Active Standard ASTM E2721 | Developed by Subcommittee: E35.15
Book of Standards Volume: 11.05
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 droplet generator, preparation of the test specimen, application of the challenge virus, enumeration of viable viruses, assessing data quality, and calculation of decontamination efficiency.
This test method provides defined procedures for creating droplets that approximate those produced by human respiratory secretions, with particular emphasis on droplet 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 virus to the surface. The aforementioned test methods use liquid inoculum to contaminate carrier surfaces, whereas this method presents the virus in droplets that are representative of human respiratory secretions
This method differs from Test Method , 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.
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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E1052 Test Method to Assess the Activity of Microbicides against Viruses in Suspension
E2197 Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
E2720 Test Method for Evaluation of Effectiveness of Decontamination Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses
WHO StandardsWHO Manual on Animal Influenza Diagnosis and SurveillanceWebster, R., Cox, N., Stohr, K. WHO Manual on Animal Influenza Diagnosis and Surveillance. World Health Organization, Department of Communicable Disease Surveillance and Response. WHO/CDS/CDR/2002.5 Rev. 1.
EPA StandardsEPA 600/4-84/013 (N1 USEPA Manual of Methods for Virology Available from United States Environmental Protection Agency (EPA), Ariel Rios Bldg., 1200 Pennsylvania Ave., NW, Washington, DC 20460, http://www.epa.gov.
ICS Number Code 11.080.99 (Other standards related to sterilization and disinfection)
UNSPSC Code 60104000(Biotechnology and bio chemistry and genetics and microbiology and related materials)