ASTM_E_2721_-_10.pdf

Designation:E272110Standard Test Method forEvaluation of Effectiveness of Decontamination Proceduresfor Surfaces When Challenged with Droplets ContainingHuman Pathogenic Viruses1This standard is issued under the fixed designation E2721;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.INTRODUCTIONMany communicable diseases can often spread through droplets containing infectious agents.Such“contagious droplets”may expose susceptible individuals directly or contaminate environmentalsurfaces in the immediate vicinity and render them as fomites for further spread of the disease.Thecharacteristics of the droplets(particle size and composition)will influence the viability of themicroorganisms when exposed to environmental stresses but also shield them from physical andchemical decontaminants.The wide variations in the types and levels of such protective/shieldingingredients can impact on the effectiveness of surface decontaminants.This test method is designedto simulate surface deposition of contagious droplets from human respiratory secretions.It is primarilyfocused on influenza viruses but other respiratory viruses or surrogates could be used.Protocols forassessing the microbicidal activity of disinfectants are also described.1.Scope1.1 This test method is designed to evaluate decontamina-tion methods(physical,chemical,self-decontaminating mate-rials)when used on surfaces contaminated with virus-containing droplets.1.2 This test method defines the conditions for simulatingrespiratory droplets produced by humans and depositing thedroplets onto surfaces.1.3 The method is specific to influenza viruses but could beadapted for work with other types of respiratory viruses orsurrogates(Appendix X5).1.4 This test method is suitable for working with a widevariety of environmental surfaces.1.5 This test method does not address the performance ofdecontaminants against microbes expelled via blood splatter,vomit,or fecal contamination.1.6 This test method should be performed only by thosetrained in bioaerosols,microbiology,or virology,or combina-tions thereof.1.7 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.8 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E1052 Test Method to Assess the Activity of Microbicidesagainst Viruses in SuspensionE2197 Quantitative Disk Carrier Test Method for Determin-ing Bactericidal,Virucidal,Fungicidal,Mycobactericidal,and Sporicidal Activities of ChemicalsE2720 Test Method for Evaluation of Effectiveness of De-contamination Procedures for Air-Permeable Materialswhen Challenged with Biological Aerosols ContainingHuman Pathogenic Viruses1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved Oct.1,2010.Published February 2011.DOI:10.1520/E272110.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 2.2 EPA Standards:EPA 6004-84013(N16)USEPA Manual of Methods forVirology32.3 WHO Standards:WHO Manual on Animal Influenza Diagnosis and Surveil-lance43.Terminology3.1 Definitions:3.1.1 aerosol,na suspension of solid or liquid particles ina gas medium.3.1.2 biological aerosol,naerosol comprising particles ofbiological origin or activity which may affect living thingsthrough infectivity,allergencity,toxicity,or pharmacologicaland other processes.3.1.3 contact transmission,ninfections caused by directskin-to-skin contact or indirect contact with objects contami-nated with pathogens.3.1.4 contagious respiratory droplet,nrespiratory secre-tions containing infectious microorganisms that form largedroplets(5 m)and settle out of the air over short distances.3.1.5 droplet transmission,ndirect transfer of pathogen-containing droplets to conjuncitval or mucous membranes.3.1.6 influenza,nan infectious disease of birds and mam-mals caused by RNA viruses of the family Orthomyxoviridae.3.1.7 protective factor,nsoluble or insoluble materialco-deposited with microorganisms that directly protects themicroorganism from environmental stresses or decontami-nants.3.1.8 self-sanitizing mat