ASTM_E_2870_-_19.pdf

Designation:E287019Standard Practice forEvaluating Relative Effectiveness of AntimicrobialHandwashing Formulations using the Palmar Surface andMechanical Hand Sampling1This standard is issued under the fixed designation E2870;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.1.Scope1.1 This practice covers and is designed to determine therelative effectiveness of antimicrobial handwashing agents inreducing transient microorganisms using a controlled hand-wash.1.2 Knowledge of microbiological techniques is requiredfor these procedures.1.3 This practice is used to evaluate topical antimicrobialhandwashing formulations.1.4 Performance of this procedure requires the knowledgeof regulations pertaining to the protection of human subjects(21 CFR Parts 50 and 56).1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.For more specific precautionary statements,see 8.1.1.7 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2E1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE1174 Test Method for Evaluation of the Effectiveness ofHealth Care Personnel Handwash FormulationsE2755 TestMethodforDeterminingtheBacteria-Eliminating Effectiveness of Healthcare Personnel HandRub Formulations Using Hands of AdultsE2756 Terminology Relating to Antimicrobial and AntiviralAgentsE2784 Test Method for Evaluation of the Effectiveness ofHandwash Formulations Using the Paper Towel(Palmar)Method of Hand Contamination2.2 Other Standards:AATCC Test Method 147 Antibacterial Assessment of Tex-tile Materials:Parallel Streak Method321 CFR Part 50 Protection of Human Subjects421 CFR Part 56 Institutional Review Boards43.Terminology3.1 DefinitionsFor definitions of terms used in thisdocument,see Terminology E2756.3.2 Definitions of Terms Specific to This Standard:3.2.1 active ingredient,na substance added to a formula-tion specifically for the inhibition or inactivation of microor-ganisms.3.2.2 reference formulation,nformulation against whichthe activity of the test formulation is compared,for example,ahandwash without an active ingredient or a handwash with adifferent active ingredient than the test formulation.Thisformulation is not considered a standard.3.2.3 test material,na product or formulation whichincorporates antimicrobial ingredients(s).3.2.4 test organism,nan applied inoculum of an organismthat has characteristics which allow it to be readily identified.1This practice is under the jurisdiction of ASTM Committee E35 on Pesticides,Antimicrobials,and Alternative Control Agents and is the direct responsibility ofSubcommittee E35.15 on Antimicrobial Agents.Current edition approved April 1,2019.Published May 2019.Originallyapproved 2013.Last previous edition approved 2013 as E287013.DOI:10.1520/E2870-19.2For 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.3Available from American Association of Textile Chemists and Colorists(AATCC),P.O.Box 12215,Research Triangle Park,NC 27709,http:/www.aatcc.org.4Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 The test organism is used to simulate a transient topicalmicrobial contaminant.It may also be referred to as a markerorganism,bacterial simulant,or bacterial contaminant.4.Summary of Practice4.1 This practice uses adult subjects who have provided awritten informed consent and whose hands have been deter-mined to be free from any apparent damage at the time ofparticipation in the stud