from physical and
chemical decontaminants. The wide variations in the types and levels of such protective/shielding
ingredients can impact on the effectiveness of surface decontaminants. This practice is designed to
simulate surface deposition of contagious droplets from human respiratory secretions. It is primarily
focused on influenza viruses but other respiratory viruses or surrogates 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)
1.7 The values stated in SI units are to be regarded as
when used on surfaces contaminated with virus-containing
standard. No other units of measurement are included in this
droplets.
standard.
1.2 This practice defines the conditions for simulating
1.8 This standard does not purport to address all of the
respiratory droplets produced by humans and depositing the
safety concerns, if any, associated with its use. It is the
droplets onto surfaces.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
1.3 The practice is specific to influenza viruses but could be
mine the applicability of regulatory limitations prior to use.
adapted for work with other types of respiratory viruses or
surrogates.
2. Referenced Documents
2
1.4 This practice is suitable for working with a wide variety
2.1 ASTM Standards:
of environmental surfaces.
E1052 Practice to Assess the Activity of Microbicides
against Viruses in Suspension
1.5 This practice does not address the performance of
E2197 Quantitative 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
E2720 Practice for Evaluation of Effectiveness of Decon-
tamination Procedures for Air-Permeable Materials when
1
This practice is under the jurisdiction of ASTM 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 E2721–10. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E2721–16. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2721 − 16
Challenged with Biological Aerosols Containing Human 4.1.3 Virus particles are eluted from the test and control
Pathogenic Viruses carriers and viability is assessed by 50 % tissue culture
infectious dose assay (log TCID ).
2.2 EPA Standards: 10 50
EPA 600 ⁄4-84 ⁄013 (N16) USEPA Manual of Methods for
NOTE 2—Non-viable techniques for viral enumeration such as poly-
3
Virology merase chain reaction (PCR) or hemagglutination cannot be used.
2.3 WHO Standards:
4.1.4 The virucidal activity of the decontamination proce-
WHO Manual on Animal Influenza Diagnosis and Surveil-
dure is determined from the log difference in viability between
4
lance
treated and test carriers.
3. Terminology 5. Significan
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E2721 − 10 E2721 − 16
Standard Test Method Practice for
Evaluation of Effectiveness of Decontamination Procedures
for Surfaces When Challenged with Droplets Containing
1
Human Pathogenic Viruses
This standard is issued under the fixed designation E2721; 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 can often spread through droplets containing infectious agents. Such
“contagious droplets” may expose susceptible individuals directly or contaminate environmental
surfaces in the immediate vicinity and render them as fomites for further spread of the disease. The
characteristics of the droplets (particle size and composition) will influence the viability of the
microorganisms when exposed to environmental stresses but also shield them from physical and
chemical decontaminants. The wide variations in the types and levels of such protective/shielding
ingredients can impact on the effectiveness of surface decontaminants. This test method practice is
designed to simulate surface deposition of contagious droplets from human respiratory secretions. It
is primarily focused on influenza viruses but other respiratory viruses or surrogates could be used.
Protocols for assessing the microbicidal activity of disinfectants are also described.
1. Scope
1.1 This test method is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials)
when used on surfaces contaminated with virus-containing droplets.
1.2 This test method defines the conditions for simulating respiratory droplets produced by humans and depositing the droplets
onto surfaces.
1.3 The method is specific to influenza viruses but could be adapted for work with other types of respiratory viruses or
surrogates (Appendix X5).
1.4 This test method is suitable for working with a wide variety of environmental surfaces.
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.
2. Referenced Documents
2
2.1 ASTM Standards:
E1052 Test Method to Assess the Activity of Microbicides against Viruses in Suspension
1
This test method practice is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility
of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Oct. 1, 2010April 1, 2016. Published February 2011May 2016. Originally approved in 2010. Last previous edition approved in 2010 as E2721–10.
DOI: 10.1520/E2721–10.10.1520/E2721–16.
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2721 − 16
E2197 Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and
Sporicidal Activities of Chemicals
E2720 Practice for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged
with Biological Aerosols Containing Human Pathogenic Viruses
2.2 EPA Standards:
3
EPA 600 ⁄4-84 ⁄013 (N16) USEPA Manual of Methods for Virology
2.3 WHO Standards:
4
WHO Manual on Animal Influenza Diagnosis and Surveillance
3. Terminology
3.1 Definitions:
3.1.1 aerosol, n—a suspension of solid or liquid particles in a gas medium.
3.1.2 biological aerosol, n—aerosol comprising particles of biological origin or activity which may affect living things through
infectivity,
...
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: E2721 − 16
Standard Practice for
Evaluation of Effectiveness of Decontamination Procedures
for Surfaces When Challenged with Droplets Containing
1
Human Pathogenic Viruses
This standard is issued under the fixed designation E2721; 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 can often spread through droplets containing infectious agents. Such
“contagious droplets” may expose susceptible individuals directly or contaminate environmental
surfaces in the immediate vicinity and render them as fomites for further spread of the disease. The
characteristics of the droplets (particle size and composition) will influence the viability of the
microorganisms when exposed to environmental stresses but also shield them from physical and
chemical decontaminants. The wide variations in the types and levels of such protective/shielding
ingredients can impact on the effectiveness of surface decontaminants. This practice is designed to
simulate surface deposition of contagious droplets from human respiratory secretions. It is primarily
focused on influenza viruses but other respiratory viruses or surrogates 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)
1.7 The values stated in SI units are to be regarded as
when used on surfaces contaminated with virus-containing
standard. No other units of measurement are included in this
droplets.
standard.
1.2 This practice defines the conditions for simulating
1.8 This standard does not purport to address all of the
respiratory droplets produced by humans and depositing the
safety concerns, if any, associated with its use. It is the
droplets onto surfaces.
responsibility of the user of this standard to establish appro-
1.3 The practice is specific to influenza viruses but could be
priate safety, health, and environmental practices and deter-
adapted for work with other types of respiratory viruses or
mine the applicability of regulatory limitations prior to use.
surrogates.
2. Referenced Documents
1.4 This practice is suitable for working with a wide variety
2
2.1 ASTM Standards:
of environmental surfaces.
E1052 Practice to Assess the Activity of Microbicides
1.5 This practice does not address the performance of against Viruses in Suspension
E2197 Quantitative Disk Carrier Test Method for Determin-
decontaminants against microbes expelled via blood splatter,
vomit, or fecal contamination. ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
and Sporicidal Activities of Chemicals
E2720 Practice for Evaluation of Effectiveness of Decon-
tamination Procedures for Air-Permeable Materials when
1
This practice is under the jurisdiction of ASTM 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 E2721–10. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E2721–16. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2721 − 16
Challenged with Biological Aerosols Containing Human 4.1.3 Virus particles are eluted from the test and control
Pathogenic Viruses carriers and viability is assessed by 50 % tissue culture
infectious dose assay (log TCID ).
2.2 EPA Standards: 10 50
EPA 600 ⁄4-84 ⁄013 (N16) USEPA Manual of Methods for
NOTE 2—Non-viable techniques for viral enumeration such as poly-
3
Virology
merase chain reaction (PCR) or hemagglutination cannot be used.
2.3 WHO Standards:
4.1.4 The virucidal activity of the decontamination proce-
WHO Manual on Animal Influenza Diagnosis and Surveil-
dure is determined from the log difference in viability between
4
lance
treated and test carriers.
3. Terminology 5. Significance and Use
3.1 Definitions: 5.1 The efficacy of disinfection technologies can be evalu-
3.1.1 aerosol, n—a suspension of solid or liquid particles in
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.