1、Designation:E305816Standard Test Method forDetermining the Residual Kill Activity of Hand AntisepticFormulations1This standard is issued under the fixed designation E3058;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of la
2、st 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 residualkilling activity of skin antiseptics against transient microbialskin fl
3、ora on the hands.2It may be used to evaluate productsthat are used with the aid of water and rinsed off and those thatare used without the aid of water and not rinsed off.1.2 Performance of this procedure requires the knowledgeof regulations pertaining to the protection of human subjects(see 21 CFR
4、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 level 2.1.4 UnitsThe values stated in SI units are to be regardedas standard.No other units of measurement are
5、 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 regulatory limitations prior
6、 to use.For more specificprecautionary statements see 8.1.2.Referenced Documents2.1 ASTM Standards:3E1054 Test Methods for Evaluation of Inactivators of Anti-microbial AgentsE2752 Guide for Evaluation of Residual Effectiveness ofAntibacterial Personal Cleansing ProductsE1882 Test Method for Evaluati
7、on of Antimicrobial Formu-lations by the Agar Patch TechniqueE2197 Quantitative Disk Carrier Test Method for Determin-ing Bactericidal,Virucidal,Fungicidal,Mycobactericidal,and Sporicidal Activities of ChemicalsE2756 Terminology Relating to Antimicrobial and AntiviralAgents2.2Federal Standards:421 C
8、FR Part 50 Protection of Human Subjects21 CFR Part 56 Institutional Review Boards3.Terminology3.1 DefinitionsFor definitions of terms used in thisdocument,see Terminology E2756.3.2 Definitions of Terms Specific to This Standard:3.2.1 healthcare personnel hand rub,nan antimicrobialgel,foam,liquid,spr
9、ay,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,hand sanitizers,or hand antiseptics.3.2.2 healthcare personnel hand
10、 wash,na cleanser requir-ing rinsing or a non-rinse agent intended to reduce transientmicrobial skin flora on the hands.3.2.3 room temperature,ntemperature in the range of 20to 25C(68 to 77F).3.2.4 test bacteria,nan applied suspension of bacteriahaving characteristics that permit ready identificatio
11、n of colo-nies.Test bacteria are used to simulate a transient topicalmicrobial contaminant.These may also be referred to as testorganisms,marker organisms,simulants,or contaminants.3.2.5 test material,na product or formulation that incor-porates an antimicrobial ingredient(s).4.Summary of Test Metho
12、d4.1 This test method uses adult subjects who have provideda written informed consent and whose hands have beendetermined to be free from any clinical evidence of skindisorders,dermatosis,cuts,lesions,or hangnails at the time of1This test method is under the jurisdiction of ASTM Committee E35 onPest
13、icides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved Nov.15,2016.Published December 2016.DOI:10.1520/E3058162Rutter J.D.,Angiulo K.,Macinga D.R.,Measuring residual activity of topicalantimicrobial
14、s:is the residual activity of chlorhexidine an artefact of laboratorymethods?J.Hosp.Infect.88:113-115,20143For 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 D
15、ocument Summary page onthe ASTM website.4Available from U.S.Government Printing Office,Superintendent ofDocuments,732 N.Capitol St.,NW,Washington,DC 20401-0001,http:/www.access.gpo.gov.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 parti
16、cipation in the study.Subjects are to refrain from use ofany antimicrobials for at least 7 days prior to the initiation ofthe test procedure(see 12.3).4.2 Subjects hands are pre-treated with the test material toload the antimicrobial onto the skin.Test material remains onthe hands for a pre-determined time(the time selected todemonstrate the test products residual kill activity)prior tocontamination.4.3 Subjects press each fingerpad onto a stainless steel disccontaminated with approximately 7 lo
