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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.
1.1 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.
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
IEST StandardsIEST-RP-CC003.3 Garment System Considerations for Clean Rooms and Other Controlled Environments Available from Institute of Environmental Sciences and Technology (IEST), Arlington Place One, 2340 S. Arlington Heights Rd., Suite 100, Arlington Heights, IL 60005-4516, http://www.iest.org.
EPA StandardsEPA600/4-84/013(N16) 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.
WHO StandardsWHOManual 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.
Department of Defense StandardsCA06PRO411 Method for Evaluating Air Purification Technologies for Collective Protections Using Viable Microbial AerosolsFoarde, K., Heimbuch, B. K., Maxwell, A., VanOsdell, D., Method for Evaluating Air Purification Technologies for Collective Protection Using Viable Microbial Aerosols, Test Operating Procedure (TOP) Under the Army Test and Evaluation Command (ATEC), Edgewood Chemical and Biological Center, Edgewood, Md., 2010 in press.
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)