1、Designation:E275515Standard Test Method forDetermining the Bacteria-Eliminating Effectiveness ofHealthcare Personnel Hand Rub Formulations Using Handsof Adults1This standard is issued under the fixed designation E2755;the number immediately following the designation indicates the year oforiginal ado
2、ption 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 test method is designed to determine the activity ofhealthcare personnel
3、hand rubs,(also known as hand rubs,hygienic hand rubs,hand sanitizers,or hand antiseptics)against transient microbial skin flora on the hands after a singleapplication and after repeated applications.1.2 Performance of this procedure requires the knowledgeof regulations pertaining to the protection
4、of human subjects(see 21 CFR Parts 50 and 56).1.3 This test method should be performed by persons withtraining in microbiology,in facilities designed and equippedfor work with potentially infectious agents at biosafety level2.21.4 UnitsThe values stated in SI units are to be regardedas standard.No o
5、ther units of measurement are included in thisstandard.1.5 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
6、 regulatory limitations prior to use.For more specificprecautionary statements,see 8.2.2.Referenced Documents2.1 ASTM Standards:3E1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE1174 Test Method for Evaluation of the Effectiveness ofHealth Care Personnel Handwash Formulatio
7、nsE2276 TestMethodforDeterminingtheBacteria-Eliminating Effectiveness of Hygienic Handwash andHandrub Agents Using the Fingerpads of AdultsE2756 Terminology Relating to Antimicrobial and AntiviralAgents2.2 Other Standards:AATCC Test Method 147 2004 Antibacterial Activity As-sessment of Textile Mater
8、ials:Parallel Streak Method421 CFR Parts 50 and 56 Protection of Human Subjects;Institutional Review Boards53.Terminology3.1 Definitions:For definitions of terms used in thisdocument,see Terminology E2756.3.2 Definitions of Terms Specific to This Standard:3.2.1 healthcare personnel handrub,nan antim
9、icrobialgel,foam,liquid,spray,or wipe,applied by rubbing to reducethe transient microbial skin flora on hands that are not visiblysoiled,and which does not require a post-treatment water rinse.Such agents may also be referred to as hand rubs,hygienichand rubs,or hand antiseptics.3.2.2 healthcare per
10、sonnel handwash,na cleanser orwaterless agent intended to reduce transient microbial skinflora on the hands.3.2.3 test bacteria,nan applied inoculum of bacteria thathas characteristics which allow it to be readily identified.Testbacteria are used to simulate a topical transient microbialcontaminant.
11、This may also be referred to as a test organism,marker organism,simulant,or contaminant.3.2.4 test material,na product or formulation whichincorporates an antimicrobial ingredient(s).1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control
12、 Agents and is the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved May 15,2015.Published June 2015.originallyapproved in 2010.Last previous edition approved in 2010 as E275510.DOI:10.1520/E2755152CDC-NIH,Biosafety in Microbiological and Biomedical Laborat
13、ories,5th ed.,U.S.Department of Health and Human Services,U.S.Government Printing Office,Washington,DC,2007.3For 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
14、 Document Summary page onthe ASTM website.4Available from American Association of Textile Chemists and Colorists(AATCC),P.O.Box 12215,Research Triangle Park,NC 27709,http:/www.aatcc.org.5Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Wash
15、ington,DC 20401,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.Summary of Test Method4.1 This test method uses adult subjects who have provideda written informed consent and whose hands have beendetermined to b
16、e free from any apparent damage at the time ofparticipation in the study.Subjects are to refrain from use ofany antimicrobials for at least one week prior to the initiationof the test procedure(see Section 11).4.2 Subjects hands are artificially contaminated with 0.2mL of a high-titer suspension of the test bacteria which isdistributed over all surfaces of the hands and fingers to producea minimum baseline recovery level of 108cfu/hand.BecauseSerratia marcescens is relatively sensitive to drying
