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.

1. 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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

EPA Standards

ASTM Standards

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

E2721 Test Method for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses

Department of Defense Standards

IEST Standards

WHO Standards

Keywords

air-permeable materials; bioaerosol; decontamination; droplet nuclei; influenza; TCID ₅₀ ; virucidal efficacy; virus;

ICS Code

ICS Number Code 11.080.99 (Other standards related to sterilization and disinfection)

DOI: 10.1520/E2720-10

ASTM International is a member of CrossRef.

ASTM E2720