【国外标准】 Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses

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 secretions5.6 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.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.