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Procedures for Air-Permeable Materials when Challenged with Biological Aerosols Containing Human Pathogenic Viruses (Withdrawn 2023)

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.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.